AARP, startups partner to study digital healthcare technology by Mackenzie Holland

Research from AARP has found 90% of adults aged 50 and older use technology to stay connected. Based on that research, AARP has partnered with two Boston-based digital health startups that have combined technology and healthcare with a friendly face to provide a health-focused robotic companion in the homes of individuals selected to participate in a pilot study of the product.

AI in healthcare goes beyond IBM Watson. In this e-guide, discover 4 uses for AI in healthcare – particularly how it can help improve patient engagement – and whether we can overcome security and interoperability concerns surrounding the technology.

Pillo, a HIPAA-compliant digital healthcare companion robot, will be placed in the homes of six to 10 pilot study participants later this month for about four weeks to determine how the robot can improve disease management for individuals who have been newly diagnosed with diabetes.

Pillo, which was created by Pillo Health and given a voice through Orbita's voice experience management platform, is a voice- and video-enabled intelligent assistant that's able to dispense medication, connect to caregivers, issue voice reminders and perform daily tasks, like reporting the weather and playing radio stations. Emanuele Musini, CEO and co-owner of Pillo Health, said the robot features a 7-inch touchscreen and facial recognition technology. Once Pillo recognizes the patient, it is able to dispense medication that has been preloaded into the robot.

In-home digital healthcare technology is "the future of healthcare," said Brian Jack, chief of family medicine at Boston Medical Center. Jack said, over the next several years, he expects there will be gradual to rapid movement of care from the office and hospital settings to the home. And he said he believes in-home digital healthcare technology is an opportunity to "provide better care at a lower cost."

Investing in digital health startups

AARP chose to partner with Orbita and Pillo Health in May as a result of the PULSE@MassChallenge event -- a digital health innovation hub established by the city of Boston, MassChallenge and other entities to support digital health startups. AARP launched its $40 million Innovation Fund in 2015 that allows the organization to invest in companies working in three major health-related areas: aging at home, convenience and access to healthcare, and preventive health.

We want to help bring solutions to market that make life better for people 50-plus and increase their health security, financial well-being and personal fulfillment.

Andy Millersenior vice president of innovation and product development, AARP

AARP's purpose is to "empower" people to choose how they live as they age, said Andy Miller, senior vice president of innovation and product development at AARP, based in Washington, D.C.

"Innovation is a major way to make this happen," Miller said. "We want to help bring solutions to market that make life better for people 50-plus and increase their health security, financial well-being and personal fulfillment."

Technology makes it easier for providers to monitor and diagnose patients at critical moments and to provide ongoing care without having the patient always in the room with them, Miller said.

Bringing robotics into the home

Orbita CEO Bill Rogers said Pillo will empower older adults by reminding them to take their medication on time and providing education about diabetes. Pillo can also communicate information to caregivers, alerting them if a person's medication has not been taken or if some other issue occurs. 

Rogers said the challenge with mobile applications and web portals is the user needs to learn that experience to be able to collaborate with their doctors and physicians. Voice technology "changes the whole game of engagement," he explained.  

"It allows people to be able to engage and interact with their voice, which is the natural way people engage," Rogers said.

Pillo's Musini said the idea to create Pillo stemmed from his own personal experience with his father, who had serious health issues and would forget to take his medication and follow the doctor's orders.

"We started it with a mission to empower older adults living at home with chronic conditions," Musini said. "The approach I had was, 'What if there was someone with my father at that time?' There was something that could be with him 24 hours a day, 7 days a week and was alert."

Providing aftercare in-home help

Jack, who leads Project Re-Engineered Discharge (RED), a Boston University Medical Center research group responsible for developing and testing strategies to improve the hospital discharge process, helped design an animated health information technology system named Louise that provides aftercare information to people recently discharged from the hospital.

Project RED studied the system and found twice as many people who used Louise preferred to receive their discharge information from the system, rather than a doctor or nurse for several reasons, including Louise's availability and accessibility. After returning home, Jack said patients and their caregivers are able to sign onto the Louise technology and learn about medication, proper care and follow-up appointments, as well as easily connect with their clinicians.

"When patients leave the hospital, in our studies, when we ask them what they are most worried about, they say that, 'I'm all by myself,'" Jack said. "When there are at-home technologies, where the patient can access the technology, the technology can access the clinicians, and the patients are super happy. Plus, they can get their problem fixed in a timely way, rather than waiting for an appointment."

Identifying best practices for digital healthcare technology

Jack said thorough study of in-home digital healthcare technology is critical before sending it out into the public -- a sentiment echoed by John Torous, co-director of the digital psychiatry division at Beth Israel Deaconess Medical Center in Boston.

Makenzie Holland asks:

Do physicians at your organization use in-home technology to connect with patients? Why or why not?

Join the Discussion

Torous said it's up to researchers and groups like AARP to find best practices for in-home digital healthcare technology to avoid potentially harmful consequences.

"I think together we can learn how to use this technology in a productive, ethical and meaningful way, and it will have a bigger role in healthcare," Torous said.

Miller said the goal of AARP's collaborations with companies like Pillo Health and Orbita is to "gain useful and impactful information that can be used to continue to improve the customer experience and help make these products as beneficial as possible."

Along with Orbita and Pillo, AARP has partnered with digital health startups like Folia Health and One Medical Group.

"When considering which startups to work with, we are looking for mission-aligned companies who have transformational solutions and those we can work with to co-create ageless design solutions that could have meaningful impact in the lives of the 50-plus consumer," Miller said.

Source: https://searchhealthit.techtarget.com/news/252443338/AARP-startups-partner-to-study-digital-healthcare-technology

A health tech accelerator takes root in Amish country to support clinical validation by Stephanie Baum

This month the Smart Health Innovation Lab, a late-stage accelerator in Lancaster, Pennsylvania backed by a $300 million fund managed by Aspire Ventures, officially opened. The program’s goal is to help healthcare startups with market-ready connected devices and digital health technologies validate their products through pilot programs with Lancaster General Health, which is part of Penn Medicine, insurer Capital Blue Cross and Clio Health, which are partners of the Innovation Lab. Each of these organizations is also a partner in the fund.

The development reflects the steadily evolving accelerator model as well as the interest by payers and health systems in collaborating with venture firms to help them shift to value-based care.

The Lab’s first cohort includes two companies — Philadelphia-based behavioral health startup NeuroFlow and Emovi, a Canadian medical device company that developed a knee pain assessment device geared for primary care settings. NeuroFlow previously took part in the Bunker Labs program in Philadelphia and Emovi was part of the Canadian Technology Accelerator for Health IT, also in Philadelphia. The goal is to have four to five companies in each cohort and host two groups of startups per year.

One of the first thing one notices about the space, aside from the outdoor conference room, which feels like it was transported from an incubator on the West Coast, are the theme rooms. One is designed to look like a patient’s room in a hospital, another a studio apartment, an exam room and a maker space. It’s not something one frequently sees in an incubator setting. The idea is to better visualize the health technology where it will be put to work.

In an onsite interview, Kim Ireland, the CEO of the Smart Health Innovation Lab,  said the goal of the program is to serve as a test lab for entrepreneurs so they can get the validation they need for wider adoption or, conversely, go back to the drawing board, with more insight on what they have to do to improve.

“This is a very critical point for these companies,” Ireland said. “Once you have that product, you have done the clinical trials, you have FDA approval, how do you get that first customer to bite? How do you get someone to believe in your product and clinically champion that product? How do you get a payer behind you with [reimbursement] codes that will pay for it? That was Essam Abadir’s vision behind this lab.”

Abadir, the CEO and founder of Aspire Ventures, offered one example of the commitment of its partners to the innovation lab. LG Health provided hard commitments in the innovation lab’s charter to give access to doctors’ time. In the case of the two startups in the lab’s inaugural class, that includes access to specialists from the Neuroscience Institute, sports medicine practitioners, and other physicians and specialists that are relevant to the startups’ technologies.

NeuroFlow was co-founded by CEO Chris Molaro with an eye to veterans struggling to cope with stress and depression. Molaro, who is also a veteran and a Wharton grad, developed a program that serves patient engagement and remote monitoring functions by recording when patients do their journal entries, relaxation exercisesand monitoring heart rate between appointments. Therapists can track their patients remotely and check in with them when they see they’re not completing assignments or notice other departures from their baseline.

Molaro said the advantage of the certification program is that it gives the startup access to a large healthcare system and a payer.

“We are in 75 hospitals and clinics around the country and doing pilots with Lancaster General, with Penn adds a lot of validity and proves the model in a large healthcare system. In a similar fashion, Medicare came out with two brand new insurance reimbursement codes for which we received a validation that we fit under — behavioral health integration. With Capital Blue Cross partnership we are working with them to figure out how to optimally bring this system to their provider network.”

The behavioral health integration classification means clinicians can get reimbursement if they use NeuroFlow’s program can be used to treat depression as a comorbidity, alongside other chronic conditions such as chronic pain.

Although Emovi is much older than NeuroFlow, CEO Michelle LaFlamme said she hopes the certification program will help the company expand its presence in the U.S. Emovi received FDA 510(K) premarket approval for its KneeKG device in 2009. The orthopedic device is designed to be used in primary care settings to assess knee joint pain and its potential underlying causes. The device, which has electromagnetic markers, is placed around a patient’s knee. As the person walks on a treadmill, a 3D projection of how their knee joint is performing can be viewed on a screen. The idea is that primary care physicians can use the device to make referrals to orthopedic physicians, depending on the severity of the problem.

Source: https://medcitynews.com/2018/06/a-health-tech-accelerator-takes-root-in-amish-country-to-support-clinical-validation/

The best medical technology innovations at TLA’s HealthTech Innovator conference by Charlotte Edwards

Tech London Advocates’ (TLA) HealthTech Working Group and the Health Foundry organised the HealthTech Innovator conference, a London Tech Week event where it showcased innovative startups and initiatives working in the medical device and pharmaceutical sector that are in the early stages of product development, as well as those seeking investment.

Tech London Advocates’ (TLA) HealthTech Working Group and the Health Foundry organised the HealthTech Innovator conference, a London Tech Week event where it showcased innovative startups and initiatives working in the medical device and pharmaceutical sector that are in the early stages of product development, as well as those seeking investment.

The TLA is a network of technology leaders, entrepreneurs and experts who work to promote London as a world leading technology hub with working groups focusing specifically on each sector it covers. The Health Foundry is an organisation that supports and helps to accelerate digital innovators in the healthcare sector with funding from Guys and St Thomas’ hospital charity.

Here is our round-up of the most exciting medical technology companies who presented at the event.

VRTU

Supported by the University of Oxford, as well as private partners, VRTU provides virtual reminiscent experiences to improve mental wellness primarily for elderly dementia patients. It uses virtual reality (VR) technology connected with its LookBook application to provide time travel therapy, which is commonly used for dementia.

The application offers a range of high-quality, 360° VR content and cinematic experiences that are based on a destination, activity or historic period. Examples include Brighton beach in the 1970s and a 1950s tearoom.

Patients are also able to personalise their VR and can use the LookBook Companion application to share their experiences with loved ones and create wider connections. The ultimate aim for dementia patients to both revisit old memories and create new ones.

The company is founded on the principle that the pursuit of treatment should not mean that care needs of patients should be overlooked. It is currently undertaking a pilot with the NHS in care settings.

MediSieve

MediSieve is a magnetic blood filter that can selectively remove disease-causing agents from the blood. It quickly filters blood through a single-use magnetic filter and MediSieve particles, which are biocompatible magnetic particles coated with binding agents, catch molecules based on their magnetic properties.

The system is designed to filter a patient’s total blood volume in less than an hour and only requires a small volume of the blood to be outside the body at one time. The magnetic particles do not enter the patient’s body, instead they are injected into an external blood loop.

MediSieve’s primary target is malaria, but it is now starting to work with leukaemia and sepsis patients. Pre-clinical results suggest that the MediSieve filter could reduce the presence of parasites in a child with malaria’s blood by 90% in two hours, and that a one-off treatment for a patient with severe symptoms could reduce the risk of mortality, accelerate symptom decline and prevent disease escalation.

Since it was founded in 2015, the company has raised £2.1m in equity funding, as well as grant funding worth a total of £400,000 from the Wellcome Trust, Innovate UK, National Institute for Health Research i4i and the European Union (EU) Horizon 2020 Small and Medium-Sized Enterprises Instrument.

Tomo

Based on the therapeutic concept of behaviour activation, Tomo is a peer support network aimed at people with mental health conditions.

It consists of a chatbot with a human voice and character that prompts users to create and sustain behaviours. Each time a user completes a task, they can share it anonymously with the community. Other users can then validate the action, which Tomo believes encourages users to repeat the action and form habits. The aim is to encourage users to share and celebrate small victories.

It is a subscription-based service, which costs £7.50 per month after a two week free trial. However, this fee is scaled down for institutions.

Tomo is currently offering free pilots to companies seeking to improve support and understanding of the mental wellbeing of its employees. The pilot runs for between six and eight weeks and is accompanied by a workshop to explain the concept behind the platform.

Attomarker

A spin-out from the University of Exeter, Attomarker is a small, simple blood testing device that can be used by patients to perform at-home tests from a single pin prick of blood with results in approximately five minutes, making it less invasive than standard blood tests.

The blood sample is collected on a credit card-sized chip that slots into an iPhone 7 or iPhone 8; the phone’s camera is used to visualise the blood test and the results can then be linked to an electronic patient record system and artificial intelligence symptom checkers for diagnosis.

The system currently tests up to eight different blood biomarkers with launch chips for allergy, fertility and hormones and, finally, C-reactive protein or antibiotic testing.

Attomarker has had five patents granted with others in progress and its major market is the EU.

Source: https://www.medicaldevice-network.com/features/best-medical-technology-innovations-tlas-healthtech-innovator-conference/

Accenture Digital Health Technology Report Says Blockchain, AI & IoT Will Be Critical In Future by Bitcoin Exchange Guide News Team

Adoption of Intelligent Technologies by the Heath Sector

Last month a report was released focused on Vision 2018 and digital health technology by Accenture. The report brought out the actions the health industry is taking towards adopting intelligent technologies. Some of the concepts the industry were focused on the included Internet of Things and Artificial Intelligence. However, they highlighted the fact that new tools will have to be created to protect privacy and transparency.

Report Outcomes

According to the research, 9 out of 10 executives had knowledge concerning the benefits of blockchain technology. They believed that the technology would help increase the efficiency of the industry operations. Additionally, the microwave service would play a critical role in scaling ecosystems.

More than 100 executives in the healthcare were interviewed concerning intelligent technologies. 3 out of four stated that they are planning to invest in the Internet of Things and the use of smart sensor technologies. 4 out of the 5 executives interviewed highlighted the fact that their organizations were already using data to enhance automated decision making.

Another 4 out of 5 executives stated that intelligent technologies helped dissolve the distance barriers. Accessibility to people, information, and experiences were made easier through these technologies. More than half of the healthcare providers were committed to investing in these technologies within the next year.

4 out of the 5 interviewed executives stated believe to acquire valuable information from large volumes of data required expertise. They stated the fact that special computing methods would be needed to ensure critical analysis of the data before storage. Some went a step further and highlighted the fact that cloud integration would be needed. This will ensure that valuable information is able to be shared efficiently across different organizations.

Conclusion

Kaveh Safari, the managing director of Accenture’s Global Health Practice, stated that IoT will revolutionize the health sector. He highlighted that the increased efficiency and collaboration with other entities will help strengthen build strong patient relationships.

Source: https://bitcoinexchangeguide.com/accenture-digital-health-technology-report-says-blockchain-ai-iot-will-be-critical-in-future/

AI In Health Care Will Fail Without Proper Context by Brigham Hyde

“As a jazz musician, you have individual power to create the sound. You also have a responsibility to function in the context of other people who have that power also.” – Wynton Marsalis

We’re at a tipping point in health technology. Vast resources of data have been unlocked through the transition to electronic health records. Value-based care is requiring sophisticated analysis of patient outcomes. Machine learning and artificial intelligence (AI) technology have evolved quickly. All the tools are ready -- it’s the hard part that comes next.

In my career in health care and oncology, I’ve been a chemist, a pharmacologist, an entrepreneur, an analyst, an academic, a researcher, a venture capitalist and a technologist. I’ve seen this “hard part” from many angles. Change does not come easily to health care. The systems of making decisions in our sector today are inefficient, full of human flaws and bias. This is certainly true in oncology, my company’s area of focus and also my brilliant wife’s specialty. I’ve come to realize that the problem isn’t technology but context. We need to be sharing a vision. We need to be translating information back and forth seamlessly between physicians, researchers, patients and computers to ask better questions and find better answers. The way to bring health care leaders together around AI is to invite them in through the proper contextual setting of findings.

How do we contextualize this? Earlier this year, I joined the National Academy of Medicine's new Artificial Intelligence/Machine Learning in Health Care working group to tackle just that. Along with 35 other health care leaders, we’re outlining the promise, development, deployment and use of AI for policymakers, providers, payers, pharma, tech companies and patients. Every part of our healthcare system needs better translation:

• Physicians: Doctors are communicators, contextualizing their medical knowledge into care decisions and patient expectation. AI needs to understand and evolve within this framework, using physician expertise to ask informed questions from vast datasets. It shouldn't stop there: AI should be presenting complex statistical recommendations to physicians in an easy-to-use format and closing the feedback loop with analysis of what worked. As health care evolves, the value of physician translation expands. Physicians will translate increasingly complex concepts to patients, as well as translating how medical expertise is applied in machine learning and how the practice of medicine transforms based on real-world data.

• Patients: Informed patients are already changing healthcare. Dr. Google is almost always a second opinion in the exam room. With the advent of machine learning, patient data literacy should also be a focus. Patients should and can be involved in care decisions: weighing risk, cost and discomfort based on real-world data about what works in their precise situation. It is key that patients can contextualize what they really care about to their providers.

• Payers: Did the patient get better? Was the treatment we approved the most cost-effective? Where can we reduce risk while still innovating? Health plans know today’s rising health care costs are not sustainable. Adding the payer context around reimbursement goals into the science can help reduce costs and improve outcomes. Payers could certainly be doing a better job of translating why they make decisions on denials and cost than the cryptic explanation of benefits letters or prior authorization denials mailed today.

 Life sciences: How to improve our drug discovery and clinical trial process is the subject for a book, not a bullet point, but it is fair to say that there are vast opportunities for better translation in the pharma, device and biotech sectors. I’m personally excited about improving how life sciences smartly select safe patient panels for clinical trials which reduces adverse events and uses real-world data to show that a small control trial translates to broad, diverse patient segments.

• Policymakers: Regulators play a crucial role in fitting AI into the healthcare ecosystem responsibly. They translate when AI models constitute medical devices and when they should be reimbursable. They will monitor issues around safety, liability and even unintentional bias if models are built on biased data. Like physicians, policy leaders are crucial interpreters and need to be translating needs between every part of our health care system effectively.

• Technology: Technology leaders absolutely share the translation burden here, too. Health technologies are often developed in a vacuum — far from listening to what physicians, patients, payers and pharma actually need. Early hype around AI promised miracle cures and delivered few results. To be effective, AI needs to be carefully trained to contextualize results into more practical “so-what” type of actions. It’s a conversation, and it’s not easy.

Until we can clearly and consistently answer “Should this patient take this drug, and will it work better than another one, and is it worth the price?" there is more context required to do it in health care. AI is just one tool to help us get there. It will only work as well as it is trained and understood.

As I prepare to head out to the American Society of Clinical Oncology (ASCO) in a few weeks, I’m thinking about my own role as an interpreter and translator in health care. I’ll be listening a lot at that event. I hope that if you have a translation role to play, you’ll share your perspective in Chicago or online. Together, through translating our complex needs, we can realize the potential of AI in health care.

Source: https://www.forbes.com/sites/forbestechcouncil/2018/06/13/ai-in-health-care-will-fail-without-proper-context/#a23a14062526

Mobile health technology can potentially transform how patients manage heart disease risk by Elsevier

Mobile health technology has the potential to transform the way we prevent and manage heart disease, but there are unanswered questions about how to optimize this technology and maintain engagement with patients, according to a review of randomized clinical trials published in the Canadian Journal of Cardiology.

Cardiovascular disease is the leading cause of death worldwide. Recently, mobile health (mHealth) technology has been the focus of increasing interest as a means to improve the delivery of cardiovascular prevention targeting a combination of modifiable risk factors. which account for the majority of global risk factors for cardiovascular disease -- in a scalable and affordable way.

According to lead investigator Clara Chow, MBBS, FRACP, PhD, Professor of Medicine, University of Sydney, Program Director, Community Based Cardiac Services, Westmead Hospital, and Professorial Fellow, The George Institute for Global Health, Sydney, NSW, Australia, "mHealth interventions are a novel, exciting, and expanding field in medicine that will potentially transform healthcare delivery by improving access to treatments that would otherwise require frequent clinic or hospital visits. There are already an overwhelming number of cardiovascular mHealth options available to consumers. However, the utility of applications to improve health outcomes has been poorly evaluated. There is limited research evidence for their effectiveness in modifying objective measures of health, and app development and provision are largely unregulated."

In this study, investigators review the evidence on mHealth interventions for simultaneous multiple risk factor reduction in both primary and secondary prevention settings, using smartphone applications (apps) and text messaging (short messaging service -- or SMS).

In the primary setting investigators found only a few randomized controlled trials (RCTs) that assessed mHealth approaches using text messaging and could not identify any RCTs assessing the effect of mHealth smartphone apps on total cardiovascular risk.

The largest primary prevention text messaging study was an RCT conducted in China of a 12-month intervention comprising text messaging and phone calls performed among 589 Chinese workers who had been allocated to receive an annual medical examination, who were without cardiovascular disease, and between 45 and 75 years of age.

The intervention group received personalized text messages targeting lifestyle measures to reduce cardiovascular disease risk (frequency determined by risk assessment) in addition to a computerized risk evaluation, an initial 15-minute face-to-face risk counselling session, follow-up phone calls, an educational handbook, and a medical examination. Electronic health prescription software was developed to prescribe the program to the intervention group. The control group received only the annual medical examination and report detailing their results.

At 12 months, there was a significantly lower mean 10-year cardiovascular disease (CVD) risk score in the intervention group compared to the control group. However, there was no significant reduction in the mean cardiovascular disease risk at 12 months compared to baseline for the intervention group. The investigators concluded that the study was underpowered to detect differences in overall 10-year CVD risk, despite showing significant differences in the individual components of the risk score. Systolic blood pressure, total cholesterol, waist-to-hip ratio, and body mass index were all significantly lower at 12 months compared to baseline in the intervention versus controls.

There have been several mHealth interventions designed to deliver secondary prevention to patients with cardiovascular disease and which target multiple risk factors simultaneously. Investigators evaluated the approach and the results of trials using text messages: TEXT ME and Text4Heart.

After six months, the TEXT ME trial, the largest secondary prevention texting study, provided objective evidence that text message support for heart attack survivors could improve key health risk factors of cholesterol, blood pressure, weight, exercise, diet, and smoking. Patients who received TEXT ME were more than twice as likely to reach guideline targets in their risk factors. The TEXT ME messages provided advice, motivation, and support on diet, quitting smoking, exercise, and general heart health.

By contrast the intervention group in the Text4Heart trial received one message per day that decreased to five messages each week from week 13. The study identified positive effects of adherence to healthy lifestyle behaviors at three months but not at six months, raising the question about the durability of mHealth interventions, as well as the optimal frequency of text messages.

Another two-month single-blind RCT of 203 patients with prior acute coronary syndrome evaluated personalized text messages based on cardiovascular data sent via mobile phone. The intervention group was significantly more likely to have an improved cardiovascular risk profile than the control group.

The investigators also evaluated the results of three RCTs for secondary prevention using smartphone apps. They generally found no or small improvements in cardiovascular risk factors but concluded that the small trial sizes meant they were unlikely to be powered to detect small improvements in cardiovascular risk factors. They suggest that there is potential for reducing health service utilization and hospitalization, but that further research is required to clarify this.

"mHealth has great potential to prevent heart disease, but there are unanswered questions about how to optimize it and maintain engagement with patients," commented lead author Harry Klimis, MBBS, University of Sydney, Department of Cardiology, Westmead Hospital, and The George Institute for Global Health, Sydney, NSW, Australia. "Select studies such as TEXT ME, show that mHealth can improve overall heart disease risk. However, our goal needs to be high quality and effective mHealth interventions. Importantly, future mHealth producers should collaborate with clinicians and regulatory agencies to ensure the interventions are safe and effective and outcome measures standardized."

Source: https://www.sciencedaily.com/releases/2018/06/180607082617.htm

How Can Medical Technology Companies Leverage From Social Media? by Rebecca Jordan

Social media is one of the most popular communication channels that bring business closer to its consumers.  In the recent past, businesses from every vertical have joined the social bandwagon to educate their consumers, understand their issues and needs, engage with them, rope in new customers, tap new markets, and to promote their products or services. Why should medical technology companies be any different?

In fact, medical technology companies can use social media as more than a marketing tool – it can be used for serving patients, physicians, and community, uplifting the brand image and spread social awareness.

According to Pew Research, 72% of internet users admittedly searched for healthcare information online in the past year. 61% of physicians say they also use social media a few times a week to search for health information and just under half say that they participate in the conversation.

Therefore, medical technology companies can engage their audience by creating the right information pool that can benefit patients and physicians alike. Such community can be a great tool for spreading social awareness regarding health-related issues and medical conditions.

According to a recent research  by PwC, medical consumers spend 24 times as much time on health-related community sites and social media platforms than they do on a company, physician, and hospital websites. Over 67% of physicians use social media for professional use, and according to the Journal of Medical Research, more than half of them think social media as an effective way to access current, high-quality medical information.

Having a strong social media presence for a number of reasons can have a positive effect on the business goals of any medical technology company. Here are a few tips a medical technology company should apply to create a strong media presence and reap the benefits.

Define Your Brand

Social media can help medical technology companies humanize their product and define their message in the eyes of a prospective buyer. For example, a medical technology company can create a video or infographic regarding the correct way to use the latest medical technology product and put it on Facebook to help people understand the correct usage.

Promote Relevant Content

Do your products receive compliments from physicians or patients online? Is there a blog post stating how your product helped a patient/physician, feel free to share the same to establish yourself as an expert in the field. Also, share the content of experts and participate in conversation relevant to your product. You can even use historical content relevant to your products. For example – use it as an opportunity to start a conversation about Greiner Bio-One’s new square petri dish and its contribution in modern medical research.

Educating

MedTech companies can join in health-related conversations online to educate users/doctors/hospital administrators on how their product can solve the problem.

Focus On Goals

Social media can act as a link between a company and it’s sales goals as it can be used to target prospects.  You can easily get noticed by your prospect through a carefully crafted social media strategy, so when your prospects are ready to make a purchase, they choose you.

Develop Trust

Nothing can show the depth of your knowledge other than a well-written, regularly-updated blog about your industry that is promoted via Twitter, Facebook, and LinkedIn. This will help establish your expertise in your industry and engage your audience who will soon start seeing information from you. However, one has to ensure that the content you post should be in adherence to FDA guidelines. Otherwise, it can tarnish your brand reputation faster than you think.

These are sure-fire ways medical technology companies can leverage from social media and grow rapidly.

Source: http://www.sociableblog.com/2018/06/11/medical-technology-companies-leverage-from-social-media/

AI And Robotics Are Taking Robotic Surgery To New Levels by Allison Gatlin

With artificial intelligence now firmly entrenched in many hospital operating rooms, the field of robotic surgery is starting to get competitive.

Giant companies like Alphabet (GOOGL), Johnson & Johnson (JNJ) and Medtronic(MDT) are training their sights on Intuitive Surgical (ISRG), the king of robotic surgery companies. But analysts say the booming medical technology segment has lots of room to run.

Robotic surgery is an area of medical technology that could grow by billions of dollars as more machines are used to treat patients. While Intuitive now commands the space with $3.3 billion in annual sales, its signature da Vinci robotic surgeons are limited in the types of procedures they handle. The multi-limbed da Vinci can be used in a variety of procedures — including cardiac, colorectal, gynecological, head and neck, thoracic and urologic surgeries — but only as long as they're minimally invasive.

How big the market could be is still unclear, yet analysts agree the potential has yet to be tapped. So more players are moving in, and quickly.

 

"I think investors need to understand that the robotics and AI (artificial intelligence) revolution is happening, and it's touching every sector of the economy," said Jeremie Capron, the director of research and managing partner for Robo Global, an index and advisory firm specializing in robotic industry investments. "This is a technological revolution that investors can't afford to miss."

Medical Technology Applications

In March, Auris Health became the first company to directly take on Intuitive when its catheter-based Monarch Platform gained U.S. approval. Intuitive will counterpunch by seeking approval for a flexible catheter similar to the Auris device, likely this year, RBC analyst Brandon Henry said in a recent report.

Meanwhile, others are working in areas where Intuitive Surgical doesn't have a foothold. Smith & Nephew (SNN) has a robotic assistant for knee replacements. Stryker (SYK) has a robotic joint replacement system. Mazor Robotics (MZOR) and Zimmer Biomet (ZBH) have robotic offerings in brain and spinal surgery. Mazor alone could see around $3 billion in sales just from its systems.

But these players have a long way to go to take Intuitive Surgical's throne.

In 2005, Intuitive had a market cap of $1.3 billion. Today, it's worth nearly $52 billion. Capron calls Intuitive "an amazing stock."

"I think the investment community has been scratching their heads trying to figure out the impact of those new entrants for Intuitive Surgical," he told Investor's Business Daily. "We feel pretty relaxed about it. The size is big enough for small players to come in."

Intuitive Surgical: A 'Blowout' Quarter

Shares of medical tech companies have been relatively insulated from the woes frustrating biotech and pharmaceutical stocks of late. The stocks of medical equipment makers such as Intuitive and Mazor have collectively spiked 15% year to date.

Intuitive's "blowout quarter" in April helped to spur excitement, Evercore analyst Vijay Kumar said in a recent note to clients. Recent investor days from J&J and Medtronic are helping to drive that frenzy.

"Robotic surgery is the topic currently in medtech with a blowout quarter from Intuitive Surgical hinting that the pace of manual-to-robotic transition might be picking up," Kumar said. "The topic of competition elicits various responses from investors."

Intuitive Surgical stock is up 33% this year, after climbing 78% in 2017. Kumar expects Intuitive Surgical's competition to become more apparent over the next 12 to 18 months. Intuitive's da Vinci Surgical Systemnow boasts "five million patients and counting."

The da Vinci systems are also moving deeper into hernias and are seeing early-stage adoption in bariatrics surgery performed to induce weight loss.

Intuitive Surgical Opportunities

Myriam Curet, executive vice president and chief medical officer for Intuitive, noted in an email to IBD that an estimated 82% of prostatectomies in the U.S. are performed via robotic-assisted surgery. The same is true for about 80% of malignant hysterectomies.

"General surgery is our fastest-growing specialty, and one where we are still in early stages of adoption for procedures such as ventral and inguinal hernia repair, colorectal and bariatric surgery," she said. "We believe there is substantial opportunity to expand robotic usage in these categories, and we are developing additional tools and technologies to do so."

For the year, Intuitive guided on its first-quarter earnings conference call to 12%-15% growth in the number of procedures performed with its systems this year. That followed what many considered a strong fourth quarter in which recurring revenue — including instruments and accessories for its da Vinci systems — grew 11%. Recurring revenue represents 73% of the sales pie.

Still, even Intuitive Surgical sees itself in the early innings and expects robotic surgery to present a huge total addressable market. The number of da Vinci procedures performed each year grew nearly 68% from 2013 to 2017.

Among other robotic surgery companies, Intuitive's closest competitor, Auris, doesn't trade publicly. Until recently it was in "stealth mode," Kumar said. But in May the medical technology company signed a commercialization agreement with a division of J&J. The agreement came two months after Auris' Monarch system grabbed approval in the U.S.

Competition In Medical Technology

Monarch is a flexible catheter. Surgeons thread it through a patient's mouth and into the lungs by remote control. Before its approval, investors believed "credible competitors" to Intuitive would be years away, Kumar says. But Monarch got approval months ahead of views. Intuitive Surgical plans to seek approval of its own flexible catheter later this year.

On its website, Auris says Monarch's first target is lung cancer. Some experts estimate half a million lung biopsies are performed in the U.S. each year. Surgeons could also use flexible catheters in urinary tract procedures, which number roughly 400,000 procedures a year.

Intuitive isn't sweating the competition. Auris' chief executive, interestingly, is Frederic Moll, who founded Intuitive Surgical in 1995. Intuitive's current CEO, Gary Guthart, joined the medical technology firm in 1996 and took over as CEO in 2010.

"We have built technologies and made decisions about our architecture based on first principles, not by looking over our shoulder at what other people are doing, but by really engaging customers deeply and understanding their clinical needs," Guthart said on a recent earnings call.

RBC's Henry notes Auris' Monarch has a 25% larger catheter than Intuitive's to allow for its camera. Intuitive sees a benefit in a smaller catheter that can move deeper into the lungs, Henry wrote in a recent report. That would allow surgeons to potentially use it to remove diseased tissue.

Robotic Surgery Grows

Meanwhile, J&J has teamed up with Google on a company called Verb Surgical. Analysts are unsure what system the team is creating, though they expect it to enter the robotic surgery market in 2020.

At the same time, Medtronic is partnered with Mazor. Medtronic also expects its own robotic surgery system to launch in 2020.

It's not unreasonable to suggest Intuitive could keep 80% of the market, Evercore's Kumar told IBD. New robotic surgery companies will have to differentiate themselves.

"They can't have a straightforward, 'me too' product," he said. "Investors have put a pretty punchy marketable valuation on Intuitive Surgical because we're still in the early stages of this robotic conversation."

But, he added, "This market is big enough to sustain multiple players."

That's where companies like Mazor and Zimmer Biomet, which makes systems called ROSA, come in. Both have systems that surgeons use in brain and spinal procedures.

Robotic Surgery Companies: Target Market

Like others, Mazor CEO Ori Hadomi says sizing the opportunity for robotic surgery companies is difficult. Surgeons use the $1.1 million Mazor X system in spinal surgeries. The company's Renaissance system can perform spinal and brain surgeries and costs $500,000.

Disposable instruments and materials comprised 40% to 60% of Mazor's revenue, Hadomi told IBD. For each surgery performed with the Mazor X, the list price is $1,500 in terms of disposable items. An estimated half a million procedures would generate $750 million.

Stakeholders expect spine procedures to grow rapidly.

"People are being more and more active," he said, meaning they will suffer more injuries and require surgery more often. "The procedures will become less invasive. The safer the procedures will become, the more patients will be willing and interested to be treated, to be operated on."

The benefits of robotic surgery are plentiful, Hadomi says. Revision surgery — surgery to correct mistakes or tweak prior surgeries — are significantly lower with a robot assisting. The precision of the robot helps to curb potential errors, he says.

Research By Robotic Surgery Companies

Last October, Mazor unveiled the results of a 379-patient study that found a fivefold reduction of complications for surgeries performed with its Mazor robotic surgery technology. Notably, there was also a sevenfold reduction in revision surgery compared with freehand lumbar fusion surgeries.

"There's no doubt from the patient's perspective, I would not consider going to surgery without the robot there knowing the chance of going through revision (surgery) is seven times higher," he said. Revision surgery is also costly for the hospital, which can face reimbursement hurdles.

All agree that robotic surgery won't replace human surgeons. Hadomi likens his system and others like it to "the toolbox of the surgeon." These are simply medical technology tools that make operating easier on the surgeon and safer for the patient, he says.

The benefits are also growing for investors, says Robo Global's Capron.

"What's really exciting is the fact that we are at an inflection point where the technologies that enable robotic surgeries and the price point are attractive," he said. "Now there's a lot of action around J&J and Medtronic. I see that as confirmation that this is a substantial, addressable market."

Source: https://www.investors.com/news/technology/robotic-surgery-companies-medical-technology/

Mobile health technology can potentially transform how patients manage heart disease risk by Elsevier

Mobile health technology has the potential to transform the way we prevent and manage heart disease, but there are unanswered questions about how to optimize this technology and maintain engagement with patients, according to a review of randomized clinical trials published in the Canadian Journal of Cardiology.

Cardiovascular disease is the leading cause of death worldwide. Recently, mobile health (mHealth) technology has been the focus of increasing interest as a means to improve the delivery of cardiovascular prevention targeting a combination of modifiable risk factors. which account for the majority of global risk factors for cardiovascular disease—in a scalable and affordable way.

According to lead investigator Clara Chow, MBBS, FRACP, Ph.D., Professor of Medicine, University of Sydney, Program Director, Community Based Cardiac Services, Westmead Hospital, and Professorial Fellow, The George Institute for Global Health, Sydney, NSW, Australia, "mHealth interventions are a novel, exciting, and expanding field in medicine that will potentially transform healthcare delivery by improving access to treatments that would otherwise require frequent clinic or hospital visits. There are already an overwhelming number of cardiovascular mHealth options available to consumers. However, the utility of applications to improve health outcomes has been poorly evaluated. There is limited research evidence for their effectiveness in modifying objective measures of health, and app development and provision are largely unregulated."

In this study, investigators review the evidence on mHealth interventions for simultaneous multiple risk factor reduction in both primary and secondary prevention settings, using smartphone applications (apps) and text messaging (short messaging service—or SMS).

In the primary setting investigators found only a few randomized controlled trials (RCTs) that assessed mHealth approaches using text messaging and could not identify any RCTs assessing the effect of mHealth smartphone apps on total cardiovascular risk.

The largest primary prevention text messaging study was an RCT conducted in China of a 12-month intervention comprising text messaging and phone calls performed among 589 Chinese workers who had been allocated to receive an annual medical examination, who were without cardiovascular disease, and between 45 and 75 years of age.

The intervention group received personalized text messages targeting lifestyle measures to reduce cardiovascular disease risk (frequency determined by risk assessment) in addition to a computerized risk evaluation, an initial 15-minute face-to-face risk counselling session, follow-up phone calls, an educational handbook, and a medical examination. Electronic health prescription software was developed to prescribe the program to the intervention group. The control group received only the annual medical examination and report detailing their results.

An app-based secondary prevention program targeting individuals who have known ischemic heart disease. The 'My Heart, My Life' app from the Australian Heart Foundation includes educational videos on acute coronary syndromes, and a personal …more

At 12 months, there was a significantly lower mean 10-year cardiovascular disease (CVD) risk score in the intervention group compared to the control group. However, there was no significant reduction in the mean cardiovascular disease risk at 12 months compared to baseline for the intervention group. The investigators concluded that the study was underpowered to detect differences in overall 10-year CVD risk, despite showing significant differences in the individual components of the risk score. Systolic blood pressure, total cholesterol, waist-to-hip ratio, and body mass index were all significantly lower at 12 months compared to baseline in the intervention versus controls.

There have been several mHealth interventions designed to deliver secondary prevention to patients with cardiovascular disease and which target multiple risk factors simultaneously. Investigators evaluated the approach and the results of trials using text messages: TEXT ME and Text4Heart.

After six months, the TEXT ME trial, the largest secondary prevention texting study, provided objective evidence that text message support for heart attack survivors could improve key health risk factors of cholesterol, blood pressure, weight, exercise, diet, and smoking. Patients who received TEXT ME were more than twice as likely to reach guideline targets in their risk factors. The TEXT ME messages provided advice, motivation, and support on diet, quitting smoking, exercise, and general heart health.

By contrast the intervention group in the Text4Heart trial received one message per day that decreased to five messages each week from week 13. The study identified positive effects of adherence to healthy lifestyle behaviors at three months but not at six months, raising the question about the durability of mHealth interventions, as well as the optimal frequency of text messages.

Another two-month single-blind RCT of 203 patients with prior acute coronary syndrome evaluated personalized text messages based on cardiovascular data sent via mobile phone. The intervention group was significantly more likely to have an improved cardiovascular risk profile than the control group.

The investigators also evaluated the results of three RCTs for secondary prevention using smartphone apps. They generally found no or small improvements in cardiovascular risk factors but concluded that the small trial sizes meant they were unlikely to be powered to detect small improvements in cardiovascular risk factors. They suggest that there is potential for reducing health service utilization and hospitalization, but that further research is required to clarify this.

"mHealth has great potential to prevent heart disease, but there are unanswered questions about how to optimize it and maintain engagement with patients," commented lead author Harry Klimis, MBBS, University of Sydney, Department of Cardiology, Westmead Hospital, and The George Institute for Global Health, Sydney, NSW, Australia. "Select studies such as TEXT ME, show that mHealth can improve overall heart disease risk. However, our goal needs to be high quality and effective mHealth interventions. Importantly, future mHealth producers should collaborate with clinicians and regulatory agencies to ensure the interventions are safe and effective and outcome measures standardized."

Source: https://medicalxpress.com/news/2018-06-mobile-health-technology-potentially-patients.html

FDA Challenge Eyes Digital Health Technology to Combat Opioid Abuse by Eric Wicklund

May 31, 2018 - Federal officials and healthcare organizations are ramping up efforts to use mHealth and telehealth to combat the nation’s opioid abuse epidemic.

The U.S. Food and Drug Administration this week launched an effort to bring connected health technologies to bear on the issue. The FDA’s new innovation challenge seeks “to spur the development of medical devices, including digital health technologies and diagnostic tests that could provide novel solutions to detecting, treating and preventing addiction, addressing diversion and treating pain.”

“Medical devices, including digital health devices like mobile medical apps, have the potential to play a unique and important role in tackling the opioid crisis,” FDA Commissioner Scott Gottlieb, MD, said in a news release posted on the FDA’s website. “We must advance new ways to find tools to help address the human and financial toll of opioid addiction.”

Gottlieb offered an example of an mHealth device that might replace medication in helping someone manage pain. Such devices are part of the fast-growing digital therapeutics field, encompassing everything from wearables and mHealth apps to augmented and virtual reality tools. Advocates say practitioners might someday prescribe technology instead of opioids to patients.

The FDA’s challenge, running through Sept. 30, seeks mHealth technology in any stage of development, including diagnostic tools that identify those with an increased risk for addiction, treatments for pain that eliminate the need for opioid analgesics, treatments for opioid use disorder or symptoms of opioid withdrawal and technology that can prevent the diversion of prescription opioids.

“We’re hopeful that in collaborating with public health-minded innovators, we can identify and accelerate the development of new technologies, whether a device, diagnostic test, mobile medical app, or even new clinical decision support software, that can contribute in novel and effective ways to help reduce the scope of this crisis,” Gottlieb said.

A team from the FDA’s Center for Devices and Radiological Health will evaluate the entries and grant those that meet the criteria Breakthrough Device designation. Officials expect most of the entries to eventually apply for an investigational device exemption, De Novo, premarket clearance (510(k)) or premarket approval application.

“This new effort builds on the success of previous work to take a collaborative approach to promoting medical device innovation and safety, such as the 2012 challenge that led to multiple new approaches to treat life-threatening, end-stage renal disease,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in the press release. “The FDA stands ready to provide significant assistance and expedite premarket review of applications to help bring innovative devices that, if properly instituted, could help those at risk for addiction or treat those who might develop opioid use disorder. We also hope that in turn these novel products may also help pave the way for the development of future products that build on the latest technologies.”

On Capitol Hill, meanwhile, lawmakers are seeking to address the issue with legislation that would open the door to more telehealth programs. And they’re getting support from the healthcare community.

A dozen organizations have thrown their support behind the Expanding Telehealth Response to Ensure Addiction Treatment (eTREAT) Act, co-sponsored by Sens. Mark Warner (D-Va.), John Thune (R-S.D.), Ben Cardin (D-Md.), John Cornyn (R-Texas), Brian Schatz (D-Hawaii) and Roger Wicker (R-Miss). The bill, targeting telehealth guidelines enforced by the Centers for Medicare & Medicaid Services, aims to remove originating site requirements and facility fees from telehealth programs addressing opioid abuse and other substance abuse disorders.

The bill targets one of the more prominent barriers to improving treatment via telehealth: originating site restrictions. Many Medicaid programs restrict where telehealth services can be delivered, usually to hospitals or clinics, making it difficult for patients who live far away from these locations or who live near locations that fill to capacity quickly. Eliminating this geographic restriction would enable providers to create new programs and services operating out of community centers, doctor’s offices or even the patient’s home.

In a letter sent to the Senate Finance Committee, 11 groups, including the Healthcare Information and Management Systems Society (HIMSS), American Telemedicine Association and College of Healthcare Information Management Executives (CHIME), said those restrictions “have hindered telehealth use in Medicare as employers and the commercial sector generally have embraced telehealth.”

“More than 90 percent of large employers offer telehealth benefits,” the letter states. “It’s time that Medicare caught up so seniors can also use these tools. By removing the rural and originating site restrictions, the eTREAT Act will expand the number of providers who will treat elderly patients with substance abuse disorder in their own homes through telehealth. In addition, as HHS and CMS consider the new Medicare Advantage telehealth benefit, coverage of behavioral health for substance abuse disorder will be a natural addition if the restrictions are already lifted in fee-for-service.”

Also supporting the bill is Health IT Now’s Opioid Safety Alliance.

"The Medicare population has among the fastest-growing rates of opioid use disorder and the program remains unacceptably slow in embracing the power of technology to solve this crisis," Joel White, executive director of both the alliance and Health IT Now, said in a separate letter. "We know that telehealth can bridge the gap of distance and stigma by allowing beneficiaries to receive care when and where they need it, but inflexible bureaucratic restrictions are putting that possibility out of reach for too many. This bipartisan legislation will right that wrong and expand access to treatment via telehealth for Medicare beneficiaries struggling under the weight of addiction.”

The eTREAT Act is one of several bills seeking to expand telehealth and telemedicine use to combat the opioid abuse crisis. Others include:

• The Opioid Crisis Response Act of 2018, which includes provisions to enable the U.S. Drug Enforcement Administration create a rule allowing qualified healthcare providers to administer controlled substances via telemedicine.
• The Medicaid Substance Use Disorder Treatment via Telehealth Act, which would require the Health and Human Services Secretary to issue guidance on how state Medicaid programs can be reimbursed for substance abuse disorder treatment via telehealth.
• The Telehealth for Children’s Access to Services and Treatment (TeleCAST) Act, which would require the Government Accountability Office (GAO) to analyze Medicaid treatment programs for children with substance abuse disorders, and it would require CMS to report on how barriers can be reduced to enable more children on Medicaid to receive treatment via telehealth.
• The Opioid Addiction Treatment Programs Enhancement Act, which would require the HHS Secretary to publish comprehensive data on the numbers of Medicaid patients dealing with substance abuse disorders and services provided under Medicaid for their treatment.
• The Access to Telehealth Services for Opioid Abuse Disorders Act, which would waive certain Medicaid telehealth requirements in treatments for opioid abuse disorder or co-occurring mental health disorder.

Source: https://mhealthintelligence.com/news/fda-challenge-eyes-digital-health-technology-to-combat-opioid-abuse

The convergence of the technology and medical device industries is no longer a practical impossibility by Lisa Suennen

Oh hey, sorry if I bumped into you.  I should be more careful when I walk down the street, but I was distracted. By what you ask? Well, me and my trusty binoculars have been looking skyward for flying pigs and downward for massive blocks of ice because it has become apparent that things have changed.

I used to say that the medical device industry was going to figure out that the old world of selling their wares was gone sometime around when pigs fly or hell freezes over, thus my quest for the above-noted items.  I was in Minneapolis last week, self-appointed mecca of the medical device industry, and I saw, with my own eyes, some longtime medtech industry stalwarts talking about the current state of the industry in a way I have not seen before.

I was at the Minneapolis Medtech Conference and sitting in the audience watching a panel prior to mine.  Now let me add that the panel I was there to moderate was about how artificial intelligence and data are changing the medtech world, which is weird enough.  Historically there has been little discussion about the convergence of these worlds where the medtech glitterati gather. MedTech entrepreneurs of the traditional variety and data scientists of the new world order variety are rarely mixed in the same drink.  They have not been entirely imiscible  (a new vocabulary word I learned from my pal David Shaywitz recently), by which I mean they are not totally incapable of mixing.  We have seen evidence of the cocktail here and there (Propeller Health, Canary Medical, even products like implantable defibrillators from big companies like Boston Scientific and Medtronic), but they have been rare, with most of the medical device world focused more on the mechanical engineering aspects or even the bioresorbable aspects than the data-intensive ones.

And even more relevant perhaps, the medtech world has stayed largely away from the payer world, thinking about reimbursement primarily as an offensive strategy much akin to how one might guard LeBron James, rather than how one might hold hands and sing Kumbaya. Few of the medtech stalwarts have really committed to products that are intended to reduce costs to the healthcare system; the usual refrain is better medical devices are “more expensive but someday the world will thank us.”

But there I was, in the belly of the medtech beast, watching two very stalwart representatives of the field (guys who have been at it a really long time with many successful medtech companies under their belt) say things like this:

Fred Moll, Current CEO of Auris Health and Founder of Hansen Medical, Restoration Robotics and Intuitive Surgical, among other things, said:

• Electronics in and on the body is the biggest recent trend affecting medtech;
• Big technology companies are making real inroads into medtech and traditional medtech must partner with them to deliver better healthcare; and
• Use of technology to transform the cost of healthcare needs to be in the forefront of medical device thinking

Andrew Cleeland, currently CEO of the Fogarty Institute for Innovation and founder of medtech companies Twelve and Ardian, among other medtech roles, said, and I quote, “There is a roomful of people here who would completely agree with that.”

I had to pinch myself to be sure I was actually in Minneapolis.  And that’s not because I disagree with any of those statements; in fact, I violently agree.  But I haven’t heard them so starkly stipulated as fact by those who have been instrumental in building the medical device industry to what it has become.  Seriously, there was a time – and it wasn’t more than 5 or 6 years ago – when I suggested to another big medical device leader that their longtime medtech conference (a different one) might consider incorporating some stuff about the booming digital health field and how it was going to change the face of medtech.  He nearly laughed me off the phone, saying that this really wasn’t relevant to his audience.  My how the times have changed.  And that’s why I’m scanning the horizon for the flying pigs – the change in thinking is dramatic.

I used to feel like the only person who had ever given any thought to the convergence of tech and devices at these conferences.  They were littered with people who had spent their whole careers thinking that the medtech field was special and different and that to mix with the healthcare IT side was, well, weird.  But this same panel with Cleeland and Moll also featured Robin Thurston, CEO of Helix, who is at his very first medical technology company (consumer-focused genetic testing) and who most recently worked for UnderArmour after starting MapMyFitness.  Talk about an unusual mix.  It was such an interesting discussion.

And I’m so glad to see the dawn of this new convergence thinking become more and more generally accepted.  I will say that I have very recently spoken to several medtech executives who haven’t get gotten the memo that the world has changed and who are still trying to sell the old “if we build it, they will come” story. But if guys like Moll and Cleeland are preaching this gospel, it won’t be long before the rest of the converted will declare themselves.  The medtech world definitely has to recast itself as a group that contributes to reducing healthcare costs through improving quality.  The old narratives just don’t work anymore and are exactly what led to the decline in medtech investing.

My panel was a lot of fun to moderate.  I got to hand-pick my participants and decided to mix it up with three entrepreneurs working right at the nexus of digital and devices (Christine Tsien Silvers from Health Reveal, Fabien Beckers from Arterys and David Van Sickle from Propeller Health) and a big medtech leader (Ken Stein from Boston Scientific) who has also very much seen the light of the new day (or long ago realized that it was the flying pigs who were blocking out the sun).  We spoke about how the market is changing and how these companies are using data and machine learning to make medtech better, stronger and cost-reducing.

We talked about taboo topics like whether prices should drop when data yield information that certain devices are less effective than others or whether outcome and price should be tied together (short answer: yes).  We talked about how complex the issues are about maximizing corporate revenue and knowing that one’s products are better suited to a smaller market than originally hoped, as a result of seeing data that proves it. We also spoke about the complexities of knowing whether we yet have the right data to be effective in these endeavors and whether the data itself is ready for prime time or still needs much hand curation (yes it does). Good stuff.

And I was somewhat amazed to see the audience paying attention.  There were few people looking at their cell phones (at least compared to the usual conference) and people deeply focused on the new AI narrative and how it affects them.  I polled the audience at the start of the panel and asked how many felt truly comfortable with the Data/ML/AI conversation that has overtaken the healthcare space and about 1/3 of people raised their hands.  I also asked the audience how many of them were tired of hearing these buzzwords and about twice as many responded in the affirmative.  And yet, despite the buzzword fatigue, the medtech world is clearly finding a hunger to learn and think in new ways.  Finally: Watch out for the pigs.

Source: https://medcitynews.com/2018/06/convergence-of-technology-and-medical-devices/

Teladoc Buys Advance Medical For $352M In Global Telehealth Deal by Bruce Japsen

Teladoc, a fast-growing U.S. provider of virtual access to physicians, said it has purchased telehealth provider Advance Medical for $352 million to increase its presence in the global marketplace outside the U.S.

Like the U.S., there are big opportunities around the world to offering access to physicians and patients via smart phone, tablet and computer. Employers and private insurers are already embracing the trend as a way to make healthcare more convenient and avoid costly and unnecessary trips to the emergency room or a more expensive physician’s office.

“This acquisition advances our strategy to continually expand our product portfolio, as well as our operational footprint in attractive global markets,” Teladoc CEO Jason Gorevic said.

Under terms of the deal, the purchase price includes $292 million in cash and $60 million in Teladoc stock. The co-founders of Spain-based Advance Medical, Marc Subirats and Carlos Nueno, will join the Teladoc executive team, the companies said.

“We share Teladoc’s belief that a virtual care solution should be comprehensive in nature, and provide answers and outcomes for people regardless of their location or medical condition,” Nueno said in a statement. “Our clients have increasingly demanded high-quality virtual care at scale, and now we have the ability to bring this meaningful change to the healthcare system.”

In particular, the deal helps Teladoc expand into markets in Latin America and Asia  “where private health insurance growth rates are more than double that of the U.S.” The U.S. market is taking off with coverage expanding in the private sector thanks to big insurers like UnitedHealth Group, Anthem and the coming expansion of telehealth coverage under Medicare health insurance for the elderly. Such insurance coverage has been a boon to companies like Teladoc and rivals American Well and MDLive.

In announcing their deal, Teladoc and Advance Medical said more than one-third of individuals around the world are waiting “longer than four weeks to see a specialist.” Advance Medical has 8 locations around the world and its “expert medical opinion has helped people in more than 125 countries,” the company’s web site says.

The combination of Teladoc and Advance Medical "delivers care in 125 countries, in more than 20 languages," the companies said. The combined company has more than 2,000 employees.

Founded in 1999, Advance Medical said it has partnered with more than 300 large, multimational employers and insurers across Europe, Asia, Latin America and the U.S.

Source: https://www.forbes.com/sites/brucejapsen/2018/06/04/teladoc-buys-advance-medical-for-352m-in-global-telehealth-deal/#61b6fabf248a

Novel microscope technology offers images of the brain with 4K resolution and 3D visualization by News Medical

The Department of Neurosurgery at the Icahn School of Medicine at Mount Sinai is one of the first hospitals in the country to use the ZEISS KINEVO® 900 microscope, a new surgeon-driven, robotic visualization system that merges the functionality of a surgical microscope with 4K resolution and 3D visualization along with specialized robotic control. Optical, navigation, and simulation information are streamed into the microscope's eyepiece and projected on large monitors in the operating room, providing a detailed perspective for the operating room staff, including co-surgeons, surgical assistants, and medical residents, who can all view the high-resolution images in real time. 3D glasses provide an enhanced visualization of neuroanatomy.

"An important question for neurosurgeons has always been, where is the best place to view optical information from the microscope--should one look through the eyepieces as we've done traditionally, or should that information be gathered by high-resolution video and projected on a monitor," says Joshua Bederson, MD, Professor and System Chair for the Department of Neurosurgery at Mount Sinai Health System and Clinical Director of the Neurosurgery Simulation Core.

Dr. Bederson says one advantage to projecting real-time images of the brain onto a video screen is that information sources from outside the microscope can be overlaid on the monitor. This augmented reality includes navigational guidance that alerts the surgeon to "no-fly zones"--neuroanatomy that should be avoided during surgery. The KINEVO® 900 utilizes an open interface that allows for integration with navigation and image-guided software developed by the medical technology companies Brainlab and Surgical Theater.

"The analogy is the heads-up-display that aircraft pilots have when they're looking at navigation information during flight," said Dr. Bederson, a licensed pilot. "The operating room of the future is one that integrates multiple information sources streamed into the surgeon's viewpoint in a way that is non-distracting and can be used in the service of patient safety."

KINEVO® 900 has several features that are the first of their kind, including a specialized robotic control system called PointLock, which enables the surgeon to focus on a particular point in the surgical field and move the microscope in a spherical arch without losing focus, with the use of a foot pedal. This allows the surgeon to navigate safely around the patient during surgery as opposed to repositioning the patient. PositionMemory stores magnification and focus settings for key regions of the brain. A micro-inspection surgical tool called QEVO® is engineered with an angled design, allowing the surgeon to look around complex structures that are out of the microscope's range.

"Our team of neurosurgeons is driving and advancing the development of next-generation simulation and virtual reality technology, which can help improve patient outcomes and solve neurosurgical challenges," says Dr. Bederson.

The Icahn School of Medicine at Mount Sinai purchased the two robotic visualization systems with the generous support of a donor who wishes to remain anonymous. Dr. Bederson is an expert in skull-base and cerebrovascular surgery and has performed more than 3,700 neurosurgical operations at Mount Sinai. Dr. Bederson owns equity in Surgical Theater, LLC.

Source: https://www.news-medical.net/news/20180601/Novel-microscope-technology-offers-images-of-the-brain-with-4K-resolution-and-3D-visualization.aspx

Waymo just revealed plans to add 62,000 self-driving minivans to its fleet by Matthew DeBord

On the same day General Motors and Japan's SoftBank announced a massive $3.35 billion investment in GM's Cruise self-driving-car division, Waymo and Fiat Chrysler Automobiles revealed an expansion of their partnership — and dangled an intriguing new business option.

FCA plans to supply Waymo's autonomous fleet with 62,000 Chrysler Pacifica minivans, a big leap from the 600 vehicles Waymo is now operating. According to the companies, deployment will commence later this year.

"FCA is committed to bringing self-driving technology to our customers in a manner that is safe, efficient, and realistic," FCA CEO Sergio Marchionne said in a statement. "Strategic partnerships, such as the one we have with Waymo, will help to drive innovative technology to the forefront."

Marchionne is a recent and rapid convert to autonomous tech, where until the Waymo partnership emerged in 2017 the carmaker was seen as lagging peers such as GM and Ford. The CEO — who oversaw the merger of Fiat and Chrysler during the financial crisis in 2009 when Chrysler was bailed out by the federal government and entered bankruptcy — will retire in 2019.

In combination with Waymo, FCA hasn't just been playing catch-up; the automaker has surged into a leading role.

"Currently, Waymo is the only company with a fleet of fully self-driving cars, with no one in the driver seat, on public roads," the companies said in a joint statement. "Later this year, Waymo will launch the world's first self-driving transportation service, allowing the public to use Waymo's app to request a vehicle."

John Krafcik, Waymo's CEO, added: "We're excited to deepen our relationship with FCA that will support the launch of our driverless service, and explore future products that support Waymo's mission."

The self-driving-car race is heating up

Waymo CEO John Krafcik.

Waymo used to be referred to as the Google Car Project, until the division was spun off in late 2016. It has been pursuing autonomous technologies since 2009, but only recently has Krafcik begun to offer insight in how the company will build businesses around its approach.

FCA is a prominent auto-industry partner, providing a versatile minivan that can transport small groups of riders. Around the time of the New York auto show this year, Waymo announced that it would add Jaguar Land Rover as a partner, using the forthcoming Jaguar I-Pace as a luxury platform for what Waymo calls its autonomous "driver."

Thus far, fully autonomous technologies have been discussed in the context of ride-hailing or -sharing services, in which the tech and the vehicles can be "geo-fenced," or confined to specific areas that can be mapped with a high level of accuracy.

On Thursday, however, FCA and Waymo dangled the possibility of Waymo technology being licensed for use in FCA vehicles available for consumers to obtain. That would represent a significant leap into the existing car business, where self-driving systems such as Tesla's Autopilot and GM's Cadillac Super Cruise are effectively very advanced forms of cruise control.

Waymo has stressed the breadth of what the technology can achieve, ranging from models now being developed to a future in which the systems provide shipping and logistics services and augment public transportation.

FCA CEO Sergio Marchionne.

Bill Pugliano/Getty Images

Multiple approaches to a rapidly evolving business opportunity

Waymo and FCA are taking different approaches to autonomy than GM Cruise is, though both sides have bet on laser radar, or lidar, as the best technology for fully self-driving cars. (Tesla Autopilot, by contrast, uses a system of cameras and sensors, avoiding the more expensive lidar units.)

GM maintains that software and hardware have to be integrated at the level of manufacturing to achieve successful autonomy and to scale the business opportunities. Waymo, not being a huge manufacturer of automobiles, has concentrated on developing a "driver" that can be installed in a variety of vehicles.

Both approaches could work out, but what's clear is that as the race to create fully self-driving vehicles intensifies, the rubber is finally starting to seriously hit the road.

Source: http://www.businessinsider.com/waymo-fca-strengthen-self-driving-partnership-2018-5

Trump’s HIV-HPV Blunder Reveals A Fundamental Health Care Problem by Margaret Danilovich

Bill Gates recently shared a story with Gates Foundation staffers about a meeting he had with President Donald Trump, in which Trump asked about the difference between human immunodeficiency virus (HIV) and human papillomavirus (HPV). The audience laughed as the billionaire philanthropist said he told Trump “those are things that are rarely confused with each other.” Health Twitter erupted upon hearing the news, mocking the president’s confusion and ignorance.

Trump has tweeted in the past that America needs to “add more dollars to Healthcare,” but perhaps we should focus on improving the health literacy of our political representatives first.  

As a physical therapist and assistant professor at Northwestern University’s Feinberg School of Medicine, ― I’ve experienced firsthand how confusing medical terminology can be for patients. An 80-year-old patient of mine once refused to lie on her stomach for a physical therapy exercise out of fear of dying from sudden infant death syndrome; she didn’t know that SIDS only affected infants. I’ve had patients who believed fractures and broken bones were two different things, patients who sought help for “rotary cup” (rotator cuff) tears.

So while it’s frustrating as a health professional to hear that the president doesn’t know the difference between two very different diseases, I understand the confusion. Both viruses can be transmitted through sexual activity, and they are commonly referred to by similar abbreviations.

Nonetheless, such medical misunderstandings are a significant public health problem. Currently, only 12 percent of U.S. adults are proficient in health literacy.

Being ‘like, really smart’ ... does not guarantee adequate knowledge of often complex medical terminology.

Health literacy is the extent to which people are capable of obtaining, processing and understanding health information and services in order to make informed health decisions. When a person has poor health literacy, they may have difficulty completing medical forms. They may not grasp how to properly manage health conditions. They may struggle to communicate effectively with health care providers.

Health literacy also encompasses math skills, such as calculating calories or serving sizes from a nutrition label, understanding medication dosages and interpreting blood sugar levels.

And health literacy translates directly into health outcomes. Patients with lower health literacy levels experience greater risk of mortality and in one study were 52 percent more likely to be hospitalized than patients with better health literacy. They also tend to experience higher pain levels and slower recovery after surgery.

Health illiteracy is expensive both for patients and for taxpayers. One report estimates that low health literacy costs the U.S. economy between $106 billion and $238 billion annually. Individuals with low literacy pay up to $8,000 more per year in health care costs compared to those with adequate literacy.

Over the course of my career, I’ve seen countless patients labeled as “non-adherent” for missing appointments or failing to follow medical recommendations. But those with low health literacy are often not ignoring medical advice; they simply don’t understand what they’re supposed to do. The stigma of low literacy can also embarrass patients and makes them less inclined to seek future services necessary to manage their health.

As we’ve seen in recent weeks and years, even those with high levels of formal education can be health illiterate. Being “like, really smart,” as the president once described himself, does not guarantee adequate knowledge of often complex medical terminology. 

Take, for example, Mick Mulvaney, Trump’s budget director, who suggested those with diabetes are at fault for their disease because they drink sugary beverages and don’t exercise. In reality, diabetes has multiple causes, including genetics and environmental factors; sugar doesn’t directly cause diabetes.

Our politicians are particularly health illiterate when it comes to female anatomy. Former Rep. Todd Akin infamously said in 2012 that “the female body has ways to shut that whole [pregnancy] thing down,” implying that women’s bodies would somehow automatically stop a fertilized egg from becoming implanted in the uterus after sexual assault. And don’t forget Rep. Vito Barbieri, who didn’t seem to understand that the vagina is not part of the digestive system.

If we want to truly reform health care, we must start by improving health literacy among all Americans ― from individual patients to the president.

It’s concerning that those in charge of setting health policy may be ignorant of very basic health facts. If we want to truly reform health care, we must start by improving health literacy among all Americans ― from individual patients to the president of the United States.

One place to begin is by funding programs that support health education. Health classes are not required at many schools, which means many children aren’t being taught basic information about how the body works and the importance of lifestyle interventions, such as physical activity and healthy nutrition. Better education in these formative years can give people the resources to prevent and manage diseases later in life.

Medical schools should also increase the amount of time spent on health literacy education. Current curriculums spend on average only three hours teaching future health care providers how to work with patients with low health literacy, and one survey of health care providers showed 16 percent had received no such training at all. Better education will help doctors and nurses assess and address literacy issues among their patients.

Evaluating health literacy should become a standard part of every medical encounter. Routine literacy assessments will reduce the embarrassment for patients in admitting they don’t know and thereby increase the chances they can ultimately make informed decisions.

As a society, we need to de-stigmatize low literacy levels and educate, rather than laugh, when people are unfamiliar with health concepts. We have to do this even when it’s difficult ― even when the person unfamiliar with basic health concepts is a politician in charge of creating health policy. By reducing the fear and shame around asking questions, we can ensure that people will ask when they need clarification rather than letting their health suffer in silence.

Source: https://www.huffingtonpost.com/entry/opinion-danilovich-health-literacy_us_5b0eab89e4b0802d69d03cb5

3 Innovative Medical Technology Companies Shaking Up the Diabetes Market by Motley Fool

DexCom Inc. (NASDAQ:DXCM), Insulet (NASDAQ:PODD), and Tandem Diabetes(NASDAQ:TNDM) are working on new medical devices that could significantly improve the lives of people with diabetes. Addressing this massive market is a big opportunity, but are these stocks worth adding to your portfolio?

Analyst Kristine Harjes and Motley Fool contributor Todd Campbell explain how smarter continuous glucose monitors and insulin pumps are disrupting patient treatment.

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Kristine Harjes: I already started to intro our next company as the first company to get a CGM approved. This one is Dexcom, their ticker is DXCM. They're a much smaller company, around a $7.5 billion market cap. About a decade ago, they were able to achieve this distinction of being the first FDA-approved maker of a continuous glucose monitor, which was pretty revolutionary. We mentioned Abbott's system, and how that was very disruptive. Where does that leave Dexcom? Are they old news now, or are they still able to compete?

Todd Campbell: A lot of people were very concerned about what this would mean for Dexcom. Now, Dexcom is 100% exposed to the diabetes marketplace, so this would be a pure-play within the area. They were pioneers and remain, I think, pioneers in CGM technology. They have taken an agnostic approach to developing CGMs, meaning that they want their CGM to be able to be used with whatever insulin pump or insulin delivery device a patient chooses. That could be an advantage for Dexcom longer-term.

They closed the gap to the FreeStyle Libre earlier this year when the FDA approved their latest generation CGM, that's the G6. The G6 also doesn't require finger sticks for calibration. It does have one advantage in that the FDA approved it to be interoperable with other devices. That's the first time the FDA has given that kind of a nod in its language to one of these CGMs. That means that this CGM can be used, again, agnostically, with other insulin pumps made by other companies we're going to talk about in a second, or even with apps that are developed for smartphones, etc.

Harjes: Right. I'll add one other distinction that Dexcom has going for it. In a head-to-head study of the G5, which was its previous system, vs. the FreeStyle, which was Abbott's system, it showed that the G5 actually outperformed in terms of time required to detect hypoglycemia. That study just came out earlier this year and should be a little bit of a tailwind for them in trying to compete with Abbott. But, I also truly don't think that the winner that comes out on top is necessarily going to be the only winner. This is an enormous market, as we led off with at the very beginning of the episode, so I can see room for multiple winners.

Campbell: That's an awesome point. On the FreeStyle Libre, Abbott is saying that they're adding, I think, 50,000 patients a month. This is a huge market. And two-thirds of those patients, I think, are type 1, and one-third is type 2. We're barely scratching the surface in type 2 diabetes for CGMs.

I think, as these machines get more savvy, smaller, more efficient, more easily used, and potentially cheaper, payers are going to begin to reimburse them more widely. Just to put it in context, too, with the FreeStyle Libre being on the market, Dexcom still delivered year over year growth in the first quarter of 30%. That was $184 million in revenue. This year, they're guiding for sales of $850-860 million. So, despite the threat from Abbott, it's not like this company is seeing a deceleration in its sales.

Harjes: Those are your CGM makers. Let's move on and talk a little bit about the insulin pump makers themselves. One of them that we want to highlight is called Insulet, ticker PODD. They're a $5 billion market cap company, and they make something that's called the Omnipod Insulin Management System.

Campbell: These are really cool devices. They look a little bit like the old AirPort that was made by Apple, they're kind of a saucer-like device. They're relatively small, though, and you can stick them on your skin to deliver insulin directly into your body. You can wear them for up to three days. It's a very freeing device. I happen to know someone, a neighbor who's a young 15-year-old, very active, and he wears one and absolutely loves it. It's paired up, typically, with a CGM. Oftentimes, it's being paired up with CGMs that are made by Dexcom. Its sales last year, in 2017, grew 26% to $460 million. And, thanks to some new Medicare reimbursement coverage, sales should grow to between $565-580 million this year. That's up 22-25%.

So, again, a pure-play insulin pump maker that also, intriguingly, wants to challenge Medtronic. They're developing their own closed-loop system. We talked a little bit about Medtronic and their 670G, which is their artificial pancreas system. Well, Insulet is developing its own. That system will be pairing up its pods with Dexcom's CGM. And according to management, they plan on incorporating, over time, the latest Dexcom that just got approved, the G6.

Harjes: There are several different intriguing partnerships and overlaps between some of these businesses. It's actually difficult to pick apart who's going to head-to-head as a competitor and who's playing nice with interoperability and working together to develop things, because all of these companies are fairly closely tied together.

You mentioned reimbursement. I do want to stress that that's actually a really important point to look into for each of these companies. When a new device is approved, that doesn't necessarily mean that it's going to be covered, particularly by Medicare and Medicaid, which cover an enormous amount of patients. So, you'll see in some of the earnings reports and press releases for these companies that they will highlight, "Our newest device just got approved for coverage by Medicare Part D prescription drug benefit program." That's always really good news to see. So, another key development to look out for with all of these companies.

Campbell: Right, because otherwise you're paying for this stuff out of pocket and it can get pretty costly. It's been one of the things that's held back the penetration of the CGMs, especially, is showing and convincing payers that better control of your blood sugar levels over time will reduce their costs, it's a long-term money-saving thing. We've talked on the show about this in the past, Kristine, how difficult it is, because most people change their insurance within a few years. So, the company may be paying for something now that has a long-term benefit may actually not benefit from that long-term benefit, and maybe it's Medicare or someone else who actually gets the benefit from it.

Harjes: And these are largely razor-and-blade model businesses, which, from the business perspective, is really great. You have the initial sale of the device and then you have disposable consumable elements of it that produce recurring revenue. But, if you look at that from the payer side, maybe that's not quite as good, because that means that you're going to be on the hook for paying for not just the device, but also all of the consumables that go along with it.

The last company that we want to talk about today is somewhat similar to Insulet in that they are an insulin pump maker. They're called Tandem Diabetes Care, ticker TNDM. Pretty small company here. Actually, I think they're the smallest we've talked about today. They're only a $660 million market cap company. They've been extremely volatile, they have been extremely dilutive of their shareholders. But, they have some partnerships with Dexcom, and they're doing some interesting things.

Campbell: They make the touchscreen t:slim X2 insulin pump. It's the only pump, they claim, that can allow for remote feature updates from a computer. That could be advantageous to people who want to be able to buy it once and be able to get some updates on it. It is, like Dexcom and Insulate, 100% exposed to the diabetes market, so theoretically its demand and sales are going to grow right alongside diabetes growth.

It is also working, like Insulate is, on its own closed-loop artificial pancreas system that could theoretically someday challenge Medtronic. But, we're still probably at least a year away from starting to see that product come on the market, maybe two years, depending on how these trials play out. On that artificial pancreas system, it's also working with Dexcom. It's pairing up Dexcom's CGM with its pump.

You mentioned that it's the smallest of the bunch that we're talking about today, absolutely. Its revenue in the first quarter was much smaller than these other companies. It was about $27 million in the first quarter. In 2017, they only did $108 million in sales. First quarter sales, though, were up 44%. That's good. We'll have to see whether or not they continue to win market share away from these other pump makers.

I think one of the things, though, that we have to remember, Kristine, to tell all of our investors is that these pure-plays that we're talking about? They're all losing money.

Harjes: That's true. It makes them kind of hard to value on traditional metrics. And even when you use stuff like price-to-sales, they actually still look very expensive. I think that's a question worth exploring a little bit. Most of these companies do look like they're extremely expensive. Are there any bargains to be found in this space?

Campbell: Well, bargains are always relative. Right, Kristine? We talk about this when we talk about investing all the time. I think, yeah, it's great if you can buy a stock on sale. But what's more important over a ten or 20 or 30-year long-term time horizon is, how big is the market opportunity, and is there a competitive advantage that could allow one of these companies to win vs. another company.

So, yes, the price-to-sales ratios are elevated on these stocks. You're running anywhere between 5-10X for the pure-plays. But you can justify that if you say to yourself, "Yeah, but, we're only scratching the surface on the tens of millions of patients, theoretically, that could begin to use CGMs and pumps over the course of the next ten to 20 years."

My advice to investors would be, yeah, recognize that if you're a value investor, you're not going to be buying these three pure-plays. You might want to look at Medtronic and Abbott instead. But, if you're a growth investor, stay focused on the big picture, which is that the patient population, the addressable market, is going to climb significantly over the course of the next decade.

Harjes: And if, by chance, you're looking at Tandem specifically because it's so small, and saying, "Why shouldn't they be just as large as Insulet? Let me buy them now," I do want to make sure that I mention, this is a company that, as you mentioned, Todd, is losing money. But, that alone is not a terribly bad thing. That's OK for the place that they are right now in their business cycle.

But, they have a large amount of debt. They have $72 million in cash. Most of that came from an equity offering in February. They have been extremely dilutive. Shares outstanding have risen 900% over the last one year, 400% since just January. This is a company that is fairly early stage relative to a company like Insulet, so they need financing, and they need to take these sorts of actions in order to keep their business running.

So, when you're comparing your stocks, I wouldn't necessarily say, "Hey, these two have the same addressable market, but Tandem is so much cheaper on a market cap basis, let me immediately go for that." I mean, I think it's an interesting company, but it's a lot riskier than the more developed, more mature Insulet, which is, by its own accord, also not going to be as mature and as developed as something like Medtronic.

Campbell: Yeah. Maybe, of the three pure-plays, Dexcom is the more mature. I don't want to say it's less risky, because it's a plenty risky stock, Kristine. [laughs] Just look at its stock price chart over the course of the last three years, right? But, the fact that it's agnostic and it has exposure to both Tandem and to Insulet, maybe that makes it a little bit less risky, because it doesn't matter which one of Insulet or Tandem gets to market first with a competitor to Medtronic's closed-loop system.'

Source: https://www.fool.com/investing/2018/05/28/3-innovative-medical-technology-companies-shaking.aspx

Health Insurance Coverage For Healthy Groceries? More Food-Based Interventions May Be Coming by Tommy Tobin

Health insurance plans cover a variety of medical procedures, prescriptions and provider visits. A recent change in how some plans interpret health-related insurance benefits may see more plans offering food-based benefits, including meals and healthy groceries.

Hippocrates, of the eponymous Oath, famously wrote “Let food be thy medicine.” A little over a decade ago, the editor of the British Medical Journallamented, “Although many patients are convinced of the importance of food in both causing and relieving their problems, many doctors' knowledge of nutrition is rudimentary.” Fortunately, food as prevention-based medicine is gaining traction across the country, with some seeing the paradigm already shifting.

The federal government recently gave the go-ahead for Medicare Advantage plans to broaden the scope of supplemental, “health-related benefits” for individuals. The Centers for Medicare & Medicaid Services (CMS) has signaled that they will consider approving insurance plans with additional benefits that “compensate for physical impairments, diminish the impact of injuries or health conditions, and/or reduce avoidable emergency room utilization.”

The scope of these new “health-related benefits” is considerably broad. Insurers are readying their 2019 plans to incorporate this new definition, and it remains to be seen what these benefits will include. Kaiser Health News reports that insurers might include “air conditioners for people with asthma, healthy groceries, rides to medical appointments and home-delivered meals.”

The new supplemental benefits might induce more beneficiaries to switch from traditional Medicare to Medicare Advantage, despite CMS’ caution to the contrary. Unlike the traditional government Medicare program, Medicare Advantage program is run via private insurers offering CMS-approved plans. Given the inclusion of the word “Medicare” in Medicare Advantage, the similarities in name between the two programs may be confusing to some beneficiaries.

Time will tell how successful these additional “health-related benefits” will be at improving health outcomes or driving down the costs of healthcare. As Kaiser Health News noted, some consumer advocates warn that the extra benefits in Medicare Advantage could come at the detriment of individuals on traditional Medicare.  The decision to enroll in Medicare or Medicare Advantage can have ramifications for the beneficiary, including coverage limitations regarding providers and hospitals. Additional money for groceries should not come at the expense of a plan that more appropriately meets an individual's healthcare coverage needs. Even so, two aspects of the “health-related benefits” program are particularly exciting.

First, the new plans could lead to new data available for health quality researchers, which would increase the body of knowledge regarding evidence-based interventions around food and health.  Given that the parameters of the “health-related” food benefits are undetermined, they might be specifically tailored to meet the needs of particular health conditions, like heart disease or diabetes. The variety of potential interventions could provide ample room for researchers to determine what interventions have the greatest impact for individuals and the healthcare system overall.

Data regarding costs and health outcomes gleaned from the new plans might be in line with a recent Health Affairs study, in which participants in a food program experienced a statistically significant decrease in overall medical spending. Those in a medically-tailored meal program not only had a 16% decrease in overall medical spending but also reduced emergency department visits, inpatient hospital admissions, and emergency transports.

Second, many Medicare Advantage insurers also operate individual and group plans. If these extra benefits in Medicare Advantage are successful in reducing costs and advancing beneficiaries’ health, more plans could offer similar benefits. In doing so, insurers could be incentivized to increase their use of food as a preventative tool to improve health or food as medicine, providing individuals with medically-tailored meals to meet the nutritional needs of particular disease processes.

While the details of the new Medicare Advantage plans are still undetermined, one hopes they build on the existing evidence regarding successful interventions. Food-based interventions in the healthcare system are only set to grow to stem rising healthcare costs and improve individual and community health. The new plans could be a step in the right direction for insurers, and the basis for future pilots or studies to build evidence for further food-related health interventions to lower costs and improve health outcomes.

Source: https://www.forbes.com/sites/tommytobin/2018/05/24/health-insurance/#1182b06c459b

How To Democratize Healthcare: AI Gives Everyone The Very Best Doctor by Vijay Pande

The greatest problem of health care in United States -- the world leader in health inequality -- isn’t actually about the quality of care. The greatest problem we have is access to care. According to the CDC, nearly 20% of adults in the United States have no regular source of healthcare. One of the places this is most stark is in lifespan -- where the wealthiest Americans have benefits from steady gains, about five years of additional longevity from 2000-2014 -- versus the poorest, for whom, during the same period, life expectancy hasn’t changed at all.

There are many factors that contribute to this growing divide in mortality, socioeconomic and medical -- but one of the biggest is simply not enough physicians in the right places. The best doctors and providers are drawn to similar circumstances: top hospitals, with the top tier of colleagues, in the most desirable places to live, with patients that can pay for services. But soaring prices of medical care is also a critical part of the growing problem. The costs of treating chronic conditions like diabetes continues to grow with the aging population. The rising cost of doctors (already high, and rising at 7-10% per year), pharmaceuticals, and expensive medical technology lies squarely on what’s referred to as Eroom’s law, the evil twin of Moore’s law, where the cost of healthcare exponentially increases over time.

This leaves us with more needs, but fewer, more expensive providers. The pressing question today is: Can new technologies slow or even reverse the exponentially rising costs to help truly democratize healthcare? The wealthiest patients today benefit not only from being able to afford the top medical services -- but also maybe even to fly somewhere to get the opinion of more than one of the top doctors in the world. Imagine we could all do this -- if to diagnose any condition, every patient called in, say, a conference call of the top 50 specialists in their field, who all drew upon their unique experiences and knowledge to confer and reach a consensus on an accurate diagnoses and treatment for that patient – who they had been following for years and years. Pretty good medical care, right? And probably the current best possible treatment for that patient. Unfortunately there’s no way in which this kind of approach or scenario is cost feasible -- or scalable.

Magnifying and speeding up the human skill of evidence gathering and analysis is exactly what Artificial Intelligence and Machine Learning do best. They canbring 50 experts to bear for a single patient -- by codifying the knowledge, taxonomy, and understanding of those experts. Machine learning is built on what the best doctors have learned, and now know: whether a suspicious looking mole is malignant or benign, whether an irregular heartbeat might be atrial fibrillation. Machine learning would be nothing without this essential human input; the technology trains on and scales the knowledge of the best doctors. And modern AI has the remarkable ability to keep learning, continuing to identify new features in the data which will give the most accurate diagnoses. This data is drawn not from a handful patients seen in an exam room but from thousands and thousands of examples -- more than most specialists will ever see in a lifetime.

Now imagine that your doctor had the ability to follow your individual history over time, thinking not just about the heart flutter that brought you in, or the suspicious mole, but knowing your entire history with perfect memory and recall. This is what’s called longitudinal data: understanding what your health has been like over time, and what’s anomalous for you versus what’s anomalous for the broader population. Like the best doctors, AI can constantly be retrained with new data sets to improve its accuracy, just the way you learn something new from each patient, each case. But the unique ability of AI to apply time-series methods to understand a patient’s deviation from baseline on a granular level may allow us to achieve a statistical understanding of causality for the first time -- figuring out exactly what elements of your particular lifestyle and/or treatment have led to your current state. In other words, while a good doctor might guess that a man might have prostate cancer because his PSA levels have risen above a “normal” threshold, a great doctor might suspect prostate cancer not because his PSA levels were high compared to the population, but high compared to his own baseline. In fact, this is precisely how doctors discovered Ben Stiller’s cancer so early. AI understands how you have changed over timemore than any human could -- and this, it turns out, is much more predictive.

AI’s broadest and most important application may be its amplification of our own collective crowd wisdom. When you look at it that way, it begins to seem absurd that we rely on the opinion of any single doctor (or two, or three!), looking at data from only one person, drawn from only one moment of time. No matter how superb that doctor might be, individuals can, and inevitably do, make mistakes. But the wisdom of a crowd of doctors – hundreds, thousands of them – and the data of thousands and thousands of patients, with more coming every day -- is very strong. The opinion of two doctors will never match terabytes of data. This is how human learning is scaled, in just the same way that the internet enabled the spread of knowledge to go faster than reading printed books. Imagine if doctors could telepathically teach each other their new findings. For modern AI methods, this is exactly what is happening.

Perhaps the most important way AI’s capabilities are super human may be the fact that AI can be replicated. Trivially. And at low cost. AI approaches are already often driven with relatively modest computational requirements, sometimes with a single GPU or a few CPUs. Thanks to Moore’s law’s continued push in this space, the cost of compute resources will soon be essentially free. So those 50 person conference calls for a single patient, tracking the patient’s health over a lifetime, are now no longer looking impossible. They are beginning to look cheap, and easy. And with the potential to reach corners of the world rife with doctor shortages, from near and far -- places like prisons, or rural areas in the US, or developing countries -- not with just a doctor, but the very best doctor humanly possible.

But democratization of healthcare will not happen on its own. The standard of care would need to change to incorporate this new technology. Using AI should be seen as amplifying and scaling the best human skills – and as such has a natural place in virtually all areas of care, including prevention, diagnosis, and treatment, from sending patients to the doctor at very early (previously undetectable) stages of disease to improving both outcomes and decreasing costs.

Scaling the doctor won’t replace doctors. It will magnify them, extend their reach, making it possible to recreate the advice of 10,000 doctors quickly and easily at lower costs -- and bringing the best medical care to any corner of our country or the world. It might even reinvent what we think of as patient-doctor interactions altogether. In the not so far off future, you might wake up, take a look in the mirror, use the toilet, and brush your teeth…where the mirror is AI enabled to look for dermatology, ophthalmology, and muscular-skelatory issues; the toilet will run a urinanalysis on analytes on your urine; and the toothbrush will gather DNA from saliva --  with clinicians getting updates as needed to give you the very best care. Making your own bathroom the doctor’s office for a mini physical every single morning would give a longitudinal analysis from months to years to decades of information about you and your deviation from your personal baseline. Imagine the benefits of the very best doctors assessing each of us daily, no matter how remote, how rural the area, around the globe, every day, for our entire lives. This has the potential to give each of us the very best standard of care derived from not just your own, but billions of people’s longitudinal data sets.

When it comes to AI and healthcare, it’s actually the status quo we should be afraid of. Without these new technological tools, inequality will certainly continue getting worse. With AI, we have the potential to give everyone the best doctor, the best tests, the best analysis, anywhere in the world and at low cost––the potential to truly democratize healthcare.

Source: https://www.forbes.com/sites/valleyvoices/2018/05/23/how-to-democratize-healthcare/2/#71359a36783f

The revolutionising potential of medical AI by Jane Griffiths

The news that Theresa May has urged the NHS and technology companies to adopt artificial intelligence techniques in order to diagnose diseases such as cancer is extremely positive for both the healthcare community and for patients (May to promise millions for AI tools to help fight cancer, 21 May).

But to usher in an age of AI, there are several obstacles that must first be overcome. Beyond the prime minister encouraging greater adoption, increased investment into how AI can safely and successfully augment healthcare and research is needed. Far greater collaboration across different disciplines and geographies is also needed to fully realise AI’s potential.

It’s important to remember that while AI has great promise, it’s not simply a case of “plug and play”. The use of AI in healthcare will necessitate purpose-built platforms that are not only technologically advanced but scientifically nuanced. Such platforms will require huge volumes of accurate, varied, multidisciplinary data, along with many years of training and algorithm-building by human “masters”

Together, AI and science can be a force for good. If the healthcare, research and technology industries can collaborate to overcome these barriers, then the future looks bright. But all parties involved must look past the hype around AI to put in place practical steps that make its widespread adoption a reality.
Dr Jabe Wilson
Consulting director, Text and Data Analytics at Elsevier

• I welcome the investment into AI helping to save up to 22,000 more lives a year by early diagnosis of cancer. However, the more patients that enter the cancer treatment pathway, the more we will need extra clinicians (endoscopists are already in short supply), all of whom need to be trained. We will also need more scanners, drugs, pharmacists, outpatient clinics and administrative staff, theatres, hospital beds, wards and cleaners.

Can Theresa May pledge the hundreds of millions of pounds that will be needed to make this scheme worthwhile and save lives?

• It is disappointing that the chief executive of Cancer Research UK has fallen into the trap of not taking into account lead-time bias when he states that the benefit of earlier diagnosis of cancer is that “fewer people each year would die within five years of their diagnosis”.

Five-year survival is measured from time of diagnosis. It is self-evident therefore that the earlier the diagnosis, the better the five-year survival figures, even if there is no gain in lifespan. In the absence of effective treatment, earlier diagnosis will simply result in more patients spending longer with the worry and anxiety of having cancer and all that the diagnosis entails in terms of invasive investigations and therapy, and the adverse effects on the patient and their family. The fight to improve the lot of patients with cancer must continue, but the numerical information on which any improvement is based must be honestly and impartially presented.
Peter Trewby
President, Association of North of England Physicians

• I applaud the prime minister’s pledge to use artificial intelligence to detect chronic diseases earlier and hence reduce premature mortality. Although the news coverage of the announcement focused mainly on cancer, the positive implications should reach people affected by countless other treatable illnesses, where late diagnosis is one of the biggest causes of avoidable deaths.

Many rare diseases, such as pulmonary arterial hypertension (PAH), a poorly known disease more often seen in women, reduce life expectancy and seriously impact a patient’s everyday life. Early detection and initiation of effective treatment are key to optimising the chances of improved survival in people with PAH.

Source: https://www.theguardian.com/technology/2018/may/22/the-revolutionising-potential-of-medical-ai

Will FDA turn to neuroscience-based human factors research? by Heather Thompson

There is a new wind blowing in medical technology — one that many believe is overdue: an overhaul of human factors.

At the recent Patient Safety Initiative, Charles Murphy, Chief Patient Safety Officer at the Inova Heart and Vascular Institute, called out human factors as one of the key factors he believed needed to be improved in medical technology development.

“In healthcare…we’d love to see safety built and designed into the system. So, I think about human factors being incorporated, and I think that’s exceedingly important—we don’t have that to the same level as other safety-critical industries,” Murphy said during the Patient Safety Movement event in March.

The need to focus more on human factors is clear. And recently FDA, has expressed interest in updating the methodologies used in healthcare, which Charles L. Mauro said still rely mostly on an old-school research style.

In particular, Mauro, who leads Mauro Usability Science, referred to methods for simulated use testing, as spelled out in FDA’s guidance on Applying Human Factors and Usability Engineering to Medical Devices, section 6.4.3.2 Simulated-Use Testing, which says:

Data can be obtained by observing participants interacting with the device and interviewing them. Automated data capture can also be used if interactions of interest are subtle, complex, or occur rapidly, making them difficult to observe. The participants can be asked questions or encouraged to “think aloud” while they use the device. They should be interviewed after using the device to obtain their perspectives on device use, particularly related to any use problems that occurred, such as obvious use error.

Mauro said there is an opportunity to improve the observational methodologies using sophisticated neuroscience-based research. He believes the tools can reveal far greater information that helps design and development teams build devices that really meet user needs while providing a greater level of safety and efficacy.

He said the main reason traditional observational research persists is that there are no alternatives yet. “My bet is that the FDA guidance is going to change, and it’s going to change quickly because they’re responsible for the quality of the safety of the patient,“ Mauro said.

“It’s really a sea change in terms of what the methodologies can do,” he said.

The future of human factors research

Mauro Usability Science employs tools such as:

• 3D spatial tracking
• Newtonian force measurement
• High definition electromyography
• High-resolution eye tracking
• Micro-facial expression analysis
• Automated task analysis and data capture
• Cognitive workload analysis
• Information foraging theory

Mauro said these new techniques provide multi-dimensional and scientifically valid data on patient interactions with the entire drug delivery patient experience.  Further, they effectively fill in where FDA guidance ends.

For example, detailed human factors specifications for patient populations that have unique limitations do not exist in research data. The effects of BMI index, size ranges, dexterity, strength, vision, or hearing might have on a patient’s ability to use a device, for example, are not well-documented. However, those factors could make usability testing more complicated. Moreover, Mauro said, the lack of objective data on patient limitations does not reduce a corporation’s duty to create a usable product under FDA guidance.

However, he also cautions that using these tools is not something any research group can do successfully. “It is quite complex. A research group can’t go out and just spend $500,000 on a bunch of sensing technology, throw it into a lab and think they’re going to have a system that works.”

The challenges

First, these methods produce vast amounts of data that are useless without advanced data aggregation and data analysis methods, according to Mauro. “If you look at the traditional system where you just had an observer in a room with a respondent, you may have a videotape of the session, but that’s it. The videotape can be viewed over and over again if you want to, but in these more advanced data capture systems, a 60-minute trial with one respondent produces about 30 gigabytes of hard data.”

Each 3D tracker, EMG or micro-facial expression capture produces a huge amount of data, said Mauro. To get a true picture, hardware and software systems need to combine the channels into a unified collection steam that provides hard data on the HFE performance. “You have to be able to visualize all those data points as they happened in real time.”

Achieving that unified system has taken Mauro and his team six years to develop, and he said it is probably the biggest challenge the team has faced. But that doesn’t mean the work is over. There are day-to-day challenges he and his team address to ensure the technology capture works correctly.

“These advanced technologies have to be calibrated before each study and sometimes they have to be calibrated during each study.” Further, he said, many of the suppliers of the technology are small firms. These firms might not have effective customer service, meaning if a portion breaks down, the team on hand can either wait or troubleshoot the systems themselves. The technology is so new, Mauro said his team is often waiting for software updates just to use it.

And that means the HFE team needs to have a certain level of expertise to set up the systems and understand the data coming in. Those skills are something Mauro said don’t usually come with the human factors engineering degree. “These are educated people, but they probably have had no experience with 3D tracking or EMGs because the technology comes from other applications.”

The teams must also have a skill set that includes statistical analysis. Traditional human factor studies have minor levels of statistical validity because the methodologies are unstructured and samples sizes are small. “But, with these new methods, you can apply extremely robust, contemporary statistical methods to the data such as conjoint analysis, multi-dimensional scaling and factor analysis.” Although these methodologies have been used in the marketing sciences but have been rarely employed in the human factors field.

Mauro also mentions that any software built must be in compliance with FDA in order to be used with a medtech product. “That is not so tough if you start with software fresh in the beginning. . . but if you forget and then come back to it, chances are you’ve got to go back and look at 500,000 lines of JavaScript.” Mauro said his team spends a lot of time verifying that the methodologies really do what they claim, including funding their own pilot testing to make sure that the technology is working properly.

As the technology matures, Mauro said he foresees a huge gain in patient outcomes, even if the cost of conducting human factors this way rises. He also said there are less-obvious ways developers can benefit from using the technology:

“When you convert human factors engineering or patient usability data to a format that is basically engineering terms and engineering quantities, the engineering, product, and development teams really adopt the information much more directly than they otherwise might with traditional observation-based subjective studies.”

In addition, the robust level of data provides clear direction for design enhancements that benefit the patient directly. Mauro also predicted that the data could allow companies to write patent claims and intellectual property claims on innovations to get patents based on human factors engineering performance. Companies could theoretically make an IP claim that a device reduces errors and improves efficiency by these human factors engineering innovations. “It produces a whole new area of IP for companies that want to capture and protect their devices.”

Source: https://www.medicaldesignandoutsourcing.com/fda-neuroscience-human-factors-research/