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Articles from 2015 In October


Healing Broken Bones with Biodegradable Implants

Recent findings suggest a new synthetic biodegradable material could help heal bones in patients with orthopedic injuries.

Kevin Baker Beaumont
Kevin Baker (Image courtesy of Beaumont Hospital)

Kristopher Sturgis

Researchers at Beaumont Hospital (Royal Oak, MI) and Johns Hopkins are hopeful that a new experimental material could someday become a gold standard for patients who require bone replacement surgery after instances like tumor removal, spinal fusion surgery, or fracture repair.

However, the material--essentially a plastic derived from cornstarch and a volcanic ash compound known as Montmorillonite clay--still faces many experimental and regulatory hurdles.

The experimental material is created by injecting a polymer-clay mixture with carbon dioxide, resulting in an implant the resembles foam, but is actually rigid and porous like our bones. The biodegradable polymer was reinforced with Montmorillonite clay nanoparticles for strength, and could potentially dissolve in the body within 18 months.

"The polymer itself has very predictable degradation rates inside the body," says Kevin Baker, PhD,  director at the Beaumont Orthopedic Research Laboratories. Baker has been working alongside Rangaramanujam Kannan, PhD, of Johns Hopkins to develop the unique material.

"The idea to reinforce the polymer with organically-modified Montmorillonite clay comes from Dr. Kannan's previous work developing polymer-clay nanocomposite materials. This leads to very high reinforcement of the mechanical properties of the polymer. This high strength is necessary when you are creating a material that needs to withstand the same loading that our bones do on a daily basis."

Baker and Kannan hope this new material can be used without the need for any additional permanent hardware placed into the patient's body. Many procedures today require metal or plastic supports for bone grafts--materials that carry the danger for potential infection, and can also complicate MRI and CT imaging tests in the future.

However the regulatory process for bone graft materials can be both lengthy and difficult. And the process becomes even more tricky when you're dealing with a technology that is among the first of its kind.

"The regulatory process for bone graft materials is arduous for a reason," Baker says. "We still have a great deal of preclinical testing that would be required before this would be approved for use in humans. Of course, the other challenge is that there really aren't any materials like ours that have achieved FDA approval."

Baker says they hope to continue their in vivo work in an effort to demonstrate the various abilities of the new technology. He believes the material could have great potential to heal fractures, fuse spines, and even fill bony defects. He's even hopeful that along the way, their work will lead to new ideas and developments that could push the technology to new heights.

"I think that if we choose the right testing framework and can demonstrate that our material achieves unique properties that can make a difference in the lives of patients, then we could find a partner willing to help us move this to market," Baker says.

Baker believes their technology could be a success because it provides a solution that is both reliable and efficient in improving patient care.

"This technology is extremely promising," he says. "We are hopeful that with the right partner, we can advance toward human use, and maybe even come up with a few new ideas along the way." 

Learn more about cutting-edge medical devices at Minnesota Medtech Week, November 4-5 in Minneapolis.

Kristopher Sturgis is a contributor to Qmed and MPMN.

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6 Medtech Predictions to Watch Out for in 2016

From home healthcare taking some baby steps to retailers driving telemedicine, there is change on the way next year, say experts at Frost & Sullivan and the design firm Nottingham Spirk.

Brian Buntz

Voltron
Get ready for a Voltron approach to healthcare (see point #6)

While 2016 will see the election of a new president, the trends that categorize the year are likely to be outgrowths of existing movements in healthcare, but by no means does that mean that 2016 will hold more of the same. Qmed spoke with Venkat Rajan, industry manager, medical devices at Frost & Sullivan and designers at Nottingham Spirk to come up with these six predictions for medtech next year:

1. Survival of the Fittest for Home Healthcare Companies

Home healthcare seems to be one of the trends that everyone in the industry talks about and for good reason. A national survey conducted by Harris Poll on behalf of Nottingham Spirk in fall 2015 showed chronic health conditions--such as diabetes, arthritis, and hypertension--as one of the top drivers of the consumer medical product market's rapid growth. This is truly a new era for in-home medical products, with analysts at IHS expecting the global market for consumer medical devices to exceed $10 billion by 2017.

Still, these are still early days yet for the home healthcare technology field, and some of the companies active in the niche have yet to identify a winning approach for their technology. "There is a lot of movement and a lot of new pilots, but the model hasn't really gained traction yet," Rajan says, who expects to see a Darwinian-like thinning of the playing field. "We will start to see some of the more ideal approaches gaining traction," Rajan says.

As for which home-healthcare approaches will likely fail, Rajan believes that non-technological hurdles are challenging for some companies in the field. "The ones that are failing are ones that maybe don't have the right partner or maybe they have a user interface that is hard to use. Or their technology collects the right data but they have trouble getting people to look at it," he says. "I think those nuances are going to be what determines the model that gains traction more than the technology behind it."

2. Retailers Driving Telemedicine Forward

As early as 1964, NASA had telemedicine capabilities; however, the potential of remotely cooperative medicine has remained more of an abstract possibility than a reality until recently. Expect retailers like Walgreens, CVS, and Walmart to help propel telemedicine forward in 2016.

Many of the pharmacies in these stores have already begun offering telehealth consultations with board-certified doctors. RiteAid has begun piloting the use of HealthSpot kiosks, which enable patients to interact with doctors remotely in a manner that mirrors an actual visit for minor complaints. The booth gives patients access to a stethoscope, blood pressure cuff, and so forth, giving patients the ability to monitor their vital signs with a doctor's remote supervision. The HealthSpot kiosks, which are manufactured in the United States, will drive opportunities across all types of manufacturing from printed electronics to fluid management and on-the-spot diagnostics, according to the design team at Nottingham Spirk.

3. A Ground-Up Approach to Serving Needs of Emerging Markets

It's nothing new that major medical device companies are seeking to stave off slowing growth in their traditional markets by expanding their business in emerging markets like China. But their approach in doing so is changing, says Rajan, who expects such companies to ramp up product development for entirely new product types to meet the unique needs of healthcare in countries like China, India, or Kenya.

Remote clinics in these countries (which are often relatively low-tech affairs--in some cases, clinics are air-conditioned shipping containers) are making extensive use of smartphone- and tablet-based diagnostics. Such clinics can share the resulting data with hospitals to help triage patients, identifying which are sickest. "I think there is potential with cloud computing, devices that could allow for innovative ways to provide testing," Rajan says. "The approaches that take hold in the developing world might be different than the ones that take hold here. You might have to develop it from ground up."

This would represent a considerable shift in thinking for major medical device companies, which have long noticed the importance of emerging markets to their future business but have sometimes struggled to meet their specific needs. "Big medical device companies would sometimes take their technology that they sold in the United States or Europe and cut the price by 20% and try to sell it in emerging markets," Rajan says. Oftentimes, that approach didn't work as well as they would have hoped. 

4. Demand Will Grow for U.S. to Get More for Its Healthcare Dollars

It seems we are constantly being reminded that the United States spends on healthcare more than any other developed nation--more than $9000 per person per year. More disturbing is that the country is not getting a good deal for the money--outcomes in the United States lag behind countries than spend considerably less money.

Rajan, however, sees the rate of increase in U.S. healthcare spending slowing. "We are seeing a leveling off of healthcare spending in the US. It will continue to climb, but we are seeing a stemming of that acceleration," Rajan says. "There is not anything immediately on the horizon that will drastically alter the course of that."

There will be, however, an increased demand to cut down on wasted spending--things like misdiagnosed conditions and unnecessary testing or procedures. "According to CMS, the hospital procedure they spent the most one was sepsis patients," Rajan notes. Each year, sepsis in the United States is linked to $20 billion in spending and 200,000 deaths. CMS, however, has targeted improving how sepsis is treated as a key priority, outlining a plan to improve early diagnosis of the condition as well as improving its treatment.

Medical device companies would be well served to adopt their business models to align with this waste-reduction trend that also prioritizes evidence-based care and priority quality over quantity.

5. Amidst Commoditization Worries, Medtech Firms Launch New Services

"There are not many industries in which the entire business model changes, but that is exactly what is happening in healthcare with the change from fee-for-service to outcomes-based or values-based reimbursement," Rajan says."If you think about it, a lot of what gets paid for already has a component of value-based care included in it." We're on track to see a CMS shift in 2016 and a more dramatic shift in 2018 to be more aligned with outcomes-based disease-management. "We seem to be moving to a true population-health-based model," Rajan says.

"Device companies are worried that their product may become commoditized," Rajan notes. As a result, many are rethinking how they could bundle services with their products and are drafting risk-based sharing contracts they could establish with hospitals. Philips even recently debuted a subscription model for its app-based ultrasound.

"Medical device companies want to be seen not as a retailer to the hospital but as solutions partners." The goals of medical device companies will be more closely aligned with those of hospitals, which, incidentally, are not just thinking about getting procedures done but about matters such as preventing infections, reducing procedure times, patient comfort, and patient satisfaction.

6. A Voltron-Approach to Innovation

Since the introduction of the drug-eluting stent, the medical device industry has struggled to identity another blockbuster medical device. And even the profit margins for drug-eluting stents began to fall not long after their introduction, convincing former stent innovator Johnson & Johnson to exit the market by 2011.

Other recent promises of the "next big thing" in medtech have also fallen flat. Take the case of renal-denervation, which not long ago, was thought to be a billion-dollar business. Perhaps renal denervation is not dead yet, but it may end up as more of a niche technology than a blockbuster one.

Silicon Valley-unicorn Theranos may possibly be another cautionary tale of the sheer difficulties of a single technology disrupting healthcare. Previously valued at more than $9 billion, the firm has attracted considerable skepticism and after a series of exposés by the Wall Street Journal. "They are facing the blowback of trying to move at the pace of Silicon Valley in healthcare," Rajan says.

Perhaps 2016 will be the year when the medical device industry takes a more of a Voltron-like approach, where individual technologies joined together prove to be more effective than the proverbial sum of their parts. "It is not about which device you use but the entirety of the process," Rajan says. "Ideally everything is working together and your devices are interoperable. One device might work great for its given indication, but if it doesn't work with the EMR system, it can create a lot of inefficiency."

Still, the healthcare industry is poised for an Uber-style disruption, but accomplishing such a breakthrough in healthcare can be nearly impossible for a single firm to pull off.

Perhaps the disruption will be triggered by the increasing overlap of connectivity and analytics into healthcare. "The biggest problems in healthcare aren't going to be solved by a new MRI machine," Rajan says. Instead, they could be solved by the application of computing technologies that are taking hold in different industries in other forms. "In healthcare, decision-support artificial intelligence is one example of a technology that could help drive value in healthcare both inside and outside of the hospital," Rajan notes. "An analytics and connectivity have not been competencies for a lot of the traditional medical device companies."

Learn more about cutting-edge medical devices at Minnesota Medtech Week, November 4-5 in Minneapolis.

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A $250 Million Legal Settlement over ICDs

The U.S. Justice Department claimed that hundreds of hospitals across the country implanted implantable cardioverter defibrillators into people--and billed Medicare--when they should have been waiting. Could the crackdown curtail use of ICDs?

Chris Newmarker

Federal prosecutors claim it is a victory for using evidence-based medicine to rein in healthcare costs. Cardiac device company officials may be wondering whether it will affect future sales.

The U.S. Justice Department on Friday announced that it had reached 70 settlements worth more than $250 million over hospitals implanting ICDs before a Medicare-related waiting period expired. The settlement involves 457 hospitals in 43 states.

"While recognizing and respecting physician judgment, the department will hold accountable hospitals and health systems for procedures performed by physicians at their facilities that fail to comply with Medicare billing rules," said Benjamin C. Mizer, head of the Justice Department's Civil Division, said in a news release.

The largest settlements included HCA Holdings Inc. (Nashville, TN) paying $15.8 million over alleged ICD billing practices at 42 affiliated hospitals, Ascension Health (St. Louis) paying $14.9 million over ICD billing at 32 affiliated hospitals, and Community Health Systems (Franklin, TN) paying $13 million to settle claims involving 31 affiliated hospitals.

HCA noted in an August filing with the SEC that 95 of its hospitals were originally under investigation. "HCA makes no admission of wrongdoing in the settlement. The settlement resolves the government's review of this matter," the company said.

Community Health Systems in a statement said the issue involved a highly technical interpretation of a Medicare national coverage determination that was the subject of strong disagreement in the medical community. "There were no findings of wrongdoing or liability on behalf of our affiliated hospitals, however, we agreed to the settlement to avoid the continuing delay, uncertainty, inconvenience and expense of protracted litigation."

Ascension spokesman Nick Ragone says the health system is pleased to have reached an agreement with federal prosecutors over the matter. "We are proud and appreciative of the cardiac care provided by our physicians, nurses and other caregivers nationwide to individuals in the communities we serve," Ragone said.

The cases are related to a National Coverage Determination, implemented by Centers for Medicare and Medicaid Services, that health providers should wait 40 days after a heart attack or 90 days after a bypass/angioplasty to implant an ICD in a patient. The guidance--which officials say was informed by cardiologists and other health care providers, professional cardiology societies, cardiac device manufacturers, and patient advocates--is meant to give people's hearts time to potentially function well on their own. Giving hearts a bit of time to heal could reduce the need of having to implant ICDs, which cost about $25,000 apiece under Medicare.

"Guided by a panel of leading cardiologists and the review of thousands of patients' charts, the extensive investigation behind the settlements was heavily influenced by evidence-based medicine," said U.S. Attorney Wifredo A. Ferrer of the Southern District of Florida.

In Minneapolis, Allina Health ended up paying $2.56 million over alleged billing practices at four hospitals. Allina, in a statement shared by a spokesman, stood behind the decisions made by its hospitals, saying that highest-quality, evidence-based, safe patient care is a top priority. "We continue to maintain that ICDs implanted at our hospitals were medically necessary, and that such procedures were performed by highly specialized cardiologists board certified in electrophysiology consistent with current standards of medical practice. That said, we chose to settle this case to avoid the time and expense of protracted litigation."

Learn more about cutting-edge medical devices at Minnesota Medtech Week, November 4-5 in Minneapolis.

Chris Newmarker is senior editor of Qmed and MPMN. Follow him on Twitter at @newmarker.

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So Far, No Sign of MVAD Needing a Redesign

So Far, No Sign of MVAD Needing a Redesign

Marie Thibault

The good news on HeartWare’s next-generation left ventricular assist device (VAD), the MVAD, is that company executives haven’t seen any signs that the device needs a redesign. But it seems patients, investors, and onlookers will have to wait longer to get an all-clear signal on when the device’s CE Mark trial can resume enrolling patients.

That trial, designed to gather data to support a CE Mark, had implanted 11 patients before being paused in early September to allow for minor fix of a circuit board in the device’s external controller. In October, management announced that they had decided to investigate certain adverse events seen in some trial patients, and that the trial might not start again in November, as previously expected. According to the announcement, the adverse events are similar to those seen in other VAD trials and the company also investigated adverse events during it 2007 CE Mark trial for its HVAD device.

The LVAD maker’s management team dove deeper into specifics on the company’s October 29 earnings call. According to a Seeking Alpha transcript of the earnings call, Doug Godshall, HeartWare’s president and CEO, said, “We are encouraged by our initial findings from the clinical and technical review and presently, we do not see any evidence that a redesign will be warranted. We will have plenty of opportunities this fall to provide update as we progress back to the clinic.”

Godshall went on to explain that on the controller side, a solution for the assembly issue with the circuit board has been found, tested, and has passed validation, so controller production is restarting. In addition, the source of a bug in the controller software, which management said did not present a safety problem, has been found and a solution is being tested. A submission to the regulators, necessitated by the software change, is anticipated in early-to-mid-December.

On the adverse event side, Godshall said the company is looking closely at certain steps in the MVAD manufacturing process that may result in “a small amount of variability between pumps.” Godshall said, “If we determine that tightening certain specs will further improve pump performance, it is clear that we have the ability to measure and control our processes far better than what we have ever had in the past.”

Throughout the call, Godshall referenced the similarity to the company’s actions during the HVAD CE Mark trial. Describing the initial HVAD adverse events, Godshall said:

After our 14th patient, we had to pause enrollment to investigate some adverse events in a few patients. We restarted enrollment within a few months after implementing a more stringent screening process for our pumps and subsequently identified some tolerances in our manufacturing process that we tightened up, and which has served [us] exceedingly well ever since.”

Still, the company isn’t yet ready to give a more detailed timeline for a trial restart. Godshall said, “We’ll have to stay tuned before we can give you—give exact specificity on what we found, what we’ve changed, if anything, and when we’re going to restart the trial.”

Asked about clinician and FDA feedback on the MVAD, Godshall struck an optimistic tone, saying the “dialogue with the FDA is going very well” and that clinical investigators are “very excited about the device, both U.S. and internationally.”

Want to catch up on the latest in medical device innovation? Register for the MD&M Minneapolis conference, November 4–5, 2015.

Marie Thibault is the associate editor at MD+DI. Reach her at marie.thibault@ubm.com and on Twitter @medtechmarie

[Image courtesy of HEARTWARE, INC.]

Obamacare is Coming into Sharper Focus

Obamacare is Coming into Sharper Focus

Lofty ideals like empowering patients, accountable care, and the need to disrupt healthcare as we know it are starting to sound a lot more down to earth.

Jamie Hartford

When the U.S. Supreme Court upheld the constitutionality of the Patient Protection and Affordable Care Act (ACA) for a second time this past summer, the message was clear: Like it or not, Obamacare is here to stay. Sure, Congress may chip away a provision here or there, but it’s unlikely that the crux of the law—expanding insurance coverage to more Americans and reducing overall healthcare costs—will change. Since that decision was handed down, lofty ideals like empowering patients, accountable care, and the need to disrupt healthcare as we know it have started to sound a lot more down to earth. 

Take, for example, the atmosphere at the AdvaMed 2015 conference last month in San Diego. This was the third time I’ve attended the medical device trade association’s annual gathering, and while much of the messaging remained the same as in years past, it seemed to be delivered more earnestly and with greater conviction and urgency than ever before.

Over and over again at the event, I heard speakers hammer home the so-called triple aim: improving the experience of care, improving the health of populations, and reducing the per capita costs of healthcare. Identified by the nonprofit Institute for Healthcare Improvement back in 2008—two years before Obamacare became the law of the land—the concept of the triple aim is not new. But with the uncertainty over the ACA finally put to rest, there’s a sense that it’s time to quit worrying about which arrow you’ll choose from the quiver and instead set your sights on the bullseye. 

What in the past had seemed like theoretical discussions about the direction healthcare is headed took on more concrete meaning at this year’s conference. For years now, we’ve had it pounded into our heads that the same old devices updated with new bells and whistles aren’t going to cut it in the new healthcare landscape. This year, we got more of a sense of what that topography might look like when Jo Carol Hiatt, chair of Kaiser Permanente’s National Product Council, explained in one session that the managed care consortium is pushing back when vendors try to charge it more for devices that don’t meet its definition of new technology.   

Of course, AdvaMed was keen to showcase several examples of devices that seem to meet providers’ and patients’ demand for disruption, but the discussion around those technologies was less fawning and more nuanced than it might have been in the past. St. Jude Medical medical director Phillip Adamson, for example, defended the nearly $18,000 average selling price of his company’s CardioMEMS HF System during one session. Few would argue that the system, which uses an implantable sensor and external transmitter to monitor heart failure patients outside the hospital, is not disruptive, but some have criticized it for being too costly. 

No AdvaMed conference would be complete without an uplifting patient story or two, and this year’s event was no different. Former Disney CEO Michael Eisner paused briefly during his lunchtime keynote to thank the industry for technology that saved his life during quadruple bypass surgery more than 20 years ago,  and there was hardly a dry eye in the room after the showing of a video chronicling the first year in the life of a baby born three-and-a-half months early. But in addition to the typical emotional testimonials from patients who have benefitted from medical technology, attendees also heard from patient advocates like Bray Patrick-Lake, director of stakeholder engagement at the Duke University Clinical Trials Transformation Initiative, and Eric Topol, physician and author of the seminal book The Patient Will See You Now

To be fair, there were still a few sessions (disguised as “CEOs Unplugged”) in which AdvaMed board members predictably railed against the device tax—some things never change, after all. But overall it felt like the medtech industry’s lobby arm was affirming that instead of endlessly debating healthcare reform, it’s time for device companies to get down to the business of reforming. 

Don't miss the BIOMEDevice San Jose conference and expo, December 2-3, 2015 at the San Jose Convention Center.

Jamie Hartford is editor-in-chief of MD+DI. Reach her at jamie.hartford@ubm.com or on Twitter @MedTechJamie.

[image courtesy of SUPHAKIT73/FREEDIGITALPHOTOS.NET]

Study At Mayo Wields Digital Health To Fight COPD

Study At Mayo Wields Digital Health To Fight COPD

Arundhati Parmar

Digital health is gaining steam. Evidence abounds.

Earlier this year, the Centers for Medicare and Medicaid Services acknowledged the power of digital health as a preventive measure that can help pre-diabetic patients from getting the full-blown chronic condition.

And now a study at Mayo Clinic treating chronic obstructive pulmonary disorder (COPD) is wielding a digital platform from Novu to tackle the disease. What is common to both examples: patient engagement. And that is one of the tools through which quality of care can be measured, something that has gained urgency under healthcare reform.  

"With the traditional business model that has been in place within health - the primarily sort fee-for-service transaction based model -  there wasn’t necessarily an inherent need for quality at all times in that traditional model," says Stephen Hiser, lead associate at consulting firm Booz Allen Hamilton. "We've seen that shift in healthcare reform with more of an emphasis on quality metrics and quality-based care."

That focus on quality combined with patients wanting to take a more active role in their care has brought patient engagement to the fore. The study of Mayo in essence will aim to validate the efficacy of patient engagement, said Tom Wicka, founder and CEO of Novu, a consumer engagement startup whose software platform is being tested.

Minnesota HealthSolutions Corporation, which won the National Institutes of Health grant is working with Novu and Mayo to enrol patients and conduct the study. The goal is to demonstrate that heightened engagement through digital tools can improve efficacy by comparing it with patients who were treated without a digital component.

The study which will enrol 75 patients will evaluate how pulmonary rehabilitiation, which includes daily breathing exercises, can function in a remote setting compared to one in a clinical setting, Wicka pointed out.

Echoing Hiser, Wicka said that as payers reimburse on outcomes and quality, providers and companies are looking to put the patient at the center of the healthcare conversation. The consumer trend in healthcare is also driving a new attitude toward patient engagement.

"There is an awakening of the individual and the awakening of the marketplace to say that the individual does have choices and will have choices," Wicka says. 

In the COPD trial that will run for 18 months, Novu expects to be able show evidence that interacting through digital tools with care managers and performing the daily breathing exercises will have a positive effect on respiratory capacity for instance. The patients using the Novu solution receive a daily communication on tablet device that tells them how to complete their breathing exercises as well as have them answer a few questions and provide relevant content such as video. Notably COPD patients using the digital health application on the trial are connected to each other.

"This allows them to share experiences and best practices," Wicka explained.

Once the trial is complete and resutls are available - and Wicka hopes to show a clear correlation between digital health boosting patient engagement and improved outcomes - Novu can approach payers to reimburse these emerging tools in chronic care.  Novu can be deployed in a number of different chronic and acute conditions. 

"For us, this is a validation of our platform, but the argument to get it reimbursed is a big opportunity in the marketplace and the payer is the right place to start with that."

Hiser with Booz Allen Hamilton believes that there is an increasing awareness of the importance of patient engagement in healthcare than before.

Yet there are certain challenges to patient engagement, an important one being security.

"We need to be making sure that not only the front end infrastructure is secure to interface with folks, but the back end infrastructure is also secure so that HIPAA regulations are not breached, and if there is a breach then to make sure that the most sensitive information is not compromised,"

Both Hiser and Wicka will be part of a panel discussing patient engagement at a two-day conference in Minneapolis hosted by LifeScience Alley and MD&M Minneapolis on Nov.5.

To learn about medical devices trends and the broader industry, attend the LifeScience Alley and MD& Minneapolis conference in Minneapolis, Nov. 4-5 at the Minneapolis Convention Center. 
 

This Is Heavy: What Does the Future of Healthcare Hold?

This Is Heavy: What Does the Future of Healthcare Hold?

A visionary and vanguard of the Internet and now healthcare tells MD+DI why he thinks revenues for the healthcare industry will decline and what device makers can do to succeed.

Marie Thibault

"Back to the Future Day" has come and gone, but questions about the future remain. Dr. John R. Patrick has been called an Internet pioneer, both for his roles in helping facilitate the technology and for his predictions about the evolution of the Internet. Patrick worked at IBM for 35 years, was vice president of Internet Technology there, and was a founding member of MIT's World Wide Web Consortium in 1994. He published a book in 2001, Net Attitude: What It Is, How To Get It, And Why Your Company Can't Survive Without It, about his thoughts on the future of the Internet and its impacts.

Patrick is also involved in the world of healthcare, as a member of the American College of Healthcare Executives and with 10 years of experience on the board of the Danbury Hospital. His new book, Health Attitude: Unraveling and Solving the Complexities of Healthcare, tackles the attitude change he sees as necessary for all stakeholders in order to improve the healthcare system. 

Through e-mailed answers, below, Patrick shared more about his expectations for healthcare and what medical device makers need to know to thrive. 

MD+DI: As you take a look into the future of healthcare, what are the major changes you envision?

Dr. John R. Patrick: The American healthcare system has many problems, perhaps more than we realize. However, the solutions are closer to reality than we may realize. The solutions fall in three categories: attitudes, technology, and policy. Attitudes need to change for patients, providers, payers, and policymakers.

Patients need to take more responsibility for their health. We need to ask more questions, gather personal data with mobile technology (mHealth), collaborate with physicians on diagnoses and treatment plans, and comparison shop for the treatments needed.

Providers need to re-focus on keeping us healthy instead of treating our ailments. Hospitals need to focus on the population it cares for and embrace the accountable care organization (ACO) model which will compensate them for value, not volume of care.

Payers need to collaborate with providers to increase patient safety and quality and cost effectiveness. They should demand that the providers they pay make their price lists transparent to consumers. They should adopt administrative standards so providers do not spend so much time with paperwork in working with multiple payers.

Policymakers need to eliminate the corruption that has crept into healthcare. Congress should immediately remove the provision in the prescription drug plan that prohibits Medicare from negotiating the price of drugs they pay for. They should also eliminate the approval for pharmaceutical companies to use TV advertising to entice consumers to seek drugs the vast majority of consumers do not need.

MD+DI: In your book, Health Attitude, you discuss the impact of empowered patients. In 20–30 years, what role do you see patients playing in their medical care and how does that differ from today’s proactive patient?

JP: The rapid introduction of mHealth devices is going to give consumers new tools to measure and monitor their health. They will accumulate data about their activity, heart rate, weight, body mass index, blood chemistry, and much more. Healthcare will become data driven. This does not eliminate doctors but it gives patients data and preliminary diagnoses which will facilitate collaboration with providers. In 20-30 years, some people believe it will not be possible to tell the difference between biological and non-biological beings. I prefer to keep my focus on what is coming in the next few years. I don’t think anyone knows what the world will be like in 30 years. If you look backward 30 years, there were no websites. Not one.

MD+DI: What new tools do you expect to exist to help empower patients and what should individual patients be doing to prepare for the future of healthcare?

JP: In 1976, Seymour Cray introduced the first supercomputer, the Cray-1. It cost 5-10 million dollars, weighed more than 5 tons, and used as much electricity as ten homes. Today’s smartphones are more than 100 times as powerful as the Cray-1. Hundreds of millions of people around the world carry them in their pocket or purse. I call them PSCs (personal supercomputers).  The PSC will enable consumers to do things previously thought impossible. An example of what is to come is the AliveCor Mobile ECG. The device attaches to the back of an Apple or Android smartphone. In 2016, the AliveCor function will be incorporated in the Apple Watch. A consumer holds the smartphone with both hands and touches two or three fingers of each hand on the sensor on the back of the smartphone. In 30 seconds, the smartphone displays an electrocardiogram (ECG). There is no need to go to a physician office. It can be done at home or on-the-go. The consumer will know right away if the ECG is normal. The AliveCor app will tell you immediately if it detects atrial fibrillation (AF), a leading cause of stroke which afflicts millions of people. The ECG can be emailed to a physician. With a simple in-app purchase for $12, the ECG will be sent to a board certified cardiologist with a minimum of 12 years of advanced education who will provide an analysis of the ECG within 24 hours. This is one of many examples of the power of the PSC and mHealth. The FDA has now approved more than 150 mHealth devices and apps.

MD+DI: You also believe healthcare costs per patient will go down. How do you see this happening and what might it mean for the kind of healthcare we receive?

JP: The Patient Protection and Affordable Care Act (ACA) has ten parts to it. We hear a lot about the health insurance part of it, which needs significant repair. However, there are some good things in the ACA we don’t hear much about it. The accountable care organization (ACO) will help bring down the cost of healthcare. For hospitals and physician organizations which participate in an ACO, they will receive a fixed amount of compensation for patients they take care of. For example, a hospital might enter into an ACO agreement with Medicare to provide healthcare for 30,000 patients in a particular zip code. The hospital might receive a fixed monthly payment of $750 to care for the patients. If a patient is readmitted for a problem or gets an infection while in the hospital, there is no additional reimbursement. Hospitals will look for ways to keep patients out of the hospital. They will focus on patient safety and quality for patients that are in the hospital. The population under the ACO will be healthier and the cost will be lower. 

MD+DI: What should medical device makers be doing to prepare for the future of healthcare?

JP: Consumers and policymakers will be demanding more transparency of healthcare costs. Imagine shopping on Amazon and seeing no prices. That is what we have with healthcare. With larger deductibles, consumers are going to comparison shop. Some will choose medical tourism and have procedures done in other countries with lower costs. Hospitals receiving fixed payments under an ACO are going to evaluate medical devices for efficacy and cost. Medical device manufacturers will need to display and justify their pricing. They will need to be competitive with the alternatives.

MD+DI: If healthcare costs per patient might go down, what does this mean for the revenue and profits that medical device manufacturers make?

JP: The biggest problem in the American healthcare system is the cost. Between 1975 and 2008, Medicare spending grew 2.5 % faster than our nation’s economy consuming an increasingly larger share of our nation’s economic resources. America spends 50-100% per person more than other developed countries. With 10,000 new seniors turning 65 and joining Medicare every day, we cannot afford the out of line cost. Affordability has become a matter of great concern to individuals, families, and businesses across the country. Businesses cannot remain competitive in the face of continued increases in healthcare cost. Many individuals struggle with their own share of healthcare expenses. More than one out of five Americans has medical debt. The high cost forces some to avoid care they may need, or thrust them into bankruptcy.

Getting American healthcare cost in line with other developed countries will mean reduced revenue for the healthcare industry. The reduced revenue will lead to lower costs which may include fewer employees. Hopefully, the realignment will occur through improved efficiency and headcount reductions can occur through normal attrition. Healthcare is choking growth in other segments of the economy. Warren Buffet, in 2013 on CNBC, said healthcare costs are “a tapeworm in the US economy.” More growth in other segments will create employment opportunities and economic growth. The healthcare industry will continue to thrive.

MD+DI: Robots already play a large part in certain surgical procedures. Do you see the role of robots changing in the future and if so, how so?

JP: Robotic surgery is growing because more new surgeons are trained on them and the outcomes continue to be at least as good as open surgery. Incisions are smaller, blood loss is less, time in the hospital is shorter, and recovery times are speedier. The reliability and speed of the Internet has now reached the point where remote robotic surgery can be a reality. A patient can be on an operating room table while the surgeon at the robot console is 1,000 miles away instead of just across the room. Remote robotic surgery will allow expert surgeons to deploy their skill wherever it may be needed.

Robots will also play an important role in home healthcare. As the senior population and chronic illness grow, the need for home health aides will increase. Robots will fulfill some of the demand. Basic care and rehabilitation can be highly repetitive and robots do not get bored. Robots will continue to gain attributes and capabilities of humans, including facial expressions. In many cases they will become the best friend of a homebound patient.

MD+DI: What trends do you see today among medical device makers that you think will expand in the future? Any trends today that you think are merely fads?

JP: The power of the PSC combined with medical devices, apps, and the cloud will open many new opportunities to do things at home not previously thought possible. Outset Medical, in San Jose, CA, believes there is a better way to do kidney dialysis. The company has landed FDA clearance for an innovation, called the Tablo System, about the size of a PC server on. A large touchscreen display leads the user through the dialysis process, using animation and intuitive step-by-step instructions. The system can connect to a water tap and create the needed filtered water. It can also produce the required dialysis solution. The system reduces the size of the equipment and the complexity of the process. The company’s vision is to enable consumers to perform their own dialysis at home and by themselves.

MD+DI: How do we get from today’s reality to the tomorrow you are envisioning? What are key changes, requirements, or legislation needed to move us into the future of healthcare?

JP: Continued evolution of technology will empower consumers to care for themselves at home and on the go. Big data and analytics will enable providers to focus on population health instead of just the traditional model of treating one patient at a time. As I discussed in Health Attitude, patients, providers, payers, and policymakers all need to change their attitudes toward how healthcare is delivered. Reimbursements need to be provided for telehealth. Laws need to be modified to allow consumers to obtain care across state borders if they choose. The healthcare information technology industry must accelerate efforts to provide complete compatibility between electronic health record systems so that providers and patients can collaborate more effectively. Adoption of new health attitudes will result in safer and more affordable healthcare.

Want to catch up on the latest in medical device innovation? Register for the MD&M Minneapolis conference, November 4–5, 2015.

Marie Thibault is the associate editor at MD+DI. Reach her at marie.thibault@ubm.com and on Twitter @medtechmarie

[Image courtesy of HYENA REALITY/FREEDIGITALPHOTOS.NET]

Theranos' FDA Headaches Could Cost Them Dearly

Theranos' regulatory troubles could cost them over $1 million, according to one regulatory expert. Here's a timeline of how they got there.

Qmed Staff

Holmes
An image of Theranos CEO Holmes pulled from the company's website.

Blood testing firm Theranos will likely have to spend considerable money to address observations addressed in two FDA Form 483 documents, which list a total of 14 observations. "I'm guessing their remediation efforts can easily approach $1 million," says Jon Speer, founder of Creo Quality and co-founder of greenlight.guru (Indianapolis, IN). "With the publicity that this has garnered, Theranos has likely hired a big D.C. law firm like Hogan Lovells or King & Spalding that specializes in getting med device companies out of hot water. Those firms charge well north of $500 per hour," he adds.

A recent request for comment to Hogan Lovells on the Theranos case could support that theory; the request was denied, citing a conflict of interest.

"I suspect this is just the very beginning of FDA headaches for Theranos," Speer continues. "FDA works on an escalation approach. 483 observations are the results from a FDA inspection. Now someone at FDA office of compliance is reviewing the 483s to determine whether or not a warning letter needs to be issued in addition. My bet is yes. Theranos will obviously work to prevent that, hence they likely have hired a big D.C. firm," he says.

To Speer's point, some of the problems outlined in the 483 documents seemed to indicate significant problems. One such comment states: "Complaints involving the possible failure of a device to meet any of its specifications were not reviewed, evaluated and investigated where necessary."

Michael Drues, a regulatory consultant and president of Vascular Sciences (Boston), breaks down the problems cited in the Form 483 documents into two buckets. "The first is the documentation and quality problems. I consider those to be pretty basic. Those things are all regulatory 101 and should have never happened," he says. "Bucket number two is the whole question of whether they were marketing a Class II device without permission. It is not quite as simple as it might seem as they are in the gray area of LDTs," he says.

"Determining classification is not always black and white. It is also possible that Theranos was marketing the device for an indication that is Class II. There are a few unknowns here," says Speer.

Theranos founder and CEO Elizabeth Holmes, however, has repeatedly stressed that the company intends to obtain FDA's clearance for her company's tests. The company boasts on its website: "Theranos is a CLIA-certified laboratory. And the first and only lab to proactively begin submitting all our Laboratory Developed Tests to the FDA for clearance and approval."

A recent piece from Wired also speculates that lawsuits could follow the negative attention from a series of exposés from the Wall Street Journal. Theranos could potentially sue the Journal for libel, acknowledged famed attorney and newly appointed Theranos board member David Boies to Wired. "I would not preclude the possibility of a defamation case if this continues," he said.

Boies himself has been involved in several high-profile lawsuits, having represented Al Gore in Bush v. Gore, Napster, documentarian Michael Moore, the NFL, and Sony Pictures. He also helped overturn Proposition 8 in California and prosecuted Bill Gates in the late 1990s. Vanity Fair has called him "The Man Who Ate Microsoft," while Fortune has dubbed him "Corporate America's No. 1 Hired Gun."

Other attorneys interviewed by Wired also note the possibility that Theranos itself could be targeted by class action lawsuits on behalf of consumers or investors or from the government.

Below is a timeline detailing our coverage of Theranos from 2014 to present:

February 2014

Theranos CEO Elizabeth Holmes breaks her customary silence to grant Wired magazine a softball interview, published online on February 18. Something appears to be afoot at the futuristic blood testing firm, which says it can perform a "full range" of lab tests on a single drop of blood.

November 2014

Walgreens says it is teaming up with Theranos to open on-site laboratories within its stores in the Phoenix and Palo Alto areas, with plans for potential expansion across the United States.

February 2015

JAMA publishes an article shunning "stealth science," which specifically mentions Theranos, criticising its lack of peer review. 

Summer 2015

Theranos is now in about 40 Walgreens stores in Arizona, as well as a Walgreens in Palo Alto, CA. Holmes has meanwhile become an entrepreneurial celebrity, with Theranos valued in the billions of dollars.

July 2, 2015

Theranos gets its first FDA clearance, involving a test and system that can detect herpes simplex 1 virus with but a drop or two of blood. The clearance, which was not required, nevertheless adds weight to the company's claims that finger prick blood tests are the future.

July 23, 2015

Vice President Joe Biden provided a personal endorsement for the futuristic blood testing firm in a visit to the firm's manufacturing facilities in Newark, CA.

October 15, 2015

The Wall Street Journal, after spending months researching Theranos and interviewing several sources, published a nearly 3000-word article stating that the company had been misrepresenting the capabilities of its technology. Theranos quickly moved into full-fledged damage control mode after scathing press from the WSJ and other press outlets. In its second report, the Journal questioned the accuracy of the firm's trademark finger-prick blood tests and reported that the firm has stopped using them for all but a single test. As October draws to a close, the newspaper has continued to publish critical reports about the company.

October 26, 2015

The Wall Street Journal reports that Walgreens is scrutinizing the Theranos blood testing technology it uses in Arizona pharmacies, and has no concrete plans to expand it into more Walgreens pharmacies.

October 27, 2015

FDA inspection forms describe the young blood testing company's nanotainer as an "uncleared medical device" and cite a spate of other noncompliance with FDA standards and protocols.

Learn more about cutting-edge medical devices at Minnesota Medtech Week, November 4-5 in Minneapolis.

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Bos Sci Co-Founder: Medtechs that can Integrate Systems Will Win Future

Bos Sci Co-Founder: Medtechs that can Integrate Systems Will Win Future

Arundhati Parmar

Boston Scientific's co-founder, John Abele, is a big believer of systems and the power they have in being able to drive value in healthcare.

Abele, who will be a speaker at a conference in Minneapolis jointly hosted by MD&M Minneapolis and Lifescience Alley on Nov. 4 at the Minneapolis Convention Center, recently explained how integrating systems will prove valuable in the future.

"I think the need today is for better systems," Abele said. "I would look for opportunities to change the system..."

For instance, he pointed to the trend of healthcare moving to the home as an opportunity for medtechs to develop devices and systems that can help patients receive diagnostic care at home. 

"How do you take technologies into the home and make it work reliably," Abele said.

Improving systems could also come from partnering with companies who are not traditional healthcare players. Partnerships and collaboration, Abele seems to think will be the wave of the future.
 
"To borrow from a Republican candidate, 'I think it's going to be uuuuge,'" guffawing as he mimicked Donald Trump, a presidential candidate for 2016. 
 
But improving systems may also mean fundamentally altering what it means to be a medical device firm. Take for instance, Medtronic. The company's desire to play a bigger role in the management of diabetes patients and integrate devices and services led it to acquire a Dutch diabetes clinic earlier this year.
 
In essence Medtronic now employs physicians who actively treat and manage patients.
 
"I’ve often wondered whether companies are going to practice medicine - in fact Medtronic already is. They are just doing this outside of this country right now," Abele said. "There have been lot of proposals for that floating around from medical practices that want to merge with companies. Obviously this is a very very difficult thing. but from a systems point of view that could deliver a lot of value."
 
Other examples of unlikely partnerships and alliances, (and M&As like Medtronic's deal) abound. Google is working with Johnson & Johnson to make surgical robots smaller, much cheaper and layered with analytics that can help physicians take decisions during surgery. Apple has used both Epic and Mayo Clinic to make its HealthKit more of a platform. Medtronic is working with IBM to see if it can detect patterns in data captured from insulin pumps to improve diabetes management for patients. 
 
Improving systems not surprisingly also means closing the interoperability gap, something that has been achieved in the tech industry but has remained a stumbling block within the confines of healthcare. 
 
"I think it's ridiculous that we cannot connect A to B," Abele charged. "Unfortunately with the electronic medical record, we lost the opportunity to have that on an open source basis...."
 
Yet, Abele is optimistic about the future - especially for those who can evolve and adapt based on what the market wants. 
 
"I think the future is going to be marvelous for those can integrate their products with services and systems that provide real value that today just is not there," he said. "The hospital has to do the integration and they are not good at it."
 
[Photo Credit: istockphoto.com user Onur Dongel]

Arundhati Parmar is senior editor at MD+DI. Reach her at arundhati.parmar@ubm.com and on Twitter @aparmarbb

To learn about medical devices trends and the broader industry, attend the LifeScience Alley and MD& Minneapolis conference in Minneapolis, Nov. 4-5 at the Minneapolis Convention Center. 

Orders Coming in for Varian Medical’s VitalBeam

Orders Coming in for Varian Medical’s VitalBeam

Marie Thibault

The VitalBeam system is a lower-priced product offering that may help increase use of radiotherapy in emerging markets.

Varian Medical Systems, known as the leading global player in the linear accelerator radiation therapy market, is aiming to bring more radiotherapy equipments to the emerging markets. The goal isn't new, but the company's new VitalBeam system, announced in April at the European Society for Radiotherapy and Oncology (ESTRO) annual meeting in Barcelona, may boost its strategy.

Earlier this month, Varian announced that the VitalBeam had secured FDA 510(k) clearance and CE Mark. As part of the announcement, the company highlighted a purchase of the VitalBeam platform by The Chirayu Medical College and Hospital in Bhopal, India. According to the press release, Kolleen Kennedy, president of Varian's Oncology Systems business, said, "Our goal, with this platform, was to help increase access to quality cancer care around the world." 

The owner of The Chirayu Medical College and Hospital, Ajay Goenka, MD, said in the release, "We chose VitalBeam because we wanted something with the advantages of the TrueBeam platform that would enable us to go beyond basic intensity-modulated radiotherapy."

On the company's October 28 earnings call, Dow Wilson, president and CEO, said, “We’ve received several VitalBeam orders, and early signs are this affordable extension of the TrueBeam platform will be a winner, particularly in emerging markets," according to a Seeking Alpha transcript. According to the regulatory clearance announcement, orders have come in from centers in the United States and Europe.

Wilson also mentioned a recent study from The Lancet Oncology Commission that details the need for more than 20,000 new radiotherapy systems, with the majority needed in low- and middle-income countries. Wilson said on the earnings call:
"The report is recommending that, by 2020, 80% of these countries should establish national cancer plans, and make radiotherapy part of their universal health coverage. Over the next 10 years, the commission recommends investing $46 billion in these countries to expand radiotherapy capacity. This will require education and training of thousands of doctors, physicists, and therapists. Varian has established a market development team that is partnering with governments, financiers, clinicians . . . and patient advocacy groups to support this effort." 
The VitalBeam seems to make sense for Varian's business strategy when it comes to pricing and market expansion as well. Wilson pointed out on the October 28 call, "It's a product that we think is great for emerging markets and is really going to help us expand the market. It's an entry point for value markets and a chance to sell up . . . We have seen good price stability on the TrueBeam as VitalBeam is coming into these markets."
Want to catch up on the latest in medical device innovation? Register for the MD&M Minneapolis conference, November 4–5, 2015.

Marie Thibault is the associate editor at MD+DI. Reach her at marie.thibault@ubm.com and on Twitter @medtechmarie

[Image courtesy of VARIAN MEDICAL SYSTEMS]