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Articles from 2016 In January


Why St. Jude Medical Could Have a Tough 2016

The Minnesota-based medical device company is dealing with gaps in its pacemaker and ICD folder, as well as reimbursement problems around its CardioMEMS heart failure monitoring system.

Chris Newmarker

St. Jude Medical could be facing a rocky road this year. The Little Canada, MN-based maker of heart failure devices and more recently announced an earnings forecast that fell behind what analysts were predicting for the company.

Earnings could fall in the range of $3.95 to $4.05 per share, St. Jude announced Wednesday. Analysts at had been expecting around $4.18 per share on average, according to the Thomson Financial Network.

For the fourth quarter ended January 2, the company earned $113 million off $1.45 billion in sales, versus $245 million in profits off $1.44 billion in sales a year before. For the full year, the company earned $880 million off $5.54 billion in sales, versus $1.00 billion in profits off $5.62 billion in sales a year before.

Part of the tough situation is due to a temporary gap in St. Jude Medical's pacemaker and ICD portfolio: a lack of MRI-compatible devices available in the U.S. The situation has provided an inroad for Medtronic and other competitors already selling MRI-safe devices in the U.S. St. Jude is presently anticipating FDA approval of its MRI compatible pacemaker in the first half of 2016, and its MRI compatible ICD in the first half of 2017.

Overall Cardiac Rhythm Management sales were down 10% in the fourth quarter after adjusting for the impact of foreign currency.

Meanwhile, St. Jude Medical's new CEO Mike Rousseau told analysts on Wednesday that the company's CardioMEMS heart failure monitoring system is an "important clinical advancement and will in fact change the way heart failure is managed." For now, though, U.S. health providers are facing reimbursement problems. Rousseau says the company is "now in discussion with CMS to create a national coverage determination for implanted hemodynamic monitoring in order to establish clear coverage guidelines for CardioMEMS and increase access and coverage pathways for medicare eligible patients nationwide."

On a brighter note, sales at LVAD maker Thoratec, which St. Jude acquired for about $3.4 billion last year, grew 15% on a comparable constant currency basis for the full fourth quarter 2015.

Rousseau insists that St. Jude Medical has a solid strategy in place: "We are leading the market in our strategy to surround the patient care continuum in AF, heart failure and neuromodulation. Within these areas, we are bringing to market innovative, relevant technologies that help our customers treat patients throughout key stages of care. We are positioning ourselves to be the partner of choice in these targeted disease state areas."

Learn more about cutting-edge medical devices at MD&M West, February 9-11 at the Anaheim Convention Center in Anaheim, CA.

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

J&J Pressured to Spin-Off Medical Device Business

An activist investor at Artisan Partners is angered by J&J's M&A strategy and underperforming medical device segment.

Qmed Staff

Johnson & Johnson's sluggish medtech and consumer sectors and its aggressive M&A strategy are killing the company, according to the activist investor Artisan Partners Limited Partnership, which owns some $445 million of the company's stock.  

Artisan notes that JNJ has spent more than $150 billion on mergers and acquisitions in the past decade, which include paying $17 billion for Pfizer's consumer business in 2006 and $19 billion for Synthes in 2012. JNJ has announced that it has spent some $5 billion on restructuring costs related to the Synthes merger, yet the purchase has failed to boost the profitability of J&J's medical device segment. "Despite this $24 billion investment, the medical device business is generating adjusted EBITA of less than $8 billion, roughly the same level of profit it made in 2010," reads part of a letter to JNJ from Daniel J O'Keefe, managing director and portfolio manager at Artisan Partners. In addition, the profits from the JNJ division that formerly belonged to Pfizer are smaller now than they were before the acquisition.

Despite spending $150 billion on M&A, integration, capital expenditures, and research and development in a decade, the company's earnings before interest, taxes, and amortization has increased about $7 billion. "By any measure, the return on capital reinvested in the Company has been unacceptable," reads part of the letter.

The letter continues by criticizing JNJ CEO Alex Gorsky's public proclamation that the company would like to make another large acquisition. "Mr. Gorsky was responsible for the Synthes acquisition in 2012 and in my view, the results have been disastrous," O'Keefe continues.

As of mid-January, Gorsky seemed skeptical of making a big acquisition soon. In an interview with Bloomberg, he said: "Because we're more of an innovation-focused company, the ideal deal for us is early, great innovation, great science, then we scale it, versus going in and simply ripping out costs and trying to find other synergies."

O'Keefe also balks at Gorsky's compensation, which, he argues, greatly outstrips the performance of the company. In 2015, he made $25 million in total compensation. "[I]t is difficult to understand why the Board of Directors awarded the CEO and his predecessor [William C. Weldon] compensation totaling more than $200 million from 2007 through 2014," O'Keefe writes.

Gorsky has also drawn heat for the company's aggressive promotion of Risperdal. Last year, The New York Timesexplained that Gorsky had been directly involved in a plan to market the drug to the elderly and to boys despite its possibility of causing strokes and boys to grow breasts. The company pleaded guilty to the allegations and paid $2 billion in legal expenses. (The drug, however, generated some $30 million in global profits.)

Since 2007, Johnson & Johnson has spent more than $8 billion in charges related to litigation and product liability expenses, and spent billions more on restructuring charges totally $16 billion or more than $5 per share.

A substantial proportion of those litigation expenses trace back to the company's medical device segment, which has seen several of its products become lawsuit magnets, including the DePuy ASR metal-on-metal hips and transvaginal mesh. The company is facing 26,000 federal cases related to its transvaginal mesh products. In addition, fraud charges have been filed related to its Acclarent business; two of the company's executives are facing 18 cases of fraud.

Artisan goes on to refer to JNJ's medical device and consumer businesses as some of the "worst-performing participants in their industry."

Because there is "no evidence" in the conglomerate having a financial upside, O'Keefe therefore advocates splitting the company into three businesses to improve the focus and accountability devoted to each, while acknowledging the different business models inherent in each. The letter also advocates for a developing "publicly-disclosed financial targets for the faltering medical devices and consumer businesses."

Artisan is also a major holder of Medtronic stock.
 

Learn more about cutting-edge medical devices at MD&M West, February 9-11 at the Anaheim Convention Center in Anaheim, CA.

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Citizens United Asks Why Wasn’t Former Synthes CEO Jailed

Citizens United has filed a Freedom of Information Act request to determine whether the former Synthes CEO was shielded from prosecution in the Norian XR cement scandal, in which five people died.

Qmed Staff

Hansjorg Wyss

The conservative political organization Citizens United has asked for federal documents explaining why the Department of Justice did not act on a federal grand jury indictment of former Synthes CEO Hansjörg Wyss, who is a prominent donor to the Democratic Party, a prominent Clinton foundation donor, and one of the wealthiest people in the medical device industry.

Synthes had been embroiled in a scandal relating to the off-label use of the Norian XR bone cement that left five elderly patients dead in the early 2000s. Ultimately in 2011, four of the company's executives were jailed as a result of the scandal. The company was fined $22 million and its executives also admitted their intent to "defraud" the United States and the FDA, but the billionaire Wyss was not among them. The executives who served jail time in the case were also excluded from participating in federal healthcare programs for at least five years. Convicted felons also are not allowed to serve on executive boards owing to SEC regulations.

The Daily Caller recently reported that Wyss had been named as "Person No. 7" in a 2009 indictment, which alleges that he instructed other executives to conduct human trials on the Norian XR cement for applications not approved by FDA.

Late last year, however,the Daily Caller reported that Wyss would face "criminal profiteering" charges. That revelation came after Washington State Superior Court Judge Dean Lum ruled in October 2015 that Wyss could stand trial under the state's profiteering laws for his company's role in the death of Reba Golden, who was treated by an off-label use of Norian XR in 2007. That suitis being brought by Cynthia Wilson, the daughter of Reba Golden.

Wyss had also recently settled for $1.5 million an unrelated case a former employee of the Wyss foundation alleged that her boss had sexually assaulted her. Wyss' attorney had asked the judge in that case be held in contempt for "continued refusal" to obey several court orders.

Wyss had served as the CEO of Synthes until 2007, when the company was acquired by Johnson & Johnson for some $21 billion.

Wyss is a prominent philanthropist, donating hundreds of millions of dollars to charitable and research causes.

Learn more about cutting-edge medical devices at MD&M West, February 9-11 at the Anaheim Convention Center in Anaheim, CA.

Like what you're reading? Subscribe to our daily e-newsletter.

More Indications Coming for C.R. Bard's Drug-Coated Balloon

More Indications Coming for C.R. Bard's Drug-Coated Balloon

Marie Thibault

C.R. Bard's Lutonix 035 drug-coated balloon catheter is expected to enter new indications in the coming years.

C.R. Bard's Lutonix 035 drug-coated balloon (DCB) catheter will soon reach a wider audience. The device has been on the market for just over a year in the United States and already new indications are in the works. 

Lutonix was originally approved by FDA in October 2014 for use in the thigh and knee in patients with peripheral artery disease. The DCB is used to widen or unblock arteries and apply a coating of paclitaxel to the artery walls to prevent restenosis. That original indication covered lesions of up to 150 mm in the femoropopliteal arteries with 4-6 mm reference vessel diameters, according to a company release. At that time, Lutonix was the first and only DCB approved for use by FDA. The agency approved Medtronic's IN.PACT Admiral balloon in January 2015.

Now, Bard's management is detailing a packed pipeline for Lutonix. On the company's fourth quarter earnings call this week, executives called out near-term opportunities like longer lesions and new geographies, as well as longer-term expansion into use below the knee, arteriovenous fistulae access in the upper extremities, and in-stent restenosis, according to a Seeking Alpha transcript of the call. 

John DeFord, PhD, senior vice president of Science, Technology, and Clinical Affairs at Bard told analysts that the company is readying its inventory to launch a wider range of the Lutonix line in the first quarter of 2016. That November 2015 PMA supplement approval granted use of the 7x40 mm and 7x60 mm Lutonix device sizes and expanded the reference vessel diameters from 4-6 mm to a 4-7 mm range. 

The company has also filed an FDA submission for an indication in longer lesions, up to about 300 mm. The current approval covers lesions up to 150 mm in length. DeFord summarized results presented this week at the Leipzig Interventional Course in Leipzig, Germany that showed one-year results from a retrospective, single-center study in patients with an average lesion length of over 280 millimeters. While there was not a statistical difference between patients treated with Lutonix versus stents, patients had more than 82% freedom from reintervention at one year, he said.

Clinicians in new countries may soon start using Lutonix. Bard is planning to file a submission in the first half of 2016 for Japanese regulatory approval of the DCB. A Chinese study is also expected to start ramping enrollment. 

The company has a few IDE studies running right now, too. An in-stent restenosis IDE trial, for patients who have had vessel narrowing after stent placement, is underway. Management anticipates being able to file a PMA submission in the second half of 2016 for that indication. The arteriovenous (AV) Access DCB IDE study in the upper extremities may finish enrolling patients as soon as the end of first quarter or second quarter 2016, which could lead to an FDA submission in the first half of 2017.

Finally, an IDE study for treatments below the knee (the current indication is in the thigh and knee) is expected to keep running throughout the year, with a PMA submission anticipated in late 2017 or in 2018.

These eventual expansions could mean significant sales growth for the Lutonix platform. Rick Wise, an analyst with Stifel, wrote in a January 28 research note, "Lutonix DCB Has a Long Growth Runway . . . Over the next 2+ years, indicated expansion—below-the-knee, A/V access, in-stent restenosis, etc—could increase Lutonix's addressable market by 50+%, suggesting potential for continued, meaningful through-end-of-decade growth."

John Weiland, president and chief operating officer at Bard, told analysts, "We are very pleased with the first year of our drug-coated balloon sales in the United States. Sales in Q4 were as expected, and we estimate that end customer usage, which more than doubled the prior year."

According to the Seeking Alpha transcript, Weiland also pointed to the growing acceptance of Bard's DCB technology by physicians, saying:

"After a little bit over a year into this now, physicians now are getting to the point that have started using DCBs on some of their patients, they're not only looking at the data, they're looking at the fact that patients aren't coming back for re-intervention. And as patients don't come back for re-interventions, they get great confidence in using the device on more and more and more patients in the future."

Check out the future of medical technology at the world's largest medical design and manufacturing event—register for the MD&M West Conference, February 9-11, 2016.

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

[Image courtesy of C.R. BARD, INC.]

To Ensure Cybersecurity Focus on These 6 Areas

To Ensure Cybersecurity Focus on These 6 Areas

When dealing with medical device security, it is important to focus on six areas that will ensure that the entire system — the network environment and the device efficacy — is taken into account. 

Ali Youssef

When dealing with medical device cybersecurity, three quotes by Bruce Schneier, a prominent security expert and author come to mind.  These are:

If you think technology can solve your security problems, then you don't understand the problems and you don't understand the technology.”

People often represent the weakest link in the security chain and are chronically responsible for the failure of security systems.”

“Security is a not a product, but a process”

The burden of medical device cybersecurity is a shared one between the device manufacturer and the organization that is introducing the device on to its IT network.  In some cases, that organization can be a large hospital or clinic, but in others it’s the consumer leveraging a connected medical device as part of his or her home care.

One thing to remember when developing devices is that companies need to focus on the entire system by taking into account the network environment of a clinic or hospital as well as the clinical efficacy of the device. There are risks associated with the device itself, as well as how the device interacts with the network and the rest of the hospital or clinic ecosystem.  

So, if I had to sum up six key areas to focus on, they would be:

  1.  Ensure that end users are not leveraging default, or shared, passwords on the device or the network that the device is relying on
  • Device manufacturers can create workflows to ensure that the passwords in use are sophisticated and difficult to decipher using dictionary attacks.
  • In its factory default state, a device should be password protected.
  • Discourage the use of Pre-shared keys, WEP (Wired Equivalent Privacy), or TKIP (Temporal Key Integrity Protocol) and rather promote AES (Advanced Encryption Standard) encryption and authentication.

      2.  Validate that Patient Data is not compromised, or intercepted

  • Enforce that data is encrypted in transit as well as while at rest, or being stored on a given device.

      3.  Scrutinize the Medical device and its  susceptibility  to attack from within or outside the network

  • Manufacturers can take measures to ensure that only secure protocols are used to access the device configuration.
  • Work with the hospitals and clinics to implement role based access controls to ensure that a given device can only access what it requires on the hospital or clinic network.
  • Work with the hospital to ensure that a defense in depth strategy is in place to protect medical devices and the data they transmit. This means focus on Authentication, Authorization, and Accounting.

      4.   Identify and understand underlying OS vulnerabilities

  • Manufacturers should move away from using backend Operating Systems that are no longer supported such as Windows XP.
  • Promote regular security patch management.
  • Promote routine security audits and penetration tests.

      5.   Promoting Redundancy

  • Manufacturers can build a layer of redundancy in the device to ensure that if a given communication medium is disrupted, the device can continue to safely and effectively function.
  • The network supporting the device should be designed to be highly redundant, and prevent SPOF as much as possible.

      6.  Focus on Risk Management

  • Security is never absolute. There needs to be a process in place identifying the weakest potential link, and pursuing continuous improvement.
  • AAMI IEC 80001 is a great roadmap for a robust risk assessment strategy.

It is difficult for medical device manufacturers to mimic a hospital network, so every measure should be taken to test the devices on test beds that are configured as closely as possible to a hospital network, or on the hospital network itself.  Hospitals can implement formal risk assessment and device onboarding strategies to help improve cybersecurity. 

When dealing with home networks, the burden of running a secure network falls on average consumers which is an unreasonable expectation.  This will continue to be an Achilles heel for the cybersecurity of medical devices and patient data.

[Image courtesy of DAVID CASTILLO DOMINICI/FREEDIGITALPHOTOS.NET]

Ali Youssef, PMP CPHIMS CWNE, is senior clinical mobile solutions architect, Henry Ford Health System. He will be speaking on two sessions dealing with cybersecurity at the MD&M Conference, Feb 9-11, at the Anaheim Convention Center, Anaheim, California 

Why the Future of Computing Could Be in Our Heads

A neuroscientist explains why brain discoveries may pave the way for the future of computing.

Qmed Staff

brain image
A computational reconstruction of brain tissue in the hippocampus revealed a complex structure that had been previously unknown. Credit: Salk Institute.

Salk Institute recently announced a neuroscience bombshell, proclaiming that the brain had ten times the memory capacity than previously assumed. The discovery could help spur the development of super-energy-efficient neuro-inspired computers.

To learn more about the research breakthrough, we reached out to Cailey Bromer, a fourth-year graduate student in the UCSD Neuroscience PhD program who was involved in the research project.


Qmed: Can you explain how this new understanding of the brain's memory capacity could help us make computers more efficient?


Bromer
Cailey Bromer

Bromer: One of the questions our lab (like so many others in neuroscience) tries to answer is: how does the brain compute? Often we are looking at only a tiny piece of the brain,which has many structures and layers and cell types, so our answers are constrained by the specifics of our data. The area of the brain that we looked at in the study is the hippocampus, which is important for constructing memories, as well as spatial navigation. If we think about bits in a computer as the lowest common denominator for communication there, we think of the information exchanged as binary (0 or 1). 

Our finding suggests that the lowest common denominator for communication in the brain, the synapse, or the connection point between neurons, exchanges more information than that of a computer. This finding certainly suggests that more energy efficient ways of computing are possible than those that are currently standard. Many people are working on building models that mimic the brain's computations, and we think our finding supports the validity of their pursuits.


Qmed: Do you think that this kind of enhanced understanding of the size and shapes of synapses could help one day lead ultra-precise, energy efficient computers that can employ "deep learning" techniques such as speech and object recognition?

Bromer:In order to accurately model the brain (or a piece of the brain, such as hippocampus), and employ such a model in techniques like "deep learning", we need to understand more than just the limits for energy exchange at the synapse. Our data represents a static image of a brain, frozen in a single moment in time. While we were able to use the connectivity of neurons in the sample and our understanding of the hippocampus from previous experiments in the field, additional modeling and experimentation is required to fully understand how a single neuron integrates the information it receives at each of its many synapses.

A neuron's firing (its output signal) is an all or none event, but even between firing events (called action potentials), the size of synapses is changing. Understanding what the changes at the synapse mean functionally will enable us to better imitate and capitalize on nature's energy efficient computation (the brain). This is work we hope to continue to pursue.
 

Qmed: What kind of an impact do you think such advanced computer systems could have, and how significant do you think your research could be in creating that kind of technology?

Bromer: Science is a collaborative effort, and we've published in an open access journal and made our data available in the hopes that our research can be used by others interested in similar questions. Our work is important, but its only a tiny piece of the puzzle. There are a lot of potential wonderful uses for advanced, energy-efficient computational models of the brain. One of the biggest concerns I have about the rate at which computing is improving is whether we are educating students, at all stages of education, to be competitive and self-sufficient in a world where more and more jobs are being automated. 

Trying to understand the brain is a fascinating and rewarding pursuit in and of itself, but the impact improved computing based on this understanding could have is enormous and exciting, and will raise lots of ethical and political questions. It is my hope that we will be able to harness this kind of efficiency for the greater good.

Learn more about cutting-edge medical devices at MD&M West, February 9-11 at the Anaheim Convention Center in Anaheim, CA.

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CMS: Theranos Could Have Jeopardized Patients

The blood testing company's Newark, CA-based lab has had deficient testing practices, according to CMS. In addition, Walgreens, which had been one of the biggest Theranos supporters, has announced that it will temporarily stop using Theranos technology in its wellness centers. 

Nancy Crotti

Theranos CEO Elizabeth Holmes has insisted that many of the allegations about her company were untrue. The CMS report allegations, however, may be difficult to explain away.

The federal government is threatening cut-rate blood-test company Theranos with fines of $10,000 per day, or even possibly yanking the certification of its California laboratory.

In related news, the WSJ also reported that Walgreens will stop sending patient blood samples to the Theranos lab based in Newark, CA following the CMS report. Theranos had operated 41 Wellness Centers, 40 located in Arizona and one in Palo Alto. The pharmacy chain states that it will not work with Theranos for blood tests until "all issues raised by [regulatory authorities] have been fully resolved." 

In a letter dated January 25, the Centers for Medicare and Medicaid Services (CMS) said the Newark, CA, lab's "deficient" hematology testing practices "pose immediate jeopardy to patient health and safety," including "serious injury, or harm, or death to individuals." The agency, which certifies laboratories under the Clinical Laboratory Improvement Amendments law, also cited the laboratory for problems with its director, technical supervisor, and testing personnel.

CMS conducted the survey November 20, 2015, and received "critical" information from Theranos on December 23, according to the letter. The agency gave Theranos 10 days to respond.

"We are still reviewing the report, but we addressed many of the observations during the survey and are actively continuing to take corrective action," the company said in a statement. "A full plan of correction will be submitted to CMS within days."

Those corrective actions included hiring a new lab director, Kingshuk Das, MD, who is also associate medical director of UCLA's clinical laboratories, and a new clinical consultant, Waldo Concepcion, MD, the chief of clinical transplantation at Stanford University Medical Center. The company also noted that its Arizona lab processes more than 90% of its tests. 

The Silicon Valley lab's CLIA woes are just the latest in a series of difficulties for Theranos. Company founder and CEO Elizabeth Holmes has admitted that the company has stopped using its proprietary technology for all but a herpes test, which FDA cleared in summer 2015. For the rest of its 200-plus tests, the company is using traditional lab testing machines while also relying on external partners such as University of California, San Francisco, and ARUP Laboratories, to perform some of the tests, the Wall Street Journal has reported.

The WSJ has earlier reported that a former Theranos employee has submitted a complaint to CMS alleging that a Theranos lab supervisor had deleted data in 2013 that would call into question the accuracy of its technology. Theranos denies that the incident took place. 

The Journal, other media outlets, and FDA have been scrutinizing the $9-billion startup that promised to perform multiple diagnostic tests with a single drop of blood. 

Learn more about cutting-edge medical devices at MD&M West, February 9-11 at the Anaheim Convention Center in Anaheim, CA.

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

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Bernie Sanders: Medicare for All

    Arrow  backBernie Sanders

And don't expect FDA to cozy up to industry under a Sanders administration.

Qmed Staff

Medical device companies will likely face more vigorous regulation if Sen. Bernie Sanders, D-VT, becomes president. The self-described democratic socialist, who is giving Hillary Clinton a run for her money in the Democratic nomination, has already suggested just as much with his move to delay a Senate vote to confirm Robert Califf, MD, as FDA commissioner. Sanders questions whether Califf would stand up to drug companies instead of being cozy with them; he likely wouldn't want an FDA that's overly friendly with device companies, either.

Also expect the federal government to become even more involved in healthcare than it already is. Sanders calls the Affordable Care Act a "critically important step towards the goal of universal healthcare," but he wants the federal government to go even further and simply provide Medicare for everyone.

Obamacare already has U.S. health providers doing more to control costs, including when it comes to medical devices. Expect that to happen even more if Sanders' plan became law. "Creating a single, public insurance system will go a long way towards getting healthcare spending under control," Sanders' website says.

Much of Sanders' universal healthcare system would be paid by higher taxes on employers and the rich.

When it comes to R&D, Sanders would want to make it more independent of the market. For example, he has proposed a Medical Innovation Prize Fund in the past.

Image courtesy of Gage Skidmore 

Hillary Clinton: Business as Usual

    Arrow  backHillary Clinton

Clinton wants to build on the Affordable Care Act.

Qmed Staff

Last year, Hillary Clinton seemed like a shoe-in for the Democratic nomination. Now, after winning the Iowa caucuses by a razor-thin margin, her odds are somewhat less certain, although she currently remains the frontrunner.

Healthcare has been an issue near and dear to Hillary Clinton. She spearheaded efforts to reform healthcare (later dubbed "Hillarycare") under her husband Bill Clinton's administration in the 1990s, and sought to expand healthcare in Arkansas in the late 1970s.

Clinton has stressed her commitment to preserve and build on Obamacare and has called the law "one of the greatest achievements of president Obama." She has criticized Bernie Sander's Medicare-for-all plan. In other words, expect business as usual if Clinton succeeds Barack Obama as president.

That includes efforts under Obamacare to further control healthcare costs, which would make health providers pickier when it comes to choosing and using medical devices.

Companies developing Alzheimer's disease treatments would also have reason to cheer under a new Clinton administration. Hillary Clinton wants the federal government to spend $2 billion a year to make an Alzheimer's cure possible by 2025. 

Image courtesy of Marc Nozell

Jeb Bush: Reform FDA

    Arrow  backJeb Bush

Bush thinks regulatory barriers are hindering health innovation.

Qmed Staff

Former Florida governor Jeb Bush has direct experience in the medical device industry, having served on the board of CorMatrix Cardiovascular Inc. (Roswell, GA) until 2014.

His position on the ACA remains clear: "As president of the United States, I would make fixing our broken healthcare system one of my top priorities. I will work with Congress to repeal and replace this flawed law with conservative reforms that empower consumers with more choices and control over their healthcare decisions."

Bush's healthcare plan includes promotion of HSAs and tax credits to help people buy their own health insurance, as well as empowering states to do more.

Expect reforms at FDA, too, under a new Bush presidency. Bush's campaign, among other things, says the government should "modernize the Food and Drug Administration's regulatory morass and increase funding and accountability at the National Institutes of Health" to promote innovation. Bush also wants a "comprehensive review of regulatory barriers to health innovation."

Image courtesy of Gage Skidmore