Sen. Warner enlists healthcare industry help on cybersecurity


[Image courtesy of Blogtrepreneur on Flickr, per Creative Commons 2.0 license]

U.S. Senator Mark Warner (D-Va.) is wrote a letter to several healthcare organizations yesterday, asking their help in improving cybersecurity in the industry.

A member of the Senate Finance Committee and chair of the Senate cybersecurity caucus, Warner pointed to apparent gaps in oversight, expressed concern about the impact of cyberattacks on the health care sector, and said he wants to help develop strategies that strengthen information security.

Ransomeware and other cyberattacks have stunned the healthcare industry. The 2017 WannaCry attack affected hospitals in the U.S. and U.K., including medical devices made by Bayer, Siemens and others, according to the Health Information Trust Alliance. A 2017 report by internet security software company Trend Micro found that more than 100,000 medical devices and systems were exposed directly to the public internet. The U.S. Department of Homeland Security issued an alert in 2018 indicating that several GE Healthcare imaging devices were vulnerable to cyberattack.

Healthcare hacking incidents accounted for 44% of all tracked data breaches in 2018,  the most of any type of breach, according to a report published in HIPAA Journal.  FDA published an updated draft of its cybersecurity premarket guidance for medical device makers in October 2018.

Warner’s office sent the letters to medtech trade group AdvaMed, the Healthcare Information and Management Systems Society, the American Hospital Association, and several other organizations.

“I would like to work with you and other industry stakeholders to develop a short and long term strategy for reducing cybersecurity vulnerabilities in the health care sector,” Warner said in the letter. “It is my hope that with thoughtful and carefully considered feedback we can develop a national strategy that improves the safety, resilience, and security of our health care industry.”





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AdvaMed president & CEO Scott Whitaker to participate in keynote interview at DeviceTalks Boston 2019

DeviceTalks Boston 2019 - Scott WhitakerWTWH Media and announced today that Scott Whitaker, president and CEO of AdvaMed, will be a featured keynote speaker at DeviceTalks Boston 2019.

DeviceTalks Boston, which takes place on June 5-6, 2019 at the Seaport World Trade Center, brings together engineering, product development and commercialization professionals to share the challenges and best practices of getting medical devices to the market.

“We are very excited that Scott Whitaker will provide the DeviceTalks Boston audience with an inside look at AdvaMed’s priorities for 2019. Scott is a leading voice in the medical device industry, helping to shape the policies that affect every device company. The DeviceTalks team is thrilled that he will join us in June for our eighth year in Boston,” said DeviceTalks content manager Sarah Faulkner.

“It’s a pleasure to be returning to Boston for DeviceTalks in June, and also for The MedTech Conference powered by AdvaMed this September,” Scott Whitaker said. “Boston is at the epicenter of medtech innovation across the region, helping to provide life-changing solutions for patients around the world, and we’re excited to be there.”

Recruiting from the best of Boston’s medtech ecosystem, DeviceTalks Boston highlights speakers who explore how to build better devices and better companies. To register, visit

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3M names CEO Roman as board chair | Personnel Moves – February 7, 2019

3M CEO Roman

3M (NYSE:MMM) said yesterday that its board of directors nominated CEO Mike Roman as its new chairperson, with current exec chair Inge Thulin announcing their intention to retire.

The move is slated to take effect following the St. Paul, Minn.-based company’s annual meeting of shareholders on May 14.

“Under Inge’s leadership, 3M evolved into a more agile and competitive enterprise while generating tremendous value for customers and shareholders. Today’s decision underscores the Board’s confidence in Mike’s leadership and strong character to lead 3M into the future as both CEO and chairman of the board,” board independent lead director Mike Eskew said in a prepared statement.

“I am proud of 3M, our people, and what we’ve accomplished together. I’ve known and worked very closely with Mike, including since his appointment as CEO. I’m very confident that 3M’s best days are ahead and Mike will do a fantastic job leading 3M into the future,” Thulin said in a press release.

“It’s an honor to be nominated to the additional role of chairman of the board. I thank Inge for his leadership and partnership throughout my career, especially over the past year in his role as executive chairman,” Roman said in prepared remarks.

 VentureMed names former NxThera prez Paulson as CEO

VentureMed said on Tuesday that it named former NxThera prez & CEO J. Robert Paulson, Jr. as its new prez & chief executive, effective January 1.

Paulson will replace Gary Smith, who the Toledo, Ohio-based company said will continue to serve as a member of the leadership team.

Prior to joining VentureMed, Paulson served as prez, CEO and board director of NxThera from 2009 until the company’s acquisition by Boston Scientific (NYSE:BSX) last year.

Before joining NxThera, Paulson also held president and CEO positions with Restore Medical, which was acquired by Medtronic (NYSE:MDT) in 2008.

“Bob brings tremendous knowledge and experience to the VentureMed Group, together with a strong track record of building successful teams and commercializing compelling new medical technologies. We look forward to Bob’s contributions and leadership during this next phase of the company’s growth. On behalf of the board of directors, I would like to thank Gary for his significant contributions, which have created a solid foundation for the future success of the VentureMed Group,” board member and Endeavour Vision partner Alexander Schmitz said in a press release.

“I am thrilled to be working with our team and physician partners to expand adoption of our Flex VP System, to improve the treatment of peripheral arterial disease, and AV fistulas and grafts, in millions of patients around the world,” Paulson said in a prepared statement.

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 Repro-Med Systems lifts prez & CCO Petigrew to the corner office

Repro-Med Systems said on Monday that its reconstituted board of directors promoted prez & CCO Don Petigrew to the position of CEO.

Petigrew will replace interim CEO and chair Dan Goldberger, who is assuming the position of exec board chair, the Chester, N.Y.-based company said.

“As an industry leader in the home infusion market, RMS delivers invaluable medical and lifestyle solutions to patients who rely on our products. My vision as CEO is to innovate and improve our products such as the FREEDOM system, partner with the medical community to identify new patient needs and expand our reach in the US and abroad. Achieving these goals is a win-win for patients, providers and shareholders alike,” prez & CEO Petigrew said in a prepared statement.

“Don’s presence since joining the company has been immediately accretive. His experience in the infusion industry has uniquely positioned him to build upon the company’s successful foundation. I look forward to working with Don and the team at RMS and our newly reconstituted Board of Directors in my role as Executive Chairman to help the company achieve its potential and execute on our strategy,” exec chair Goldberger said in a press release.

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 Myomo taps Henry as CFO

Myomo said yesterday that it named David Henry as its new CFO, taking over for current chief financial officer Ralph Goldwasser, who is retiring effective February 18.

The Cambridge, Mass.-based company said that Goldwasser will stay on to help in the transition for an anticipated three months.

Prior to joining Myomo, Henry served as chief financial officer of Eos Energy Storage, and has also held CFO positions with American Semiconductor Corp and AMI Semiconductor.

“I would like to thank Ralph, who has worked with me at Myomo for the past eight years, first as a consulting CFO and later as our chief financial officer, enabling us to raise growth capital, including leading our June 2017 IPO and listing on the NYSE American exchange and our follow-on equity financing in December of 2017. We wish Ralph the best in his retirement. We are pleased to have David Henry join Myomo’s executive team as chief financial officer. David has extensive experience to support our efforts to grow the company,” chair & CEO Paul Gudonis said in a press release.

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 Amazon, Berkshire Hathaway & JP Morgan venture snags Kutan as CTO

The joint healthcare venture between Amazon (NSDQ:AMZN), Berkshire Hathaway and J.P. Morgan Chase has picked up former tech chief at digital healthcare startup ZocDoc Serkan Kutan as its new chief technology officer, according to a recent CNBC report.

The move was confirmed as official by the new health venture, according to the report.

“I am thrilled to now announced that I am serving as CTO of this new venture,” Kutan wrote in a LinkedIn posting, according to CNBC.

During his time at ZocDoc, Kutan was tasked with building technology allowing consumers to book doctors appoints digitally, according to the report.

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FDA opts not to change device class definitions

FDA-logo-newThe medtech industry appears to have won a round in the regulatory arena.

The FDA issued a final rule amending its regulations on classifying and reclassifying medical devices under the Food and Drug Administration Safety and Innovation Act (FDASIA), passed in 2012. Published today in the Federal Register, the rule says it “provides for the classification of devices in the lowest regulatory class consistent with the public health and the statutory scheme for device regulation.”

When it was proposed in 2014, the rule drew comments from the industry arguing that the changes in definitions would result in more devices being classified into “burdensome, higher-class device categories, particularly into class III.”  Other commenters said the changes would make class definitions too specific and narrow, particularly for class III devices. This could lead to “unwarranted reclassification of high-risk devices into lower classes,” the document says.

AdvaMed and the Medical Device Manufacturers Association were among those that warned the definition changes would result in more devices being classified as posing a high risk to human health.

“MDMA is concerned that the Proposed Rule creates an unjustified and, indeed,
what we believe is an unlawful burden on industry that will result in significant delays in patient access to critical new products,” the organization wrote.

In its objection, AdvaMed wrote that the proposed changes amounted to “substantial rewriting of the device class definitions, changes in well-settled terminology, and new definitions with likely significant impact on the reclassification process.”

“We believe that unsettling longstanding understandings of the classification
process and attempting to integrate decision-making criteria into definitions that do not need clarification is a dangerous practice that can create confusion, inefficiency and weak decision-making for both the regulators and regulated persons,” AdvaMed continued. “In other words, we believe the proposed revisions will cause confusion where there was none.”

Others said that the proposed definition of class II was too broad and that it would capture devices that they thought should be regulated as class III.

In the end, the FDA decided not to finalize any of the proposed definition changes.

“We do not believe, given the volume and diversity of opposing comments, that finalizing these definitions would add clarity or transparency to stakeholders’ understanding” of the regulation, the agency said.

The decision to pull back on its definition changes was the second in two weeks that could affect the classification of devices. Last week, the FDA published a new proposed rule looking to establish procedures and criteria for its De Novo certification pathway.

If finalized, the rule would establish classifications for new types of medical devices and provide guidelines for the de novo classification process. It would also establish requirements for the formatting and content of de novo requests and would clarify the agency’s criteria for approval, declining and withdrawing such requests.

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Medtech companies, industry groups shrug off ICIJ’s “Implant Files” report

Medtech companies and industry groups have shrugged off the recently released “Implant Files” report from the International Consortium of Investigative that was highly critical of the industry, seeing shares stay steady or rising only days after the report was posted.

The highly critical “Implant Files” report, which was released early this week, is a collaborative effort overseen by the ICIJ and includes work from 252 journalists from 59 media groups across 36 countries.

On its first day of trading this week after the release of the report, industry giant Medtronic (NYSE:MDT) saw its shares rise 1.6% to close at $92.06. Other major players, including Johnson & Johnson (NYSE:JNJ), Boston Scientific (NYSE:BSX) and Zimmer Biomet (NYSE:ZBH) saw shares drop less than 1% in response to the report.

Responses from medical device industry groups varied greatly, with some expressing sympathy to the issues presented in the report and reiterating their intentions to improve global health and wellness through the use of advanced technology.

“The medical device industry understands that just one adverse event is too many, particularly if it affects you or your loved ones. It is heartbreaking when our healthcare system, which is set up to heal people, results in patients being harmed. Everyone involved in care feels the pain when a patient is hurt, from the nurses and doctors on the front lines of care, to the women and men building medical technology. Our first and primary purpose is to help patients and we do that, every day for millions of people around the globe,” MassMEDIC president & former MassDevice publisher Brian Johnson wrote in a statement in response to the ICIJ report. “Patients can feel confident that the medical devices being used to treat them are safe and have been rigorously vetted by a robust and stringent regulatory system. Independent research has shown that the overall recall rate of medical devices, cleared through the FDA is remarkably low, less than 1%. However, nobody involved in this system believes in resting on their laurels. The medical device industry, the FDA and our healthcare system will continue to seek ways to improve the process of patient safety, while giving patients access to groundbreaking new treatments that will improve their lives.”

“While there is no medical procedure that can be performed without risk, Medical Alley companies always strive to innovate and produce the safest possible technologies that deliver better outcomes for patients. Medical Alley has a history of leadership, as the birthplace of the modern medical technology industry and as the co-creator of the Medical Device Innovation Consortium. Medical Alley looks forward to working with all health stakeholders to improve the products, the regulatory process and the press coverage of the medical technology industry and the patients whose lives depend on these products,” Minnesota’s Medical Alley Association representatives wrote in response to the report.

Other groups were more dismissive of the issues covered in the release and accused investigators of “cherry-picking” dramatic stories and “overlooking the overwhelmingly positive experiences” that the industry supports.

“The ICIJ’s coverage of this dynamic industry is cherry-picking a handful of adverse outcomes at the exclusion of the nearly 200,000 medical devices currently on the market improving patient care. This only serves to frighten the millions of patients who benefit from medical technology innovation every day, while inaccurately portraying the rigorous regulatory pathways that are in place to ensure patient safety,” Medical Device Manufacturer’s Association prez & CEO Mark Leahey said in press release responding to the ICIJ report.

“Every one of us will inevitably face a moment where we will hope for a miracle to make a child, sibling, parent, grandparent or loved one well again. Whether it’s a pacemaker that keeps a heart beating, an implant that allows a child to hear for the first time, or an artificial knee that allows a grandmother to play with her grandkids, medical devices are the foundation of modern medicine, providing physicians and nurses the tools they rely on to improve patient care. Yet, instead of a comprehensive look at both the challenges and the achievements of an industry that touches almost every human life, these stories counterfeit the life-changing and life-saving solutions delivered to billions of people worldwide,” AdvaMed wrote in response to the ICIJ report. “We should never discount any patient’s experience. But by magnifying the stories of only a few individuals, we overlook the overwhelmingly positive experiences of millions of others. We take seriously all reports of patient impact, and though the medical community can never completely eliminate risk, we always strive to improve our technologies and care delivery.”

The report is the second major examination of the medtech industry to release this year, after Netflix released a highly critical documentary, titled “The Bleeding Edge,” earlier this summer.

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Is the medical device industry endangering people?

(Image from Unsplash)

The highly critical “Implant Files” report overseen by the International Consortium of Investigative Journalists skewers the medtech industry as a whole and singles out particular companies and regulatory agencies for more intense scrutiny.

The Implant Files is the second large-scale swipe at the medtech industry this year, following Netflix’s documentary, The Bleeding Edge. It includes six stories about medtech companies, the FDA and the European device approval system, a new International Medical Devices Database, resources for patients, and a list of its many international media collaborators. Investigators collected more than 8 million device-related health records over the course of the investigation, the majority of which came from the more than 5.4 million adverse event reports filed with the FDA over the past 10 years.

Get the full story on our sister site, Medical Design & Outsourcing,

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Trump’s tariffs on $34B of Chinese products kick in

Tariffs imposed by President Donald Trump on $34 billion of Chinese goods, including a slew of medical devices, went into effect on Friday. China immediately retaliated, kicking off tariffs of equal size for American goods.

Trump said this week that his administration will implement tariffs for another $16 billion worth of Chinese goods in the coming weeks. He’s also reportedly considering additional tariffs on $500 billion worth of products, according to CNBC.

The China-made medical devices on the list of products affected by new U.S. tariffs include pacemakers, X-ray generators, anesthetic devices and optical instruments, CNN reported.

All told, the levies imposed by the Trump administration could take a $5 billion bite out of the U.S. medtech industry, according to AdvaMed public affairs EVP Greg Crist.

Industry representatives lobbied against the move, arguing that the tariffs could damage their companies’ ability to compete. Executives from GE Healthcare reportedly asked the Trump administration to remove certain components made in China from the list of products slated to take a hit from the tariffs.

“GE’s requests for adjustments to the proposed tariff list have been limited … to those products that should be removed because tariffs would impose significant and disproportionate costs on U.S. business, workers and consumers without advancing — or potentially even undermining — the President’s goals,” GE wrote to the US Trade Representative, according to the BBJ.

Beyond the medical technology industry, there is the looming concern that the relationship between the U.S. and China economies has devolved into an escalating ‘tit-for-tat.’

“We’ll probably see escalation upon escalation. China has made it absolutely clear,” Australia’s former ambassador to China, Geoff Raby, told CNBC.

In a statement, China’s Ministry of Commerce declared that the U.S. has “violated [World Trade Organization] rules and launched the largest trade war in economic history to date.”

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India’s medical device industry protests NPPA stent price caps


Indian medical device manufacturers and associations are voicing their opposition to price caps on stents and other devices imposed by India’s National Pharmaceutical Pricing Authority, according to a report from the Economic Times India.

The price cap has reportedly left little to no room for innovation in the country, with industry groups now demanding an expansion of the National List of Essential Medicine board, which evaluates the price caps, to include different stakeholders within the industry.

“Continuing in the spirit of inclusiveness, we request the ministry of Health & Family Welfare to reconstitute the NLEM committee to enable inclusion of representatives from other relevant sections of the healthcare ecosystem. The broader constitution will give a real chance to the committee to review its previous decision on price capping. The committee, in its current form, is invested in the decision it took last year and the review would be fair if it is done by a broader panel,” Medical Technology Association of India director general Pavan Choudary said, according to the Economic Times India.

The industry groups have floated solutions to the caps, including labeling of higher priced, more “innovative” stents under a different sub-category, but so far the efforts have been rejected by the NPPA citing a lack of evidence.

Advocates for removal of the price cap, including industry groups such as AdvaMed, have argued that medical devices, unlike pharmaceuticals, cannot be adjudged on clinical superiority evidence, according to the report. They also argue that the lifecycle of medical devices are often cut short due to continuous improvements, making it difficult to make appropriate efficacy comparisons.

Industry groups are reportedly supportive of an idea floated by the government’s Committee on High Trade Margins in the Sale of Drugs which recommended capping of margins instead of flat price caps.

“Singular focus on controlling the price of devices without attempting to address the larger picture will not improve patient access. We need to consider alternatives to price control such as trade margin rationalization and more scientific approaches that facilitate differential pricing for innovative medical technologies,” AdvaMed VP Dr. Abby Prat said, according to Economic Times India.

Last November, the NPPA was reportedly looking to revisit its decision to impose price caps on coronary stents in February of 2018 and it is looking for input from manufacturers, the agency said in a statement last week.

AdvaMed goes social with anti-medtech tax ad

The Advanced Medical Technology Assn. is unleashing the latest ad in a social media campaign aimed at winning more legislative support for a repeal of the medical device tax, hoping to sway Congress members during the August recess.

The apparent demise last month of Republican plans to repeal Obamacare and replace it with their own version of healthcare reform, which would have done away with the medtech tax, has the industry casting about for another vehicle to latch on to.

The 2.3% levy was imposed on U.S. medical device sales by the Affordable Care Act in 2013. During the three years it was in effect (a two-year moratorium went into effect at the beginning of last year), the tax brought in $5.3 billion, well short of the $8.7 billion it was expected to bring in to IRS coffers. Repealing the tax is predicted to cut nearly $20 billion in revenues from the federal budget from 2018 to 2026.

Now AdvaMed is aiming to up the public pressure on legislators who have yet to sign on to the repeal push, which enjoys bipartisan support in both chambers. The social media campaign, under the #repealdevicetax hashtag on Twitter, features ads highlighting the industry’s positive impact on public health, jobs and the economy.

The new ad is slated to run from August 14 through Labor Day in 15 states, a spokesman for the lobby told today via email. It aims to influence senators and representatives in states with large medtech clusters including California, Indiana, Massachusetts, Michigan and Minnesota.

“Our goal is to ensure repeal remains top of the priority list through recess. We’re calling this phase, ‘It’s Time,’ because, in the wake of the fight over ACA, it’s time to get some clear economic and health policy wins such as full repeal on the books,” the spokesman told us.

“It’s time to protect innovation, it’s time to advance life-changing research, it’s time to permanently repeal the jobs-killing device tax!” the ad reads:

“It’s time to put innovation first. Thousands of companies face a massive, billion-dollar tax increase in a matter of months. We know full repeal can make it across the finish line and become law, so it’s time to do something about that when Congress returns,” AdvaMed CEO Scott Whitaker added in prepared remarks.

The latest repeal campaign is nothing new for AdvaMed, which has been running anti-medtech tax ads since at least early 2016 on Twitter.

“U.S. medtech companies support nearly 2 million jobs,” one ad reads.

“Between 2000 and 2014, medical advancements helped reduce fatalities from heart disease by 35%,” reads another.

Emphasizing the “real-world impact” of the tax, another asserts that resumption of the tax next year “threatens to stall” companies’ planned innovations.

“Congress, it’s time to permanently repeal the medical device tax: for jobs, for innovation, for patients,” according to the Twitter campaign.

“Any moving vehicle”

Although the Senate recently voted to approve the FDA user fee bill without including any repeal language, the medtech industry hopes to tack the measure onto any of a number of upcoming legislative pushes. Candidates include reauthorizing the Children’s Health Insurance Program, an omnibus budget bill expected next year and the next item on the agend: Reforming the tax code.

Last month Whitaker told media outlets that he’s “frustrated” by Washington’s inability to act, saying the lobby is prepared to “pivot to any moving vehicle.”

“We’re not going to give up,” he told Modern Healthcare.

“The medtech industry is frustrated, because if Congress doesn’t do something, a tax increase is looming,” he said to the Minneapolis Star Tribune.

That said, another temporary reprieve lacks appeal, Whitaker said.

“While we’d be grateful for anything beyond a tax increase,” he told the newspaper, “that’s not the right health policy or tax policy solution.”

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