If you belong to the medical device industry, a perfect storm of regulatory changes is heading your way.
The changes in Canada and Europe are at the top of a list of developments and trends to watch for this year, according to four medical device experts.
GxP Lifeline asked the following experts to identify the top trends they are anticipating:
Alex Butler, manager of medical device solutions at MasterControl; Rob Packard, president of Medical Device Academy Inc.; Christopher Devine, Ph.D., president of Devine Guidance International and a columnist for MedTech Intelligence; and Michelle Lott, principal and founder of Lean RAQA.
The experts shared their insights in a new white paper, “Top 5 Medical Device Industry Trends in 2019.”
Here are the highlights:
#1 Prepare for the impact of new regulations, namely:
- The Medical Device Single Audit Program (MDSAP) is replacing the Canadian Medical Devices Conformity Assessment System (CMDCAS) beginning January 2019.
- This is the last year for device companies to transition to the European Union’s (EU) Medical Device Regulation (MDR).
- The deadline for transitioning to ISO 13485:2016 is March 2019.
The shifting regulatory landscape is bound to hit procrastinating companies the hardest. Alex Butler, manager of medical device solutions at MasterControl, described the changing regulatory landscape combined with understaffed regulatory teams dealing with the changes as the “perfect storm.” Likewise, regulatory agencies and notification bodies worldwide are understaffed and struggling to address the changes (1).
Given this challenging situation, he said: “You can’t guarantee that your released product will not experience a hiccup in the next few years.” He advised attendees to educate their executive teams on the burdens faced by regulatory teams in the quest to launch their medical devices successfully.
#2 Human factors engineering (HFE) is more important than ever.
In a guidance on HFE, the U.S. Food and Drug Administration (FDA) stated that it “considers human factors testing for medical devices as a part of a robust design control subsystem.” It recommended the inclusion of HFE data in premarket submissions for devices with risk analysis that shows incorrect use of the device could result in serious harm.
A recent warning letter sent by the FDA to a medical device company highlights the importance of HFE. The citation was due to a failure to conduct a postmarket HFE study and testing. The FDA warned the company that without HFE, the failure of the device could cause infection and possibly serious adverse health consequences (2).
#3 Don’t expect any major product breakthroughs, but existing products are likely to gain momentum.
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Although the four experts are not expecting any major product breakthroughs this year, they thought certain medical products are likely to gain momentum, such as:
- Devices for minimally invasive procedures.
- Light-therapy-based devices.
- Human cells, tissues, and cellular and tissue products (HCTP).
Michelle Lott, principal and founder of Lean RAQA, anticipated an increase in on-indication developments in the human cells, tissues, and cellular and tissue products (HCTP) as a result of FDA guidances issued at the end of 2017. “We will start to see HCTPs with specific on-label indications cleared by the FDA and supported by clinical data. To facilitate biologics license application approvals, the FDA has opened five new pathways to expedite and facilitate review,” she said (3).
#4 The pace of regulatory change will accelerate.
The regulations and standards mentioned in the first item will serve as key drivers for change in the industry. “In fiscal year 2018, the FDA had planned to release 20 new guidances, but in reality, it issued 65! For fiscal year 2019, the FDA’s agenda includes another 27 new guidances,” said Lott. “And that’s not to mention the fast-approaching MDR implementation date in May 2020.”
Christopher Devine, Ph.D., president of Devine Guidance International and a columnist for MedTech Intelligence highlighted the urgency of new regulations. “From a regulatory standpoint, if your organization has not started migration to the EU MDR, there’s no time like the present to begin that journey. What was considered ‘optional’ under the old regulation will become mandated,” he said (4).
#5 The role of medical devices in digital health will continue to grow.
FDA Commissioner Scott Gottlieb lauded the marketing authorization of two medical apps for Apple Watch Series 4 on Sept. 12, 2018, as a “significant step forward for the agency’s overall approach to the development of digital health.” The first app is an electrocardiogram monitor, which can detect heartbeats that are too low, while the second app can detect irregular heartbeat.
The devices were De Novo applications. The FDA granted them marketing authorizations as opposed to a clearance or a premarket approval. “I expect an increase in the number of De Novo applications and small human clinical studies to support efficacy,” said Rob Packard, president of Medical Device Academy Inc. (5).
The global medical device industry is expected to grow annually by about 5 percent, with annual sales worldwide reaching $800 billion by 2030, according to the consulting firm KPMG Global Strategy Group. Given such a rosy forecast, device firms have every reason to be optimistic about their prospects this year.
(1) Alex Butler, manager of medical device solutions at MasterControl, oversees development and continuous improvement initiatives for several MasterControl core products, including MasterControl Regulatory Excellence. He has an extensive background in medical device technology and innovation, with over eight years devoted to product development, strategic planning, quality assurance and process improvement. Prior to joining MasterControl, he served as a product development manager for Opal Orthodontics, where he was directly involved in the development, quality and compliance, risk management, registrations, and launch of several Class II medical devices.
(2) FDA warning letter to Olympus Corporation, issued on March 9, 2018.
(3) Michelle Lott is the principal and founder of Lean RAQA, a regulatory and quality system solutions company. She has nearly 20 years of health care product experience, including holding executive roles for international regulatory and quality operations. She’s currently serving on the FDA’s Device Good Manufacturing Practices Advisory Committee as an industry representative.
(4) Christopher Devine, Ph.D., president of Devine Guidance International, has 32 years of experience in quality assurance, regulatory compliance and program management. His consulting firm specializes in providing solutions for regulatory compliance, quality, supplier management and supply-chain issues facing the medical device industry. He’s a senior member of the American Society for Quality (ASQ) and a member of the Regulatory Affairs Professionals Society (RAPS) and Project Management Institute. Check out his MedTech Intelligence column.
(5) Rob Packard is the president of Medical Device Academy, Inc. He has 25 years of experience in the medical device, pharmaceutical and biotechnology industries. He has served in senior management positions at several medical device companies, including as president and CEO of a laparoscopic imaging company. His quality management system expertise covers all aspects of developing, training, implementing and maintaining ISO 13485 and ISO 14971 certification.
Cindy Fazzi writes about the life science industry and other regulated environments for MasterControl. She has worked as a journalist in three countries. Her two decades of experience as a news reporter, writer, and editor includes working for the Associated Press in Ohio and New York City. She has a master’s degree in journalism from Ohio State University.