The U.S. FDA and makers of medical devices have several collaborative programs, but the two sides have joined forces yet again in a new collaboration, this time to address both product quality issues and supply chain resiliency.
The Medical Device Innovation Consortium (MDIC) has played a key role in fostering a stronger industrial appreciation for the need for robust cybersecurity, but a recent MDIC report noted that many device makers are deficient in pushing cybersecurity considerations into the domain of design controls. However, the most critical element in cybersecurity may be whether a company has a chief product security officer (CPSO), the presence of absence of which seems to correlate strongly and uniformly with all aspects of cybersecurity in a manufacturer’s products.
Computational modeling and simulation (CM&S) isn’t the new flavor of the month in the medical device industry, but it hasn’t exactly achieved the status of a buzzword, either. However, the Medical Device Innovation Consortium (MDIC) has published a report which makes clear that these software tools are continuing to open new frontiers in device development, a trend that seems certain to continue to expand in the decades ahead as to-market costs continue to grow.
Cybersecurity has become one of the core concerns for med tech in this part of the 21st Century, and a collaboration between the FDA and the Mitre Corp., has yielded a new playbook that calls for a regional response to issues such as ransomware. However, this new document calls on medical device manufacturers to take part in cybersecurity exercises along with health care delivery organizations, an exercise that some manufacturers might not be prepared to undertake.
Entities that lack experience in FDA regulation of medical devices may find the going both expensive and time consuming, but there are resources available to these players in the digital health space. Bakul Patel, director of the Digital Health Center of Excellence at the FDA’s device center, said that while he understands that reading through agency guidance is an unpleasant task, the companies that take the time to do so may find their interactions with the agency less iterative and more productive, thus speeding their path to market.
The Medical Device Innovation Consortium (MDIC) has launched a digital health initiative that will aid the FDA in its efforts to devise a workable regulatory system for these products, which includes a work stream for change control. This work stream promises to be a massive effort, but Joe Sapiente, MDIC's vice president for clinical science and technology, told BioWorld that MDIC needs subject matter experts in this and several other areas to sustain the group’s momentum and thus aid the FDA’s efforts to produce guidance for digital health products.
The decision by the U.S. Centers for Medicare & Medicaid Services (CMS) to suspend the Medicare Coverage of Innovative Technology (MCIT) rule a second time was controversial, but CMS’s Tamara Syrek Jensen vowed that the agency has made no final decision. Jensen acknowledged that the agency has not foreclosed a full-blown rescission of the MCIT proposal, a not-implausible outcome given the prospect that legislation in the works in the House Energy and Commerce Committee could render the rule moot.
Early feasibility studies for cardiology devices were a massive problem for the FDA and industry in times gone by, a problem that was believed to drive device flight from the U.S. That problem has been largely solved, according to the FDA’s Andrew Farb, but Farb noted that neurological devices are the next target for improved early feasibility study (EFS) development in the U.S., which suggests that the path to pivotal studies for devices in this space will soon be much less cumbersome.
Acting FDA commissioner Janet Woodcock appeared at the annual forum held by the Medical Device Innovation Consortium (MDIC) and noted that real-world evidence (RWE) has tremendous potential in regulatory decision making. However, she cautioned that while “the future is very bright” for RWE, “it’s going to take longer than some of the enthusiasts might have thought” to maximize this source of data in product reviews.
Corrective and preventive action (CAPA) has a long and difficult history where med tech is concerned. Kathryn Merrill, the global quality/regulatory program director for Medtronic plc, of Dublin, said on a recent webinar that one of the main sources of uncertainty is that many in industry are not clear as to which circumstances dictate that a CAPA should be opened.
