FDA On-Site Inspections of Medical Device Makers Drops 93% (MedTech Download)

Kelly Springs-Kelley
December 11, 2020

Key Takeaways

  • The FDA has announced a virtual inspections pilot program after on-site inspections of medical device makers dropped a shocking 93% from the year prior.
  • MissionGo and MediGO’s partnership resulted in 2 unmanned test flights that carried and successfully delivered human organs for transplant.
  • Wondering which MedTech stocks are on the rise? There are 3, in particular, that stand out.

On-Site Inspections Of US Device Makers Plummet 93% As FDA Scrambles For Virtual Solutions

Though at one point it seemed that there was some light at the end of the tunnel, the past few months have shown us that COVID-19 is as pervasive as ever. The pandemic has forced most industries to make dramatic adaptations in the way that they conduct business, MedTech included. While some have seamlessly swapped conference rooms for Zoom meetings, there are elements of the industry that can’t adapt so easily.

Last month MedTech Insight reported that the FDA announced a virtual inspection pilot program after revealing that on-site inspections had plummeted a dramatic 93% from the year before. While the agency hasn’t elaborated on its initial announcement, the article went on to say that the agency kicked off a program to “virtually (gather) data from manufacturers. The first involves the use of live or recorded video to assess compliance, while the other would allow investigators to remotely review records.”

MissionGO and MediGO Complete Successful Organ Deliveries in Unmanned Flights

Photo: MissionGo

Today, organ transplantation is commonplace. It is also an example of the exponential development of medical technology. The first organ transplant took place a mere 66 years ago in 1954. At that time, there were a number of barriers to successful transplantation, from organ rejection to industry regulations. Yet, as time has marched on, so too have advancements that have led to successful transplants and hundreds of thousands of lives saved.

Flash forward to today, where we continue to optimize the transplantation process, including how the organs are transported. Recently MissionGO and MediGo completed two successful test flights carrying human organs via unmanned aircraft. The partnership aims to “decrease the time between organ donation and transplantation, and reduce the carbon footprint – all while expanding organ procurement efficiency and ultimately saving lives.”

CDRH Headed for ‘Reset’ in 2021 After COVID-19 Derailed Priorities, Shuren Says

Stocks fell on Neovasc Angina device failing to get FDA approval.

The FDA’s Center for Devices and Radiological Health is experiencing a tremendous backlog in the wake of the events of 2020. Like other health-related government entities, COVID-19 has taken its place at the top of everyone’s priority list. Not only has the department been inundated with pandemic-related work, but “non-coronavirus submissions have also continued to pour into the center at the same or higher rates than previous years.”   

With all that is on the horizon, Jeff Shuren, director of the CDRH, said at an event that 2021 will be a “reset” as the department seeks to get a handle on all of its medical device priorities. In addition, the department will focus on the “next round of the medical device user fees program (MDUFA V), applying regulatory flexibilities used during the pandemic to traditional processes.” He also discussed the CDRH’s intention to launch or pilot several programs such as the Safer Technologies Program, which will be a top goal in 2021 as it seeks to prioritize new technologies that are significantly safer than existing treatments.

3 Growth Stocks to Tap In the COVID-Driven Shift in MedTech

The pandemic’s effect on MedTech has varied dramatically. If you exist in a space that catered to elective procedures, you likely experienced an unwelcome loss in revenue, as procedures were delayed across the world to cater to COVID patients. However, labs and diagnostics companies have had a different type of year, with demand for their services shooting sky-high. Another sector in the winners’ column is digital health, as providers seek solutions for remote and distance care.

Nasdaq published an article that details how the MedTech boom has shaken out in terms of the stock market and which companies are a good investment play. And while it’s worth noting that MedTech experienced a March stock dive alongside the market as a whole, the rebound has been exceptional. The article discloses that “an EY Global report claims that by the end of August 2020, MedTech’s valuations were 50% above its January 2019 level.” While the article gives a nod to companies like Quest Diagnostics, it’s not one of the 3 worth investing in.

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