How Medical Manufacturers Are Pivoting During the Coronavirus Pandemic

Development Challenges

At KCK Group, Inc., a Trabuco Canyon, Calif., venture capital firm that invests in a variety of areas including medical technology companies on the verge or at the start of commercialization, the fate of projects hangs in the balance, although no projects have had to be abandoned so far, said Susan Stimson, executive in residence at KCK, who works in the medical technologies division.

“One of the actions the team has taken is to spend time with those CEOs to really understand how we can help,” she said. “What are their needs? How can we help them scenario-plan to evaluate many of the potential ways in which this pandemic could impact them? The reality is, no one knows exactly what to expect.”

The hold on elective procedures has affected the development of some of the medical devices in projects supported by KCK, Stimson said. In some cases, clinical study enrollment has been halted. But many studies had already been fully enrolled, and those patients need follow-up. Much of that is being done remotely through telephone or video conferencing.

“It’s ethically responsible to find a way to follow up with those patients, particularly when you’re talking about investigational devices, and especially if those devices are pre-FDA approval,” said Stimson. “You need to be able to continue to collect that data.”

If more contact is necessary, decisions have to be made about whether those visits are carried out. Medical device companies have had to call clinical sites to find out what they and their patients are comfortable with, and consider the type of procedure that’s involved, Stimson said. “I’ve heard some physicians talk about if a patient had to wait, say, two months, do they believe that patient’s outcome would change? If not, can we hold off for a while?” she noted.

At some centers, particularly academic medical centers, clinical research staff have been shifted away from existing studies to studies involving COVID-19, she said. For the most part, however, said Stimson, “I think people are looking at this as a pause—one of unknown duration, of course,” and are now thinking about a plan for the right timing and pace to resume activity once hospitals and offices start seeing patients regularly again.

While most companies are experiencing a slowdown, one company associated with KCK, Lungpacer Medical, Inc., has the opposite problem: It has been granted emergency FDA approval for its technology, which had been in Phase 3 trials, that helps wean patients off ventilators more quickly by stimulating the phrenic nerve and keeping the diaphragm active and well-conditioned. Wider deployment of the technology is happening now rather than later, requiring planning for the sudden training of healthcare workers on how to use the system that will have to be done remotely on computer tablets rather than in person.

The Lungpacer situation illustrates the unpredictability that has been wrought by the pandemic, Stimson said. “It isn’t uncommon for start-up medical companies to, at some point, face a curveball and need to come up with plans B and C, because that’s just the nature of the business,” she said. “It is certainly unusual for all of them to face a curveball at the same time and related to the same issue.”