Medical Device Innovation Consortium Archives

CAPA doesn’t have to be a four-letter word, Medtronic Quality/Regulatory Director Kathryn Merrill says

[Illustration by Vitalii Vodolazskyi via Adobe Stock]

Medtronic Quality/Regulatory Program Director Kathryn Merrill is a problem-solver’s problem solver.

Right now, the problem she wants to solve is the way device manufacturers approach corrective and preventative actions — CAPA, an abbreviation that can trigger an avalanche of documentation and headaches for medtech engineers.

For five years, Merrill’s been part of a Medical Device Innovation Consortium (MDIC) team developing a new approach to CAPA, stemming out of conversations across the medtech industry and beyond. The goal was to implement improvements in months instead of years and allow teams to be more proactive.

“I’ve been at Medtronic for 26 years and very often we’d say, ‘Hey, I think we’re making this more complicated than it needs to be,'” said Merrill, who is lead co-author of MDIC̵…

How can medtech companies use more patient input to improve clinical trials?

The Medical Device Innovation Consortium (MDIC) has laid out some recommendations for improving medical device clinical trials with increased patient input.

Having observed that clinical trial sponsors seldom refer to patient input — something the FDA issued guidance for in September 2019 — MDIC offered its view on how to increase and utilize patient input to improve clinical trials in the medtech space.

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

How can medtech companies get more patient input in clinical trials?

The Medical Device Innovation Consortium (MDIC) has laid out some recommendations for improving medical device clinical trials with increased patient input.

Having observed that clinical trial sponsors seldom refer to patient input — something the FDA issued guidance for in September 2019 — MDIC offered its view on how to increase and utilize patient input to improve clinical trials in the medtech space.

In the report, MDIC cited that FDA guidance, which defined patient engagement as “intentional, meaningful interactions with patients that provide opportunities for mutual learning, and effective collaborations.” Effective engagement, according to the administration, could result in faster recruitment, enrollment and completion for studies, greater participant commitment and less follow-up loss, greater compliance, fewer protocol revisions, streamlined data collection and more relevant data on important patient outcomes.

Patient input, according to MDIC, …