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 […]
Medical Device Innovation Consortium
FDA grants $3m to MDIC for quality improvment, cybersecurity programs
The Medical Device Innovation Consortium said this week that it won nearly $3 million in funding from the FDA for the expansion of its case for quality and medical device cybersecurity programs. MDIC plans to put the $2.8 million award toward medical device manufacturing sites with quality system issues or ones that have been out […]
Ex-Medtronic CFO Ellis joins Inspire Medical board | Personnel Moves, August 2, 2019
Inspire Medical Systems last week named Gary Ellis, the former CFO at Medtronic (NYSE:MDT), to its board of directors effective immediately. Minneapolis-based Inspire Medical also said that Amzak Health managing partner Joyce Erony left the board effective yesterday. Ellis spent 27 years at Medtronic before retiring in 2016. “On behalf of the entire Inspire board […]
Spinal Elements lifts former COO Blain to the corner office | Personnel Moves November 30, 2017
Spinal Elements, previously known as Amendia, said this week it is lifting co-founder and current prez & COO Jason Blain to the position of prez & CEO, effective immediately. Prior to coming on to co-found Spinal Elements, Blain served in various roles with medtech companies Smith & Nephew (NYSE:SNN), Alphatec (NSDQ:ATEC) and NuVasive Inc. (NSDQ:NUVA). Blain is replacing […]
Patients with Parkinson’s disease help to shape clinical trial design
Margaret Sheehan isn’t a scientist, but she is 1 of many patient scientists joining an effort to incorporate Parkinson’s patients’ preference into the design of clinical trials for new treatments. Sheehan, a Virginia-based lawyer, has had Parkinson’s disease since 2004. She told Drug Delivery Business News that when the folks at the Medical Device Innovation Consortium presented last spring […]
Prioritizing patient preference & risk in device trials
Patients with a rare, chronic disease can find themselves in a conundrum when seeking treatment: Researchers can’t find enough patients to enroll in a statistically rigorous clinical trial and there is uncertainty in the regulatory path. Frustrated by the lack of treatment options on the market, patients may be willing to accept a certain level of […]
FDA, MDIC press their ‘Case for Quality’
The Case for Quality, a collaborative effort between the FDA and the medical device industry, released its 1st report today, focused on the safety and efficacy of knee implants and cardioverter defibrillators. The Case for Quality looks to assess the feasibility and effectiveness of using standardized medical device performance data and analytics in an effort to help […]
