Global Medical Device Podcast powered by Greenlight Guru

‌

Episodes

‌

Greenlight Guru + Medical Device Entrepreneurs•www.greenlight.guru

The Global Medical Device Podcast, powered by Greenlight Guru, is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

Episodes

How General Wellness Devices Have Opened a Pandora's Box of Confusion

Do you have a Fitbit, Apple Watch, or other general wellness device to track your activity, monitor your heart rate, lose weight, or count calories? Are these smart technologies considered medical devices, general wellness devices, or both? In this episode, Jon Speer invites guest Mike Drues of Vascular Sciences to join the show as the two discuss the pros and cons, go-to-market pathways, and other considerations for general wellness products. Some of the highlights of the show include: ● FDA do...

Nov 07, 2019•34 min•Ep 113•Transcript available on Metacast

Regulating Artificial Intelligence and Machine Learning-based Software as a Medical Device

Artificial intelligence (AI) and machine learning (ML) seem to be involved in everything, including medical devices and software as a medical device (SaMD). So, regulatory ramifications are possible with such technology and innovation. In this episode, Allison Komiyama and Michelle Rubin-Onur of Acknowledge Regulatory Strategies discuss regulatory guidance documents related to SaMD created by the International Medical Device Regulators Forum (IMDRF) and U.S. Food and Drug Administration (FDA). S...

Nov 07, 2019•41 min•Ep 112•Transcript available on Metacast

When Should You Start a QMS?

Early-stage startups often wonder when the right time is to consider a quality management system (QMS)? Is it ever too soon to start a QMS? Today’s guest is Devon Campbell, founder of Prodct LLC, which helps establish and implement holistic, efficient, and practical product development and manufacturing strategies. Devon and Jon Speer discuss the importance of timing when starting a QMS for medical device companies to ensure future product success.. Some of the highlights of the show include: ● ...

Nov 07, 2019•31 min•Ep 114•Transcript available on Metacast

Challenges with Pediatric Medical Devices

Challenges continue with the design and development of pediatric medical devices. In this episode, Mike Drues of Vascular Sciences, and I discuss the lack of availability for such devices and prescription drugs, specifically with children in mind. Some of the highlights of the show include: ● Smaller versions of adult medical devices and drugs for pediatric population may not be the best solution or solve the problem. ● Lack of availability is due to lack of market. Drugs approved by the FDA for...

Nov 07, 2019•31 min•Ep 115•Transcript available on Metacast

Right-sizing your QMS

Is your quality management system (QMS) right-sized to fit with the people, processes and purpose of your medical device company? How do you know if it is or isn't? If it is wrong-sized, what can you do to correct it? Today’s guest, Mike Drues of Vascular Sciences, and I discuss this topic through the lenses of regulatory and quality factors to share with listeners the best ways to approach and succeed in right-sizing your QMS. Some of the highlights of the show include: ● QMS: Policies and proc...

Nov 07, 2019•38 min•Ep 116•Transcript available on Metacast