Medical Development Group (MDG)

Join Paolo Pescio, MBA, ERT, Former Global Director Biocompatibility & Toxicology at Fresenius Medical Care and Geoffrey Moodie, Ph.D. Principal Biocompatibility Engineer, Group Leader at ZOLL for an in-depth discussion on biocompatibility and what the latest regulatory changes mean for you.

Paolo is a technical expert on the ISO committee that developed the new ISO 10993-1:2025 standard and is currently contributing to the development of the forthcoming ISO guidance document on the application of this standard throughout the medical device lifecycle, so you will have opportunity to hear the most current thinking.

Geoff has over 20 years of experience in medical device safety and efficacy testing and is on multiple AAMI committees providing US industry feedback to multiple standards.

Biological risk assessment is not just a checkbox: it’s a critical risk assessment that needs to be treated as such, exploring potential risks from raw materials to manufacturing processes to final packaging and aging, Regulatory agencies are already asking tough questions that go well beyond rote test results. Are you ready to meet this modern expectation?

If you have open questions this is your opportunity to talk to two seasoned experts actively engaged in the field. You’ll gain practical insights into implementing strategies that satisfy regulators while ensuring patient safety. Whether you’re in R&D, regulatory affairs, or quality assurance, this discussion will help you stay ahead of evolving expectations and avoid costly delays or compliance issues.

Register here: https://www.eventbrite.com/e/biocompatibility-documenting-all-the-risks-online-tickets-2000051581119?aff=oddtdtcreator

Great science doesn’t protect a Medtech startup from bad assumptions & losing time, capital, and credibility with the wrong problem & story.

#### Medtech and biopharma companies lose time, capital, and credibility when they solve the wrong problem, pitch investors the wrong story, mistake interest for traction, or build evidence for approval without planning for adoption.

#### Join Katherine King French, MBA, Director of Strategy at Smith+Nephew, and Bill Schick, MBA, Strategic Growth Advisor for Medtech, Biopharma, and Life Sciences, for a hands-on MDG Boston Lunch & Learn Masterclass.

Grounded in research, market data, company stories, and more than 25 years of startup, investor, commercialization, and IPO experience, the session will unpack seven costly mistakes that can derail a raise, pilot, launch, or next stage of growth.

You will use a practical founder workbook to pressure-test your assumptions and identify weaknesses in your commercial story, evidence, traction, audience, and adoption plan.

You will leave with a clearer view of your biggest risks and a focused 30-day action plan for what to validate, fix, and move forward next.

Register here: https://www.eventbrite.com/e/why-great-science-still-fails-how-to-avoid-7-costly-mistakes-in-medtech-tickets-1997982670953?aff=oddtdtcreator&keep_tld=true