Everything you need to know about biocompatibility - in one podcast.

From a webinar hosted by MedTech Leading Voice and featuring Michelle and Marina Daineko from Intrinsic Medical Group.

𝗕𝗶𝗼𝗰𝗼𝗺𝗽 𝟭𝟬𝟭: 𝗙𝘂𝗻𝗱𝗮𝗺𝗲𝗻𝘁𝗮𝗹𝘀 𝗳𝗼𝗿 𝗠𝗲𝗱𝗧𝗲𝗰𝗵 𝗣𝗿𝗼𝗳𝗲𝘀𝘀𝗶𝗼𝗻𝗮𝗹𝘀

By understanding biocompatibility and following best practices, manufacturers can ensure the safety and efficacy of their medical devices:

- Biocompatibility involves material selection, device design, testing, and risk management.

- Direct and indirect contact with the body are key considerations.

- Regulatory requirements and risk assessment are essential.

- Material selection can be challenging due to potential adverse reactions.

- Device design must minimize the risk of complications.

- Testing limitations and regulatory compliance can be complex.

𝗕𝗮𝘀𝗶𝗰𝘀 𝗼𝗳 𝗕𝗶𝗼𝗰𝗼𝗺𝗽𝗮𝘁𝗶𝗯𝗶𝗹𝗶𝘁𝘆

What is assessed, when is it assessed

𝗖𝗮𝘀𝗲 𝗦𝘁𝘂𝗱𝘆 #𝟭

- IEC standard 60601-1

- ISO 14971

- ISO 10993

𝗖𝗮𝘀𝗲 𝗦𝘁𝘂𝗱𝘆 #𝟮

- Testing connector cables for leachables

𝗖𝗮𝘀𝗲 𝗦𝘁𝘂𝗱𝘆 #𝟯

- Intended Use vs Depicted Use

- Costs and documentation changes arising from failed biocompatibility testing

𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗖𝗵𝗮𝗻𝗴𝗲𝘀 𝗥𝗲𝗾𝘂𝗶𝗿𝗶𝗻𝗴 𝗕𝗶𝗼𝗰𝗼𝗺𝗽𝗮𝘁𝗶𝗯𝗶𝗹𝗶𝘁𝘆 𝗧𝗲𝘀𝘁𝗶𝗻𝗴

𝗖𝗮𝘀𝗲 𝗦𝘁𝘂𝗱𝘆 #4

- Heat changes chemistry, which means biocompatibility testing

𝗕𝗶𝗼𝗰𝗼𝗺𝗽𝗮𝘁𝗶𝗯𝗶𝗹𝗶𝘁𝘆 𝗧𝗲𝘀𝘁𝗶𝗻𝗴 𝗘𝘅𝗲𝗺𝗽𝘁𝗶𝗼𝗻𝘀 𝗮𝗻𝗱 𝗪𝗵𝗲𝗻 𝗧𝗵𝗲𝘆 𝗔𝗽𝗽𝗹𝘆

𝗠𝗮𝗻𝗮𝗴𝗶𝗻𝗴 𝗕𝗶𝗼𝗰𝗼𝗺𝗽𝗮𝘁𝗶𝗯𝗶𝗹𝗶𝘁𝘆 𝗥𝗲𝗾𝘂𝗶𝗿𝗲𝗺𝗲𝗻𝘁𝘀 𝗯𝘆 𝗖𝗼𝘂𝗻𝘁𝗿𝘆

- Animal testing

- Biocompatibility testing labs

- ASCA program

𝗖𝗼𝗻𝘁𝗮𝗰𝘁 𝗗𝘂𝗿𝗮𝘁𝗶𝗼𝗻

Which market is best for your product - the EU or the US?

The answer is not always straightforward, but Ronald Boumans, Nika Mendelev and I did our level best to answer your questions in this Master Class presentation.

Michelle leads off with a review of FDA strategies and pathways.

15:34 - Ronald dives into the particulars of MDR and dealing with notified bodies.

27:15 - Nika Mendelev explains whether you really need to choose one or the other.

32:10 - the Q+A session begins.

Link to the full presentation on YouTube: https://youtu.be/4wyZzVibiAY

Biocompatibility testing is hot right now, in part because of the sharp increase in the number of FDA submissions containing fraudulent data. Some unethical third-party testing labs are sending their clients data mined from old 510(k) submissions - and passing it off as fresh data.

So what's a medical device manufacturer to do? That was the topic of conversation this month when I chatted with Mike McGrew and Sandi Schaible from WuXi AppTech.

The good folks at Vistatec invited me to participate in their Life Science In-Focus podcast last month, where host Karen Tkaczyk and I chatted about the intricacies of regulatory affairs within the life sciences.

We also discussed just how I ended up in the field, and the many challenges companies face when choosing regulatory pathways in the United States and Europe.

This is not last year's eSTAR - a LOT has changed, and there are things you need to know before you try to submit your 510k.

In this episode, we'll guide you through the intricacies of the latest eSTAR 5.0 platform, crucial for those of you planning a 510k or PMA submission.

We'll review the eSTAR 5.0 platform and what you need to know to use it effectively –the good, the bad, and the ugly.

The new features, including premarket approval content and updated cybersecurity documentation and dive into the simplified EMC questions, revised sterility section, and new biocompatibility testing options - we'll cover it all.

Why would you use a 3rd party reviewer for your submission? How does a 3rd party reviewer function? How is it different from working with the FDA?

I sat down with my good friend Shawnnah Monterrey from Beanstock Ventures to answer all your pressing questions about using 3rd party reviewers.

Question, questions, everyone has questions about eSTAR 5.0, so I sat down with the FDA's Patrick Axtell to answer the most pressing ones I've received.

From file size to eSTAR type to biocompatibility - we cover it all.

When is it better for a medtech startup to hire a fractional quality professional, and when is it time to hire full-time?

This is not necessarily an easy question to answer, and there can be a lot of factors impacting the decision.

In this joint podcast with Mitch Robbins, we discuss the challenges and opportunities of today's topsy-turvy QA hiring market, and why many companies are opting for fractional QA professionals rather than full-time employees.

As medical devices become more connected, concerns about security increase, leaving manufacturers - and regulatory staff - uncertain as to the best path forward. Listen in as Michelle and guest Randy Horton discuss industry needs and what the FDA plans to do to ensure the safety of connected and AI-driven devices.

Many manufacturers see quality as a necessary evil, a box to be checked just to placate the FDA on the way to market launch. But it can be SO much more.

In this episode, Ti Benson and I discuss how quality can actually be a business benefit and not simply something to be endured.