Does regulatory strategy really impact your business strategy? Yes! Stephanie Schull, founder of kegelbell, explains how defining the regulatory strategy for her fledgling business early on helped promote her product both to investors and distributors around the globe.

How A Strong Regulatory Strategy Can Boost Your Business with Stephanie Schull

It's no longer a secret that MDR has morphed into an unmitigated disaster for the medical device industry - and Michelle has the goods to prove it. In this first in a series, she spills the beans on notified body readiness, the roadblocks that have been causing the most trouble, and the FDA's long-term plan to become the easier pathway to market.

The Aftermath of MDR - Part I

Six months into MDR and manufacturers and notified bodies are clashing over differences in opinion and fighting over their respective interpretation of the standards in pursuit of product certification.

In this second installment of a series, I share three real-world examples of what actual clients faced when going through the MDR certification process.

You'll want to listen and learn from their experiences, so you'll be better prepared for your boxing match with your notified body.

The Aftermath of MDR - Part II

You've developed a novel technology and want to bring it to market in the US. Now what? Can you submit as a breakthrough device, or is the de novo route a better choice? How are they different? How are they similar? 

Breathe - and listen in as Michelle walks you through the options.

Breakthrough, de novo, or PMA? FDA Submission Pathways for Novel Devices

Which comes first - design controls or risk management? Both - because the two are inextricably linked. In this podcast, we'll take an in-depth look at both design controls and risk management, the waterfall design process, how/where risk management fits into that process - and vice versa - as well as discuss the ISO and 21 CFR 820 requirements for each stage of the product life cycle.

Design Controls and Risk Management

So - you're a hot new startup with a snappy new medical device. 

Now what? 

Do you have an intended use statement? Do you have the 𝘳𝘪𝘨𝘩𝘵 intended use statement? Do you know for sure that your product qualifies as a medical device? What about your predicate device?

There are a lot of potholes along the road to market clearance or approval, so come along with me as I explain what you need to avoid derailing your go-to-market plans.

Five Steps to Bring a Medical Device to Market

So - you have a product, and you have a submission ready to go to the FDA. You're all set, right? You know how the e-Submitter works, you know exactly what FDA Form 3514 is for, and you know the best questions to ask the FDA during your pre-sub?

If you've answered NO to any of these, then listen in as Michelle explains what you need to do to help your product move smoothly through the submission process and on to premarket approval.

Crash Course in FDA Submissions

Digital health technologies are exactly new, but they did get a huge boost from COVID and will define how we deliver healthcare in the future. 

Digital health includes telemedicine, software functions that allow providers to monitor patients remotely, apps that track medication use and provide user-configured reminders for improved compliance - and more.

In this podcast, we dive into the whys and the hows of regulating digital health while still managing to bring products to market.

Digital Health: The Future of Medicine and Medical Devices

If you're struggling to determine whether your devices qualify as state of the art - and how that can impact your submission strategy - then check out this presentation I did with my friends at Greenlight Guru in August.

Etienne Nichols and I sort through all the acronyms - SOTA, SOC, MDR, MEDDEV, IVDR - and try to shed some light on what MDR says about state of the art, what it doesn't say, and how to determine your best path forward.

Is your State of Affairs for MDR State of the Art?

Do you know how your end users will use your device? Are you sure?Do you know how end use will differ between demographic groups? Do you know why this is important, and how usability testing fits into your risk assessment?

Shannon Clark has been doing human factors/usability testing for some time, and she can tell you exactly why usability testing is required and the impact it can have on your final product design.

Usability Testing and the FDA

Similar but different is a good way to describe how FDA inspections and MDSAP and notified body audits compare. On the surface, they appear to be looking at the same things, but dig a little deeper and the differences in agenda - and outcome - become plain.

Split Personalities of QMS Audits for FDA, MDSAP and ISO 13485

There's the pre-submission, of course, but did you know there are other ways to get FDA feedback without breaking the budget? In this episode, Michelle reviews three pathways that can help startups save some cash while working their way through the commercialization process.

Free FDA Communications with the FDA? What you Need to Know

Risk management can be difficult to understand, even for seasoned quality and regulatory professionals, because there are SO. MANY. ACRONYMS.

I mean, there's FMEA, uFMEA, ISO, FDA, PMA to name a few.

We discussed acronyms and more at the November meeting of the Dallas ASQ - Section 1402, so if you're ready to go beyond the basics and right into the very heart of risk management, then this is the podcast for you.

Risk Management - Beyond the Basics

What happens when two regulatory consultants sit down for a chat about MDR?
A lot of distressed head shaking, for sure and an equal measure of what-were-they-thinking eye rolls, but we also dug into the meat of the proposed extension and what it might mean for industry.

Monir El Azzouzi and I chatted last month about MDR, and while we didn't solve all of the EU's problems, we did touch on some of the biggest challenges facing manufacturers.

From the Front Lines of EU Medical Device Regulation

Upload to EUDAMED is a requirement of MDR, but adoption has been slower than anticipated. Manufacturers are reluctant to invest in the time required to upload their product catalog, and the platform itself has been plagued with issues. Listen in as Richard Houlihan lifts the curtain on why industry has been reluctant to embrace EUDAMED and what the future might hold for both sides.

EUDAMED Update: January 2023

MDR has been puzzling me for a few years now, and it's getting worse, not better. In this webinar hosted by Greenlight Guru, we look at the data gathered from recent MDCG guidance documents, industry and notified body surveys, and personal interviews with stakeholders (including notified bodies) who shared their first-hand experiences with implementation (spoiler alert: it ain't pretty).

MDR By The Numbers: Leveraging New Data for Implementation Planning

The best leaders know that quality is much more than a box to be checked, or a necessary evil to be endured along the road to FDA (or MDR) approval.

This is the third in a series of conversations talking about quality and how it can actually benefit a company, and even give you an advantage over your competition.

Make Quality Make $en$e:  Management's Role in Quality

You may think document control is boring, but wait until you hear these stories:

Red-lined post-it notes. Uncontrolled copies passed around during inspections. Master files stored on a desktop instead of in the eQMS system. Secret file cabinets in locked closets full of uncontrolled, red-lined specifications documents.

Oh, the joy of document control!

The Joy of Document Control

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.

Medical Devices, Cloud Computing and Cybersecurity with Randy Horton

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.

Fractional or Full Time Quality Support: Which is Right for You?

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.

eSTAR 5.0 Q+A with Patrick Axtell from the FDA

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.

The Benefits of 3rd Party FDA Reviewers

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.

eSTAR 5.0 - What You Must Know

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.

A Conversation with Vistatec's Life Science In-Focus Podcast

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.

ASCA, CLAP, Fraudulent Biocompatibility Data and You

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

CE Certification vs FDA Submission Strategy: Which is Right for You?

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 



Biocompatibility for MedTech Professionals

Podcast of a July 2024 webinar event presented by Etienne Nichols and Greenlight Guru and featuring Karandeep Singh Badwal

𝗖𝗵𝗮𝗽𝘁𝗲𝗿 𝟭: 𝗜𝗻𝘁𝗿𝗼𝗱𝘂𝗰𝘁𝗶𝗼𝗻 𝘁𝗼 𝗘𝗨 𝗠𝗗𝗥 𝗮𝗻𝗱 𝗜𝘁𝘀 𝗜𝗺𝗽𝗮𝗰𝘁 
This chapter provides a general introduction to the EU Medical Device Regulation (MDR) and its significance in the medical device industry.
Key Points:
The MDR is a comprehensive regulation that aims to improve patient safety and quality in the European Union.
It replaces the Medical Device Directive (MDD) and introduces more stringent requirements for manufacturers.
The MDR has significant implications for companies operating in the European market, including increased regulatory burden and higher costs.

𝗖𝗵𝗮𝗽𝘁𝗲𝗿 𝟮: 𝗞𝗲𝘆 𝗗𝗶𝗳𝗳𝗲𝗿𝗲𝗻𝗰𝗲𝘀 𝗕𝗲𝘁𝘄𝗲𝗲𝗻 𝗠𝗗𝗥 𝗮𝗻𝗱 𝗠𝗗𝗗 
This chapter delves into the key differences between the MDR and the MDD.
Key Points:
Classifications: The MDR introduces new device classifications and expanded definitions, which can impact regulatory requirements.
Notified Bodies: The MDR requires more stringent notified body involvement, including increased auditing and oversight.
Risk Management: The MDR places greater emphasis on risk management throughout the product lifecycle.
Post-Market Surveillance: The MDR introduces more robust post-market surveillance requirements to monitor device performance and safety.

𝗖𝗵𝗮𝗽𝘁𝗲𝗿 𝟯: 𝗖𝗵𝗮𝗹𝗹𝗲𝗻𝗴𝗲𝘀 𝗮𝗻𝗱 𝗢𝗽𝗽𝗼𝗿𝘁𝘂𝗻𝗶𝘁𝗶𝗲𝘀 𝗶𝗻 𝗜𝗺𝗽𝗹𝗲𝗺𝗲𝗻𝘁𝗶𝗻𝗴 𝗠𝗗𝗥 
This chapter discusses the challenges and opportunities associated with implementing the MDR.
Key Points:
Regulatory Burden: The MDR imposes a significant regulatory burden on manufacturers, including increased documentation requirements and more frequent audits.
Notified Body Capacity: The limited number of notified bodies and their capacity constraints can lead to delays in approvals and increased costs.
Transitional Periods: The MDR provides transitional periods for existing devices, but manufacturers must comply with specific requirements to benefit from these provisions.
Opportunities: The MDR also presents opportunities for manufacturers to demonstrate their commitment to patient safety and quality, and to differentiate themselves in the market.

𝗖𝗵𝗮𝗽𝘁𝗲𝗿 𝟰: 𝗣𝗿𝗲𝗽𝗮𝗿𝗶𝗻𝗴 𝗳𝗼𝗿 𝗠𝗗𝗥: 𝗕𝗲𝘀𝘁 𝗣𝗿𝗮𝗰𝘁𝗶𝗰𝗲𝘀 𝗮𝗻𝗱 𝗥𝗲𝗰𝗼𝗺𝗺𝗲𝗻𝗱𝗮𝘁𝗶𝗼𝗻𝘀 
This chapter offers practical advice and recommendations for manufacturers preparing to implement the MDR.
Key Points:
Early Planning: Manufacturers should begin their MDR implementation efforts well in advance to ensure compliance and avoid delays.
Risk Assessment: Conduct a thorough risk assessment to identify potential hazards and develop appropriate mitigation strategies.
Quality Management System: Implement a robust quality management system that aligns with MDR requirements and ISO 13485 standards.
Notified Body Selection: Carefully select a notified body that has the expertise and capacity to support your device and regulatory needs.
Post-Market Surveillance: Develop a comprehensive post-market surveillance plan to monitor device performance and address any safety issues.

 𝗖𝗵𝗮𝗽𝘁𝗲𝗿 𝟱: 𝗧𝗵𝗲 𝗙𝘂𝘁𝘂𝗿𝗲 𝗼𝗳 𝗠𝗗𝗥 𝗮𝗻𝗱 𝗜𝘁𝘀 𝗜𝗺𝗽𝗮𝗰𝘁 𝗼𝗻 𝘁𝗵𝗲 𝗜𝗻𝗱𝘂𝘀𝘁𝗿𝘆 
This chapter explores the future of the MDR and its potential impact on the medical device industry.
Key Points:
Regulatory Updates: The MDR may undergo further updates and clarifications to address emerging challenges and technologies.
Industry Adaptations: Manufacturers will need to continue adapting to the evolving regulatory landscape and invest in compliance initiatives.
Global Harmonization: Efforts are underway to harmonize medical device regulations globally, which could simplify compliance for manufacturers operating in multiple market

EU Hot Takes: MDD vs MDR featuring Etienne Nichols and Karandeep Singh Badwal

Did you know that 60% of startups cannot survive beyond five years, and 75% will ultimately fail?

These failures frequently stem from late regulatory involvement, underestimation of remaining development work, and the compounding effect of early oversights. 

To mitigate these risks, a structured approach is essential, emphasizing early and continuous regulatory engagement, meticulous documentation through a trace matrix to ensure cross-functional alignment, and a well-defined regulatory strategy that aligns with the chosen FDA pathway. Prototyping and manufacturing must be carefully managed, considering the impact of material and process changes, and prioritizing design for manufacturability.

 Finally, a strategic commercialization plan, including appropriate sales strategies, a clear understanding of the target market, robust intellectual property protection, and adequate funding, are crucial for navigating the complex medtech landscape and achieving sustainable success.

Medical Device Product Development: From Concept to Commercialization

In this clip from Elemed's Entrepreneurial Roundtable series, Michelle sits down with Monir El Azzouzi, Stefan Boelleininger and Elena Kyria to talk about the benefits and challenges of running your own business.

You can hear the entire discussion at http://www.elemed.eu/mentoring

Entrepreneurial Roundtable with Elena Kyria

The recent FDA device downclassification decision is not good news - for industry or for patients. Several devices on this list - namely ventilators - have benefitted from close FDA scrutiny during the 510(k) submission process. They are safe precisely because they have been so closely regulated, not because they are simple to use and present limited risk to the patient.

This podcast combines three different interviews into one narrative about the FDA decision, the reasoning behind it, and the action we need to take to keep ventilators and other devices under the careful watch of federal regulations.

Link to the original post and instructions for submitting your comments to the Federal Register: https://leanraqa.com/regulatory-quality/fda-down-classified-classification/

FDA Device Downclassification - This is Not Good News

Are regulatory and reimbursement at all related? Does one influence the other? Or are they more like oil and water, both necessary but not really something you should mix?

Michelle and Nic Anderson answer questions about how regulatory and reimbursement issues can impact a product's go-to-market strategy, and how these two seemingly disparate areas actually may overlap in a variety of medical device scenarios.

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