Three MedTech Industry Insider Takes on "Structured Dialogue"

In this Issue

From the Editor ????| In Brief ?? |?What's Happening ??? | Featured Interview ?? | Sections ? | Postscript ??

From the Editor????

Live from Spain: In case you missed my live updates from TEAM-PRRC 's Third Annual Summit last week in Malaga, be sure to follow me and "ring the bell" on my profile for live coverage of this week's RAPS European Clinical, Risk, and Postmarket Surveillance Conference in Barcelona.

?? Plus 10 more HOT new posts, Martin King’s Regulatory Roundup, and the latest 510(k) Clearances from Marcus Engineering, LLC.

Online Training Opportunity ??

In Brief ??

• Stefano Bolleta shared MDCG 2021-25 Rev. 1 and the MDCG’s standardisation state of play agenda.
• The MDCG’s guidance on IVD qualification, FDA’s updates on dental implants, and more regulatory insights were highlighted by Marina Daineko.
• EU MDR Compliance explained the secret codes behind standards names in a useful infographic.
• Georg Digel underlined the importance of project management skills for on-time CAPA closure.
• A great infographic breaking down the sections of a technical dossier for a 510(k) submission was posted by Dr. Pallavi Dasgupta.
• Jan Hellqvist explained the difference between clinical evaluation and clinical investigation under MDR.
• 7 steps for managing PMCF activities were underscored by Michael Galliker
• Jacob Barkai suggests PASTA as a better methodology than STRIDE for medical device cybersecurity.
• ?? Trending: The importance of regulatory clearance for all medical devices, even low-risk items like wooden tongue depressors, was emphasized by Dr Hugh Harvey
• Plenty of interesting posts from last week's The MedTech Conference in Toronto, including insights from David Filmore, RQM+, and Innolitics.

Featured Interview ??

Enhancing Regulatory Success Through Structured Dialogue with Notified Bodies

Last week, at lunch during the TEAM-PRRC Third Annual Summit, I spoke with Bassil Akra , Tom Patten from GMED, and veteran consultant Stephanie Grassmann , about Structured Dialogue—a critical tool for manufacturers working with notified bodies.

As the heated response to my recent post indicates, there’s a lot of confusion around structured dialogue in the industry.

But it’s actually simple: structured dialogue is just a new name for conversations that have been happening between notified bodies and manufacturers for years.

The confusion seems to come from the blurred lines between what’s considered “consulting” and what’s just regulatory feedback.

Here’s what the three industry insiders had to say on the subject.

What is Structured Dialogue?

Structured dialogue is a formal communication process that clarifies expectations between manufacturers and notified bodies.

It’s not consulting, but it gives feedback to avoid costly mistakes.

Manufacturers, especially new ones, find it invaluable.

Why Structured Dialogue Matters for Manufacturers

Bassil Akra explained why manufacturers should use structured dialogue early to avoid major issues:

"When manufacturers go to a Notified Body, they should not expect to get consulting, but they can gain insight into potential issues early on. If your sample size or biocompatibility testing doesn’t meet the standard, a structured dialogue can point that out before submission, saving both time and resources."

Early structured dialogue clarifies important things like clinical investigations and submission requirements, which prevents expensive mistakes later.

What Notified Bodies Can and Cannot Do

Notified Bodies can give feedback on documents, timelines, and submission requirements, but they have limitations.

Tom Patten explained:

"Notified Bodies can’t do a gap analysis or tell you how to fix specific problems. But we can flag when something crucial—like biocompatibility testing—is missing. We want to review good files, not send things back for corrections."

Manufacturers need to know what to expect and avoid asking for things outside the Notified Body’s scope.

Vague or poorly researched questions won’t lead to productive talks.

Practical Communication Tips

Stephanie Grassman reminded manufacturers that the right questions are crucial:

"Manufacturers sometimes ask questions they should already know the answer to. It’s essential to come prepared with specific challenges and justifications, not just looking for someone to solve the problem for you."

Focused questions keep the dialogue productive.

Open-ended or vague questions waste time and frustrate Notified Bodies.

Early Engagement for Greater Predictability

Structured dialogue brings predictability for manufacturers.

Tom Patten highlighted:

"You need to build trust and ensure the Notified Body understands your product from the start. Structured dialogue can flag potential issues like missing documentation, saving time down the line."

Early engagement helps avoid delays and makes the submission process smoother.

Avoid Common Pitfalls

Common mistakes manufacturers make during structured dialogue include:

• Asking basic questions: Notified Bodies expect you to come prepared. Tom Patten pointed out, "If you’re asking something you should already know, you’re not adding value to the dialogue."
• Vague questions: Manufacturers should focus on specific issues, not open-ended requests.
• Expecting consultation: Structured dialogue isn’t consultancy. Notified Bodies offer guidance but can’t provide technical solutions or in-depth regulatory analysis.

Structured Dialogue Builds Investor Confidence

Predictability isn’t just about regulatory timelines—it also boosts investor confidence.

Bassil Akra said:

"Many companies come to Notified Bodies because their investors are watching closely. Having a structured dialogue early on gives them the confidence to proceed, knowing there won’t be major surprises later."

For manufacturers with tight deadlines and investors, structured dialogue keeps things moving smoothly and builds trust.

Leverage Structured Dialogue for Success

Structured dialogue with Notified Bodies is a powerful tool for MedTech manufacturers looking to streamline their regulatory process.

Notified Bodies can’t consult, but their feedback improves predictability and helps avoid costly mistakes.

To make the most of structured dialogue:

1. Engage early.
2. Prepare specific questions and justifications.
3. Don’t ask basic or vague questions.
4. Focus on key regulatory issues like clinical investigations and biocompatibility.

Early engagement and clear communication with Notified Bodies can make a big difference in bringing your product to market efficiently.

Stay tuned for details on the upcoming webinar, where we’ll explore how to use structured dialogue to your advantage.

Sections ?

Regulatory Roundup by Martin King - Week of 14 October

Featuring the latest regulatory updates from: ?? ???????? ???????????????????? ?????????????????? ???? ?????????????????? ???????????????? ???????? ???????????????????? ???????????????? ?????????????????????? ???????????????? ?????????????????? ?????????????? ???????????????? ?????????????????????? ?????? ?????? ?????????????? ???? ?????????????????? & ?????????????????????? ???????????? & ?????????? ???????? ????????????????????????, ???????????????????????? ?????????????????????????? ???????????????????????????? ???????????????????? ?????????????? ???????????????????? (????????)?? ?????????????????? ?????? ???????????????????? ???????????????? ???????????????????? ?????????????? ?????????????????????????? ?????????????? ???????????? ???????????????????? ???????????? ?????????? ?????????????? ???????????? ???????????????? ???????????????????? ???????????????????? ?????????????????????? ?????????????????????? ?????????? ???????????????????????????? (??????), ???????????????????? ?????? ???????? & ???????? ???????????????????????????? ??????

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? 510(k)s at a Glance for the week of October 14, 2024

Marcus Engineering, LLC highlights 72 new FDA 510(k) cleared devices this week, including 31 first-time clearances ??. Featured categories include:

For full details, visit Marcus Engineering’s report.

??? What’s Happening

• RWE-Driven MedTech Symposium: October 29, 2024 – Boston, MA.
• Webinar on Structured Dialogue: The date and speakers will be announced soon!

Postscript ??

I am enjoying Spain, but I look forward to getting home and seeing my dog Frankie!

Sean ??