What's the deal with Regulatory Stacking?

What's inside?

Happy Saturday! I'm trying a new posting schedule - something to read while sipping your Saturday coffee. Or Monday AM if you check-out for the weekend.

In this newsletter, we'll recap on some recent Linked-In conversations. Why do this? Well, it's an invitation for you to weigh-in. You'll not only hear my takes but you'll also see how others think. So, join the chat - links embedded below.

Some juicy topics were covered over the last couple of weeks. These included: regulatory stacking, the limitations of MVP, the dreaded redo loop, and the most critical risk - execution. Essential for anyone involved in medtech development, from engineers to regulatory pros, commercialization experts, and investors.

Here we go..

Regulatory Stacking in MedTech

Heard about 'regulatory stacking'? Here’s a quick case study on the header image:

"A digital thermometer with an electrochemical sensor to detect viral and bacterial infection through saliva. The regulatory stacking strategy would be to start with an easy indication (510(k), Digital Thermometer), then stack a more difficult indication (De Novo, Saliva-based bacteria and virus detection device) on top of it..."

While this strategy might seem beneficial, the reality can be different. Early revenue from a basic device is unlikely, valuation bumps might not materialize, and referencing a simple 510(k) doesn’t significantly ease the De Novo process. Instead, going straight for the more complex classification ensures you define value upfront, demonstrate clinical efficacy, and obtain comprehensive labeling.

Wanna fight me on this one? Jump in. There are already some different views brewing. Share yours HERE.

MVP in MedTech: A Flawed Approach

Can you MVP an airplane? A skyscraper? Nope. Here’s my take:

"MVP works when iteration time is rapid (i.e., apps). Rather than overthinking an app, just build it. See how customers react. See if they buy. But this is flawed thinking for airplanes, skyscrapers, and medtech too. Iteration time is too long and expensive..."

In medtech, the iteration cycles are long and costly due to design control, design review, tooling changes, long-term testing, risk management, regulatory review, and complex sales processes. Instead of MVP, focus on isolating risk factors and conducting brief, rapid tests to understand clinical endpoints, healthcare economics, workflow changes, usability issues, and COGS thresholds.

Where are the MVP mavens? Get in there and stir the pot. HERE's a link.

What's the Longest Process in MedTech?

Getting PO sign-off at your company? J/K.. N/K. Seriously, what process takes the longest time? It’s the redo loop. My take:

"When teams make critical assumptions (and don't test them), that's usually when the redo loop occurs. Some of the common timeline-killing assumptions: Of course customers will pay - It hits an unmet need. We don't need usability studies - It's intuitive..."

The redo loop happens when assumptions about customer payment, usability, regulatory needs, and reliability turn out to be false. This can lead to massive architectural changes and significant delays. To avoid the redo loop, engage with customers, conduct usability studies, plan for clinical trials, and perform reliability tests early.

What else? I know you've seen the killer redo loop. What are some other reasons? Drop 'em in the comments HERE.

Execution Risk: The Biggest Threat to MedTech Startups

What's the biggest risk facing medtech startup existence? Here’s what an accomplished investor once told me:

"It's not clinical risk. It's not regulatory risk. It's not IP risk. It's definitely not technical risk. No, it's none of those things... It's execution risk."

Execution risk includes not knowing the right questions to ask, not having the right people on speed dial, not thinking about key tests, and not knowing when to change gears. Execution isn't about having all the answers but about knowing when you don't and having the processes, tools, network, and resourcefulness to find the right answers quickly.

Think the biggest threat is something else? Get in there and name it. HERE's a link.

Note from Eric

Navigating medtech ain't easy - especially when all you hear from the #medtechgurus is, "Well, it depends.." Ugh, my pet peeve.

I'm here to crack open the black box. You'll get my take on the key medtech issues. I'm not claiming guru status or staking claim to Mr. Medtech. I'm doing it to get the conversation flowing in hopes that others chime in with their thoughts. Got a different take on anything I'm preaching? Or a question? Put it out there. I'd love to see you in the comments.

Hope you found these topics useful. Enjoy your morning joe and see you in next week's posts. Some good ones coming up.. Also, let me know what you think of this format. Love it? Hate it? Curious to know either way. As always, drop a comment or send me a DM.

Thanks for tuning in!

Eric @ Archimedic