Archimedic Blog

Fundraising Lessons from MedTech: Insights from Vessl Prosthetics’ Sydney Robinson

Raising funds for a MedTech startup isn’t just about pitching investors—it’s about building relationships, gathering...

It’s been just over a year since I joined Robin Hood Ventures as an angel investor. While many investors in the group are far more seasoned, I’ve gained invaluable insights by diving into the due dili...

I had the privilege of interviewing the Value Analysis Whisperer himself, Mark Copeland, who cracked open the black box of Value Analysis Committees and shared the secrets that MedTech companies need ...

Here's what usually happens in MedTech. A development team is thick in the details -- designing, prototyping, and testing... They reach a level of technical maturity when they believe they're at "Desi...

Introduction

Design Freeze is a significant milestone in MedTech. It's the point when you're ready to start the Verification & Validation (V&V) process. It implies maturity of your technical design a...

Prototyping is an essential part of medical device development. But, the vast majority of companies get it all wrong. I've been in medical device design and development (with a heavy dose of prototypi...

I hear it often -- "We need an MVP." But most of the time it really means, we need a prototype on the cheap. Or, we need to get our first product launched and we're operating on a shoestring.

Funds a...

Ever built the wrong medtech device? I’ve worked at a number of medical device companies and each one took a different approach to writing User Needs and Design Inputs. And it’s no wonder—FDA CFR and ...

You’ve probably heard of Proteus.  mAt one time it was the darling of digital health. But within a single year, Proteus went from a $1.5B valuation to a fire sale at $15m. Here's a recreation of event...

Quick 510(k) = Quick exit. Right? Not quite.

Here's some interesting data in the chart below. The data is a bit dated. But the push for the quick 510(k) happens just as much today as it did back when...

In many medical device organizations, the role of quality management is limited to reactive and compliance-focused activities. In these situations, quality managers primarily focus on identifying and ...

In the complex world of medical device development, one area that often causes confusion is understanding the division of responsibilities between Design, Quality, and Regulatory functions. Questions ...