OpenQMS
Let's Connect

Archimedic Blog

The Latest Medtech Insights from Archimedic.

FDA’s Early Payor Feedback Program (EPFP): What MedTech Companies Should Know payor strategy regulatory strategy May 04, 2022

The prospect of obtaining a new reimbursement code and corresponding coverage for a new medical device is daunting. So much so that many investors simply refuse to pursue medical device opportunities ...

Continue Reading...
The #1 Thing that Prevents Medtech Companies from Raising Funds fundraising Apr 27, 2022

Happy Wednesday to 602 motivated medtech business leaders. Here's one short tip on how to refine your medtech strategy.


In this week's issue, I'm going to break down the #1 thing that prevents medt...

Continue Reading...
4 Steps to Defining Your Clinical Outcome clinical strategy market driven innovation technology development Apr 20, 2022

Here are 4 steps on how to clearly define the clinical outcome that compels adoption of your new medical device.


If you are growing a medical device business, a big part of your mission is to impro...

Continue Reading...
Why Starting with Small Markets Provides Superior Financial Returns clinical strategy market driven innovation Apr 13, 2022

Consider a medical device startup, facing a critical market decision: Should the company go big, aiming for the $1B market out of the gate? Or should the company go small, proving value with an initia...

Continue Reading...
3 Secrets to Capturing Reliable Clinical Data at Home clinical strategy market driven innovation regulatory strategy Apr 06, 2022

True story. A medical device manufacturer developed an at-home wearable defibrillator for populations at high risk of sudden cardiac death. This device was intended to be a bridge – worn for approxima...

Continue Reading...
Why Fast-Tracking Clinical Use can Slow your Medical Device Progress clinical strategy market driven innovation Mar 30, 2022

Clinical use is a significant milestone for most medical device companies. Investors often see this milestone as a significant de-risking activity – one that can come with valuation bumps and subseque...

Continue Reading...
Which Path to Take – Consumer Product or Medical Device? market driven innovation technology development Mar 23, 2022

It’s a critical decision that defines your commercial strategy – but it’s one that is often taken without carefully weighing the pros and cons of each route.

What are the motivations for heading down...

Continue Reading...
The IP Anchor Effect intellectual property market driven innovation technology development Mar 16, 2022

New technology is one of the primary drivers of growth in the medical device industry. Developing new tech can be long, iterative, and expensive -- so it is understandable that companies secure patent...

Continue Reading...
Is Clinical Data Enough to Drive Market Adoption? clinical strategy market driven innovation Mar 09, 2022

“You need to show clinical evidence that your medical device provides a benefit.” It's a common request that early medical device innovators hear after they gain regulatory clearance. It’s rational, e...

Continue Reading...
The Paper 510(k) Strategy regulatory strategy Mar 02, 2022

Many medtech leaders are pressured by investors and others to rapidly achieve regulatory clearance with a product design that is not intended for the market. This is sometimes referred to as a “paper ...

Continue Reading...
Proof-of-Concept Pitfalls in Medtech market driven innovation technology development Feb 23, 2022

The phrase “proof-of-concept” (POC) is widely used and engrained in the accepted formula of innovation. Engineers, scientists, researchers, and instructors operate under this mantra – fulfilling a hyp...

Continue Reading...
Who Pays and Why? market driven innovation Feb 16, 2022

It’s a critical decision that defines your commercial strategy – one that affects your market time horizon, pricing, marketing claims, distribution strategy, and more. Who pays and why?

It sounds fun...

Continue Reading...

Join the conversation

Drop your email in the form below, and you will receive our medtech articles as soon as they're published.