DRG Framework
Apr 28, 2026
Why do so many medical devices fail to make it to market? The market is there. The concept is novel. The technology is achievable. It can’t NOT work, right?
And yet, the vast majority of medical device companies shut down before shipping a single unit.
Why? The answer can often be found by looking at where companies put their resources throughout the device development process.
The road to successful commercialization of a medical device requires navigation through three distinct, yet related, workflows; Design, Regulatory, and Go-to-Market. This is known as the “DRG” Framework.
Too often, developers focus solely on the Design aspects, putting off Regulatory and Go-to-Market considerations for another day.
To be clear, Design is of the utmost importance. However, in our experience, most development projects go to the graveyard based on Regulatory or Go-to-Market deficiencies, not technical roadblocks. .
- Maybe the wrong regulatory pathway is pursued because communication with the agency isn’t initiated early enough in the development process.
- Is the IP portfolio strong enough to withstand market pressure while not encroaching on other’s IP “turf?”
- Is the business model fleshed out and supported by the market?
- …and a million other Regulatory and Go-to-Market considerations.
What we have found is that the greatest chance of success occurs when Design, Regulatory, and Go-to-Market workflows advance simultaneously in lockstep.
I’ve been in the field for a long time, and I’ve seen many companies go down for these and other similar preventable reasons. The DRG Framework provides an integrated approach to medical device development that delivers medical device companies the maximum likelihood of turning their visionary dreams into successful market adoption.
Support for MedTech at Every Stage
Archimedic partners with medical device teams to solve complex design, development, regulatory, and go-to-market challenges.
