How process excellence leads to product excellence

Mike Fisher, Director of Product Development of GCMI

GCMI’s Director of Product Development, Mike Fisher, recently spoke about the ins and outs of successful medical device development as a guest on Greenlight Guru’s Global Medical Device Podcast.

“A good rule of thumb for innovators is that your product, your prototype, or your idea should lead the conversation but right behind it needs to be a strategic portfolio of assessments that isn’t necessarily aimed at regulatory compliance but more aimed at product excellence.”

Recently, Mike Fisher, Director of Product Development of GCMI, spoke with Jon Speer during an episode of Greenlight Guru’s Global Medical Device podcast. The two discussed process excellence and how it leads to product excellence. With 20 years of experience developing and commercializing medical products Mike shares his insights as a seasoned medical device engineer- from market assessment to intellectual property procurement, and more. Here are a few things that he said during the podcast that really stood out.

  • Product development is not an event, it is a process.
  • You do not necessarily need a patent to innovate, but you do need the freedom to operate. You do not want to infringe on someone else’s intellectual property.
  • Gaining regulatory approval does not mean you have an excellent product.
  • You should not wait until late in the process to have your design validated. You need to talk to your key users as early as the concept phase.
  • Keep the end user in mind in every decision.
  • Understand your market and where your market is heading.

Listen to his insights on the medical product development pathway, in full, here.

The Global Center of Medical Innovation (GCMI) and its wholly owned subsidiary T3 Labs, is the world’s leader in driving efficient medical product innovation. Using our proven processes, our expert staff works alongside physician innovators, hospital teams, Fortune 500s, and startups, every day, to commercialize innovative medical devices and products.


If you are an early stage medical technology company or an innovator and want to talk about your device or product’s path to regulatory approval, including design and development or you are ready to engage the preclinical process, Contact info@devices.net or info@t3labs.org to learn more about GCMI’s process and capabilities.