TransMed7
About the Team
Industry: Medical Devices
Product: Devices for advanced biopsy diagnostics and cardiovascular intervention procedures using TransMed7’s Zero5® technology
Location: Portola Valley, CA
Why Fictiv
Customer Challenges: Needed faster and more cost-efficient turnaround on parts to iterate on prototype designs more quickly and a partner who could seamlessly scale production to meet customer demand.
Capabilities Leveraged: Selective Laser Sintering (SLS) 3D printing, CNC, Injection molding
Result: Cut design and development from weeks to days, and production from months to weeks. Accelerated final design commercial NPI from 10 to 2 years for five new breakthrough medical devices. Saved millions in infrastructure and overhead costs with Fictiv’s Digital Manufacturing Ecosystem.
Building Breakthrough Medical Technology
TransMed7 was founded to bring new diagnostic and therapeutic medical device solutions for diseases around the world — with a focus on oncology, regenerative medicine, and cardiovascular interventions. Their technology can accurately retrieve multiple pieces of tissue with a single insertion while being the least invasive, least disruptive way to get a piece of tissue out of a human body and to a lab for complete diagnosis and therapy planning.
Their mission is to get these breakthrough medical technologies in the hands of doctors around the world — and start saving lives as fast as possible.
“Patients have had to suffer with the same biopsy technology that’s been around for the past 40 years,” said Gene Vetter, TransMed7’s CEO. “Every day that passes means another patient is not getting the best information about their cancer diagnosis.”
Choosing A Faster, Leaner Path to Market
“We knew from inception that we intended to field multiple new next-generation technologies and that the traditional development cost to market numbers scenario would be prohibitive. Recent studies show that the average cost to bring a single new Class II medical device from initial concept to FDA 510(k) clearance before market launch is $31 Million USD,” said Vetter.
“So, we decided to take a different approach leveraging Fictiv’s cloud manufacturing network to match with our extremely talented, but lean and mean internal team. It enabled us to save millions of dollars in infrastructure, people, and time costs when compared to traditional development and supply chain strategies.”
Reducing Cycles From Months & Weeks to Weeks & Days
With Fictiv, the team realized they could automate workflow tasks, such as vendor sourcing & management, quoting, and quality control to dramatically accelerate cycle times. Immediately, timelines went from 2-3 weeks for Selective Laser Sintering down to just 3-5 days, and from months for injection molding down to just weeks — without sacrificing quality.
This was huge, according to Robert Sauchyn, TransMed7 Lead Design Engineer. “Working with Fictiv let us keep the momentum going on product iterations. Before, we’d have to put projects down for weeks and not think about them, then waste time re-engaging with a particular project once the parts arrived.”
Exacting Quality Standards & Manufacturing Guidance
Because TransMed7 is commercializing medical devices, it has exacting quality, documentation, and inspection requirements. Every medical device must meet standards set forth by the FDA here in the US and by other regulatory bodies around the world.
“When you’re ready to scale, you have to have a very robust quality system,” according to Dr. James Vetter, TransMed7’s Co-Founder and Chief Medical Officer. As he worked with us, our quality system became another key selling point.
And in Europe especially, regulations for medical devices are focused on evaluating the manufacturing data of the devices. So, it was critical for TransMed7 to find a partner who not only has world-class quality assurance but has the capability to meet TransMed7’s quality expectations as well.
It wasn’t just the faster turnaround times that facilitated their product development. “It’s also about the communication,” according to Dr. Vetter. “They’re great about answering our questions and giving us immediate attention and feedback when we have issues. And everybody we speak with at Fictiv knows what they’re talking about.”
