When I worked in large medical device organizations, product development in an FDA-regulated environment came with a very specific weight.
Not the kind you feel when you’re building something new; that part is energizing. The weight came from everything around it. Documentation. Process. Layers of review. Entire teams are dedicated not to iteration, but to compliance.
In some cases, we would spend months, sometimes half a year, documenting decisions before we could move the design forward meaningfully.
And while that rigor is necessary, it often slows down the part of innovation that matters most in the early stages: experimentation.
The reality is, some of the most valuable learning happens before formal, regulated development fully begins, when teams are testing, refining, and proving that something works.
But most teams don’t have the luxury of dedicating time, talent, and capital to that phase alone.
That’s precisely why a new model is needed.
Extending Capability Without Adding Friction
At the TMC Innovation Factory, our goal has always been to help founders move faster and more efficiently, without compromising the quality of what they’re building.
That doesn’t happen by doing everything internally.
It happens by working with the right collaborators, those who can extend our capabilities without adding operational drag.
Medical Device Labs @ TMC collaborates with engineering partners like Merge | Medical Device Studio to extend technical capabilities without adding operational friction.
Led on-site by Nicolò Garbin, the team operates as a focused, engineering-driven group that supports early-stage companies through Phase Zero development — helping transform ideas into functional prototypes before they move into further development, testing, and eventual validation.
What founders gain isn’t just access to one engineer; it’s access to a flexible, extended team.
Merge | Medical Device Studio operates with a lean core team, supported by a broader network of industrial designers, robotic engineers, and specialized experts that can be activated based on each project’s needs. This allows startups to access high-level talent without the burden of building full-time teams too early.
Work can be structured as defined-scope projects or as embedded engineering support, where Merge | Medical Device Studio team members act as a temporary extension of a startup’s internal team.
The result is a system where capability expands, but friction does not.
As Jason Sakamoto, Associate Director of Medical Device Labs @ TMC, explains:
“What makes the TMC Innovation Factory unique is that innovators can access the entire development pathway in one place. A clinician can walk in with an unmet need and quickly connect with engineers, prototyping resources, and preclinical testing capabilities without leaving the building. Through Medical Device Labs @ TMC, Merge Medical Device Studio, and adjacent testing facilities, innovators have access to the tools and expertise needed to move from concept to validation faster than traditional development models allow.”
Function First. Then Scale.
One of the biggest traps in early-stage medical device development is over-engineering too soon.
In larger organizations, it’s common to design for every edge case from the beginning. The result is often a product that is technically robust, but slow to build, expensive to iterate, and disconnected from real-world use.
What we’ve seen through this model is the opposite approach:
Start with the function. Prove the concept. Then refine.
This is where Merge | Medical Device Studio’s engineering philosophy stands out.
As Nicolò Garbin explains:
“We focus on what we call Phase Zero: the stage before formal development even begins. The goal is simple: prove that the device works. You don’t need a perfect system or full infrastructure to get there. You need to be resourceful, build quickly, and validate early. If you can demonstrate function, you give founders something real to show investors, and that’s what creates momentum.”
Phase Zero is not a shortcut around regulated development. It is the work that helps teams enter regulated development with a clearer concept, better evidence, and fewer unknowns. That philosophy shows up directly in how teams work inside Medical Device Labs @ TMC.
The prototyping infrastructure inside the lab is built for speed. Engineers can iterate through multiple physical design iterations in a single day, testing form factor, usability, and performance on actual hardware rather than in CAD. What would take weeks of design cycles in a traditional environment can be resolved through hands-on iteration.
The same applies to testing. Engineers don’t just build devices; they build the environments to test them. From benchtop simulations to custom fixtures, teams can validate performance early, without immediately relying on costly animal or clinical studies.
The goal isn’t a finished product. It’s to learn something meaningful, reduce the next risk, and keep moving forward.
Left to Right: Jose Guzman, Scott Parazynski, Nicolò Garbin
A Model Built for Early Momentum
This model comes to life in the work of Scott Parazynski, physician, astronaut, and now Entrepreneur in Residence at the Texas Medical Center.
When Scott set out to address pain and significant complications as a result of fracture care, the goal wasn’t to build a fully realized product; it was to prove that the concept could work.
Working alongside Nicolò Garbin and the Merge | Medical Device Studio team, the approach was deliberate: move quickly, build only what’s necessary, and validate early.
Within six months, the team progressed from concept to a series of functioning prototypes.
That progress wasn’t just mechanical; it was integrated. Rapid hardware iteration was paired with software development and sensor integration, allowing the team to test not only form and function, but also how the device performs in real-world conditions.
Each iteration added clarity. Each test reduced uncertainty.
And that’s the inflection point.
Because once you can demonstrate function, supported by real data, you’re no longer presenting an idea. You’re presenting evidence.
As Scott puts it:
“In early-stage development, your job isn’t to build the final device, it’s to prove that it can work for your patients. If you can get to a functional prototype with meaningful data in a matter of months, you change the entire conversation. You move from speculation to evidence, and that’s what unlocks everything next.”
That’s what this model enables.
Not just speed, but meaningful progress, grounded in function, data, and real-world validation.
Across projects like this, the pattern is consistent:
Identify a significant clinical unmet need.
Iterate rapidly to demonstrate functionality.
Reduce upfront costs.
Streamline the path to the clinic.
Bridging Clinical Insight and Engineering Execution
This collaborative model has also become a powerful resource for clinical innovators like Dr. Mohammad Ghasemi Rad, Associate Professor of Vascular and Interventional Radiology at Baylor College of Medicine.
After training at Harvard, Massachusetts General Hospital, and completing postdoctoral work in bioengineering at MIT, Dr. Ghasemi Rad saw firsthand how closely physicians and engineers worked together to advance innovation. But finding that same bridge between clinical insight, engineering resources, and capital can be difficult, especially for early-stage innovators.
That search ultimately led him to Medical Device Labs @ TMC.
What began as early conversations around a device concept grew into an active collaboration, one that draws on the full depth of the lab’s engineering infrastructure and its partner network, including Merge | Medical Device Studio.
One project focused on improving care for patients suffering from recurrent abdominal fluid buildup caused by advanced liver disease.
Today, many of these patients must repeatedly return to the hospital, sometimes daily, to undergo fluid drainage procedures. The goal of the project was to explore a solution that could help reduce the frequency and burden of these interventions by creating a more efficient way to manage and return valuable fluids back to the body.
Working inside Medical Device Labs @ TMC, Dr. Ghasemi Rad was able to take a complex clinical challenge and rapidly reduce it to a testable hardware concept, something that typically requires navigating external vendors, timelines, and budgets that most early-stage innovators simply don’t have.
Merge | Medical Device Studio also supported prototype refinement and preparation for animal testing, extending the work from early concept into the next stage of validation.
Beyond a single project, the environment enables something equally important: efficiency across multiple ideas simultaneously.
By bringing clinicians, engineers, students, and technical collaborators into a single ecosystem, innovators can move faster across multiple concepts without needing to build every capability independently.
Why This Matters Now
Medical device innovation is becoming more complex.
Regulatory pathways are evolving. Capital efficiency is under greater scrutiny. And founders are expected to move faster while de-risking earlier.
No single organization can solve all these challenges alone.
But the right combination of infrastructure and expertise can.
That’s what this model represents.
Not just access to tools.
Not just access to talent.
But a way of working that prioritizes:
- Speed to insight
- Efficiency of capital
- Practical, functional progress
Because in the end, innovation doesn’t scale through resources alone.
It scales through how those resources are connected and how quickly they can be activated.
What Comes Next
As this model continues to grow in Houston, the focus remains the same:
Support founders earlier.
Reduce friction in development.
Create pathways that allow great ideas to become real, usable solutions faster.
Merge | Medical Device Studio is already looking ahead to the next phase, expanding capabilities to support small-batch manufacturing for first-in-human studies, enabling startups to produce initial devices efficiently without the cost of full-scale production.
Because the sooner we can move from concept to function, the sooner we can move toward impact.
If you’re a clinician with an unmet need, an engineer with a concept, or a founder trying to figure out how to get from idea to evidence without overextending your resources, I’d encourage you to explore what this ecosystem has to offer. TMC Innovation Factory and Medical Device Labs @ TMC exist precisely for this stage of the journey.