Interest and excellence in subjects like biology and mathematics can be precursors to pre-med study initiation or investigation, but it is far from all that is required to succeed. There are also frequently superseding areas of interest and excellence that influence one’s academic and career path.
Franco Zapata, medical device and phase zero research engineer at GCMI embodies that profile.
“It turns out I’m much more of an engineer like my parents than a physician,” Franco says. “After exploring pre-med studies, I discovered it wasn’t for me. And while I wasn’t exactly sure what biomedical engineers did when I started classes in the School of Biomedical Engineering (BME) at Georgia Tech, but working at the intersection of design, engineering and medicine is where I’ve landed with GCMI. It’s a perfect place for me to be and to contribute, especially to the BME Capstone teams that GCMI supports.”
Franco graduated with a bachelor’s degree in biomedical engineering from Georgia Tech in 2020, a journey that included a teaching assistant role in medtech design and a Capstone project that created an innovative patient monitoring harness under the mentorship of James Rains.
GCMI Interim Executive Director Saylan Lukas says, “Franco was just the person GCMI needed to fill the Phase Zero project manager and research engineer role in 2022.”
Confidence in process starts at Phase Zero and allows for creative thinking
At GCMI, Phase Zero focuses on evaluating critical product elements early, minimizing risk, cost and effort. What is the clinical need or problem to be solved? How will the product’s critical features address clinical needs? What is the product’s regulatory pathway? Can the innovator’s intellectual property be protected? Is there a market for the product? Who are the competitors?
Answering these questions validates the project direction and anticipates your resource requirements, timeline and team needs.
At the completion of Phase Zero, an innovator will have a customized scope for product development. It removes the emotional side of the equation and delivers data that directs innovators to a go / no-go decision and starts the path to commercialization. Phase Zero deliverables and results are based on facts and data supporting the value in launching a full development program for the product.
“Phase Zero also creates a ‘mini quality management system’ or QMS before diving deeper into designs, controls, inputs and user needs that follow on in Phase One,” Franco says. “Every phase flows seamlessly into the next, especially in terms of design flow, documentation and maturity. While every project or device is unique, diligently following our phase gated process creates safeguards that make room for creative solutions. The process usually leads to an elegant solution and increases the likelihood of success in commercialization.
Leaning into project management for Phase Zero customers, Franco “graduated” into more advanced phases with more detailed documentation, QMS and regulatory implications and requirements.
The cascading impact of early medical device design decisions
If asked to do a TED Talk in his professional area of expertise, Franco says it would focus on the early steps of medical device design.
Since every decision cascades into the next steps, next products, next iterations and outcomes, the process should ensure that at the end of it, you have something that fulfills the established needs and inputs.
“Medical device design is not unlike evolution, and nature is a top notch designer,” Franco says. “Nature likes trial and error. Some early design decisions that get carried out no longer make sense. Take the recurrent laryngeal nerve (RLN), a branch of the vagus nerve, as an example. In early vertebrates, such as fish, the heart and gills were close together, so the nerve’s path was short and direct. As evolution led to longer necks in animals like giraffes, the nerve maintained its original developmental route, stretching dramatically. This results in a long detour, where the nerve travels down to loop around major arteries (like the aorta), then ascends back up to the larynx. The lesson is early decisions affect design, manufacturability and ultimately success in commercialization throughout a product’s life and in ways you might not notice. Ways that might cripple a new device until it’s too late to save it. Always ask why. Trust the process and make room for creative thinking.
“In early stages of medical device design and development, including Phase Zero, it is also important to know that prototyping is never trivial. Sometimes a clear idea can require dozens of iterations, not the three to four prototypes innovators commonly anticipate. That can be hard to believe until you see the process unfold in front of your own eyes, but it is true and it is very real.”
Members of the Jackson Medical and GCMI Team. Image credit: Jackson Medical
Supporting the future innovators, especially including BME Capstone teams
When asked what he has been most proud of in his work at GCMI, Franco points quickly to his former self; BME students at Georgia Tech.
“I’m proud to have supported, and continuing to support, dozens of BME Capstone teams comprised of more than 100 students who have the potential to achieve what we state as our own mission: the development, testing, and commercialization of innovative medical products that improve quality based outcomes and delivery of healthcare for patients,” Franco says.
“Franco always pushes me to ensure he’s able to help wherever BME students are connected to or engage with GCMI,” Saylan says. “He is always the first to dive in, especially to the Georgia Tech BME Capstone teams we support.”
What can medtech innovators, be they researchers, students or clinicians, learn from your experience, we asked?
“For researchers and engineers including BME students, do not underestimate the importance of risk management. Regulatory bodies who will require you to demonstrate your device is safe are almost solely concerned about risk mitigation and safety. Your designs need to be fool-proof when it comes to the user. Your devices need to be hit with every possible failure mode before moving to any next step. If you don’t, it will almost certainly become a more complicated, more costly mess to fix and potentially trigger a recall.”
“Short term, I’m focused on helping our clients reach their next milestone efficiently, regardless of their position in its commercialization pathway and continuing to contribute to the BME Capstone students’ medical device design work,” Franco says. “I feel like I’m definitely in the right place and the right time. And if a device I’ve contributed to successfully achieves commercialization and patient care with staying power in the next three to five years, that would be an immensely fulfilling goal to achieve.”
“We are proud of all Franco has accomplished with Georgia Tech and GCMI,” Saylan says. “Our work and its results on behalf of all of our innovative customers and BME students are all the more effective because of his contributions.”