Joining Qserve in June 2026, José brings extensive experience in the medical device industry, with a particular focus on novel, first-in-class devices and US market entry pathways. Throughout his career, he has supported manufacturers in navigating complex regulatory requirements and bringing novel technologies to market. In this interview, José shares his professional journey, the trends shaping the future of MedTech, and what motivated him to join the MedTech industry, specifically Qserve.
- What first drew you into the medical device world? Was there a specific moment or experience that made you realize this was what you wanted to do?
It started when I was an infantry medic in the US Army. I was trained in emergency medicine in the battlefield, which is the best initial training in the medical field that you can get for free. It was there that I was first introduced to the field of medicine and to battlefield medical technologies designed to save lives after catastrophic injuries. After my short-lived military career ended, I enrolled in undergraduate studies in biology at the University of Dallas and graduated in May 1994. I began a graduate program in neurophysiology after being mentored by one of my cellular biology professors during my senior year. I was very interested in the emerging field commonly known as “The Hard Problem of Consciousness” – and its relation to quantum field generation within crystalline cellular structures with uniquely physical properties – structures derived from tryptophan, a common amino acid found in neurons. At the time, I was also thinking that medical school was the way to go because I was seeing all the new stuff exploding thanks to software technology. Medicine had finally caught up – even before the term medtech was coined. So, I wanted to be part of that paradigm shift in medicine – I didn’t know how, except maybe to become a doctor.
Well, after dropping out of medical school, I realized that you can’t specialize in everything, so I began teaching science and technology; first to high school students, then in a junior technical college. That kept me interested for a little while – I loved teaching; it is very rewarding - until you have kids, and the bills need more attention than the kids.
So, I answered an ad in the job-seeking section of the local newspaper (by the way, 26 years ago, we found jobs in the newspaper). The position called for a Clinical Study Manager. I had no idea what that was – but it was close to my house, and it required a science degree – and I had one. Turns out it was a Dutch medical device company in Groningen that specialized in designing and manufacturing highly specialized intraocular lenses, aka IOLs. They needed someone to monitor the clinical sites around the country at very prestigious academic institutions specializing in refractive eye surgery. Two IDEs and two PMAs, 3 years later, including a crash course on biostatistical software, and all of a sudden, I’m in love. I still love the strategic planning and execution of product development and clinical trial design for medical devices. In this career, I can work with a wide range of technologies and clinical applications. Here I am, 25 years later – and the technology I’m seeing now is something I would never have dreamed of.
2. Your career has taken you through very different environments: large corporates, start-ups, and independents. What has that range taught you that you wouldn't have learned any other way?
The first thing I learned is that product development happens much faster in smaller, start-up environments. Large, global companies know this – that is why they let innovation happen outside their sandbox and then step in when they see commercial viability. Smaller companies are willing to take more development risks (not risks to the patient, even though that might happen sometimes), which may give them a slight edge when speed-to-market is critical to a successful launch. It’s a double-edged sword, though. Larger companies are less strategic and more about just executing; smaller companies are more strategic, but that can get in the way of execution. They sometimes call it “paralysis by analysis”.
3. You've built a particular specialism around De Novo submissions and Breakthrough Device Designation. For companies unfamiliar with that pathway, what do they most commonly underestimate?
The value of being a De Novo medical device. Period!
This means you have contributed to setting a standard on new technology that the US FDA has NEVER regulated. This process requires legislative writing – yes, the Sponsor writes a NEW regulation (well, you assist the FDA in writing it), which is then published in the National Register.
What does this mean to a company?
That you are the first-in-class, and that every product that will compete with you in the market will have to conduct the same testing and implement the same controls that you have established in your letter of approval. Also, don’t underestimate the cost. It is more expensive than a 510(k), mainly because of clinical testing. Still, there is a return on investment: the product multiplies any market success due to its first-of-kind, first-in-the-market advantages. However, this success depends on the users, so the product must actually be used – the market demand must be well understood. Lastly, don’t underestimate the value of having key opinion leaders promote the use of your device, as they truly believe in the new technology.
4. When you step into a new client engagement, what's the first thing you need to understand before you can be genuinely useful?
I need to understand the device's clinical application – imagining it being used in the setting for which it is intended. Part of that is understanding the interaction with the patient, the clinician, or surgeon, where it will be used, and what qualifications are needed to use the device, if any, etc. That allows me to paint the BIG PICTURE of how this device will be regulated by the US FDA, covering all aspects of safety and performance. I also need to understand whether the device meets or exceeds the threshold for a predicate device. This is a MAJOR contributor to the time needed to complete the development process, and subsequently adds to regulatory review timelines. If no equivalency is found in a short period of time, then it is time to submit a Q-Submission and speak to the FDA.
5. What's something about your background that might surprise people who only know you from your CV?
Part of my lifelong interest in biological sciences stems from a deep connection to and love for the ocean and all types of marine environments. I have lived in Florida, near the Florida Keys, my whole life. I consider myself a professional boater (not so much for fishing). I was offered a full scholarship out of high school to the University of Miami to become a marine biologist. I would have never lived up, even close, to the adventures of Jacques Cousteau – he was one of my heroes growing up. I obviously did not accept it; instead, I joined the Army to be a medic, and the rest is history.
6. What are you reading, thinking about, or paying close attention to in the industry right now?
I enjoy keeping my regulatory finger on the pulse of the FDA’s “current thinking” by monitoring the new DENs published under Section 513(f)(2) – which are the De Novos. I then read up on their development pathways, clinical studies, and the regulatory plan they crafted. This information is important because it provides insight into the innovation currently happening in the industry and how the FDA is regulating these novel devices. The FDA needs to be educated in these cases – they are not the innovators, we are, industry – so it is up to the Sponsor to create a “story” that is understandable (speaking their language) and defendable (with solid data and science).
Get in touch with José
Want to know more about José? He will be attending and presenting at the 6th Qserve MedTech Conference in Amsterdam on 10-12 November, 2026. Join his sessions on engaging with regulators (MDR vs FDA) and overcoming regulatory challenges for start-ups (EU vs USA), pull him aside for a conversation, or contact him today!