Epinephrine auto-injectors, first developed in the 1970s, are the most common emergency treatments for anaphylaxis, often deadly allergic reactions. The limitations of liquid epinephrine and the device’s decades-old technology have kept these life-saving devices out of patients’ hands. Austin-based startup Windgap Medical, Inc. plans to break these barriers with a more convenient, shelf-stable alternative.

In Episode 41 of the MedTech Speed to Data podcast Key Tech’s Andy Rogers and Thomas James sit down with Windgap’s co-founder and Chief Business Officer, Brent Buchine, to discuss the data-driven development of the company’s life-saving technology.

Need to know

· Epinephrine auto-injectors are big business — A $1.3 billion market at Windgap’s founding, sales of epinephrine auto-injectors exceeded $3.1 billion in 2024.

· Few eligible patients get these life-saving devices — Only 52% of American food allergy patients ever receive prescriptions, and epinephrine auto-injectors are only available in 32% of the world’s 195 countries.

· Traditional auto-injectors are relatively large and inconvenient — Only 55% of patients with prescriptions report having immediate access to their auto-injectors.

· Liquid epinephrine is thermally unstable — Doses lose their effectiveness with prolonged heat exposure, forcing patients to refill their prescriptions more frequently.

The nitty-gritty

Buchine and his co-founders saw an opportunity to make epinephrine delivery more convenient and accessible. “We developed a freeze-dried version of epinephrine to make it more stable and double, if not triple, the shelf life,” Buchine explains.

However, lyophilization introduces an extra step in the treatment process. The dried epinephrine must be rehydrated and mixed in a solution before injection.

“If you have a rescue product for emergency use, you have to get it very quickly,” Buchine says. “With modest training, you need to make sure people know how to use the product because their life is at risk if it doesn’t work.”

Windgap’s ANDI® platform is a small, highly portable single-dose auto-injector, Buchine explains. “Simply twisting the cap automatically rehydrates that dose in a couple of seconds — no shaking, no swirling required. It’s ready to inject by pressing the device next to the injection site.”

Windgap and its pharmaceutical clients are still in the commercialization phase, but the company is already looking at the future of complex injectables.

“We see that, fundamentally, formulation pipelines are getting more and more challenging,” Buchine says. “You have multiple injections, you have mixing, you have high viscosity/high volume. The conventional options out there are not as suitable anymore. We’re solving those problems specifically because we think there’s an opportunity to be best in class in that area.”

Data that made the difference:

Developing combination products is a multi-stakeholder problem. “It’s drug, it’s device, it’s patient, it’s prescriber, it’s payer. You’ve got to think about all of those stakeholders along your development.”

Get in front of stakeholders to understand the problem. “We did a lot of surveys and uncovered the opportunity. Patients weren’t getting prescriptions filled or weren’t even going to the doctor to get prescriptions. It was that segment that we spent a lot of time talking to.”

Listen to your customers. “We’ll talk to pharmaceutical companies [and ask] what are some of the biggest challenges you’re facing in your pipeline? And then you just listen. Over time, you look for that recurring theme. That’s what really drove our product strategy.”

Use data to convince investors. “There was a vastly underserved market. Our ability to communicate that to investors and help them understand the opportunity of taking [at the time] a $1.3 billion business to something substantially above that.”

Hundreds of approved devices use artificial intelligence to help physicians diagnose patients faster and more accurately. Brooke & Associates is a legal and regulatory advisory firm that helps medical device makers get AI-powered devices through FDA pre-market approval.

In Episode #40 of the MedTech Speed to Data podcast, Key Tech’s Andy Rogers and Lei Zong speak with the firm’s managing member, Jason Brooke, about the FDA’s latest guidance to medical device developers for integrating AI into their products.

Need to know

• AI’s role in MedTech — AI identifies otherwise undetectable data patterns that humans can apply in clinically meaningful ways.
• FDA’s AI staffing surges — The agency accelerated hiring to develop internal AI applications and support pre-market reviews of new AI-powered devices.
• Radiological imaging leads the pack — More than half of 900+ FDA-approved AI-based products are in radiological imaging.
• Other fields are catching up — Cardiology and neurology applications are more recent entrants in AI-powered devices, but their numbers are growing.

The nitty-gritty

The FDA published “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations” in early 2025 to explain how it will address AI’s adaptive nature in medical device regulation.

“This guidance is really focused on a total product lifecycle approach,” Brooke explains.

Good management practices govern traditional medical device development, so documenting the development process in pre-market submissions is not as critical. AI model development is different because the model can evolve once in service.

“There’s a level of information that’s necessary in submissions for AI-based technologies that we haven’t had to provide to the FDA before,” Brooke says. “They want a lot of information,” Brooke says. “That’s an area I think may be problematic because a lot of that is somewhat trade secret.”

AI-specific guidance touches almost every aspect of a company’s submission, from risk assessment to labeling to cybersecurity. Brooke highlighted how the FDA’s approach to AI data management could change development practices to ensure the independence of training and validation data sets. For example, companies must separate their clinical sites geographically and temporally.

“This guidance gets into the weeds,” Brooke says. “It’s important for companies to understand this if they’re developing an AI-based product.”

Data that made the difference:

In addition to discussing the FDA’s proposed AI regulations, Brooke discusses the challenges companies face in bringing AI-powered medical devices to market.

“If you take away anything from this podcast,” Brooke says, “it’s that there’s a lot of burden associated with developing an AI-based medical device. If you don’t need to, then I wouldn’t recommend doing it.”

Slow and steady wins the race. Do your homework, plan for the FDA review, and then engage the agency at the right time to get them on board.

Thoroughly characterize your data sources. Devices like ECGs can vary by vendor, model, site location, patient, and many other factors. The FDA wants to know how this variability could affect the downstream AI model.

Develop a strong clinical validation plan. The FDA will limit claims and require disclosures when a device that performs well overall underperforms among certain patient groups.

Successful organ transplants depend on quickly getting donor organs to their recipients. MediGO, now part of CareDx, pioneered logistics technologies that help make these life-saving procedures more successful than ever.

In Episode #39 of the MedTech Speed to Data podcast, Key Tech’s Andy Rogers and Lauren Eskew speak with MediGO co-founder Dr. Joseph Scalea about how data led the startup to solve challenges in the organ donation supply chain.

Need to know

America’s nationwide organ donor network — From Hawaii and Alaska to Puerto Rico, patients are on a nationwide waitlist for compatible donor organs.

Organ donation used to be local — As recently as the 1990s, most organ transplants came from local Organ Procurement Organizations (OPOs), so long-distance transport was rare.

Today’s organ logistics are complex — Every organ donation requires a singular supply chain combining private or commercial aircraft and ground vehicles to link fifty-six OPOs with hospitals.

The nitty-gritty

A practicing transplant surgeon and currently the Vice Chair of Innovation in the Department of Surgery at the Medical University of South Carolina, Dr. Scalea has seen a dramatic improvement in the efficiency and survivability of organ transplants.

Operations that once took hours are now routinely completed within an hour. At the same time, complication rates are at all-time lows. Many technological advances made these improvements possible, but Dr. Scalea saw opportunities in the organ transplant system’s operations.

“We have about twenty-four hours to move a human kidney from the donor hospital,” he explains. This tight turnaround led Dr. Scalea to explore the potential for drone delivery. “We were watching the [transportation] time go up,” he recalls. “We hypothesized that using drones to seamlessly go from the donor to the recipient hospital might allow the recipient side more flexibility to get better outcomes.”

Data that made the difference:

Data drove MediGO’s decision-making and ultimately led to a pivot from drone to supply chain technology. “We fundamentally believe that this problem is worth solving for the community,” Dr. Scalea says, “so what data are required to make this a business? It was through a combination of customer discovery, key informant interviews, and a ton of research into the space.”

Identifying the actual customer was key. “We initially focused on the transplant centers,” Dr. Scalea says, “and then fundamentally recognized the organ banks responsible for moving the organs were the right customers. Organ banks didn’t see as much immediate value in the biotelemetry. What they needed was logistics.”

From there, the MediGO team could understand their customers’ financial concerns. “We needed to understand funds flow — how those customers get reimbursed for the work they do.”

As a practicing surgeon, Dr. Scalea inherently understood the customer’s customers. “I was very fortunate to be an active transplant surgeon while standing up MediGO. Every day, I’d go to the hospital and ask myself, ‘Where’s the organ?’ This problem was real.”

“As our colleagues around the country read the research we were publishing, it became clear there was a groundswell of interest in this problem being solved.”