How Resource Constraints Can Enhance Your Development Process

How to Design Medical Devices on a Limited Budget

After graduation, Kaitlin and her co-founders kept working on the idea that had started in the Dartmouth lab.

With no outside funding and only evenings and weekends to spare, progress depended on persistence and creativity.

All funding came from small pitch competitions worth a few hundred to a few thousand dollars. Every penny went straight into prototyping. The team couldn’t afford to pursue any design without clear validation, which forced constant check-ins with practitioners and patients.

They began with five distinct concepts and, through feedback, narrowed to one. From there, they iterated more than 50 times — often with cardboard, string, and hand-cut silicone.

“We couldn’t spend too much effort going down any one path without some validation,” Kaitlin explains. “That reinforced continual check-ins with all of our stakeholders to make sure each decision worked for both patients and practitioners.”

Designing for Approachability

The aesthetics weren’t about vanity — they were about usability and trust.

Traditional pessaries can appear clinical and intimidating: stiff pink or white silicone disks that discolor over time. As Kaitlin puts it, “large pieces of silicone that immediately make you think, this does not look comfortable to insert inside me.”

Reia chose the softest silicone durometer that remained structurally effective. The team ran focus groups on color alone and selected light blue — a shade users associated with medical reliability but still pleasant to handle. It also resists discoloration. Details like grip texture and finger placement reflect Reia’s broader goal: designing a device that remains easy to use for patients with limited hand dexterity. To support these users, Reia later developed a companion applicator.

User testing revealed that even language mattered. When participants described prototypes as “a flower” or “an umbrella,” the team recognized those associations — words that suggested both support and comfort — and moved in that direction.

Building IP the Smart Way

While iterating on design, Kaitlin also had to navigate Dartmouth’s tech-transfer process. Her early career in intellectual property proved invaluable. The negotiation took about a year, and Reia retained full rights to its IP by structuring the buyback from the start. “Understanding that relationship early with your tech-transfer office is critical,” she says. “It can really affect what happens with your company in terms of who controls the rights.”

For patent strategy, Reia started with a provisional filing — inexpensive, idea-rich, and flexible for one year. That document covered roughly ten early designs. Over time, most dropped away, leaving the foundation for five strategic patents covering the core structure, key features, and the companion applicator. “Engineers want to patent everything,” Kaitlin says. “But that doesn’t always make sense for a startup where IP is expensive.”

Working with an experienced attorney, they used continuation patents to keep options open without filing everything at once. The result: a lean but defensible portfolio — exactly what investors and acquirers expect from early-stage medtech.

The Payoff of Working Within Constraints

Even after landing their first NIH grant, the team stayed resource-constrained. 

Rather than hire a clinical research organization (CRO), they built their own quality management system and ran their own clinical trial — a decision Kaitlin describes as necessary given their limited funding. “It wasn’t the best use of our funding at the time to hire consultants,” Kaitlin says. “We just learned to do it ourselves.”

Seven years later, the same original co-founders still lead Reia, supported by specialized consultants. That flexibility — honing regulatory submissions one day and production line work the next — became the company’s cultural DNA. “That mindset of being flexible and willing to take on every new task,” she says, “can only help you later on.”

How to Turn FDA Feedback into Momentum

When Kaitlin’s team entered their first pre-submission meeting, they assumed their 510(k) pathway wouldn’t require clinical data. The FDA disagreed. “We tried to pitch a non-clinical path, but they wanted clinical data,” Kaitlin recalls. “At that point, you have to decide which battles are worth fighting.”

The Reia team collaborated with the agency to design the required study. They fostered open communication — formal pre-subs when needed, quick follow-ups when possible. “They’re the ones reviewing your submission,” Kaitlin notes. “Being transparent from the start makes the process faster.”

The resulting trial compared Reia’s pessary with existing devices. Current users served as their own controls — one month with their usual device, followed by three months with Reia’s. The primary endpoints focused on safety and efficacy, but Kaitlin’s team added their own secondary endpoints around usability and comfort.

That mindset — doing more than the minimum — carried into their next phase. After clearance in May 2024, the team faced a choice: conserve resources for commercialization or invest in more clinical evidence. They chose to pursue more evidence. 

Reia launched a randomized controlled trial (RCT) not required by the FDA but designed to test its own hypotheses about patient outcomes. Kaitlin viewed the study as both a scientific opportunity and a business one — a way to build long-term credibility in a space that historically lacked rigorous data.

The trial is fully funded by NIH (more on that in the next section), which made it financially possible despite the company’s lean structure. It enrolls women who’ve never used a pessary before and compares Reia’s device to existing options across nine U.S. hospitals. The lead site manages operations to preserve objectivity and keep Reia’s internal costs low.

“Practitioners generally assume that removability helps prevent complications like abrasions or bleeding,” Kaitlin says. “We wanted to actually test that.”

For Kaitlin, the RCT isn’t just about validation — it’s about setting a higher standard for the category. “More data is always better for new technology,” she says. “It builds confidence for practitioners and patients alike.”