Solve the Workflow, Unlock the Market

Solve the Workflow Problem First — Patient Outcomes Won't Matter If Systems Can't Adopt 

Scalp cooling existed before Cooler Heads but as Kate explains, it was the "red-headed orphan stepchild of oncology" — offered at places like Sloan Kettering and Dana Farber but avoided by most infusion centers. The barrier wasn't efficacy; it was implementation. The therapy could double chair time, and infusion centers make more money from chemotherapy than symptom management.

Kate's approach broke down into three core design principles:

1. Solve the workflow bottleneck first

Kate built a portable machine that allows post-chemo cooling away from the infusion chair, preserving valuable chair time while delivering the same clinical outcome. Coming from software and having never worked in hardware, she spent her first six months talking to both patients and providers. 

"I have such a strong lock on what patients want, because I was the patient," she explains. "But what do providers want?" The answers she got helped her identify gaps: providers needed a solution that preserved chair time and didn't overburden nursing staff — constraints that existing devices ignored.

Kate turned those insights into a concrete litmus test. She picked a specific target customer — Sharp Health System in San Diego — that had never offered scalp cooling and asked: What would it take to get them to say yes? 

Every design decision ran through that filter: would this solve Sharp's workflow problem? Would their nursing staff adopt it? Could they implement it without hiring more people or redesigning their infusion centers?

The result? FDA clearance in October 2021 for Cooler Heads’ minimum viable product — proving equivalence to competitors but with a unique, differentiated use case. And Sharp? They became a customer and have been public about their partnership with Cooler Heads.

2. Make the economics work, not just the ergonomics

Understanding workflow meant understanding the business model. Kate needed payers to see scalp cooling not as a cosmetic luxury, but as a legitimate side effect management — just like the anti-nausea medications and hydration infusions that insurance already covered.

The clinical rationale was there: 8% of patients recommended for chemotherapy refuse it because they don't want to lose their hair. "How do we make chemo more bearable so we can get patients into treatment and keep them in treatment?" Kate asks. If scalp cooling could keep patients in treatment, it wasn't vanity — it was supporting better outcomes.

The regulatory environment is also shifting in Kate's favor. The National Comprehensive Cancer Network — the 33 academic institutions that set standards of care — issued a formal recommendation for scalp cooling. Even more significant: in January 2026, Medicare is expected to reclassify the reimbursement codes, moving scalp cooling from temporary (Category III) to permanent (Category I) CPT codes. That shift signals to the entire payer ecosystem that scalp cooling is now part of the standard of care and isn’t just a luxury add-on. These developments make it easier for health systems to confidently invest in the technology knowing insurance would pay for it.

3. Think B2B2C from day one

Sharp and University of Pittsburgh Medical Center (UPMC) are Cooler Heads' accounts, but they enroll their patients — a B2B2C dynamic that requires trust at both levels. Kate needed health systems to believe in the technology enough to recommend it, and she needed patients to actually use it.

Her solution: get medical oncologists as early investors. These weren't just capital sources — they were her entry point into health systems. "Getting them bought in that way means you also have leads to go to for customers when you're ready for commercialization," Kate says. A physician investor could make an introduction to their hospital's head of oncology or nursing director. Better yet, they could vouch for the technology's clinical value in conversations Kate couldn't be part of.

The strategy worked. Most of Cooler Heads' accounts had never offered scalp cooling before. Kate wasn't just winning market share from competitors — she was creating new adopters, converting health systems that previously said "we can't do this" into active customers.

Focus on What Your First Medtech Product Needs to Prove, Not What It Could Do

For Amma, Kate applied design thinking principles from her software background: focus on outcomes and key inputs, not features. It had to be portable. It had to allow patients to cool elsewhere. It had to enable self-adjustment. It had to be FDA-cleared. And it had to have a price point that made sense — not the $8,000 she had personally spent on an over-the-counter method.

The hardest part? Saying no.

“It’s really easy to let design creep take over,” Kate says. “Everyone has ideas — especially engineers — about what else the product could do. And sure, it would be cool if it did all those things. But if they’re not part of what customers truly need, you have to stop and say no.”

For Cooler Heads, that meant focusing on the few features that mattered most to its core users — community health systems, academic centers, and private practices — the ones that would determine whether scalp cooling could actually fit into real clinical workflows.

That discipline extended to investor conversations. When board members asked about additional capabilities, Kate held the line: "That's for the next version. This is what we set out to prove." The first generation showed equivalence to competitors with a differentiated workflow. The next version, launching at the end of next year, will build on that foundation — but only after the first generation demonstrated product-market fit.

Cooler Heads conducted a soft launch with patients in mid-2022 before signing its first account later that year. To do this legally, Kate obtained a home medical device retailer license in California, where the company is based, allowing them to provide therapy and process prescriptions. "We needed to know what we didn't know," she explains. That de-risking paid off. Within six months of launching, they won UPMC — a marquee customer.

One area where Kate wishes she'd invested earlier? Quality systems. "Documentation. Learn everything you don't know," she advises. Coming from national security software, where she managed facility and personnel clearances, Kate understood that compliance mattered. But she wasn't fluent enough in medical device quality requirements during development. "I wish I had invested more early in having that quality person really digging in alongside our development partner.” By having better quality systems earlier on, Kate says Cooler Heads could have saved six to nine months on FDA clearance. "And time is money in startup land."