From Jodi · Business How a Women’s Health Idea Becomes a ProductFour gates stand between a good idea and a paying customer, and every one of them is a job. I get a version of the same note almost every week. Someone wants to understand the business side of women’s health, and when I read closely, they are asking how an idea actually becomes something a company sells and someone pays for. Nobody teaches this in a straight line, so it looks like a black box, and a lot of smart people apply to companies without knowing which part of the journey those companies are in. Here is how I think about it. There are four gates, a different function owns each one, and the function a company is hiring for tells you which gate it is standing in front of. Once you see that, job listings read very differently. Gate 1: Prove it works, and fund the provingBefore anything is sold, someone has to show it works, and that costs money long before there is revenue. One common early source is the NIH’s small business grants (SBIR and STTR). NIH lists a Phase I budget of $323,090 for feasibility work, and a Phase II budget of $2,153,927 for development, though individual institutes can set their own limits (NIH SEED). NIH is not usually the end customer, so the grants stop right where selling begins. The owners here are clinical research and clinical operations. Gate 2: Decide what the product legally isThis is the gate people skip, and it shapes everything after it. If a product is a medical device, FDA sorts it by risk. A 510(k) works when a similar device is already cleared, called the predicate. When there is no predicate, a company looks at De Novo or Premarket Approval (NIH SEED). Under FDA’s January 2026 general wellness guidance, software meant to encourage a healthy lifestyle and unrelated to diagnosing or treating a disease is generally not something FDA regulates as a device. So a single claim in the marketing, like “treats” or “diagnoses,” can change which side of the line a product lands on. The owner here is regulatory affairs. Here is what that looks like in real life. One AI tool that reads pregnancy ultrasound images to predict a delivery date was granted De Novo by FDA in February (decision summary). That is gate two cleared. Now comes gate three, because a granted De Novo says a product can be sold, not that anyone has agreed to pay for it. Gate 3: Get it paid forBeing legal to sell is not the same as getting paid. Providers bill with codes, and new codes come from the AMA’s CPT Editorial Panel. The process can take up to 24 months, and then CMS and the RUC assign a value (ASRM). New technology often starts with a Category III code, a temporary tracking code that lasts up to five years and has no fee attached, so payment is up to the insurer. “A code is not coverage.” Some insurers go further. Excellus BlueCross BlueShield’s policy, for one, treats Category III services as investigational unless specific coverage criteria exist. The owners here are market access, health economics, and reimbursement. Gate 4: Get someone to buy it and use itHealth systems, employers, health plans, clinics, or consumers have to say yes, and then people have to actually use the thing. The owners are partnerships, provider-facing sales, and customer success, often where a young company staffs first because it sits closest to revenue. What to search for at each gate- Gate 1: clinical research associate, clinical operations manager, grants or research program manager
- Gate 2: regulatory affairs specialist or manager, clinical affairs, quality and regulatory
- Gate 3: market access manager, reimbursement or payer strategy, health economics and outcomes research
- Gate 4: partnerships manager, provider or health system sales, customer success, implementation manager
Try this in 20 minutesPick one women’s health product you admire and look up where it stands. - Search FDA’s 510(k) and De Novo databases for the product or company. Public summaries show the intended use and predicate.
- Search ClinicalTrials.gov for the company name to see what evidence it is generating.
- Search “[service] medical policy” plus a large insurer’s name and see whether it is covered or labeled investigational.
- Open this week’s job listings and note which of the four functions that company is hiring for. That is the gate it is standing in front of.
Not sure where to start? This week’s featured roles are good practice. The Gates Foundation role is gate four at regional scale, the Kyndred role is gate four at the patient level, and the Ōura role sits across the wellness and device lanes. Here’s the part that’s genuinely hardEarly companies usually staff one or two gates at a time, and many women’s health companies sit in the wellness lane and will never have an FDA gate at all. Regulatory and market access roles also tend to want direct experience, so the realistic first step for many of you is an adjacent seat, like clinical operations or partnerships, and then learning the next gate from the inside. I don’t love saying that, but I would rather you plan for it than get surprised by it. Here is what that looks like in practice. A clinical operations coordinator at a device company sits next to the regulatory team every day, and a partnerships hire at an early company hears every objection a buyer raises. Both are seats where you can watch the next gate up close, and that is how a lot of people end up owning it. Final thoughtIf the business side of women’s health has felt like a club with a secret handshake, it is really a sequence. Learn the order of the gates and you can see where you would be useful. If you want to go deeper on the third gate, I am hosting our second Reimbursement Summit, a live virtual program on how reimbursement really works. Dates are coming soon, and the waitlist gets you the news first.  Jodi Neuhauser, Founder & CEO, In Women’s Health |
