I get the appeal. A wellness launch gets you to market in months rather than years, brings in revenue, and builds a user base that investors like to see. It also teaches you things no protocol will: how people actually use the product, what they misunderstand, what they ignore. For a young company, that learning is worth a lot.
In the US, the window has also widened. The FDA’s 2026 general wellness update made room for some non-invasive wearables that measure things like blood pressure, which the agency had been treating as devices only months earlier. More on how it got there below, because it’s instructive.
So can you start as wellness and become a medical device later? Sometimes, and more and more founders are trying out this strategy. But it isn’t a yes-or-no question. It depends on your product, your market, and what you’re building beyond the product itself. There’s a version of this strategy that works and a version that just postpones the hard part, usually at a higher price. The difference is whether you build the wellness product as stage one of the medical device, or as a separate thing you plan to “upgrade” later.
Why are you considering the wellness route?
First, an unconditional statement from me: women deserve evidence-based solutions that bring real improvements to health and quality of life. If you’re looking to ‘go the wellness route’ because you’re not sure you can demonstrate that your product is safe and effective, seriously, go take a long hard look in the mirror and ask yourself what you’re doing here. Your early users can absolutely be a source of valuable product development data, and it would be silly not to learn from their product experience, but they shouldn’t be unwitting participants in testing whether the product actually works.
Still with me? Great. There are reasonable reasons to consider the wellness route:
Your product truly is a general wellness product that does not treat, prevent, monitor, or manage any disease or condition. Not sure if you’re building a wellness device or not? Take the device positioning tool for a spin.
Your product could be legitimately positioned as a general wellness or consumer product in at least one geography, allowing you to start generating revenue and collect real-world usage and effectiveness data that will be used to build your clinical evidence base.
Your product has some features that are unregulated, and you have other features planned later in your pipeline that you know will push you into regulated device territory. Your launch is therefore truly a two-phase operation.
Where it goes wrong
Your claims drift, and the regulator notices
Wellness positioning holds only as long as every claim holds. As marketing grows, medical language tends to creep in one campaign at a time, and if you haven't planned guardrails and checks ahead of time, nobody on the team may notice. Regulators will also consider how your device is being used by end-users, regardless of what you claim.
In July 2025, the FDA sent WHOOP a warning letter over its Blood Pressure Insights feature. The agency argued that estimating blood pressure is inherently tied to diagnosing hypertension, that phrases like “medical-grade” undercut the wellness framing, and that disclaimers didn’t help when people were clearly using the feature to keep an eye on their blood pressure. The FDA later closed the letter after WHOOP changed the feature and its labelling, and many in this field consider that WHOOP's arguments played a major role in the updated wellness guidance that was subsequently released.
Your wellness data may not count as clinical evidence
Many founders plan to use their wellness users as the evidence base for the medical version. Sometimes that works in part, for feasibility or as supporting real-world evidence. But data collected without a clinical plan, the right endpoints, ethics approval and consent for that purpose is hard to turn into evidence a notified body or the FDA will accept. You can end up with an impressive dataset that you're not allowed to use, and still need a clinical investigation.
Your design history doesn’t exist
Device regulators want to see how the product was designed: requirements, risk management, verification and software lifecycle records, kept under a quality system (think ISO 13485, ISO 14971 and IEC 62304). If version one was built like a consumer gadget, those records don’t exist, and you can’t honestly recreate them after the fact. This can turn into a massive waste of time and money if you end up having to rebuild the product later with proper documentation.
Health data is health data
If you collect information about periods, fertility, pregnancy or symptoms from people in Europe, you’re processing health data, a special category under GDPR. Being a wellness product doesn’t change that, and neither does a future device plan.
Does starting as wellness dilute what makes you different?
This is the question founders ask least, and it’s often the one that matters most.
To stay on the wellness side, you have to give up your strongest claims. “Treats incontinence” becomes “supports pelvic floor strength”. “Reduces period pain” becomes “supports you during your cycle”. Diluting your claims to check the 'wellness' box can turn a product with a real clinical benefit into one more wellness gadget in a very crowded aisle. It's also going to be more difficult to get healthcare providers on board to recommend your device if you can't claim anything about it.
So before you choose the wellness route, ask yourself honestly:
How are you building your brand with the women who will use your product? Will “supports” and “helps you understand” persuade them when a competitor can say “clinically proven to treat”?
How are you building credibility with the healthcare community? Clinicians recommend what has evidence behind it. A wellness positioning can make it harder to get onto their radar, and harder to change their minds later.
How are you establishing trust? In intimate and often stigmatised areas of women’s health, credibility should be a critical part of the product, not a layer of marketing on top.
Do your diluted claims still set you apart? If they sound like everyone else’s, the wellness launch may be costing you the very thing you’re trying to build.
Is it working for you or against you? Wellness can be the right call. But it should be a choice you make for your brand and your users, not a default you drift into because the device route looked expensive.
Will this impact who pays? Some wellness devices may qualify for healthcare spending under FSA/HSA rules, but if you're targeting institutional payers (B2B, B2G), being a cleared medical device may be the first condition to meet.
Old-school regulatory advice will tell you, correctly, what you can and can’t claim. They won’t always ask whether you should want to make those claims at all, or what giving them up does to your brand, your clinical relationships and your fundraising story. Those questions sit where regulatory, science, product and marketing meet, and they’re much easier to answer with someone who has been on all sides of that table, including building health credibility with users and clinicians. That’s a big part of how I work with founders at Evidentia.
How to do wellness properly
If you opt to launch outside of regulated device territory first, treat the wellness launch as stage one of the device, not a detour. Build first, validate later, regulate last is a fiction, and an expensive one. In practice, that means:
Write the intended purpose of the eventual medical device first, then work backwards to a wellness claim set that sits safely inside it. Are you satisfied with your diluted claims? Will they allow you to differentiate your brand, reach your target audience, and build traction? Great. Move to step two. Not satisfied? Maybe the wellness route isn't right for you.
Do you have data to demonstrate that your product is safe and effective, and that you are improving women’s health or quality of life? While consumer products aren’t bound by the same standards as devices, they still need to meet standards around safety and performance, and truth in advertising. Also, building products that actually work is the right thing to do.
Build under a quality system from the start, sized to your stage. You don’t need a QMS that buries a five-person team, but you do need risk management, design controls and software documentation that will survive scrutiny later. ISO 13485 (and the associated standards for risk management, safety and performance, usability) is your eventual goal. Start building a system that can eventually fit within this framework. Need help building a QMS light? Get in touch.
Lock your claims down. One owner, one approved claims list, checked before every campaign, ambassador brief and app store update. I've seen companies who claim to be wellness, but regularly re-post screenshots from users saying that their product helped them [treat a disease, resolve symptoms, improve pain...]. These are counted as claims, too, if you are repeating or promoting them on your own socials.
Collect data with the device in mind: consent, protocols and endpoints that could support your future clinical evaluation, with ethics approval where you need it. I've seen a company collect lots of data using a scale that wasn't clinically validated. It's hard to argue afterwards that the data collection tool was accurate, and you can't go back and edit the quesionnaire afterwards.
Plan the switch before you need it: which market will you seek first, which pathway, and what happens to existing users when the medical version launches.
When it isn’t an option
For some products there’s no wellness phase to have. If your product goes into the body, sends energy into it, or changes how it works, the technology may make it a device whatever you claim. I go into this in more detail in Is my women’s health product a medical device?
Where I’d start
If you’re weighing a wellness-first launch, I find that many founders start by asking "can we?" instead of focusing on "should we?", and , "what do we have to build now so the medical version doesn’t mean starting over?" That conversation is worth having before you start building, before you start approaching institutional investors, and before your device is in the hands of your first users.
You can start by drafting your future device’s intended purpose with our free device positioning tool. Or book a free 30-minute call and we’ll explore how we can map out the path together. I’d love to help.
Sources
Mintz, FDA warning letter reminds industry that wellness claims only go so far (July 2025)
MobiHealthNews, FDA closes warning letter on WHOOP’s Blood Pressure Insights feature
US FDA, General Wellness: Policy for Low Risk Devices (updated January 2026)
European Union, Regulation (EU) 2017/745 on medical devices
This article is general information, not regulatory advice for a specific product. Status as of November 2026.