The difference between wellness and medical products
July 2025 , Sam Moreland
There is a pernicious movement in the health-tech space which is the conflation between wellness and medical products. This will cause an increase in poor quality healthcare for patients and potentially lead to bad outcomes. I’ll give a quick breakdown of what I mean by wellness and medical product:
Wellness Product: A product that is designed to be sold to an upper/middle-class demographic to help with wellness or fitness goals. Often this incorporates off the shelf technologies and invariably some consumer desirable product such as a watch or armband.
Medical Product: A product that is designed to be used on the sickest patients in difficult conditions to keep patients safe. This often means custom design of solutions (as well as off the shelf) to optimize for collection of data that is imperative to keep the patient safe.
These are not the same thing! Here's a few differences:
Wellness products look to fit existing products into a new space, rather than designing for true medical use cases.
Wellness products start by getting products into the market quickly, rather than designing the solution to the market.
Medical products require a team and company to be fully medically compliant in how they design/build/test/market/support their products. Wellness companies do not do this!
Medical products are tested on the outlier patient populations and are designed to serivce them. Wellness products are designed for the average consumer.
Problems are now arising where wellness products claim or market themselves as equivalent to medical products. It is particularly pernicious because they prey on a serious gap in healthcare provision with solutions that don’t do what the patients want. Patients usually have no understanding of the differences between a validated medical product or an app on their phone. They just see the product “measures” heart rate, or it does BP, without the ability to discriminate between quality or applicability. Patients buy products that at best work on the worried well where it won't make a difference. At worst patients buy products that give incorrect information to sick patients, giving them a false sense of understanding and control.
For example the Aktiia (now Hilo) device was analysed for accuracy and found that the device did not accurately track night-time BP decline and results suggested it was unable to track medication-induced BP changes. These are serious issues as night-time BP decline and medication induced changes are the two primary use cases for long term BP monitoring!
This doesn’t help when healthcare providers do not truly understand the difference between different monitors and there capabilities. Correctly providers will identify battle tested Medtech companies like Omron for BP or Massimo for SpO2, and recommend them for patients. This is the best case scenario for that patient. But buying a cheap device from Walmart or Amazon is likely going to end up with poor quality information going to that patient! A study did just this and found huge variances in accuracy between different low cost widely available SpO2 monitors. A Harvard study found that 79% of the top selling upper arm cuff BP monitors and 83% of wrist monitors were not even validated!
Another issue is modern influencers who discuss their wellness goals and promote the use of wellness products to meet them. This gives false credibility to products that ill patients may confuse for applicability to actual medical use cases.
Even worse are the totally phone based apps. Now smart phones are great for helping manage chronic conditions. But because you can now read your newspaper on the phone or browse the internet, does not mean that phones can now meet your medical needs. Scheduling your pills or accessing data is fine, measuring your blood pressure or SpO2 is not!
Going from wellness to medical
There is an awful trend in funding at the moment in medtech. Time to market is put at a premium. It is better to get something less functional to market quickly, than taking 2-3 years to develop and medically regulate the product. Creating and supporting a true medical product means creating the company from the ground up to be able to create/support/iterate in the medical space. This requires large, highly skilled teams of people developing structures in place to support this. Wellness companies do not have to do this, and investors actively push the companies to avoid it!
It is very difficult to pivot from a generic consumer good into a medical space. It requires retraining the entire company, changing the entire company structure, taking time to gather real world evidence, and get regulated. Regulation is not just about proving that a heart rate is accurate, it's about the company being medically competent. I have never seen a wellness company do this kind of re-structuring (although I would be very happy to see it!).
I will never forget the time I went to a talk given by the ex head of product at an extremely large (now failed) wellness company. They tried to pivot into the medical space. The speaker told us how they tried at every turn to avoid going through the regulation hurdles. They proudly boasted the fact that they wanted to provide something that should be medically regulated to patients, but because they changed the name of it to something that isn’t in the regulation documentation, they internally decided it didn’t need to be a medical product (and require regulation). It was one of the most shameful things I have ever heard and they were proud!
Now do all wellness companies do this. I don’t think (or hope) so. But I do see wellness companies putting marketing first rather than creating applicable medical products.
Does Wellness have a use in the population?
Yes and no. If its helpful to get people thinking and being proactive about their fitness goals then its great. Get those step counts in, eat healthily, be mindful of your body. But beyond that these devices can be wildly misleading, especially without a qualified medical professional who is familiar with how the wellness technology works.
Conclusion
I genuinely think we are building a house of cards for patients who are currently being failed by the overwhelmed medical systems. Patients will look for certainty in third party solutions that do not meet their needs. The good news is adoption of hospital at home systems by credible companies is starting to bridge that gap and hopefully this will become less of an issue.
Regulators really need to start clamping down on the promises of wellness companies. I wrote a blog about blood pressure in smart watches which is a prime example of this. It would be like saying this generic drug that reduces pain, will also be able to alleviate allergies in the future (wink wink, nudge nudge). Wellness companies that want to get into the medical space need to seriously go beyond marketing and restructure companies to be able to support this. It’s not just about creating a fancy AI algorithm that does X, it's about supporting patients and clinicians to get the best outcomes.
If you're a wellness or medical company wanting to improve your monitoring device please feel free to reach out.
