Blythe Karow · The Device Files: From Concept to Commercialization
Last week I joined the first ever MedTech Innovator Radar Forum in Manhattan Beach, a really great event that showcased approximately 150 MedTech companies through seven rounds of pitch events, plus additional content and networking.
For anyone who doesn’t know, I’m a MedTech Innovator alum. As CEO of my company, Evren, I was an Execution Finalist and we won for the Best Video in 2021, so MTI has a special place in my heart. It’s really fun being at an event like that as one of only a handful of judges who also knows what it’s like to be on the other side of the table. I hope I get a lot of opportunities in the future to work with some of the great companies I met!
One of the most interesting moments at the Radar Forum, besides the pitches, was a panel featuring both Michelle Tarver from the FDA’s Center for Devices and Radiological Health and Brian Waldersen from CMS Innovation Center. During the CMS portion, they announced that the application deadline for the ACCESS program is being extended to May 15th![1] So, I thought that might be a good topic this week – you have a month to apply if you think the program might be useful to your organization and we can talk about whether it may or may not be.
I was already writing the article about the ACCESS program when yesterday, WHOOP announced they are participating in the program through a newly created entity called WHOOP Physician Services, PC.[2]
So here we are. This is the first time since the inception of The Device Files that I have not published on a Wednesday morning. I pushed it to this morning (Thursday) to incorporate the WHOOP news! (I bet you didn’t even notice! :D)
And can I just start by saying, “I TOTALLY CALLED IT!!!”
Last week, I published
My core argument: WHOOP and Oura are not just consumer wellness platforms anymore. They are becoming health gatekeepers. They have continuous data. They have the user’s daily attention. They could redirect users to specialty services, devices, and treatments. They could replace a large chunk of what a primary care physician currently does.
Within a week of that article, WHOOP announced they’re doing exactly that!
Maybe I should stop calling myself the Queen of Wearables and start going by something more accurate. Maybe I can be the new Carnac the Magnificent? (Or for the Millennials… Miss Cleo)
On April 13, WHOOP announced that its affiliated healthcare provider, WHOOP Physician Services, PC, was selected into the first cohort of CMS’s ACCESS program.[2] They expect to begin enrolling Medicare beneficiaries this summer when the program launches on July 5.
A few things worth noting about this structure:
A Professional Corporation (PC) is a legal entity that allows licensed physicians to incorporate a medical practice. It is required when a healthcare provider wants to operate as a Medicare-enrolled entity. The PC must be controlled and operated by licensed professionals, which means WHOOP itself cannot just enroll as a Medicare provider. They needed a physician-led entity to participate.
WHOOP Physician Services lists Dr. Dan Henderson as Medical Director. In the press release, Dr. Henderson noted that since ACCESS was announced in December, the team has been focused on building a care journey for individuals with early cardiometabolic risk, combining continuous data, personalized coaching, and clinical oversight.[2]
WHOOP Physician Services will cover patient cost-sharing associated with the ACCESS program, removing financial barriers for Medicare beneficiaries.[2] I can’t wait to get more details on how this will be structured and the resulting benefits of this model!
What we do not know is substantial. There is no website for WHOOP Physician Services. There is no information beyond the press release about how this entity will actually operate, what the clinical workflows look like, how many physicians are involved, what scope of services they plan to deliver, or whether this is a permanent organizational structure or something built specifically for ACCESS participation. The press release describes it as an entity “founded to provide technology-enabled care supported by WHOOP,” but that language is pretty vague on timing and scope.[3]
My educated guess: WHOOP probably does not have all of these answers fully worked out yet either. They moved fast to get into the first cohort. And with Mayo Clinic now on their cap table after the $575 million Series G raise, they have access to some of the best healthcare delivery advisors in the country to help them figure out the operational details on the fly.
If WHOOP Physician Services can deliver chronic care management through a wearable, they have essentially built the infrastructure for exactly the model I described last week: own the data, own the patient relationship, own the clinical decision pathway. That is the gatekeeper model. And now they have a physician-led entity they can funnel users to in order to execute it.
Crazy news!
But now lets pivot to whether this extended deadline is something you should pay more attention to.
For readers who have not been tracking this, the ACCESS Model (Advancing Chronic Care with Effective, Scalable Solutions) was announced by CMS on December 1, 2025.[4] It is a 10-year voluntary payment model that launches July 5, 2026.
The basic concept: CMS will pay participating organizations recurring, outcome-aligned payments for managing Medicare beneficiaries’ chronic conditions using technology-enabled care. Instead of the traditional fee-for-service model where providers bill for specific activities or time spent, ACCESS pays for results. Organizations receive a fixed payment for managing a patient’s condition over a 12-month period, and full payment depends on achieving measurable health outcomes, like reducing a hypertensive patient’s blood pressure by 10 mmHg.[4]
Four clinical tracks at launch:
Early Cardio-Kidney-Metabolic (eCKM): Hypertension, dyslipidemia, obesity or overweight with central obesity markers, prediabetes
These conditions affect more than two-thirds of Medicare beneficiaries, so the addressable population is enormous.[4]
As of April 13, more than 150 organizations have been accepted into the first cohort.[5] CMS officials say the volume of applications exceeded their expectations, and that the modest payment rates and restrictions did not discourage digital health companies from applying.[6] They say that – but word on the street from my Healthcare Economics folks is that a lot of companies don’t think this is worth their time and effort due to the low payments. Most of the accepted participants had not previously served Medicare patients, which tells you something about who sees this as an opportunity.[6]
The participating organizations are an interesting mix. Alongside WHOOP, the first cohort includes companies like Noom, Verily (Alphabet’s life sciences arm), Weight Watchers, Withings Medical Group, and several virtual care startups, plus a handful of community health centers and hospital-affiliated groups.[7]
In February, 14 major health insurers representing 165 million members across Medicare Advantage, Medicaid, and commercial coverage signed what CMS is calling the ACCESS Payer Pledge, committing to offer outcome-aligned payment arrangements by January 2028. That is worth watching, because if commercial payers adopt similar models, the addressable market for technology-enabled chronic care management extends well beyond Original Medicare. That said, it is worth noting that outcome-aligned payments shift financial risk from the insurer to the provider. Insurers committing to this model is the easy part. Whether providers are willing to accept that risk structure at scale is a different question.
This is where it gets into the weeds, but it matters for anyone considering whether to apply.
ACCESS is for Medicare Part B-enrolled providers or suppliers. Pure technology vendors, device manufacturers, and software companies cannot participate directly. To be an ACCESS participant, you need a clinical entity with physicians that can enroll in Medicare and deliver care.[8] That is exactly what WHOOP did by creating their PC.
If your company wants to participate directly, you would need to either build or acquire a physician-led clinical entity (like WHOOP’s PC model), or partner with an existing Medicare-enrolled provider who is an ACCESS participant and deliver your technology as part of their care model.[8] The first path is not trivial. Once you are a Medicare provider, you take on compliance requirements, data privacy obligations, and constraints on how you can bill Medicare beneficiaries for other services. Companies evaluating this path need to understand what they are signing up for beyond just the ACCESS payments.
There is a third option that is lower friction. CMS is launching an ACCESS Tools Directory, a CMS-hosted resource where companies can list their products for use by ACCESS participants.[9] CMS describes the directory as including software and hardware tools such as data exchange and interoperability solutions, connected clinical devices like blood pressure cuffs, remote monitoring technologies, and HIPAA compliance support tools.[9] If you make a connected device or any product that monitors biomarkers or supports chronic disease management for the four clinical tracks, this directory could put your product in front of 150+ organizations that need exactly those tools to deliver care and hit their outcome targets.
Vendors can include optional promotional offers like discounts or service credits, provided they comply with federal beneficiary inducement laws. There is no published deadline for getting listed on the directory, and no fee to be listed based on what has been released so far. Vendors listed in the directory are not compensated by CMS, but the directory is essentially a sales channel, a place where ACCESS participants go to find the tools they need to succeed.[9]
So, the application deadline for the first cohort launch on July 5, 2026, has been extended to May 15, 2026. But unless you’re going to be a service provider, this date might not be that important to you. I do, however, wonder if Oura is now scrambling to do the same or if their announcement will come with the next round. Applications received after that date will be considered for a January 1, 2027 start.[5]
So, there has been some confusion around ACCESS and TEMPO. We just reviewed ACCESS, now let’s discuss the FDA sister program. Four days after ACCESS was announced, the FDA announced the TEMPO pilot (Technology-Enabled Meaningful Patient Outcomes) on December 5, 2025.[10]
TEMPO is an FDA program, not a CMS program, but it is designed to work in coordination with ACCESS. The basic concept: manufacturers of certain digital health devices that do not yet have FDA authorization can apply to TEMPO and request that the FDA exercise enforcement discretion while they collect real-world performance data through participation in the ACCESS model.[10]
In practical terms, this means a manufacturer could participate in TEMPO, offer their device to ACCESS organizations without having completed the traditional 510(k), De Novo, or PMA pathway, collect real-world data on how the device performs, and then use that data to eventually seek FDA marketing authorization.[10]
The FDA currently expects to select up to 10 manufacturers in each of the four ACCESS clinical areas, so approximately 40 total.[10] That’s a pretty limited start.
For companies that do not have any FDA-cleared features, TEMPO offers a potentially interesting pathway. You could offer your device within the ACCESS framework while simultaneously building the real-world evidence base you will eventually need for FDA authorization. That is a meaningful opportunity, particularly for companies that have been stuck in the gap between having a working product and having the clinical evidence to support a marketing submission.
If you are running a medical device, digital health, or wearables company, here is how I would think about this landscape:
If you already have FDA-cleared features or devices: Look at whether your product aligns with one of the four ACCESS clinical tracks. If it does, you could either apply to participate directly (building or contracting with a Medicare-enrolled provider entity) or get listed on the Tools Directory to make your product available to ACCESS participants. The May 15 deadline for the first cohort is coming up fast, but rolling applications continue through 2033, meaning you could work this into a commercialization strategy for a future time.
If you are pre-clearance and your device fits the clinical tracks: TEMPO might be worth exploring. The enforcement discretion pathway lets you collect real-world data while your device is actually being used in clinical care, which is a meaningful advantage over traditional clinical trials for building your evidence base. Keep in mind the program is limited to approximately 40 manufacturers total. That said, no one has any clue at the moment how the FDA is evaluating and selecting the up to 40 manufacturers and the lack of a deadline means you should probably be as proactive as possible and try to get a meeting with the FDA for more information STAT.
If you want to replicate what WHOOP did: You could create a physician-led PC structure affiliated with your technology company. This is not simple. You need physicians willing to serve as the clinical leadership, you need to understand the full implications of Medicare enrollment on your business model, and you need to be able to deliver actual clinical care, not just provide a device. WHOOP has the advantage of Mayo Clinic advisors and $575 million in recent funding to build this infrastructure. Most companies will not have those resources. But I see a lot of options for both building and interesting partnerships in the future.
If none of the four clinical tracks fit your device: You wait. ACCESS is a 10-year program with rolling admissions through 2033. CMS could expand the clinical tracks over time. And the fact that commercial payers are already committing to aligned payment approaches suggests that similar outcome-based models could emerge for other conditions.
I am just really happy that CMS and the FDA seem to actually be coordinating on something that could potentially get good medical devices into the hands of people that need them AND push our healthcare system to start figuring out Value Based Care more seriously.
What’s really interesting to me is that the old-school hospital systems are so resistant to taking on the risk that the insurance companies were created for, that they could end up in the dust - while a bunch of Silicon Valley wearable and telehealth upstarts take away a big chunk of their future revenue - if they don’t figure out how to properly harness this. And if they don’t, they’ll be the last one in the patient journey, forced to pay whatever it takes to get the prior step in the funnel to send patients their way. That, or just wait for an ambulance to show up.
And WHOOP, the company that spent the last year fighting with the FDA over whether their blood pressure feature was a medical device, just became a Medicare healthcare provider. The company that got an FDA warning letter is now going to be enrolling Medicare beneficiaries and delivering care supported by their wearable. Say what you will about their regulatory strategy, they are not standing still.
Blythe Karow is a strategic management consultant and founder of The Karow Advisory Group. She writes The Device Files, a Substack publication on MedTech strategy, market access, and commercialization.
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