“The FDA created the Medical Device Development Tools (MDDT) program to reduce uncertainty in device development.…Through MDDT, the FDA has created a portfolio of qualified tools that sponsors know the agency will accept without needing to reconfirm their suitability for use in a study.”
And now the Apple Watch is one of those qualified tools.
“Apple applied to get its AFib history feature qualified as a MDDT in December (2023). It is the first digital health technology qualified under the program.”
The advantage of using an Apple Watch to gather this data?
“Officials said the wearable can help address the challenges ‘by allowing for passive, opportunistic AFib burden estimation in a wearable form that is already familiar to Apple Watch users.’”
Medical measurements are often skewed by stress from the health experience itself. But if you’re already wearing an Apple Watch, and you always wear an Apple Watch, the passive nature of AFib data collection means you don’t even know you’re being measured.
He had purchased a feature-rich home security system and received an alarm while he was traveling. That’s all—an alarm, with no context.
“The security company then asked me, ‘Should we dispatch the police?’ At that moment, the reality hit: I was expected to make a decision that could impact my family’s safety, and I had no information to base that decision on. It was a gut-wrenching experience. The very reason I invested in security—peace of mind—had failed me.”
On Threads, Dr. Jen Gunter called our attention to the newly-introduced H.R. 238, “To amend the Federal Food, Drug, and Cosmetic Act to clarify that artificial intelligence and machine learning technologies can qualify as a practitioner eligible to prescribe drugs if authorized by the State involved and approved, cleared, or authorized by the Food and Drug Administration, and for other purposes.”
Presumably these non-person entities would not be your run-of-the-mill consumer generative AI packages, by rather specially trained Large Medical Models (LMMs).
Even so, don’t count on this becoming law in the next two years. For one, Rep. David Schweikert introduced a similar bill in 2023 which never made it out of committee.
““How do I make sure we’re embracing technology and using it to bring disruptive cures to market, or other opportunities to market?” Schweikert asked. “And does that also now help lower drug pricing?””
Before you reject this idea entirely, Rep. Schweikert cited one example of technology decision-making:
“Schweikert noted that the FDA last month approved Apple Watch’s atrial fibrillation feature for use in clinical trials — the first such digital health tool approved for inclusion in the agency’s Medical Device Development Tools program.”
But before anything like this will ever happen with prescriptions, the FDA will insist on extremely rigorous testing, including double-blind tests in which some prescriptions are written by currently-authorized medical professionals, while other prescriptions are written by LMMs.
And even when the ethical questions surrounding this are overcome, this won’t happen overnight.
From the early 1990s to 2019, the majority of my identity/biometric proposal work was with U.S. state and local agencies, with some work with foreign agencies (such as Canada’s RCMP), private entities, and a few proposals to U.S. federal agencies.
I had no idea what was going to happen in 2020, and one of the surprises is that the majority of my identity/biometric proposal work since 2020 has been with U.S. federal agencies. Many requests for information (RFIs) as well as other responses.
The L & N, not M, but close enough for government work.
I’ve worked on client proposals (and Bredemarket’s own responses) to the Departments of Defense, Homeland Security, Justice, and perhaps some others along the way.
And no, there’s no uniformity
Same department, different requirements.
Coincidentally, the two most recent identity/biometric proposals I managed for Bredemarket clients went to the same government department. But that’s where the similarities ended.
The first required an e-mail submission of a PDF (10 pages maximum) to two email addresses. A relative piece of cake.
Mmm…cake. Always reward your proposal people.
The last required an online submission. No, not a simple upload of a PDF to a government website. While my client did have to upload 2 PDFs, the majority of the submission required my client to complete a bunch of online screens.
And there were two separate sets of instructions regarding how to complete these online screens…which contradicted each other. So I had to ask a clarification question…and you know how THAT can go.
Oh, and as the consulting proposal expert, I could not complete the online screens on behalf of the client. The client’s company had a single login, which was assigned to a single person (a company executive) and could NOT be used by anybody else.
So on the day of proposal submission the executive and I videoconferenced, and I watched as the executive answered the responses, in part using a document in which I had drafted responses.
And of course things were not perfect. The executive pasted one of my responses into the space provided, and only THEN did we discover that the response had an unadvertised character limit. So I rewrote it…at the same time that I resized a required image with unadvertised dimension restrictions.
But there’s some uniformity
Perhaps if I had written more federal proposals at Printrak, Motorola, MorphoTrak, IDEMIA, and Incode, I would have known these things. Perhaps not; as late as 2014 I was still printing proposals on paper and submitting 10 or more volumes of binders (yes, binders) along with CDs that had to be virus-checked.
Some Requests for Proposal (RFPs) provide helpful checklists.
But regardless of whether you submit proposals online, via CD, or in paper volumes, some things remain constant.
Follow the instructions.
Answer the questions.
Emphasize the benefits.
And don’t misspell the name of the Contracting Officer.
“So depending upon your needs, you can argue that”
This frame was followed by three differing answers to the “Where is ByteDance From?” question.
But isn’t there only one answer to the question? How can there be three?
It all depends upon your needs.
Who is the best age estimation vendor?
I shared an illustrative example of this last year. When the National Institute of Standards and Technology (NIST) tested its first six age estimation algorithms, it published the results for everyone to see.
“Because NIST conducts so many different tests, a vendor can turn to any single test in which it placed first and declare it is the best vendor.
“So depending upon the test, the best age estimation vendor (based upon accuracy and or resource usage) may be Dermalog, or Incode, or ROC (formerly Rank One Computing), or Unissey, or Yoti. Just look for that “(1)” superscript….
“Out of the 6 vendors, 5 are the best. And if you massage the data enough you can probably argue that Neurotechnology is the best also.
“So if I were writing for one of these vendors, I’d argue that the vendor placed first in Subtest X, Subtest X is obviously the most important one in the entire test, and all the other ones are meaningless.”
Are you the best? Only if I’m writing for you
I will let you in on a little secret.
When I wrote things for IDEMIA, I always said that IDEMIA was the best.
When I wrote things for Incode, I always said that Incode was the best.
And when I write things for each of my Bredemarket clients, I always say that my client is the best.
I recently had to remind a prospect of this fact. This particular prospect has a very strong differentiator from its competitors. When the prospect asked for past writing samples, I included this caveat:
“I have never written about (TOPIC 1) or (TOPIC 2) from (PROSPECT’S) perspective, but here are some examples of my writing on both topics.”
I then shared four writing samples, including something I wrote for my former employer Incode about two years ago. I did this knowing that my prospect would disagree with my assertions that Incode’s product is so great…and greater than the prospect’s product.
If this loses me the business, I can accept that. Anyone with any product marketing experience in the identity industry is guaranteed to have said SOMETHING offensive to most of the 80+ companies in the industry.
How do I write for YOU?
But let’s say that you’re an identity firm and you decide to contract with Bredemarket anyway, even though I’ve said nice things about your competitors in the past.
How do we work together to ensure that I say nice things about you?
By the time we’re done, we have hopefully painted a hero picture of your company, describing why you are the preferred solution for your customers—better than IDEMIA, Incode, or anyone else.
(Unless of course IDEMIA or Incode contracts with Bredemarket, in which case I will edit the sentence above just a bit.)
So let’s talk
If you would like to work with Bredemarket for differentiated content, proposal, or analysis work, book a free meeting on my “CPA” page.
If your humor has evolved to a point where the very idea of an IPVM account on TikTok amuses you—and if my use of the word “evolved” amuses you further—then perhaps Bredemarket offers the background and experience to help you convey your
I am VERY familiar with questions regarding the nationality of a company. There are three questions:
Where is it incorporated?
Where is it headquartered?
Who owns it?
IDEMIA
For my former employer IDEMIA, the answers are France, France, and primarily a U.S. investor (Advent International).
(So depending upon your needs, you can argue that IDEMIA is a French company or a U.S. company.)
ByteDance
For ByteDance, the answers are the Cayman Islands, China (Beijing), and primarily global investors (Blackrock, General Atlantic, Susquehanna International Group, etc.).
(So depending upon your needs, you can argue that ByteDance is a Chinese company, a mostly American company, or a British company off the coast of Cuba.)
Your company
Not that I create TikTok videos (at least not for paying clients), but I provide other services.
More information on Bredemarket’s Content-Proposal-Analysis marketing and writing services:
Bredemarket 