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Two key points:
Predictive AI are only useful if they are correlated real outcomes in Orthopedics.
Predictive AI will require at least 10,000 cases in the datasets, and 100,000 is a home run.

A medical exam yields, at first, an educated guess.
Take a patient whose X-ray shows signs of Covid pneumonia, for instance—a radiologist might flag that possibility for the attending physician. Now imagine that X-ray goes on to be used as a training tool to help with future diagnoses for other patients. Without additional data—like a Covid lab-test result, a genomic sequence, or a down-the-line update on how that patient ultimately fared—the X-ray is of limited use. Since it’s not tied to an outcome, it doesn’t offer a complete picture. There’s no way to know if the identified signals actually correspond to Covid pneumonia.Nightingale Open Science, a new research resource, wants to make those educated guesses smarter by making high-quality, outcomes-based datasets widely available for researchers building AI tools for health care.
The group allows anyone conducting nonprofit research to access 40 terabytes of medical data for free—a resource that could shed light on medical mysteries and promote earlier diagnoses of high-risk conditions. Nightingale’s records span persistent medical issues, like sudden cardiac death, cancer metastasis, and maternal mortality, and have been collected from patients in the US and Taiwan before being vetted and de-identified. Currently, most similar datasets are kept for internal use only in medical institutions or at tech companies developing health products, Obermeyer said.
“A particular strength of [this] data collection at this scale—in terms of volume but also in terms of time—is that it has a bird’s-eye view of what happened to the patients,” Dr. Howard Chen, chief imaging informatics officer at Cleveland Clinic, which is not involved with Nightingale, told us. He added, “You’re using a historical record, and then going back to use that historical record as the future of the scan. So I know what really happened to the patient.”
The nonprofit debuted in December with $6 million in funding with Schmidt Futures, former Google CEO Eric Schmidt’s philanthropic organization, as a key backer. Its founders, Ziad Obermeyer and Sendhil Mullainathan, are both professors and researchers specializing in machine learning and medicine.
“Several hundreds” of researchers have already signed up for access, according to Nightingale, from institutions like Berkeley, MIT, Stanford, Cornell, and the University of Chicago. Classrooms at MIT and Berkeley also started using the resource this semester for educational purposes. Google has also expressed interest in the dataset, Obermeyer said, but the company told us it “is not ready to comment on specifics for a potential partnership with Nightingale.” For-profit use is forbidden under Nightingale’s terms of use.
New frontier
For health care researchers, the current landscape of medical data can be described in one word: siloed.
Most of the time, the pre-vetted, high-quality data is either owned by medical institutions—which largely limit data access to their own researchers—or bought up by big tech companies, which can pay a premium for data to inform product development and other projects. That can make research tough for anyone in the middle, like PhD students, junior faculty members, and medtech startups.“When I do my own research projects, I just spend a ton of time that I should be spending on research negotiating for access to data—and there are so many frictions, like getting either myself into the hospital system to access the data or getting the data out, it’s like a multi-year process,” Obermeyer told us, noting that his affiliations with legacy institutions give him a leg up over many others’ requests. He added, “On a high level, there’s a whole field of study, there’s a ton of products that are just not happening because the data are so hard to access.”
That was a key driver behind Nightingale, which also tries to help fill in notorious gaps in available medical datasets, like what ultimately happened to a patient.
The project does this via linkages, which are conducted just before the data is de-identified. When Nightingale partners with a health institution, like a hospital or health system, it’s given access to raw patient data inside the partner’s records infrastructure. Nightingale processes the linkages then and there to chart a health progression, merging everything from e-health records (like lab information, vital signs, height, and weight), to cancer registry information, to Social Security data (to see if and when a patient passed away).
The linkages can “help researchers triangulate what actually happened to the patient” despite discrepancies that could interfere with data collection, like physician bias, Obermeyer said. For instance, while a doctor in one country may cite “old age” as a cause of death, a doctor in another may cite “sudden cardiac death” for the same case.
From there, Nightingale runs point on de-identifying the data, using HIPAA Safe Harbor criteria and removing patient names, Social Security numbers, and all other protected categories of identifiers. The partner health organization—or a third-party the partner enlists—then works with Nightingale to de-identify medical records,  before data is moved onto Nightingale’s cloud platform. There, researchers of all kinds can access the data as long as they’ve been verified as conducting nonprofit research and signed a data use agreement.
Approved researchers aren’t required to share their plans for the data, but Nightingale says it takes additional steps to secure it, including keeping anyone from downloading, removing, or exporting data or models, and keeping track of what researchers do. “When you’re on the platform, you’re doing research in a surveillance state, where every line of code that you write is being stored and looked at and can be audited,” Obermeyer added.
But still, under the right circumstances, Chen told us it could be possible for virtually any anonymized data to be re-identified.
“One thing I worry [about] is the potential re-identification of the patient as you accumulate enough complexity and enough volume of data,” he said.
“Every time there’s data sharing occurring, there’s always that question: ‘Where is the patient in this entire conversation?’” Chen said. “Does the patient have the right to say, ‘I don’t want my data shared [with] any initiative—I understand it’s helpful to people, but that’s a picture of my body, and this is what I want being done or not being done to a picture of my body.’”
UK Biobank, a similar biomedical research database with data from more than half a million UK participants, had to get explicit consent from everyone included.
Obermeyer calls data privacy the project’s “biggest risk” and says the team is “very, very in tune to it.” Besides the data use agreement, the on-platform precautions, and HIPAA guidelines for patient privacy, Nightingale also opts to only upload data relevant to the individual medical problems, rather than a full data dump.
For its part, Nightingale does not ask patients point-blank if they’d like to be included—it goes through the hospital—but since the data has been de-identified, Obermeyer said they don’t need to. “It’s all HIPAA compliant.”
“Given that we’ve got hundreds of thousands of patients, it would be impossible to do anything that we’re doing if we needed to go back and individually ask every person for consent,” Obermeyer said. He added, “There’s, of course, the deeper question of, ‘Man, is this the right thing to do?’”
But the project’s basic guiding principles are similar to those used in other research, Obermeyer said: “Never compromise patient privacy,” “never do any harm to patients,” and data should be used for purposes that are “broadly in patients’ best interests.” He added that if anyone were to use data for anything other than nonprofit research—research conducted with the goal of publishing for the medical community—it would be grounds to kick them off the platform.
“It doesn’t mean that nobody from a for-profit company can access the data, but that they have to be doing nonprofit research,” Obermeyer said. “This is not about making products. This is purely about creating knowledge.”
Looking ahead…
Dr. Alan Karthikesalingam, a clinician research lead on Google’s Health AI team, told us Nightingale could help enable better comparison of healthcare AI systems.
“The nice thing about initiatives like the Nightingale Initiative, and there’s a few others that are really noteworthy…is that they provide a kind of scientifically rigorous benchmark that then multiple researchers, AI developers, even medical device manufacturers can potentially use…[which] then makes it possible to fairly and rigorously compare the properties, like compare the performance of AI systems, in a consistent way,” Karthikesalingam said.
Chen’s biggest hope for Nightingale: Allowing the tool to “cut through the hype of AI in medicine.” He added, “Without the relevant data, without people asking the right questions of the data, it’s really hard to think of AI in medicine as a problem-solving tool, something that actually can be used in practice.”
He thinks this project could change that, by taking advantage of machine learning algorithms’ aptitude for picking up on patterns and connections that humans may not see.
“Algorithms are very good at approximating something,” Chen said. “If you make [an algorithm] approximate the human judgment, it’s always going to chase behind the human judgment—and get really, really close, but…It’s always going to be inferior, never meeting or exceeding the human challenge. But if you train it on the future—which the human doesn’t have access to, but an algorithm can…then it can potentially start picking up some details that we never knew existed in the first place.”———————————————–The workflow doctor will see you now. 
A seamless digital experience is what patients have come to expect these days. Contactless scheduling and paperwork, virtual payments, and online sign-in are all processes and workflows Formstack can help you streamline. Don’t let your patients’ patience wear thin—learn more about Formstack today.

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CEO LEADERSHIP SERIES: HOW FLEXIBILITY AND TRANSPARENCY GOT THIS STARTUP THROUGH TOUGH TIMES (Ashton Tweed)

Falling and breaking a hip is a perpetual fear for older people and their families. A hip fracture can result in the loss of mobility and independence and lead to complications that can be fatal. Wamis Singhatat wants to prevent hip fractures from happening in the first place.
Mr. Singhatat is the CEO of ActiveProtective Technologies Inc., a start-up company based in Fort Washington, Pa., that is developing a wearable device to protect the hips of older adults in the event of a fall. Called Tango Belt, the device combines a wearable inflatable airbag with smart technology that monitors behavior and alerts caregivers to reduce traumatic injuries.
In 2019, Tango Belt received the kind of attention founders dream about when the product won the Extreme Tech Challenge, a global competition for startups sponsored by billionaire entrepreneur Richard Branson. But then the COVID-19 pandemic derailed ActiveProtective’s plans to pilot the device in skilled nursing facilities.
Mr. Singhatat was appointed interim CEO in October 2020 and CEO a year later. In an interview with Ashton Tweed, he explains how he addressed ActiveProtective’s desperate need for cash and his team’s need to know how the company was really doing:
Ashton Tweed: First of all, what is ActiveProtective’s mission?
Wamis Singhatat: We want to become the standard of care for high fall-risk older adults. Falls in the older adult population are the No. 1 cause of fatal injuries in the U.S. If you’re over 65 and fall and break your hip, it can cause a devastating downward spiral where there is a 30% mortality rate a year after the hip fracture.
If you are fortunate enough to be in the 70% that survive, the functional outcomes and the ability to live independently are hugely impacted. So, a lot of folks who survive never regain their previous mobility. They lose their ability to live independently and have to move into senior care settings.
The standard of care that has been widely adopted—developed by the American Geriatric Society in collaboration with the British Geriatric Society and the Centers for Disease Control and Prevention—is really good at identifying those who are at risk of falling, but it has shown no impact on the rate of fall injuries.
So, something has to change. We know who’s going to fall; we need to protect those fallers. The difference in ActiveProtective’s approach is to intervene in the eventuality of a fall with the means to protect the individual.
AT: You joined ActiveProtective in 2015. What initially drew you to the company?
WS: I’ve been in medical device product development for 22 years now, primarily in orthopedics. My last role was at Johnson & Johnson in their orthopedics group, where I had portfolio responsibilities for knee and periprosthetic fractures.
Part of my portfolio responsibilities was scouting for new technologies, and I came across the novel concept of ActiveProtective. My group was in the business of fixing broken bones, whereas this concept was in the business of preventing broken bones, but there was also a potential post-operative rehab angle.
So I reached out to the CEO and co-founder, Drew Lakatos, to learn more about the concept. Two things struck me. The first was how absolute early-stage the company was—it was essentially just the concept, a napkin sketch at the time. The second was how relevant the unmet need they were addressing was and how impactful that unmet need can be.
The more I learned about the company, the more I realized that I had to have the opportunity to help. And so, I did the unthinkable. I left J&J—arguably the largest company on the planet—to join arguably the smallest healthcare company on the planet as the CEO’s first hire. So it was just a two-man show in the beginning.
AT: What did your colleagues think about your decision?
WS: People looked at me like I had three heads. (He laughs.) No, seriously. J&J is a great company, and I say that in complete sincerity. When people get into J&J—and it has approximately 200 operating companies—they pretty much never leave. So, to leave and join an early-stage startup was, at the time, just insane. (He laughs.) And I can say that knowing I was the insane one. But it was worth it. I thought it was a huge opportunity and a problem I could help solve.
AT: What positions did you hold at ActiveProtective before becoming CEO?
WS: I started as the Vice President of Product Development to take the device from the concept stage to a workable prototype that we could use to generate the evidence we needed to raise the next round of funding. In July 2017, we shipped our first prototype to skilled nursing and assisted living facilities. Then I became Chief Technology Officer, and I focused on vetting and refining the technology.
AT: How did COVID-19 affect ActiveProtective’s business plans?  WS: We had a rough bout during the pandemic. At the end of 2019, we launched the commercial version of the product in skilled nursing facilities. We were having good traction with one of the largest skilled nursing providers and started to discuss expanding into multiple sites when the pandemic hit. As you probably know, the pandemic hit skilled nursing harder than any other corner of society.
The pandemic pulled the rug out from under us overnight, and we really had to do a lot of soul-searching to figure out where we were going to go as a company and where we were going to go as an executive management team that was trying to raise the next round. We were trying to raise a round of growth capital, and now we couldn’t grow the company anymore.
The board decided to reconfigure the executive team. I became interim CEO in October 2020 to target a whole new set of investors and try to live to fight another day, so to speak.
AT: What has been your biggest challenge as CEO?
WS: I had two major challenges. The first one was to raise the next round of funding to keep the company going. The second one was to rally the troops, so to speak, who had seen our inability to raise money amidst the pandemic and to convince the team to hang in there because there was still a good possibility that we could make it out.
AT: How dire was the financial situation?
WS: We had just a few months of runway—I could count them on one hand. It was truly do or die in late 2020. We had to raise the next round of funding or close up shop. Fortunately, after a few months of calling every single soul I knew, I was able to get a couple of term sheets on the table, and with a pretty rigorous due diligence process that lasted for a lot of 2021, I was able to close the structure deal with one of those term sheets.
AT: At the same time, you also had to keep everyone’s spirits up at the company. How did you do that?
WS: We have a culture of transparency at ActiveProtective. I’ve always operated by the Golden Rule—do unto others how you want done to you. And I remember being in the corporate environment at J&J and various other companies in all-hands-on-deck meetings where you just knew the executive team wasn’t telling you the whole story. It would be sugar-coated or just a partial truth. That got me frustrated, and I swore I wouldn’t be that type of executive.
The way I see it, everyone who joined this little tiny, fragile startup has a right to know the status of the company. So, we were very candid about both our runway and our effort to try to raise the next round— what investors we were talking to, what feedback we were getting, where we got some traction, where we got a hard no. We were very, very transparent with our employees, and everyone really appreciated that I think.
At the end of the day, everyone is in this company because of the mission. It sounds really cliché, but it’s true. We are all in a little boat rowing towards the goal of getting a product out to market to address the devastating condition of fall-related hip fractures. The reality is if you’re not actually trying to solve a very meaningful problem, then it can get hard trudging through the mud.
AT: ActiveProtective is taking Tango Belt in a new direction. How are you positioning the product moving forward?
WS: The product we brought to market commercially in late 2019 was a consumer product, a personal safety product similar to a Life Alert-type product. I can’t share the details, but I can say that we closed a deal with a large strategic healthcare partner, and we are now going down the medical device pathway.
As a medical device, our product now falls under a certain class of products that require a clinical trial. So, we’re conducting a clinical trial to generate safety and efficacy data to submit to the Food and Drug Administration to get market authorization. Then it’s off to the races with commercialization as a prescription-only medical device.
AT: Do you have any advice about how to stay resilient and flexible in situations that are beyond your control, like the pandemic?
WS: Try not to take anything for granted. We try not to let dogma set in, which is easy to do in the corporate environment. If you just accept foundational assumptions as truth, you’re essentially operating with blinders on. So, we’re always trying to use data and make data-driven decisions because, at the end of the day, data is still king. We believe continually checking our assumptions and making data-driven decisions will lead us in the right direction.

Bio
Wamis Singhatat previously held numerous positions at DePuy Synthes Cos. of Johnson & Johnson, including Worldwide Group Product Director, Knee and Periprosthetic Fractures; Worldwide Group Product Director, Strategic Marketing; and Global Market Segment Manager, Soft Tissue Solutions. He also served as an Applied R&D Engineer at ConMed Linvatec. Mr. Singhatat earned a master’s degree in Biomedical Engineering from the University of California, Davis, and a bachelor’s degree in Mechanical Engineering from The University of Akron in Ohio.
Mr. Singhatat is married to his high school sweetheart, and the couple has a son, 18, and a daughter, 16. The family lives in Malvern, Pa. His hobbies include golf, snowboarding, and playing in a band.

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In early May, I raised the alarm that the public companies that are not yet profitable will been punished.
Well it happened. Look at the decline in stock prices from May to Nov 2022.

This is not a statement on their businesses. It is purely a statement on the cost of capital. The cost of capital has ballooned. The IPO market is closed. Present cash is valued much higher than future cash.

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Not likely, but it’s a worthwhile thought experiment. This thought experiment highlights why most orthopedic companies are not remarkable, but just “ordinary”.
We can take an educated guess of how Elon would approach a new orthopedic startup. So far, Elon’s approach and strategy has been transparent in Telsa, SpaceX, StarLink, Solar City, and Neuralink.

10X
Elon would set out to create a 10 times better product or service.
He might ask:

How can we 10X the surgical experience?orHow can we 10X the patient’s outcome?

Most ortho companies are making improvements that are 0.1 X better (or 10% better). These are incremental changes that do not transform orthopedic medicine.
The “dirty little secret” about thriving for 10X better product or service is that it only takes 2-3X the effort, not 10 X the effort.

1st Principles Approach
Elon would take a first principles approach to the problem or goal. In other words, he would totally forget what orthopedic products are on the market right now.
Elon historically has taken a 3-step approach to any new challenge.

Identify the problem first. Do not look for a solution until you have fully understood your problems.
Break the problem down to the core fundamentals.
Welcome transformational ideas. Unlike commonplace ideas and industry patterns, first principles thinking offers you a new manner to approach a problem.

Cheerleader with a Hammer
Elon would rule the company with extreme expertise and a hammer. He would ruthlessly pursue the vision.
There are no committee decisions in an Elon company, no decisions by process, no checking in with stakeholders, no groupthink. The organization would be very flat.
Elon’s fast and decisive decision making creates speed and clarity.

Fight Bloat
Elon would fight bloat in the company. No meetings. No unnecessary processes. Streamlining. Efficiency. Simplify. Focus. Remove barriers. “The best part is no part.”
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