What happened in health care technology this week, and why it’s important.
A VERY busy news week. Let’s jump in.
Smart Orthopedic Implant to Enhance Bone Growth: Interview with Ben Hertzog, CEO at Intelligent Implants
MedGadget’s Conn Hastings interviews the CEO of Intelligent Implants, a MedTech company based in Cork, Ireland, which has developed a spinal implant intended to enhance bone healing and reduce rates of non-union following spinal fusion surgery. The implant is equipped with electrodes that are designed to enhance bone growth, as well as provide a means of monitoring bone healing. The SmartFuse implant received Breakthrough Device Designation from the FDA in 2021, and Intelligent Implants aims for a first-in-human study soon.
Why it’s important – A significant proportion of spinal fusion surgeries fail, leading to complications including pain and the requirement for corrective procedures. In many cases, spinal fusion fails because of non-union, where the vertebrae do not fuse. The technology may also have potential in other orthopedic applications beyond the spine.
AI gone astray: How subtle shifts in patient data send popular algorithms reeling, undermining patient safety
Casey Ross led an investigation by STAT and the Massachusetts Institute of Technology, which found that subtle shifts in data fed into popular health care algorithms — used to warn caregivers of impending medical crises — can cause their accuracy to plummet over time, raising the prospect AI could do more harm than good in many hospitals.
In a months-long experiment, STAT and MIT traced the performance of algorithms past their early days of peak performance into the grinding years that follow, when the hype has faded, and they must prove their reliability to caregivers. Instead of transforming care, the algorithms withered in the face of fast-moving clinical conditions — unable to keep up with the pace of change.
Chart of the Week – STAT/MIT study found that models that make their predictions on a simpler, more stable set of data points, then, might be less susceptible to that kind of data shift.
Why it’s important – This study exposes gaping holes in the governance of products whose slow deterioration in hospitals around the country threatens to mislead doctors and undermine patient safety. The initial signs of dysfunction are often faint, making it difficult to root out incorrect information before it bleeds into decision-making. While selling AI tools to hospitals has become a lucrative and fast-growing business for digital health companies, there is little to no oversight once they hit the market. The experiment’s results speak to the perils of mistaking the buzz around new technology for a medical breakthrough.
Infographic of the week – From an excellent report on telehealth usage from Trilliant Health released in February, 2022. Majority of telehealth patients had between one and four visits between 2020 and 2021.
A Spinal Cord Implant Allowed Paralyzed People to Walk in Just One Day
Singularity Hub’s Shelly Fan reported on a new implant developed by the Swiss Federal Institute of Technology in Lausanne (EPFL) that bridges signals from the brain to the lower muscles, hopping over damaged portions to restore movement. All it took was one day of stimulation. The implant is the first to precisely mimic electrical signals from the brain to control lower body movement.
Unlike previous spinal cord stimulators, the implanted electrodes are placed directly onto the spinal cord, allowing access to different neurons that control lower body muscle groups. With the help of a tablet, the implants can be adjusted to support a given activity—stand, walk, swim, bike—letting people stimulate their spinal cord neurons like keys on a piano.
Why it’s important – In spinal cord injuries, the telephone lines between the brain and muscle groups are severed, blocking data flow. Without intact nerves, muscles lack the guidance to translate movement intention into actual coordinated muscle contractions. The injury also destroys sensation, resulting in paralysis that’s usually irreversible. But the neural infrastructure below the damaged area generally remains intact. By artificially stimulating these nerve cells, it may be possible to recreate the electrical signals that govern our muscles. The results, though fascinating, remain preliminary. The team is already planning the next steps, for example, allowing people to control the implant from a smartwatch or phone directly. Because diverse motor programs depend on different stimulation algorithms, the team is also tapping AI and cloud-based computing to develop additional stimulation “recipes.”
FDA approves second CAR-T cancer therapy to treat multiple myeloma, opening the door for greater access
STAT reporter Angus Chen posted this story on the approval of this treatment, called cilta-cel and developed by Janssen and Legend Biotech, which involves taking immune cells from a patient’s own body and engineering them in a lab to fight a patient’s cancer. Since the first such treatment for multiple myeloma was approved last year, manufacturing challenges have severely hamstrung supply — leaving eligible patients waiting for weeks or months to receive the engineered cells. Industry-wide shortages of this modified virus have slowed down the production of the Bristol Myers Squibb treatment, called ide-cel.
Why it’s important – Experts said cilta-cel should increase the availability of CAR-T therapy for multiple myeloma patients, Usmani said, even though shortages of the modified virus will also affect cilta-cel production. In recent follow-up data from cilta-cel’s clinical trials, which tested cilta-cel in patients who had already gone through several other lines of treatment, Janssen showed a near-universal response rate. In many of those patients, there was no detectable trace of cancer after treatment. It’s too soon to say if that will be the case for multiple myeloma patients receiving CAR-T therapy, either cilta-cel or Bristol Myers Squibb’s ide-cel.
3D BioPrinting Skin: Guide
This blog post written by Dr. Jenny Chen on the 3DHeals site is a comprehensive look at the current status of 3D printing of skin tissue. She covers the past, current status, and future of skin bioprinting based on their recent virtual event on the subject manner.
Why it’s important – Some of the well-known benefits of 3D printing technology include automation, the ability to create reproducible complex structures previously thought impossible, personalization, decentralized manufacturing process, and many other intrinsic advantages of being part of a controllable digital manufacturing process. The complex but layered organization of skin is perhaps another reason scientists chose 3D printing in research in skin tissue engineering. Of all the organs the scientific community set out to regenerate, the skin remains the least technically challenging organ to reproduce or bioprinting,
This is by far the most comprehensive look at the topic, and the work that Dr. Chen has done in the field is outstanding. If you are interested in the subject of 3D printing in health care, this is the site to follow.
CVS files to trademark its pharmacy and health clinics in the metaverse
CNBC’s Bertha Coombs filed this report on CVS plans to be the first pharmacy in the metaverse. The drugstore and health services company filed for a trademark to sell virtual goods, NFTs, and provide health care services, joining major retailers like Walmart and Nike. In the filing, the company points to providing nutrition and wellness coaching, “namely, non-emergency medical treatments services, wellness programs, advisory services related to nutrition, providing health lifestyle and nutrition services… and counseling.”
Why it’s important – Another company jumps onto the metaverse bandwagon. I’ve written before on the topic and still believe that it’s more hype than reality. Using the Gartner Hype Cycle model, it’s right at the top of the peak of inflated expectations. CVS may feel that this “first-mover” play gives them a leg up competitively, but I’m not buying that yet.
Robotic pill can orally deliver large doses of biologic drugs
NIBIB-funded researchers are developing a robotic pill that, after swallowing, can deliver biologic drugs into the stomach, which could potentially revolutionize the way that certain conditions are treated. Their research was reported on the NIH website this past week. In their study, reported in Nature Biotechnology, the authors loaded their robotic pills with one of four biologic drugs—insulin; a glucagon-like peptide 1 (GLP-1) analog (also used for the management of diabetes); adalimumab (brand name Humira®, an immunosuppressive drug used for a variety of conditions, including arthritis and Crohn’s disease); or epinephrine (for the emergency treatment of allergic reactions or asthma attacks).
Why it’s important – Though still in the pre-clinical phase of development, an oral pill for the delivery of biologic drugs would not only positively impact those patients who already use injectable medications but could also benefit patients that are currently delaying their use. This preclinical research is an important step toward developing such an approach.
Digital Therapeutics Should Be Regulated With Gold-Standard Evidence
This excellent article in Health Affairs proposes a mechanism for FDA regulation of digital therapeutics (DTx). The central problem is that there continues to be significant confusion, amongst both clinicians and payers, about what constitutes a digital therapeutic versus a wellness app. Consequently, there is a pressing need to firmly establish standards of evidence generation that differentiate DTx as treatments from products that may support mental well-being but lack the potential of DTx to transform the mental health treatment landscape. The differentiation of a DTx app from a well-being app reflects a crucial but substantially generic challenge in mitigating clinical risk. Fortunately, we already know how to safeguard patients from potential treatment-related harm and ineffective interventions: gold-standard evidence. The authors propose using the “WHAT” criteria as shown in the table below:
Why it’s important – Payers and clinicians need to have confidence that they can quickly identify genuine DTx and select those worth adopting and integrating into services. The true potential of DTx is to provide patients and clinicians with immediate choice at the population scale of evidence-based treatments according to their needs and preference. The proposed framework and criteria can be used as a template for DTx companies and payers, and clinicians to readily establish the credentials of DTx products.
Big Tech companies are harming – not helping – healthcare
Kyle Sylvestro in MedCity News comes out strong in criticizing big tech companies for some of their failed efforts to “fix” health care. His claim: “they have often been hailed as the saviors that could free the nation from the problems of our dysfunctional, inefficient and archaic healthcare system. The reality is that these organizations continue to fail in their initiatives, ultimately stifling true healthcare innovation.” And he cites the usual examples like IBM Watson, Google Health, and Haven as proof points for his argument. His conclusion: “One consistent theme that runs through all of these missteps is that Big Tech constantly underestimates the problem that healthcare has with “dirty data.”
Why it’s important – While I don’t disagree with his “dirty data” statement, I’m not ready to condemn big tech for trying to solve some of the significant problems in U.S. health care. I’ve written before on my opinions on why big tech can’t seem to crack the health care code. But, we all know that change in health care happens at a glacial pace. Big tech’s impact on data handling, data mining, machine learning and AI are helping health care providers advance research, reimagine care delivery, streamline operations, reduce costs, and support frontline staff. What they’ve learned from the significant failures cited in the article has enabled them to partner with the “experienced experts who know and understand the industry” Mr. Sylvestro notes in his writing to significantly accelerate the use of data at the point of care.