2024s Memorable Medtech Moments
While certain government changes and all they might mean have flooded the headlines in the last month, 2024 has been a year of changes in the medical device industry that have been a long time coming. These were five 2024 moments that caught my attention.
1. No doctor, no diagnosis, no problem
Dexcom began selling the first over the counter (no prescription) continuous glucose meter in August of this year. Its sheer simplicity — vital for a blood testing product used exclusively by untrained patients — is stunning. What is not obvious from the product itself is the generation long journey, with countless pivots through different technologies, complex commercial navigation, regulatory revisions, and more, to get to what is technically little more than a Band-Aid with a microchip. While it’s $100/month price tag may be off setting, this is an early launch price that will likely drop rapidly within the next five years as operations are optimized and generics appear.
While the tiny electrode slipped under the skin is miniscule in scale, the jump to cross the skin barrier in a non-prescription, continuous use product is huge in terms of regulatory oversight and risk mitigation, not to mention public consciousness. That barrier has driven the obsessive investment in non-invasive digital biomarkers in the hope of discovering sensor combinations capable of delivering blood sample accuracy with no blood. Dexcom’s approach of minimizing the sensor element and just doing the work necessary to de-risk and normalize it for consumers is a path most consumer tech has not been willing to take. Now that Dexcom has done the work, however, the company will likely reap the reward as fully non-invasive wearables line up to partner. Dexcom has already announced a partnership with Oura ring, with a $75 million investment to expand their work in the consumer health space.
2. DIY testing keeps getting better
This year saw a series of approvals for self-collection and home tests with the potential to replace the need for clinic procedures. These include HPV self-collection, colorectal cancer screenings, and sleep apnea monitoring.
HPV is a common cancer-causing virus responsible for 95% of cervical cancers that the CDC recommends screening for every three to five years. Unfortunately, half the patients diagnosed with cervical cancer have never been screened or have only been screened infrequently. Roche’s human papillomavirus (HPV) self-collection solution was co-developed with the National Cancer Institute (NCI), part of the National Institutes of Health (NIH), in the Cervical Cancer “Last Mile” Initiative. While the current indication allows a patient to self-collect via a sampling swab without a pelvic exam, it still requires an in-clinic visit. However, this is likely just the first step to develop evidence needed for the jump to a fully at-home, unobserved collection product in the next several years.
Colon cancer screening carries similar cultural and comfort challenges. While we have had home-based stool sample testing for colon cancer for several years, existing technologies have had a high false positive rate. Exact Sciences’ Cologuard Plus, available in 2025, has a sensitivity of 95% for colorectal cancer and 94% specificity with no findings on colonoscopy. Zero prep and no need to leave the house.
Six million individuals are diagnosed with sleep apnea every year, although the actual prevalence is estimated to be closer to 30 million. Diagnosis has traditionally required over-night stays at clinical facilities filled with complex monitoring equipment, observed and studied by trained technicians. While home sleep study devices have emerged over the last several years, the SANSA home sleep apnea test is the first single point patch worn on the chest, with no wires or connectors. By reducing all collection to a single device through their proprietary AI algorithms, SANSA is following Dexcom is terms of extreme simplification to enable patient directed testing.
3. Stimulating instead of medicating
Sorry, Elon Musk, tiny, high tech blue tooth enabled implants are not only already here, but 2024 was a record year for approvals for Class III implantable stimulation devices. Axonics won a CE mark for its 4th-gen rechargeable sacral neuromodulation system, providing therapy for patients suffering from overactive bladders or fecal incontinence. It’s smaller than a match box, needs recharging only once or twice a year and can stay in the body for 20 years. Axonics is closing in on being acquired by Boston Scientific, which also received additional 2024 pre-market authorizations for its Vercise Deep Brain and WaterWriter Spinal Cord Stimulators. Abbott received new authorizations for three different products (Eterna, Liberta, and Brio), along with Medtronic (Activa, Percept, Inceptiv).
Implantable pulse generators have moved from cardiac pacing to stimulating various nerve functions — to treat motion disorders and pain, to modifying brain chemistry — providing treatments for mental health disorders, and bone health. This year’s small company approvals included multiple indications for post spinal fusion surgery: Theragen’s ActaStim-S, the Xstim Spine Fusion Stimulator, and EBI’s SpF Implantable Spinal Fusion Stimulators, as well as fractures with AccelStim.
All these indications are potential major disruptions to our sister industry in pharmaceuticals. Unlike the highly specific chemical compounds that require years of trial and error to develop, modern stim devices are using whole existing technology platforms and innovating only the dosing and anatomy involved. Stimulators are non-addictive, have minimal off-target effects, and are well tolerated by patients. Even the prospect of minor surgery is being minimalized as devices are miniaturized and even converted to surface electrode applications.
4. FDA’s changing of the guard
Dr. Jeffey Shuren, the outgoing director for the Center for Devices and Radiological Health (CDRH), was the longest running director of the agency in its history. His tenure spanned three wildly different presidencies in a position that generally only lasted a handful of years. Between launching the Digital Health Center of Excellence, the Breakthrough Devices program, and the Total Product Life Cycle Advisory Program, he was responsible for pushing the agency to evolve and meet the needs of rapidly changing health technology in the last two decades. Dr. Michelle Tarver was appointed as the acting director in July of this year, then confirmed as the new Director in October. During a recent fire-side chat, Tarver was asked how she felt about filling such a big pair of shoes. Her response was that she had no intention of filling those shoes, but that she had a fabulous pair of her own to stand in. This is a timely response, as CDRH challenges of the next couple of years will likely be very different from those that Shuren oversaw. While his agency needed to adapt and navigate regulatory pathways to address fundamental new technologies, Tarver will now need to manage the broad social, financial, and quality-of-care issues that those technologies have long promised but struggle to deliver.
5. Going from deep to wide in medical manufacturing resources
Among the news that caught my eye this year was the name Dupont being listed as the acquirer of a major medical contract manufacturer (Donatelle Plastics) for $313 million in July. This was a follow-on purchase to the acquisition of medical molding giant Spectrum Plastics for $1.75 billion just last year.
In the late 1990s, major resin manufacturers like DuPont and Dow Chemical were threatening to leave the biomedical market completely due to the impact of implant lawsuits on what was, at the time, a tiny fraction of their industrial plastics business. This led to protective legislature being signed into law by President Clinton to ensure that device manufacturers would not lose their only source of certain critical polymers. Even with these protections, major industrial chemical companies were notoriously hands-off about providing any kind of guidance for their products in medical applications.
DuPont and the Dow Chemical Company merged in 2015, then split the combined assets into three separate companies, now called Corteva Agriscience (agriculture division), Dow (material science division), and DuPont (specialty products). It is this smaller, more focused DuPont that is now directly buying up medical device manufacturing resources to partner with its existing lines of life science industry polymers. While having a corporate structure better aligned with small, niche industries justify some of the 180-turn, it is also a reflection of the overall shift to total solution providers. Being the largest of any single resource is no longer a popular business strategy. Instead, companies who can bundle the most useful collection of products and services, along with a service fee, for the biggest customer appear to be the way forward.
This has been playing out through rapid M&A activity among contract medical device manufacturers in the last couple of years. Contract manufacturing giants are continuing to tuck useful bits and pieces into their infrastructure throughout 2024. This year, Veranex made its fourth acquisition in three years, acquiring Horus Scientific. Additionally, Arterex, created out of the combination of four different companies in 2022, has brought in Micromold, while Integer Holdings acquired Pulse Technologies. Meanwhile, companies with one-off medical resources are eager to divest them at a profit to those acquirers, such as the Johnson Matthey sale of its 30 year-old medical components business to Montagu Private Equity for $700 million in cash.
If there is one forecast that I can make for 2025, is that there will continue to be change. A spokesperson for Dupont in the late 90’s said that it was unreasonable for them to ever support such a niche market as medical devices. Thirty years offers a lot of time to be proven wrong, but also to be delighted by the things never expected possible. There are so many brilliant new technologies under development, and so many people still trying to find ways to heal. I look forward to whatever new firsts 2025 will bring.
Article source:Medical Device and Diagnostic Industry
