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Femtech Is Finally One of the Cool Kids
Femtech, a term coined by Ida Tin in 2016 to describe health technologies designed specifically for women, is finally one of the cool kids in medtech.
Here at MD DI, we’ve been tracking the growing interest in the space and noting how the concept of femtech no longer applies just to reproductive and maternal health technologies. Now, the term is expanding to cover any health technology designed to address issues that impact women differently or disproportionally than men.
While it has been encouraging to see a growing interest in femtech within medtech circles, I was surprised a couple weeks ago to hear a stand-up comedian talk about women’s health during her show.
“They just ... in 2022, they finally, in the medical field, they finally started studying the [clitoris],” Reena Calm said during her recent show in my hometown, Galesburg, IL. “Like, where have you been? They just started looking into this thing. I mean, it must have been in the book. Maybe they couldn’t find the page? I don’t know, that seems crazy.”
Calm was likely referring to the 2022 study conducted at the Oregon Health & Science University (OHSU) in which researchers revealed they approximated, for the first time ever, the number of nerve fibers in the human clitoris that are responsible for sexual pleasure. The penis, on the other hand, has been extensively studied by medical researchers.
“The general story of the clitoris is that it appears to have been lost and found throughout history,” Rachel E. Gross, a science journalist and author of Vagina Obscura, a book that explores how science has long viewed the female body with a narrow focus on reproduction and how that’s changing, told the Scientific American in 2022 after the OHSU study was published.
But acknowledging women’s health issues and the burgeoning femtech space is only the beginning. Sure, it’s trendy to talk about femtech now, but what about barriers to women’s health in terms of reimbursement, health equity, and access? Finding a medical specialist who genuinely understands how certain healthcare issues impact women differently – and how those differences impact the diagnosis and treatment of such issues – is no small feat today.
“Women’s healthcare feels like they’re fixing all the planes, you know, to make the planes fly higher and last longer, go farther, but nobody cares that the airport is on fire,” Calm quipped.
Despite the progress made in recent years to break down barriers and make femtech a recognized, important part of the medical technology landscape, any femtech entrepreneur will quickly acknowledge the hurdles they continue to face.
As Spencer Chin, one of my colleagues on Design News, an MD DI sister publication, wrote last year, femtech has traditionally faced the misconception that women’s health issues are mental, rather than physical.
“Current health systems don’t allow women to be in touch with their bodies,” said Michele Wispelwey, co-founder and COO at Femgevity, a digital telemedicine platform for women.
At Sensors Converge last year, Wispelwey discussed the issue of libido loss in women. “There is a lack of knowledge and education, and most of the treatments have been designed for men,” she said.
The lack of understanding of women’s health issues has also been a barrier to funding femtech companies.
“When pitching for funding, men do not understand the depth of the problem,” said Kristina Cahojova, founder and CEO at Kegg, a femtech company that has developed a fertility tracker to measure changes in electrolyte levels to help monitor fertility cycles. “When we received funding from women-dominated groups, we opened eyes. People started to understand vaginal function problems. Once people saw we got funding, they started to realize the magnitude of the issue."
Educating the venture capital community on the importance of femtech products and services could go a long way toward leveling the playing field. But real change will only occur once the broader healthcare industry gets on board and begins to accept that several medical conditions do impact women differently than men.
Insulet Reports Positive Type 2 Diabetes Study Results
The company is now seeking expanded FDA nod for Omnipod 5 to include the type 2 population.
By Katie Hobbins, Managing Editor
With over 30 million people living with type two diabetes in the United States, no automated insulin delivery (AID) systems are currently FDA-cleared for use in this population. Insulet Corporation, however, has tasked itself with changing that.
The company, which has already dipped its toes into type two diabetes care with its FDA-cleared basal-only pod called Omnipod GO and had studies underway for years evaluating the Omnipod 5 for type two, recently shared positive results from its Secure-T2D pivotal trial evaluating the impact of using the Omnipod 5 Automated insulin delivery system in patients with type two diabetes who require insulin.
The trial, which represented 305 participants from 21 US sites — including 24% Black and 22% Hispanic participants — started by continuing individual standard therapies for the first 14 days. After that time, the participants used the Omnipod 5 AID for 13 weeks and could eat and exercise without restrictions. They were also given the option to bolus for blood glucose corrections only, for actual carbohydrate intake, or for a set carbohydrate regimen.
“More than half (55%) [of the participants] were on a stable dose of GLP-1 receptor agonists, and 73% used multiple daily injections of insulin, while 21% used basal-only insulin at baseline, and only 5.6% used an insulin pump at baseline,” according to Insulet.
The primary objective, according to the company, was to evaluate change in HbA1c with Omnipod 5 in adults aged 18 to 75 years living with type two diabetes with a current insulin regimen for at least three months.
“Other criteria included a baseline HbA1c between 7% and 12% for those using basal insulin only, and 12% or less for those using basal and bolus or pre-mixed insulin,” according to the company press release announcing the study results. “Secondary objectives included demonstrating improvements in time in range, and time in hyperglycemia, as well as demonstrating non-inferiority for hypoglycemia. Additionally assessed as a secondary objective was diabetes distress, a patient-reported outcome.”
Results from the study showed glycemic improvements when study participants used Omnipod 5 compared to treatment with injection or pump therapy for type two diabetes, including significant reductions in HbA1c, time in hyperglycemia, and total daily insulin dose. Additionally, individuals saw improvement in time in range without increasing time in hypoglycemia, and a clinically meaningful improvement in diabetes distress.
“Our findings demonstrate substantial improvements in blood glucose outcomes and overall quality of life, highlighting the potential for this innovative technology to transform type two diabetes management with automated insulin delivery,” said Francisco Pasquel, MD, MPH of Emory University and chair of the study, in the release.
Insulet reported no instances of diabetic ketoacidosis or hyperosmolar hyperglycemia syndrome in the study, one occurrence of severe hypoglycemia during treatment that was deemed to be unrelated to trial device malfunction, and an additional 13 serious adverse events not related to glycemia or the trial device.
The company has submitted the study results to FDA with hopes to expand Omnipod 5’s indications for use to those with type two diabetes. The device is already approved for use in multiple countries, including the US. If expanded use is approved by the agency, Insulet said it expects to launch to the type two diabetes population in the US in early 2025.
Researchers for Zacks highlighted the potential industry impact of expanded Omnipod 5 use in a recent report, writing that since the global market for type two diabetes was valued at $32 billion in 2022 and is expected to “witness a CAGR of 8.2% by 2023,” the introduction of new “therapeutic compounds with improved efficacy and safety opens up the possibility of developing new treatments. Also, the growing obesity epidemic in many regions of the world is supporting the profitability of the industry.”
EU & Member States Contribute Over $800M to African Vaccines Manufacturing Accelerator
By Katie Hobbins, Managing Editor
The European Union (EU) and its member states recently announced a contribution of more than $800 million, including about $233 million from the EU budget to the African Vaccines Manufacturing Accelerator (AVMA). AVMA, which complements the existing Team Europe initiative on Manufacturing and Access to Vaccines, Medicines, and Health Technologies in Africa (MAV ), will work to enhance the predictability of demand for vaccines made in Africa.
Developed by Gavi, the Vaccine Alliance together with Africa Centres for Disease Control and Prevention (Africa CDC) will help support sustainable growth of Africa’s manufacturing base and “contribute to the African Union's ambition to produce most vaccines required by African countries on the continent,” according to the European Commission (EC).
The accelerator is expected to purchase more than 800 million doses produced in Africa over the next 10 years, potentially improving African pandemic and outbreak preparedness and response, while also supporting health security globally. “For these purposes, it will make more than €1 billion ($1.1 billion) available to manufacturers as a way of offsetting high start-up costs and providing assurance of demand,” according to the EC press release. “The initiative will diversify the set of global vaccine suppliers with a target of at least four African vaccine manufacturers entering the market in a sustainable way.”
Even before this announcement, the EU, its member states, and European financial institutions have invested in Africa’s vaccine manufacturing capacity through its Global Gateway strategy. Using a 360-degree approach, MAV — part of the strategy — focuses on the supply, demand, and the enabling environment.
“MAV delivers an integrated and comprehensive support package tackling barriers to manufacturing and access to health products and technologies in Africa from all angles,” according to EC. “It places the continent’s own actors and institutions at its heart.”
Sovato Touts Successful Remote RAS Procedures Over 500 Mile Distance
By Katie Hobbins, Managing Editor
Santa Barbara-based Sovato today announced the successful completion of a series of remote robotic-assisted surgery (RAS) procedures in a preclinical technology demonstration using its Sovato Platform. Performed on porcine models between Lincoln, NE, and Chicago, IL, seven surgeons across four specialties completed nephrectomy, hysterectomy, colectomy, and cholecystectomy procedures.
Sovato touts the platform as a “comprehensive solution for enabling and orchestrating remote robotic-assisted surgeries and procedures.” Using a remote surgery ecosystem, which includes the healthcare providers and any RAS system, it delivers a curated fiberoptic network, clinical workflows, data, and supporting infrastructure to support safe, scalable, and profitable remote surgery and procedure programs.
In the preclinical tests, the Sovato Platform was paired with a modified version of Virtual Incision’s MIRA Surgical System so that surgeons from multiple specialties could perform the procedures across a 500-mile radius. This enabled “low latency, curated, fiberoptic connectivity from the surgeons console to control MIRA’s arms and integrated an articulating camera at the remote location for full situational awareness,” according to the company press release.
The platform also maintained verbal and visual communication with the remote care team.
After the tests, the surgeons completed a user experience assessment based on the NASA Task Load Index which revealed a high degree of surgeon confidence with performing the remote procedures. Additionally, they reported that they could effectively communicate with the remote care team while also having comparable situational awareness of the remote operating room when compared to in-person surgery.
"I could not tell the difference between doing surgery in my operating room or in an operating room that was 500 miles away," said Francesco Bianco, MD, associate professor of surgery, division of general, minimally invasive & robotic surgery department of surgery, at the University of Illinois, Chicago, in the release. "The experience was seamless. There was no detectable delay. There was absolute comfort in communicating with the team on the remote side. Everything looked like a normal day in my operating room."
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