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What Will be the Top Trends in Medtech in 2024?
Michael Monovoukas, co-founder and CEO of AcuityMD, shares his thoughts on which trends will be prevalent in medtech in 2024.
Prediction #1: AI will turn windshield time into work time.
In 2024, field sales reps will spend more time in transit as the makeup of their territories changes to reflect a new type of healthcare landscape. Notably, Ambulatory Surgery Centers?(ASCs) – a safe, convenient, and inexpensive alternative to hospitals – have and will continue to grow especially as more medical technology manufacturers engineer more streamlined robotics products (i.e., Livsmed’s Artisential system) that fit the smaller footprint of ASCs. Already ASCs perform more than half of all U.S. outpatient surgical procedures. Since Q1 2018, Total Knee and Total Hip Arthroplasty?procedures done at hospitals have decreased by 1.3% per quarter, whereas ASC volumes have steadily increased by 5.4% per quarter. ASCs now perform over 15% of TKA and THA surgeries in the U.S. plus an increasing number of other types of outpatient procedures.
The result is a wide dispersion of surgeries, requiring reps to spend more time driving long distances and adding to their already 2+ hours a day in transit. Artificial Intelligence (AI) and Large Language Models (LLMs) will help reps make better use of this ‘dead’ time by enabling hands-free audio productivity. When they are driving, reps will be able to listen to their AI-based system to prepare for their upcoming meeting, respond to email requests, and more. The top-performing reps will leverage LLMs to be dramatically more efficient and make the most of their longer travel stretches.
Looking beyond 2024, AI can also bring a similar audio experience into the operating room, audibly guiding surgeons on what screens to view when, and capturing surgical context that can be automatically transcribed into notes for highly individualized post-operative care.
Prediction #2: Medtech will return to demanding a return on investment.
Financial instability experienced in 2023 will continue to impact business in 2024 and will challenge organizations to prove the return on investment for every major purchasing decision. Specifically, in the Medtech industry, data and software purchases that were previously largely unchecked will now be considered with increased scrutiny. Buyers will need to justify their expenditures, which will cause them to carefully re-consider how each data purchase will be used. Whereas medical device companies blindly purchased static datasets from familiar providers, in 2024, they will seek dynamic data that captures real-time fluctuations and that can be integrated into commercial workflows to track ROI and analyze performance automatically. The resulting metrics will fuel future purchase decisions so that they are based on verifiable insights – which is good for everyone, not just the corporate bottom line.
Prediction #3: Consolidated healthcare will demand empowered quarterbacks at Medtech companies.
Healthcare providers continued to consolidate this past year, causing a consolidation of their purchasing power. The effect of such mass consolidation is that Medtech companies have started expanding their national accounts teams to provide a single point-of-contact for independent delivery networks (IDNs). In 2024, successful Medtech companies will further centralize their engagement with IDNs to offer bundled offerings while also managing contracts. Companies will empower their national account leaders with better data and insights so they can serve as quarterbacks between contracts and sales while remaining a valuable central point of contact for their healthcare customers.
Prediction #4: Breakthrough obesity drugs will change healthcare supply-and-demand dynamics.
A single event can have a material impact on the entire healthcare system, including medical device manufacturers. For example, smoking cigarettes has decreased by about half -- from 20.9% in 2005 to 11.5% in 2021 (the latest CDC data) – and not surprisingly, there’s been a commensurate decline in cardiac interventions per capita.
Today, the blazing success of Wegovy and Mounjaro has electrified the pursuit of new treatments for obesity. Novo Nordisk?and Eli Lilly?are leading the market with injectable drugs that target receptors of the?GLP-1?hormone to mimic the hormone's effects of helping people feel full. As these weight loss drugs flood the marketplace, 2024 will start to see their impact on related healthcare interventions for obesity, diabetes, and orthopedics, among others. We may not need bariatric surgery at all someday soon. How we treat diabetes – and the sheer volume of diabetic patients – is likely to drop. And, there will be a significant impact on orthopedic interventions without the strain on joints from obesity.
SEC Charges Stimwave Ex-CEO with $41 Million Fraud
The charge adds to those initiated by the DOJ in March, including conspiracy to commit wire and healthcare fraud.
Stimwave’s ex-CEO Laura Perryman has been hit with additional fraud charges for the role she played in allegedly defrauding the government after it was unveiled that the company’s white receiver was made entirely out of non-conductive plastic.
Let’s turn back the clock to 2016, six years after Perryman founded the Floridian company. The StimQ PNS system had just received 510(k) clearance and was hitting the United States market. Back then, it seems the company was on the up and up, creating the implantable, wireless device that reduced chronic neuropathic pain at most locations throughout the body. At that time, the device included three components: an implantable electrode array called the lead – which stimulated the nerve, a battery worn externally, and an implantable receiver that transmitted energy from the battery to the lead.
The receiver is where things seem to have gotten a little hinky. Known as the Pink Stylet due to its distinctive pink handle, the receiver did its job, but had to be a certain length to work. StimWave, after receiving reports from physicians that they were having problems implanting the stylet in some patients because of its length, developed the second iteration of the receiver, known as the white stylet, which could be cut to size.
The problem?
The white stylet was useless, “made entirely of plastic that served no medical purpose,” according to the Department of Justice (DOJ).
This depth of the scheme came to light in March, when Perryman was indicted by the DOJ for conspiracy to commit wire and healthcare fraud, crimes that carry a combined sentence of 30 years in prison. According to US Attorney for the Southern District of New York Damian Williams, in a release issued by the DOJ, “At the direction of its founder and CEO [Perryman], Stimwave created a dummy medical device component — made entirely of plastic — designed to be implanted in patients for the sole purpose of causing doctors to unwittingly bill Medicare and private insurance companies more than $16,000 for each implantation of the piece of plastic.”
But why continue to sell a useless device component that resulted in patients undergoing unnecessary implanting procedures? As previously reported by MD+DI, let’s follow the money.
The device was sold to medical providers for about $16,000. Medical insurance providers like Medicare would reimburse medical practitioners for implanting the device through two separate reimbursement codes, one for implanting the lead and another for the Pink Stylet. “The billing code for implanting the lead provided for reimbursement at a rate of between approximately $4,000 and $6,000, while the billing code for implanting a receiver, like the Pink Stylet, provided for reimbursement at a rate of between approximately $16,000 and $18,000,” according to DOJ.
This meant, according to reporting from Norbert Sparrow for MD+DI, that “It would have been next-to-impossible to sell the device at the list price without reimbursement for implanting the receiver since the medical provider would have been losing money with each procedure. So, Stimwave kept selling its device with the White Stylet while submitting ‘fraudulent reimbursement claims for implantation… to Medicare, resulting in millions of dollars in losses to the federal government,’ said the DOJ.”
In addition to Perryman’s arrest, Williams also announced the unsealing of a non-prosecution agreement with the company, which filed for bankruptcy in June 2022. Under the terms of the agreement, Stimwave accepted responsibility for its conduct, was fined $10 million, and will be required to maintain a compliance program overseen by a Chief Compliance Officer for three years.
Now, 9 months after the initial charge, the Securities and Exchange Commission (SEC) has tacked on an additional charge for defrauding investors out of approximately $41 million “by making false and misleading statements,” about the functionality of the white stylet —namely lying that the component wasn’t just a jumble of plastic.
The SEC complaint alleges that Perryman knew “or was reckless in not knowing, that the smaller receiver was, in reality, fake and nothing more than a piece of plastic,” the press release wrote. “According to the complaint, Perryman misrepresented to investors that the PNS Device was approved by the US Food and Drug Administration and was the only effective device of its kind on the market. The complaint also alleges that Perryman made false and misleading statements to investors about Stimwave’s historical revenues, revenue projections, and business model.”
Filed in the US District Court for the Southern District of New York, the complaint charges Perryman with violating the antifraud provisions of the federal securities laws. The SEC said it seeks permanent injections, including a conduct-based injection, disgorgement plus prejudgment interest, a civil penalty, and an officer and director bar.
Also on Dec. 19, The US Attorney’s Office for the Southern District of New York implemented a parallel, superseding indictment against Perryman that added criminal securities fraud charges.
Behind the Design: How Medtronic Found a Goldilocks Solution to Building an EV-ICD
A behind-the-scenes look at how Medtronic designed its extravascular defibrillator.
领英推荐
Medtronic's extravascular implantable cardioverter-defibrillator (EV-ICD) may have a mermaid's name, but when the company's R&D team began the project, it was another fictional character that came to mind: Goldilocks.
"When we began the EV-ICD journey, what we were looking for is what I call the 'Goldilocks' solution, or the 'just right' solution that would keep the leads out of the heart and vasculature, but could still provide all of the therapies available in modern transvenous systems such as the ability to pace, the ability to defibrillate at low energy, the ability to keep the device size small, and the ability to retain the longevity of modern systems," Amy Thompson, clinical research strategy director at Medtronic, told MD+DI.
FDA approved Medtronic's Aurora EV-ICD system earlier this year. The system incorporates the company's MRI SureScan technology and the Epsila EV MRI SureScan defibrillation lead. The Aurora EV-ICD system is designed to enable lead placement under the breastbone, outside of the heart and veins.
Thompson recently shared some teachable moments and other takeaways that emerged from the R&D process.
Lesson 1: Make the unfamiliar familiar
Thompson said one of the biggest challenges of the EV-ICD project was the challenge of belief, which she acknowledged is a common theme when developing any disruptive innovation.
"We were effectively asking our physician partners to think about a new paradigm for defibrillation and a new implant space that may not have been immediately familiar to them," Thompson said. "One story that stands out so vividly for me is one of the very first physicians I ever showed the substernal implant to wrote in his own notes from that day, 'There is a little known space between the heart and the sternum, which the team showed me we can implant within.' And that has, for 11 years, been in my brain."
That moment signaled to Thompson where the research team would need to spend its time on making the unfamiliar familiar, she said. That meant learning and then teaching the anatomy aspect and demystifying the implant procedure to make implanting physicians aware of the capability to implant in that space.
Lesson 2: Disruptive technology requires detailed thinking and a diverse, cross-functional team
To develop the Aurora EV-ICD, Medtronic didn't just need to build a new ICD.
"We needed a new implant procedure; we needed new delivery tools to facilitate that implant procedure; we needed to use imaging in a slightly different way than we had in the past to facilitate that implant procedure; we needed to prove that we could pace, sense, and defibrillate from this new region; in some ways, we needed to retool our pacing engine to provide increased voltage and longer pulse durations; and we needed to think holistically about features that could be important to EV-ICD," Thompson said.
The Aurora EV-ICD system includes features available in the company's transvenous ICDs, and offers additional advantages that are not available with the subcutenous ICD, including:
Patients who receive the commercially available Aurora device also will benefit from the addition of Smart Sense, an algorithm designed to reduce the potential for inappropriate shocks.
The work didn't stop there, of course. Thompson said the team leveraged its initial clinical implant experience, testing experience, and imaging data to further refine and optimize where the lead is positioned.
Lesson 3: Use disbelief as your fuel
From a mentoring perspective, Thompson said one of the biggest lessons she took away from the EV-ICD project that she intends to teach for the remainder of her career is to use disbelief as your fuel.
"What I mean by that is where people question you or challenge you will become the signals of where you need to spend your time, and where you need to develop the most evidence."
Lesson 4: Bring people along for the ride
The project also showed Thompson the importance of bringing people along with you on the journey. In some cases, for her team, that was the physician partners who became early champions and supporters. Other times it was Medtronic's senior leaders who the team invited into the lab for the earliest look at what they were building and to invite them to be part of the process, which helped to generate excitement at a higher level within the company.
The Redemption Arc Continues for the Renal Denervation Space
Ablative Solutions is the latest company to have a significant milestone in using renal denervation to treat hypertension.
By Omar Ford
The good news for renal denervation to treat hypertension is pouring in after years of the space being flooded with failed trials and negativity.
Ablative Solutions shared today that it has met the primary endpoint for a pivotal trial of the Peregrine System kit to treat patients with uncontrolled hypertension.
The Wakefield, MA-based company’s Peregrine System kit, is comprised of an infusion catheter and dehydrated alcohol, which is used during a minimally invasive procedure to ablate the sympathetic nerves surrounding the renal (kidney) arteries to reduce blood pressure.
The TARGET BP I Trial enrolled patients with uncontrolled hypertension despite being prescribed two to five antihypertension medications. A total of 301 patients were randomized to either receive treatment with the Peregrine System Kit or sham procedure. The study remained blinded through six months follow-up.?
"We are happy to announce the completion of the primary analysis of this landmark trial and are excited for the potential of alcohol-mediated renal denervation as a treatment option addressing the widespread public health issue of uncontrolled hypertension", stated?David Kandzari, M.D., co-principal investigator, chief of Piedmont Heart Institute and chief scientific officer for Piedmont Healthcare. "We look forward to sharing these data in the coming months.”
Renal Denervation Redeemed in 2023
Recor Medical and Medtronic helped change the paradigm on renal denervation for hypertension by both winning recent FDA nods.
Recor scored success first by securing approval in November for the Paradise ultrasound renal denervation system. The approval was a milestone in a plagued space that many companies such as Boston Scientific and St. Jude (abandoned).
Medtronic, which had failed renal denervation trials and FDA rejections in the past, finally received redemption. The Dublin-based company’s Symplicity Spyral renal denervation system was green lit by FDA in November.
MORE WEEKLY NEWS
?? Medtech's Biggest Winners in 2023: MD+DI looks at the companies and sectors that prospered in 2023.
?? 2023’s Biggest Medtech Losers: From regulatory and merger struggles to recalls and lessening demand for specific products, these companies are ready to say goodbye to a difficult 2023.
?? ZimVie to Shed Spinal Business to Focus on Dental: The Westminster, Co-based company is selling its spine business to HIG capital for $375 million.
?? Illumina Moves to Divest Grail: The San Diego, CA-based company is letting Grail go after the U.S. Fifth Circuit Court of Appeals said it agreed with FTC there was evidence the deal was anti-competitive.
?? FDA Facing Increased Scrutiny Over Medical Device Recalls: Stemming from the apparent mishandling of the Philips Respironics recall, two prominent senators suggest it’s time for a new probe examining agency oversight.