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'Not Going Back' to the Shultz Era of Medical Device Regulation
As Jeffrey Shuren, MD, approaches his retirement after 15 years leading FDA's Center for Devices and Radiological Health (CDRH), a controversial New York Times investigation casts a shadow over his legacy.
This report raises serious questions about potential conflicts of interest during his tenure, yet it fails to recognize the critical advancements in medical device regulation achieved under his leadership.
The report focuses on a potential conflict of interest: during Shuren’s tenure, his wife, Allison, co-led a team of lawyers representing medical device manufacturers at Arnold & Porter, a leading Washington law firm.
The New York Times reviewed thousands of court documents, FDA records, and conducted interviews, finding several instances where the Shurens' roles intersected.
The report highlights that while Shuren signed ethics agreements to avoid conflicts with Arnold & Porter’s business, it is unclear how strictly these were enforced. An FDA spokesperson acknowledged some instances a decade ago where Shuren should have recused himself or sought ethics authorization to prevent any appearance of bias. However, there is no evidence that he acted improperly or violated any laws.
Nevertheless, the perception of bias can undermine public trust in FDA whether any laws were broken or not. The agency’s role is not just to enforce rules but to maintain public confidence in its impartiality, especially when senior officials have potential conflicts of interest. This is why ethical guidelines are so critical—they safeguard not only against actual wrongdoing but also against any doubt that might arise about the integrity of regulatory decisions.
The problem with the New York Times report is that it misses the forest for the trees. Those who have been around the medical device industry long enough to remember what the regulatory climate was like under Shuren’s predecessor, Daniel Shultz, and the hot mess that was the CDRH when Shuren took the post, can appreciate how much progress has been made in the last 15 years, both for industry and for patient safety.
During Shultz’ reign, a group of FDA scientists and physicians known as The FDA Nine sent a whistleblower letter to Congress and the Obama administration. They alleged that CDRH managers had coerced FDA experts into altering their scientific reviews and recommendations unlawfully.
This letter, along with a follow up letter in January 2009, brought congressional scrutiny that had?a significant impact on FDA’s 510(k) review process and brought what the device industry largely perceived as negative changes.
In May 2009, new public disclosures revealed that Schultz had overruled staff objections to approve ReGen Biologics' Menaflex collagen scaffold via the 510(k)-clearance process. An internal investigation later found this posed a “definite threat” to the integrity of the device’s review.
There is plenty of room for further progress, but overall, the state of medical innovation and patient safety is far better today than it was before Shuren took the helm.
When Shuren took the CDRH director post, his goal was to set clearer guidelines on "what situations might justify a change in our decision making and to determine how to communicate those changes to our external constituencies in a timely manner in order to achieve a reasonable level of transparency."
"To foster innovation,?we need to provide industry with reasonably predictable pathways,” Shuren said at a public meeting in February 2010. “We will not accomplish this if we make our decisions to change course on an ad hoc basis or if we leave our external constituencies in the dark about our decision-making processes and our rationale.”
And so, a new era was born, one in which the medical device industry and CDRH slowly began to see one another more as partners than adversaries.
Shuren increased the use of guidance documents at CDRH, improving transparency and predictability in the medical device review process. Before this, there were few written procedures to clarify expectations and ensure consistency among reviewers.
“In the absence of guidance,” Shuren said, “expectations for material to be included in regulatory submissions were often simply passed down as ‘tribal law’ from reviewer to reviewer.”
Other examples of progress under Shuren’s tenure include the breakthrough devices program, which improves Americans’ access to new innovation for life-threatening or irreversibly debilitating diseases or conditions; the Digital Health Center of Excellence; and the Total Product Life Cycle Advisory Program (TAP), which enables medical device companies to engage with the agency earlier for devices of public health importance.
While The Times noted an increase in medical device safety issues under Shuren, this is due to improved transparency and stricter reporting requirements. Most manufacturers are more diligent in reporting, creating an impression of more issues, when in fact, the public is just better informed.
The New York Times did make some good points. I mean let’s face it, Shuren did seem a little too cozy with industry at times. But that shouldn’t negate all the progress made in the past 15 years that has benefited medical device manufacturers and consumers.
I hope future leadership will build on Shuren’s legacy of transparency and predictability rather than go backward. His successor must understand how to use medical device regulation to protect patients from shoddy devices while also bringing lifesaving and life improving innovation to the U.S. market.
And to steal a phrase from a certain political party, medtech is “not going back” to the Shultz era of medical device regulation.
Voice of Customer Necessity in Medical Device Development
By Keir Hart, Founder
I clearly remember standing in the operating room (OR). I was there with our sales representative to observe a case as part of our normal Voice of Customer (VOC) process. I had seen well over 50 procedures by this point. We gowned up and when the surgical team was ready, we quickly entered the OR and disappeared against the wall. It was supposed to be a routine case using a competitive device. The procedure would take maybe an hour to have part of the patient’s intestine removed. Our device concept was a new electrosurgical vessel sealer — basically a fancy pair of scissors that can seal blood vessels prior to cutting them. Electrosurgical tools like this have been around for decades, but our product concept was new. The market was new to us, and we needed some customer insight.
The surgical team progressed quickly and professionally through the case. Unfortunately, things got interesting. The case began to slow dramatically. The competitive device was acting abnormally. We stepped away from the wall to take a closer look. The surgeon clamped on a vessel and paused. That is when I noticed that the device was coming apart in his hand. The plastic housing was splitting along the ultrasonic weld, and in the middle of a case. This could be dangerous, leading to parts falling into the patient, or worse yet, sealed vessels that failed after the surgery. I turned to our sales rep and let him know what I saw.? He very politely leaned forward and whispered to the surgeon. The surgeon unclamped the device, looked at it, and then exchanged it for a new device from the scrub nurse. The case continued and all was well with the world.?
I later found out that the device had been reprocessed over 10 times. It was a single-use disposable even though we had been assured prior to the case that reuse did not occur. Without being physically there to see the device used, our team may never have even thought about that failure mode.
VOC is step one for a reason. Here are a few ideas to quickly and cheaply incorporate VOC into your product development process so that you don’t miss key requirements or break the bank.
Step one
I have heard more times than I can count that ‘VOC takes too long. Let’s just skip it. We know what our customers want.’? First, realize that VOC is not a box to check off. It is a methodology and a mindset. It is critical to business operations and product development. The team needs to live and breathe VOC. VOC is iterative and should be done throughout all of development, regardless of the class of medical device you are producing or the size of your company. Properly conducted VOC can provide invaluable insights at any phase of development, from in-depth knowledge into how your market thinks and how your product is used to expectations for product improvements, and more. Plan on at least one customer touch point at each phase of the development process.
Skip it at your peril.
Costs can scale
VOC does not have to be a highly expensive or formal process. Small-scale, informal activities, known as formative studies, are extremely useful. Observing a minimal number of cases or speaking with a handful of customers can be eye-opening. While it may not be as comprehensive as a formal summative study, formative studies can easily identify trends very quickly. Feeding that information back into your product development can steer an MVP into something that customers not only want but cannot live without.?
Furthermore, VOC does not have to be, nor should be, a large focus group or an over-the-top endeavor. In addition to groupthink, focus groups can be costly and it takes your customer out of their use environment. There are many different types of VOC research activities that can quickly and accurately gather key information, all for different price points. Set a budget and then ensure you can interact or observe customers in the use environment. Whether that is in the OR, using a simulator, or otherwise, being able to see how a product is actually used, versus how a customer says they use it, can be a game-changer.?
Learn who your customers actually are
When you start VOC, you should have a clear idea of who your target market is, but it may not stay that way. Put a line in the sand to establish a starting point and then keep an open mind. Look for other areas where your product may be more suitable or sales avenues you haven’t considered. Are there different customers in the same space you might not have thought about?
Approaching VOC with a problem-solving mindset, rather than pushing a solution, inevitably leads to better outcomes. This mentality has steered many a company from a solution that is simply adequate to a solution that is far more profitable.?
It’s good
How many times have you heard the dreaded phrase, ‘it’s good,’ or ‘it’s fine.’ A more neutral sentence has never been uttered. Get around these types of lackluster responses by asking open-ended questions and do not be afraid to ask follow-up questions to get a deeper answer.? Sometimes customers are so used to using a workaround that they may not have considered there might be a better way. Asking why five times can help get to the real root cause, allowing you the opportunity to solve a genuine customer pain point. Be sure to capture these user needs and refine as VOC progresses. Do other customers share those pain points?
Ask questions and then validate, validate, validate.?
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Enough is enough
It seems like VOC can go on forever. How do you know when to stop? Don’t get stuck in analysis paralysis by using two simple techniques: the 50% rule and prioritize your risks. The 50% rule isn’t really a rule, so much as a guideline. It simply says that when a concept activity or design is roughly 50% complete, it is time to start prototyping. Less than 50% and you might not have enough fidelity in the design to be useful. More than that and you start risking costly rework. We use the 50% rule to help us determine when to stop an early-stage activity and go make a prototype or run a test. You can learn a lot from sketches and CAD, but until you build it and show it to a customer or stakeholder, it has little value. Using the 50% rule, you spend less time on the computer and more time with the people buying your product.
In addition, once you have collected your user needs, it is time to dive deeply into your product and development risks. List them all.? Then, prioritize the risks by impact to your business, your product safety, and your sanity — no need to make multiple lists, one will do.? Next, focus on the highest risk and address it. Use the 50% rule as necessary to test your idea. Once adequately addressed, move on to the next lowest risk, and then the one after that, on and on until you have addressed each item to an acceptable level. Some minor residual risks are ok. Once the risks have been sufficiently addressed, then and only then is it time to begin moving to production. If you move too soon, you risk incorporating expensive fixes later. If you move too late, you risk losing time to market. By using a prioritized list, you can ride the fine line in between.
This methodology ensures that you are developing a safe and efficacious device with the customer in mind.?
Conclusion
Learning about device reuse, how a customer would view reuse, and how reuse is handled in the field was vitally important to our development process. Those insights directed our efforts from requirements development through product launch. VOC is more than a check box at the end of the concept phase. VOC is a scalable weapon that should be wielded throughout the entirety of a product’s lifecycle. It can save you time and money by avoiding costly rework. VOC gets you off top dead center and moving toward a product with deep value.
Did Tim Walz Lie About His Family’s IVF Journey?
At a rally earlier this month in Philadelphia, PA, Tim Walz talked about making personal healthcare decisions, including the choice to use?fertility treatments.
“When my wife and I decided to have children, we spent years going through infertility treatments, and I remember praying every night for a call for good news, the pit in my stomach when the phone rang, and the agony when we heard that the treatments hadn't worked,” he said. “So, it wasn't by chance that when we welcomed our daughter into the world, we named her Hope.”
The Democratic candidate for vice president has spoken openly about his struggle to have children with his wife, Gwen, since March, when an Alabama court halted in vitro fertilization (IVF) procedures in the state. Walz has also criticized JD Vance, the Republican candidate for vice president, by saying, “If it was up to him, I wouldn’t have a family because of IVF,” according to a PBS News report.
Now, Walz faces backlash because it turns out he and his wife used intrauterine insemination (IUI), not IVF. In an interview with Glamour, Gwen Walz shared how a neighbor—a nurse—would come over to give her the shots she needed as part of the IUI process.
“Today it came out that Tim Walz had lied about having a family via IVF. Who lies about something like that?” Vance wrote on X, the social media platform formerly known as Twitter.
The Harris-Walz campaign defended the candidate, saying that Walz was using “commonly understood shorthand for fertility treatments.”
So, what exactly is IUI, how does it differ from IVF, and why is the distinction important?
Both IVF and IUI use artificial fertility technology and methods.
In IVF, an individual’s eggs are fertilized with sperm in a laboratory dish under controlled conditions. One or more fertilized eggs (or embryos) are then transferred to a patient’s uterus. Pregnancy occurs when the embryo attaches to the lining of the uterus.
IUI, also known as artificial insemination, is considered a less invasive and less costly alternative to IVF. ?During an IUI procedure, sperm is placed directly into the uterus using a small catheter. The goal of this fertility treatment is to improve the chances of fertilization by increasing the number of healthy sperm that reach the fallopian tubes when the woman is most fertile.
Politically, the distinction matters because IUI doesn’t risk destroying unused embryos that anti-abortion advocates equate to unborn children. So, the Alabama Supreme Court ruling in February that frozen embryos could be considered children under state law, would not have impacted couples or individuals who choose IUI.
J&J Hops on the M&A Train
The medtech M&A train appears to be picking up speed in the back half of the year. In the past two months, we've seen deal announcements from Boston Scientific, Edwards Lifesciences, Stryker, GE HealthCare, and now Johnson & Johnson.
Today, J&J announced plans to buy V-Wave for $600 million plus up to about $1.1 billion in potential payments tied to regulatory and commercial milestones. V-Wave is a private company that has developed the Ventura Interatrial Shunt System for heart failure treatment.
J&J says the deal will extend its leadership position in the cardiovascular market and further accelerate its shift into high-growth, high-opportunity spaces. The acquisition is also expected to deepen the company's relationships with structural interventional cardiologists and heart failure specialists.
This is the company's fourth cardiac acquisition in less than two years. In late 2022, J&J bought Abiomed for $16.6 billion; about a year later J&J bought Laminar for $400 million plus milestone payments; and earlier this year J&J acquired Shockwave for $13.1 billion.
How V-Wave's device works
V-Wave’s cardiovascular implant technology specifically targets heart failure with reduced ejection fraction (HFrEF). In HFrEF, a patient’s heart muscle has insufficient ability to pump blood containing oxygen and nutrients to the body. V-Wave’s Ventura Interatrial Shunt is an implantable device designed to decrease elevated left atrial pressure seen in congestive heart failure by creating a shunt between the left and right atrium, thereby reducing cardiovascular events and heart failure hospitalizations. More specifically, the device:
"We recognize the importance of identifying more diverse and effective treatments for heart failure, and our recent track record demonstrates our focus on accelerating our impact on the most urgent and pressing unmet needs," said Tim Schmid, head of Johnson & Johnson's medtech business. "We know V-Wave well, with our relationship dating back to our original investment in the company in 2016, and we have a deep understanding of the technology and science, as well as the company’s commitment to patients."
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