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Medtronic Schools Us All on the Power of Persistence

This week in Pedersen's POV, our senior editor highlights a priceless lesson from a historic FDA approval.

By Amanda Pedersen

It was a Friday night in mid-November,?and I had just settled into bed with a good book, when my phone began blowing up with LinkedIn notifications. I resolved to ignore the intermittent buzzing – whatever it was could wait until Monday morning.

But the nuisance quickly escalated into a battle of wills?between myself and my LinkedIn app as the number of notifications continued to climb. It was a battle I ultimately lost. My determination to not think about work that Friday night was simply no match for the persistence?of my notification settings. I had to know what all the fuss was about.

The fuss, as it turns out, was very much warranted. Medtronic had just announced FDA approval for its?Symplicity Spyral renal denervation system, also known as the Symplicity blood pressure procedure. It was?welcome news for the millions of people in the United States living with high blood pressure. It also was a lesson in the power of persistence that the medtech industry won't soon forget.

The Symplicity system is designed to deliver radiofrequency energy to specific nerves near the kidneys that can become overactive and contribute to high blood pressure. Approval came about a week after FDA approved an ultrasound-based renal denervation technology from Recor Medical.

I've followed every twist?and turn?of Medtronic's renal denervation journey since the company's $800 million acquisition of Ardian in 2011, including the fateful?moment in January 2014 when the company's?SYMPLICITY HTN-3 trial failed to meet its primary efficacy endpoint. I watched as one competitor after another dropped out of the renal denervation race.?The mentality seemed to be: If Medtronic can't do it, what hope do we have?

But Medtronic persisted. The company's belief in the underlying science behind renal denervation for hypertension never wavered, at least not publicly. Not even when?interim data from SPYRAL ON MED trial was deemed?inconclusive and investors had?mostly given up on renal denervation.

In late August, an?advisory committee voted against Medtronic's?renal denervation system. And yet, Medtronic remained undaunted.

I never once doubted that the technology, if approved, would fill a critical gap in the way hypertension is treated in the United States. But FDA rarely goes against a panel rejection. It's only happened six times in the past six years, according to a study published in January, and that's out of 133 meetings across all drug,?biologic, and device advisory committees.

So, I began to speculate about Medtronic's future in renal denervation. If FDA rejected the Symplicity system, would Medtronic try to buy Recor? It's not the outcome I wanted to see, but it seemed a plausible theory. I've never been happier to be wrong.

Jason Weidman, head of Medtronic's coronary and renal denervation business, said it best in a LinkedIn article he published sharing the big news. "If bringing a device to treat hypertension to the largest healthcare market in the world were easy, it would have already been done long ago," Weidman wrote. "I am humbled by the work of our team at Medtronic, who for more than a decade has led the way in bringing this therapy to people living with hypertension. Your tireless dedication, commitment to our mission, and relentless pursuit of innovation have culminated in today’s milestone. We are proud of the journey we took to get here. We learned more about hypertension, renal denervation, our technology, and patient behavior through this process than we ever imagined when we first acquired Ardian more than a decade ago."

Competition breeds innovation, and innovation leads to better patient outcomes. Now, thanks to the tenacity of both Medtronic and Recor Medical,?the market has not one but two renal denervation options for patients with uncontrolled hypertension.?The technologies are differentiated from one another in the type of energy source they use, radiofrequency?versus?ultrasound.

As for those pesky LinkedIn notifications interrupting my bedtime routine that Friday night –?I'm glad I didn't wait until Monday to find out what the fuss was all about. And I'll remember 2023 as the year Medtronic schooled us all on the power of persistence.

Intuitive Wants to Invest Heavily in Minimally Invasive Care

Intuitive Ventures has closed on $150 million to help startups with a focus on minimally invasive care.

By Omar Ford

Intuitive Ventures is bringing $150 million to startups involved in minimally invasive care. The financing arm of Intuitive Surgical said earlier this week that it has closed its second fund.

In addition, Murielle Thinard McLane, who joined the team earlier this year, will lead the fund. She takes over the role of Managing Partner and Head of Intuitive Ventures from?Oliver Keown MD, who has decided to pursue a new chapter in entrepreneurship as a startup founder and CEO.?

MD+DI reached out to Intuitive Ventures about the round; how it might be beneficial for recipients; and Thinard McLane’s new role.

Could you elaborate on the significance of the current fund for startups? Considering the reported challenges in VC funding, can you shed light on the impact and support this fund offers to emerging businesses?

Thinard McLane: “No matter the economic climate, we believe in the opportunity for transformation in healthtech and medtech. Emerging companies that are re-imagining minimally invasive care need high-quality, committed investors now more than ever, so it’s our privilege and responsibility to continue to support this vital ecosystem with our $150 million Fund II.”

Can you discuss your new role, and can you share your vision for the fund?

Thinard McLane: “It’s an honor to build and support our incredible team of medtech investment partners, and continue to foster the ecosystem of startups working to improve patient outcomes. Intuitive Ventures has always focused on supporting startups that are re-imagining minimally invasive care, so my job is to continue to develop our portfolio of transformative companies and scale our impactful investment approach to help accelerate innovation in diagnostics, medtech, therapeutics, and digital health even further.”

In 2020, Intuitive Ventures initiated its operations with a $100 million founding fund. Could you provide insights into the companies that were recipients of funding during that year? Could you discuss the types of technologies these companies were developing??

Thinard McLane: “Since our launch, we’ve been relentlessly focused on improving healthcare access and coordination, promoting precise diagnostics and interventions, and unlocking the potential of novel (healthcare) data. We invest in startups that are creating transformative value across these three areas and ultimately reimagining minimally invasive care, including these companies in our portfolio:

·?????????Capstan Medical?(Improving Access and Precise Intervention), which is transforming the treatment of structural heart disease via endovascular robotics. In August, they launched out of stealth with an oversubscribed $31.4 million Series B round.?

·?????????Endogenex?(Precise Intervention), which is improving outcomes and quality of life for patients living with Type 2 Diabetes. In May, the company presented their exciting early clinical experience using its ReCET System in three oral presentations at Digestive Disease Week.

·?????????Flywheel.io?(Big Data), which is pioneering the future of medical imaging data management and analysis. This summer, they raised over $54 million in Series D funding and in November announced their collaboration with Microsoft and NVIDIA to Propel End-to-End AI Development Platform on Microsoft Azure.

·?????????KelaHealth?(Big Data, Precise Intervention), which provides an AI-enabled surgical intelligence platform to deliver patient-specific, predictive insights at key decision points. They recently completed a 12-month study with the Duke University Medical Center, which showed how the company’s surgical intelligence platform leads to a reduction in acute kidney injuries and readmissions after colorectal surgeries.?

·?????????MedCrypt?(Big Data), which provides data security as a service to medical device OEMs. They recently raised their Series B funding, bringing the company’s total funds raised to date to $36.4 million. In October, Medcrypt won the Digital Health Award for Patient Safety at the HLTH conference.

·?????????Neocis?(Improving Access), which is transforming dental implant surgery with advanced robotics. The Yomi Neocis robot is the first and only FDA-cleared robotic system for dental surgery.

·?????????Optellum?(Precise Diagnosis), which is redefining early interception of lung disease. They were recently ranked one of the top 150 most promising companies transforming healthcare with digital technology by CB Insights. The company continues to expand its product offerings and is engaging in strategic partnerships with a variety of Medtech players.

·?????????Surge Therapeutics?(Previse Intervention), which is dramatically improving cancer patient survival by disrupting how, when and where cancer immunotherapy is deployed. The company received FDA clearance of its IND application to proceed with a Phase 1/2a study of its intraoperative immunotherapy and has dosed its first few patients. In July, they raised $32 million in series B funding.

Finally, is there a noticeable trend in the types of technology sectors receiving funding? Are specific areas, such as diagnostics or digital health, experiencing increased innovation and investment?

Thinard McLane: “In my experience, investors are less focused on new technologies or sector trends, and more focused on great companies that are transforming their field in a meaningful way. Above all else, we seek out solid teams of people who are passionate about their work and committed to building companies that will improve people’s lives and stand the test of time.”

AdvaMed Joins National Campaign to Improve Supply-Chain Performance

The Biden Administration has launched a strategy to bring medical products and other necessities into the hands of more Americans more quickly.

By Joe Darrah

An unprecedented set of initiatives established by the Biden administration to improve national supply-chain performance is garnering support from one of the leading medical technology trade associations in the United States.

Officials at the Advanced Medical Technology Association (AdvaMed), a trade association based in Washington, DC, that leads various efforts to advance medical technology globally on behalf of its members, has announced its collaboration with the administration’s nearly 30 action plans that are expected to help strengthen the supply chain and its influence on the country’s economic and national security.

Announced Nov. 28 during the inaugural convening of the White House’s Council on Supply Chain Resilience as part of the current “Bidenomics” agenda, these plans reportedly will enable more reliable deliveries for businesses and help Americans receive products more quickly. The action plans come on the heels of multiple unanticipated events that have been blamed for causing the overall cumulative issues with the supply chain.

“The pandemic, extreme weather events, and geopolitical unrest have revealed severe supply-chain challenges that have disrupted healthcare, as medtech companies work to source and transport components, parts, raw materials, and key inputs for medical devices,” said AdvaMed CEO Scott Whitaker in a statement released by the organization Nov. 28. “AdvaMed and our member companies are working closely with the administration and Congress to address these challenges and strengthen the supply-chain resilience in order to protect patients.”

Agenda action plans announced

Among the new actions being promoted by the White House that are involved in the comprehensive supply-chain strategy are:

• Council on Supply Chain Resilience. The group is tasked with advancing Biden’s long-term, government-wide strategy to establish resilience within the supply chain. The council will be co-chaired by National Security Advisor Jake Sullivan and National Economic Advisor Jared Bernstein and include Health and Human Services (HHS) Secretary Xavier Becerra. Among the responsibilities of the council will be to identify supply-chain risks through data sharing, as well as recommendations to address those risks, and address the working conditions for those employed in the country to keep supply chains running as issues arise.
• Utilization of Defense Production Act. The primary source of presidential authority to expedite and expand the supply of materials and services from the US industrial base needed to promote the national defense, the act will be utilized to produce more essential medicines throughout the country and to mitigate drug shortages. President Biden reportedly will issue a presidential determination to broaden HHS authority to enable investment in domestic manufacturing of essential medicines, medical countermeasures, and critical inputs that have been deemed essential to the national defense. HHS has reportedly identified $35 million for investments in domestic production of key starting materials for sterile injectable medicines and will designate a supply-chain resilience and shortage coordinator dedicated to medical product and critical food supply chains. HHS also reportedly intends to institutionalize this coordination to advance the department’s supply-chain resilience and shortage mitigation goals over the long term, and the Department of Defense is expected to release a new report on pharmaceutical supply-chain resilience aimed at reducing reliance on high-risk foreign suppliers.
• Supply Chain Data-Sharing Capabilities. The administration has developed several cross-governmental partnerships to improve supply-chain monitoring and strategy, including a Supply Chain Center that’s described as a first-of-its-kind initiative to develop innovative supply chain risk assessment tools and to coordinate analyses on select critical supply chains to drive targeted actions to increase resilience. Additionally, a partnering with HHS will result in better assessment of industry to help address foreign dependency, vulnerabilities, and points of failure for critical drugs.
• Freight Logistics Optimization Works (FLOW) Program. A public-private partnership led by the Department of Transportation, FLOW will bring together supply-chain stakeholders to create a shared, common picture of supply-chain networks and facilitate a more reliable flow of goods. Stakeholders are reportedly beginning to utilize FLOW data to inform logistical decision-making to avoid bottlenecks, shorten lead times for customers, and enable a more resilient and globally competitive freight network through earlier warnings of supply-chain disruption.

Collectively, the new analytical capabilities are anticipated to enable the council to coordinate more complete, whole-of-government critical supply-chain monitoring.

“[The recent] announcement by President Biden is a major milestone in the whole-of-government approach we have championed through our role in the administration’s Joint Supply Chain Resilience Working Group and with [The Food and Drug Administration’s] Supply Chain Resilience Program,” said Whitaker. “We look forward to continuing this partnership with the administration, serving as a resource to strengthen sterilization capacity, as well as access to mature semiconductors and other critical materials such as helium. A resilient supply chain is key to protecting patients as our members continue to develop the life-saving medical technologies needed to diagnose and treat them, and we remain committed to working with our partners in the federal government to ensure patients are put first.”

Boston Scientific Packaging Engineer Earns Rising Leader Honor

IoPP recognizes James Naze for his contributions to the association and the medical device packaging community.

By Kassandra Kania

Every year, the Institute of Packaging Professionals (IoPP) honors deserving members who volunteer their time and energy to further the organization’s goals and initiatives. This year, the Board of Directors bestowed the title of Rising Leader on James Naze, senior packaging engineer at Boston Scientific.

Naze, who has been an IoPP member since 2008, has more than?25 years of packaging experience and earned his Rising Leader nomination because of his active advocacy work in the association and beyond. He?has provided valuable insight as a longtime IoPP Medical Device Packaging Technical Committee (MDPTC) member, and his continued involvement with IoPP highlights a deep commitment to the packaging industry.

Currently, Naze is president of the IoPP New England Chapter. During the pandemic, he kept the chapter active and engaged online. He frequently meets with IoPP regional vice presidents and other chapter leaders to share membership retention and growth ideas.

When asked to comment on his nomination, Naze was quick to share the credit: “Although it is nice to be recognized personally, what I think this really means is that the New England Chapter is being recognized as a strong and active group that wants to grow and enhance the experience for its members.”

Naze plans to continue growing membership in 2024 and get existing members more actively involved, particularly as hosts for plant tours. He would also like to find ways to better engage regional members outside the chapter’s historical “core zone” of Southeast New England. According to Naze, Connecticut and Southern New Hampshire are regions of untapped potential for member engagement.

“In addition to more manufacturing facility tours, we’d like to have a group outing to a Worcester Red Sox game or similar fun event,” he shares. “In regard to getting current members more involved, I’d like to fill all the open committee chair positions with members who have never been on the board before.”

Naze credits past presidents Lynne Barton and Joe Iannone with maintaining the chapter during tough times, and he believes that the chapter is stronger because of their leadership.

“I stand on the shoulders of giants,” he says. “They have taught me a lot, and I am forever grateful for their mentorship.”

If you’d like to get involved, reach Naze at [email protected].

MORE WEEKLY NEWS

?? Hottest Takes from Medical Device Professionals: MD+DI recaps some of the boldest comments from the guests on Let's Talk Medtech in 2023.

?? Digital Medtech Has a Humility Deficit: A medtech thought leader says too many digitally focused medical device companies lack the humility to build critical partner relationships. Do you agree?

?? Surviving the Headwinds in Medical Device Manufacturing: Flex will discuss how to minimize risk and steer clear of potential pitfalls in the device manufacturing realm.

?? EndoQuest Robotics Secures $42M in C-1 Financing: The capital will fund advancements to the company’s flexible endoluminal robot which is meant to address unmet needs in gastrointestinal and other endoluminal surgeries.

?? Edwards to Spin Off Critical Care Business in 2024: The Irvine, CA-based company said the measure will help it focus more on its structural heart offerings, which include transcatheter aortic valve replacement procedures.