AdvaMed Archives - Medical Design Sourcing

AdvaMed warns Biden of threat from EtO facility closures

AdvaMed CEO and President Scott Whitaker [Photo courtesy of AdvaMed]

The Advanced Medical Technology Association (AdvaMed) shared industry concerns over new ethylene oxide (EtO) regulations with President Joe Biden, warning that sterilization facility closures could cause device shortages.

In a new letter to Biden, AdvaMed President and CEO Scott Whitaker said the medtech industry welcomes updated regulations for EtO sterilization facilities and reiterated patient safety warnings.

“With 20 billion medical devices sterilized using EtO each year in the U.S. at about only 100 facilities, the closure of even a small percentage of facilities could harm patient access to health care,” Whitaker wrote. “EtO sterilization is at capacity. With 80 percent of surgical kits alone sterilized using EtO, any shutdown-induced disruption could reverberate from screening to the operating room to post-oper…

How Medtronic, Abbott, Resmed see healthcare improving through ecosystems

Medtronic’s Geoff Martha (left), Abbott’s Lisa Earnhardt (middle) and ResMed’s Mick Farrell (right). The trio discussed the medtech ecosystem at AdvaMed’s The MedTech Conference in Boston.

According to McKinsey & Company Senior Partner Rajesh Parekh, “ecosystem” is a word used plenty in the tech world. Now it’s coming into the medtech space.

So, what is an ecosystem? How can medtech companies take advantage of one to provide better care and improved patient outcomes? How can they do so with speed in an ever-changing environment? Three major medtech leaders joined Parekh at AdvaMed’s The MedTech Conference in Boston to try and explain that.

Medtronic Chair and CEO Geoff Martha, Abbott EVP of Medical Devices Lisa Earnhardt and ResMed CEO Mick Farrell offered their views on ecosystems in the space.

What is an ecosystem in healthcare?

Earnhardt said an ecosystem brings a variety of stakeholders together to …

5 top trends shaping the medtech industry

Ashley McEvoy (left), Michael Minogue (middle) and Barry Rosenberg (right) speak at AdvaMed’s The MedTech Conference in Boston.

Ashley McEvoy is an industry veteran and the EVP and worldwide chair of Johnson & Johnson MedTech. Michael Minogue, another veteran, serves as chair, president and CEO of heart pump maker Abiomed.

Together, the two bring a wealth of medtech industry knowledge to the table. They demonstrated that in a “CEOs Unplugged” discussion at AdvaMed’s The MedTech Conference today.

McEvoy and Minogue joined Boston Consulting Group Managing Director and Senior Partner Barry Rosenberg onstage to discuss major medtech trends. The two went in-depth on five that they see in the industry right now: AI, health equity, hospital care, talent and climate change.

Here is more about the five trends:

1. AI

McEvoy said there is discussion over the potential framework for how to embrace artificial intelligence (AI) and m…

How Dexcom uses wearables to deliver differentiated diabetes management

Dexcom has worked with Garmin to create apps on Garmin devices that use real-time CGM data. [Image from Garmin]Dexcom (Nasdaq:DXCM) is one of the leaders in the diabetes technology space with its continuous glucose monitoring (CGM) technology.

The company’s current-generation Dexcom G6 CGM remains one of the biggest players in the CGM space. Meanwhile, its next-generation Dexcom G7 CGM has already launched in a number of countries overseas. The wearable device — which features a 60% size reduction from G6 — still awaits FDA clearance.

Dexcom sits among a number of companies developing wearables for helping people manage their diabetes. The company’s SVP for Product, Global Marketing, Apurv Kamath, spoke today at AdvaMed’s The MedTech Conference on the impact of wearables.

While he focuses on diabetes management, the panel on which he sat covered a range of uses for wearables in medtech. It featured Alissa Hsu Lynch, global lead for medtech…

What does the future hold for AI in medical devices?

(Image courtesy of the FDA)

Digital health, artificial intelligence (AI), machine learning and more — these concepts continue to generate buzz in the medtech world.

Last month, the FDA published guidance on clinical decision support (CDS) software. It helped to clear up what constitutes a medical device and what doesn’t. Early last year, the agency published a predetermined change control plan (PCCP) to help build a regulatory structure for such technology.

These topics and more spurred intriguing commentary on a panel at AdvaMed’s MedTech Conference in Boston today.

The panel featured viewpoints across all angles of the space. Dr. Yuri Maricich, CMO and head of development at Pear Therapeutics, offered thoughts from the developer of digital therapeutics. Brendan O’Leary, acting director of the Digital Health Center of Excellence at the FDA, provided the regulatory vantage po…

5 essential leadership lessons from Cathy Burzik for medtech’s next generation of women leaders

Cathy Burzik, a seasoned senior executive in the healthcare industry, has successfully led major medical device, diagnostic, diagnostic imaging and life sciences businesses.

Cathy Burzik is CEO of CFB Interests. [Photo courtesy of CFB Interests]

Cathy Burzik, CFB Interests (as told to MedExecWomen co-founder Maria Shepherd)

One key to being a successful women leader in MedTech: “Play nice, but play to win.”

Cathy Burzik, who received a Lifetime Achievement Award from AdvaMed in 2019, shared this advice during a recent MedExecWomen conference fireside chat with co-founder Maria Shepherd.

Burzik explained how you can apply this to your own career path and leadership style, along with many other powerful lessons she’s learned throughout her career.

Build connections early in your career

If you’re just starting your career or have taken a detour and are finding your new path, buil…

AdvaMed pushes CMS for proposed TCET pathway rule this year

The Advanced Medical Technology Association (AdvaMed) is asking the Centers for Medicare & Medicaid Services (CMS) to move fast on a new way to guarantee reimbursement for new medtech innovations.

CMS repealed the Medicare Coverage of Innovative Technology (MCIT) program last year but promised to explore other options to improve the coverage process for access to innovative and beneficial medical devices.

Now, a pathway called the Transitional Coverage for Emerging Technologies (TCET) program could take its place. CMS and medtech industry representatives have discussed the need for Medicare coverage reforms in two listening sessions (transcripts with webinar replay information are here and here).

In an Aug. 1 letter to CMS Administrator Chiquita Brooks-LaSure and Principal Deputy Administrator and COO Jon Blum, AdvaMed called on them to issue a proposed rule this year.

“We believe that CMS, in order to advance its health equity and other…

AdvaMed wants diagnostic regulatory reforms in FDA user fees renewal

[Image courtesy of Amazon]

The Advanced Medical Technology Association (AdvaMed) and diagnostic test manufacturers, labs, health care nonprofits and industry associations are asking federal lawmakers to pass diagnostics regulations as part of the FDA Safety and Landmark Advancements (FDASLA) Act of 2022.

The proposed diagnostic test regulations — outlined in the Verifying Accurate, Leading-edge IVCT Development (VALID) Act — would increase FDA’s oversight of laboratory-developed tests (LDTs), treating them more like medical devices with a risk-based approach. The VALID Act would require pre-market review for diagnostic tests that have a high risk of serious injury or death due to treatment decisions based on inaccurate results.

“The current federal approach to oversight has fueled regulatory uncertainty that jeopardizes investment in the next generation of diagnostics that will provide for im…

FDA adds AEDs and other medical devices to shortage list

An automated external defibrillator (AED) [Photo by James Rein]

The FDA has added automated external defibrillators (AEDs), chest drains/suction canisters and autotransfusion systems to its list of medical devices in short supply.

AEDs — including wearable and nonwearable versions of the devices — are expected to be in limited supply for at least the rest of 2022, the FDA said. The agency cited both an increase in demand for AEDs and the global shortage of semiconductors used in the devices.

“The FDA continues to work with federal partners and other stakeholders to help mitigate challenges associated with semiconductor shortages,” the FDA said in yesterday’s update to the device shortage list. “In addition, the FDA has issued guidance documents, including enforcement policies, regarding circumstances where manufacturers may consider modifying their devices because of supply chain …

Five steps to help medical device makers deal with semiconductor shortages

[Photo by Vishnu Mohanan]

Medical device manufacturers are increasingly pessimistic about the supply of semiconductors, according to Deloitte’s latest survey of the industry.

Some said they’ve slowed down or halted manufacturing operations after depleting their semiconductor inventories, and nearly 80% of survey respondents reporting extended lead times, with some stretching more than a year.

“More than 75% of our most-recent survey respondents said that their customers have turned to alternative types of treatment for their patients,” Deloitte’s Stephen Bradley and Bill Murray wrote in a new report. “As a result, some hospitals and health systems are looking into alternate products, new usage strategies or treatment options.”

The Advanced Medical Technology Association (AdvaMed), which continues to push for the medical device industry to be prioritized fo…

‘Catastrophic explosion’ and resin shortage led Medtronic’s supply chain problems

Medtronic CEO Geoff Martha [Photo courtesy of Medtronic]

Medtronic CEO Geoff Martha today said a “catastrophic explosion” in Medtronic’s supply chain for packaging and a shortage of resins were the biggest issues hurting the company’s fourth-quarter performance.

Fridley, Minnesota-based Medtronic (NYSE:MDT) reported about $350 million less in sales than analysts were expecting for the quarter, which ended April 29.

Martha said about 75% of the miss was caused by supply chain issues, 15% by the COVID-19 lockdown in China and the last 10% due to foreign exchange rates getting worse.

Supply chain struggles “came out fast and hard” in the fourth quarter across the company’s businesses, but were most pronounced in Surgical Innovations (SI), Martha said.

“It was three things,” Martha said. “It was semiconductors, which is affecting every…

AdvaMed joins Biden’s Joint Supply Chain Resilience Working Group

AdvaMed executive Abby Pratt has joined the executive committee for the Biden administration’s Joint Supply Chain Resilience Working Group, the medtech industry association said today.

The working group’s members from government and industry will assist with implementation of the National Strategy for a Resilient Public Health Supply Chain.

Pratt oversees supply chain issues as SVP in AdvaMed’s global policy department.

“Without access to component parts, ranging from high-tech semiconductor chips to basic papers and resins, our members are struggling to meet the demands of our health care system, potentially impacting the health and wellbeing of millions of Americans,” she said in a news release. “I am grateful for the opportunity to work with members of this public-private working group to address issues impacting our industry and to help ensure our supply chain is secure for patients in need.”

Get the full sto…