Global & Trade Archives - AdvaMed

Medtech POV Podcast: Rep. Brad Wenstrup on COVID-19 Lessons, Common Sense in Health Care, and Treating Shooting Victim Scalise

Fiona Lynch — Wed, 12 Feb 2025 15:19:13 +0000

Global & Trade

Washington, D.C. –  On the Medtech POV podcast, AdvaMed President and CEO Scott Whitaker sat down with recently retired U.S. Rep. Brad Wenstrup of Ohio, discussing lessons learned from the COVID-19 pandemic, illogical budgetary scoring of health care procedures, and Wenstrup’s life-saving triage of U.S. House of Representatives Majority Leader Steve Scalise after a shooting.

Wenstrup is a podiatric surgeon, a colonel in the U.S. Army Reserve, and an Iraqi War veteran. He served as the U.S. representative for Ohio’s 2^nd congressional district from 2013 to early 2025, with service on the Ways and Means and Intelligence committees. He chaired the Select Subcommittee on the Coronavirus Pandemic and urged listeners to read the subcommittee’s final report recommendations.

“They’re nonpartisan. They just make sense for America,” Wenstrup said. “Those are the lessons learned from along the way. I’m not trying to cast as much aspersion on those that were trying to do the right thing, but let’s do better next time from the lessons learned.”

Wenstrup was the lead Republican co-sponsor of the bipartisan Ensuring Patient Access to Critical Breakthrough Products Act, H.R. 1691 in the last Congress, to give Medicare beneficiaries faster access to safe, effective, FDA-designated breakthrough medical devices. The Ways and Means Committee approved the bill, and AdvaMed will seek re-introduction and enactment in the new Congress.

Wenstrup advocates for common sense in the congressional scoring and insurance coverage, including Medicare, of medical procedures and treatments. Current consideration downplays the cost savings of preventive measures and cures that might be costly at the outset but provide considerable cost savings over a patient’s life and even more importantly, restore the patient to wellness, Wenstrup said.

“We’ve got to be patient centric,” he said. “There is a return on investment. If you have some new technology or innovation, that even if it’s a device for the rest of your life, but it allows you to go back and live your life and go to work and raise your family, that’s a pretty good return on investment.”

Wenstrup details his experience treating Scalise moments after Scalise’s shooting on a baseball field in 2017.

“Steve is such an amazing guy,” Wenstrup said. “Tremendous courage through all that, never complained, multiple surgeries and everything else, and he just keeps on going. He always says, oh, Brad, you’re my hero, and I’m like, no, you are mine, because I don’t know how many people that have had the strength and courage that he has.”

To hear the full conversation, download the Medtech POV podcast on Spotify,  Apple Podcasts or wherever podcast streaming is available. Visit AdvaMed’s website for more information on the podcast and past guests.

Call to Action…

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AdvaMed Seeks Medical Technology Exemption from All Tariffs

Fiona Lynch — Sat, 01 Feb 2025 16:48:26 +0000

Global & Trade

Washington, D.C. – AdvaMed, the Medtech Association, today released the following statement from President and CEO Scott Whitaker following the imposition of tariffs on products from Canada, Mexico, and China:

“We share President Trump’s goal to protect public health, as well as his deep concern for the terrible impact drugs have on too many Americans and on our health care system. This is also why we are concerned about tariffs on medical products from Canada, Mexico, and China.

“We have shared with the Administration our concerns about the potential impact tariffs could have on the medical technology supply chain that American patients depend on for their care. In light of that risk, an exemption was provided for most medical devices during President Trump’s first term with respect to the tariffs on China, and we are advocating for a similar approach this time. We will closely monitor for any effects the tariffs may have on this critical supply chain and share that information with the Administration.”

Whitaker continued: “Our industry is heavily regulated: FDA decides what products can be put on the market, and then Medicaid, Medicare, and the VA largely determine the reimbursement for procedures using medtech products. This means tariffs impact American companies similarly to an excise tax, which would lead to less R&D/innovation, layoffs, higher prices for the above-mentioned payors and patients, or all of the above. Additionally, moving manufacturing from one facility to a different or new facility requires FDA approval, which makes it difficult in the short term to adjust production to the U.S.

“The increased costs posed by tariffs, and their functioning essentially as an excise tax in practice, could resurrect the climate of concern the medical device excise tax created for nearly a decade.

“During the President’s first term with respect to the tariffs on China, a carve-out was provided for much of the medtech sector, given the risks to the U.S. hospital supply chain. We maintain that the potential supply chain disruption and its downstream effects on patients remain a risk, should tariffs be implemented. Shortages of critical medical technologies are a real concern in our initial modeling.

“Tariffs could hold back the innovation potential of the U.S. medtech industry. R&D spending would likely be the first and most direct casualty, threatening America’s medtech innovation leadership. And increased tariffs may even have the unintended consequence of boosting the competitiveness of medtech industries of other nations.  

“We hope that these critical facts resonate with the Administration, and we will continue to make our case on behalf of the patients our companies serve.”

Call to Action…

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EY 18th annual Pulse of the MedTech Industry Report

Wintana Zerai — Fri, 25 Oct 2024 14:44:00 +0000

Global & Trade

The Pulse of the MedTech Industry Report 2024 from EY is now available for download! While research shows that the MedTech industry is still growing, it is increasingly walking a narrow path between converging top-line and bottom-line pressures. With deep insights from EY thought leaders and perspectives from top MedTech executives on the current financing environment, capital efficiency viewpoints, what’s next in MedTech financing, and the future of innovation, the EY analysis on the state of the industry leaves no stone unturned.

Click here for details: www.ey.com/pulse

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AdvaMed Welcomes India, New Member Countries from Latin America, Middle East, Africa to IMDRF

Fiona Lynch — Thu, 10 Oct 2024 21:58:28 +0000

Global & Trade

Washington, D.C. – The International Medical Device Regulators Forum (IMDRF) consists of medical device regulators from around the world that voluntarily convene to harmonize the regulatory requirements for medical products varying from country to country. The U.S. FDA is the Chair and Secretariat of the IMDRF for 2024 and recently hosted its 26^th session. The IMDRF added 15 new affiliate members this year (Botswana, Costa Rica, Dominican Republic, El Salvador, Ethiopia, Kenya, India, Jordan, México, Oman, Nigeria, Paraguay, Peru, Tanzania, and Zimbabwe).

Scott Whitaker, president and CEO of AdvaMed, the world’s largest medtech trade association, made the following comment on India’s joining the IMDRF and the additional expansion of member countries.

“The IMDRF has the important mission of harmonizing medtech regulations from country to country. This leads to more efficient patient access to medtech innovations globally. The organization has done a great job adding new affiliate members from Latin America, Africa, the Middle East, and India. India’s joining of the esteemed ranks of the IMDRF is welcome news. We expect that this new platform will help India with its stated goal of achieving global alignment in its medical device regulatory system.

“In addition, the U.S. FDA is performing strongly as the IMDRF Chair and Secretariat. Welcoming new member countries and ensuring their productive participation is just what patients ultimately need. AdvaMed commends the FDA for its work and welcomes India as a pivotal medtech hub to an organization that does so much for public health.”

Call to Action…

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AdvaMed Welcomes APEC Recommendations for Enterprise Integrity and Public Procurement

Cody Uhing — Mon, 23 Sep 2024 21:15:37 +0000

Global & Trade

Lima, Peru – AdvaMed, the Medtech Association, issued the following press release following conclusion of the 2024 Asia-Pacific Economic Cooperation (APEC) Business Ethics for Small- and Medium-Sized Enterprises (SMEs) Forum in Lima, Peru.

“AdvaMed commends APEC’s continued focus on the importance of high-standard business ethics for the medical technology sector, incentivizing ethical business conduct in the public procurement process and continuing advancement of global harmonization of medtech industry codes of ethics,” said Christopher L. White, AdvaMed General Counsel & Chief Policy Officer. “We are delighted that this year’s forum included discussions surrounding government implementation of procurement incentives for enterprises that demonstrate ethical business conduct.”

The 2024 APEC Ethics Forum brought together hundreds of leading health care stakeholders, including the U.S. Department of Commerce and other APEC member economies, medtech associations and their member companies, patient and physician organizations, and others in health-related sectors to align on pivotal strategies for advancing business ethics.

“By focusing on collaborative solutions through collective action, these meetings aim to create a level playing field and advance high standard business ethics critical to patient safety and building trust with the patients we serve,” added AdvaMed’s VP, Assistant General Counsel, Ethics & Compliance Ida Nassar.

“As we move beyond the APEC meetings, government recognition of the value of codes of ethics and rewarding industry adherence to these codes through incentives in public procurement ensures integrity and innovation remain intertwined,” Nassar noted. “We were very pleased to see the 2024 APEC SME Ministerial Statement, which commits to furthering government-to-business interaction by incentivizing ethical business conduct.”

AdvaMed is encouraged by the APEC Recommendations for Enterprise Integrity in Public Procurement and updates to the UNODC/OECD Resource Guide on State Measures for Strengthening Business Integrity, which include recommendations and guidance for companies and governments, including government implementation of procurement incentives for enterprises that demonstrate ethical business conduct.

Since 2010, AdvaMed has been honored to help advance the APEC Business Ethics for SMEs Initiative, extending high-standard codes to 31 medical technology associations across 19 economies in the APEC region. These associations collectively represent over 12,000 member enterprises, of which over 10,000 are identified as SMEs. The initiative is also supported by a capacity building platform with an expert team of over 60 members, led by AdvaMed, and advanced in partnership with our many partners, including the U.S. Department of Commerce.

Call to Action…

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AdvaMed Signs New MOU with British Medtech Association

Cody Uhing — Wed, 26 Jun 2024 14:24:49 +0000

Global & Trade

WASHINGTON – Today, AdvaMed, the Medtech Association, signed a renewed memorandum of understanding with the Association of British HealthTech Industries (ABHI) to strengthen the relationship between two of the leading medtech organizations in the world. The new MOU, which was first signed by the two organizations in 2020, includes new AI regulatory collaboration, trade and market access policy alignment, and enhanced collaboration around regulatory reliance policy developments.

“AdvaMed is proud to partner with our friends in the United Kingdom to advance our shared goal of improving patient access to lifesaving medical technology,” said Scott Whitaker, AdvaMed President and CEO. “This updated MOU comes as our industry, both at home and abroad, innovates at a rapid pace, producing new technologies and software year after year. Agreements like this are vital to our work to seek new public policy opportunities and address any challenges before they impact our industry. We thank ABHI for their partnership and their leadership in the U.K., and we look forward to working alongside their team for years to come.“

“I am personally very proud of the strengthened partnership between ABHI and AdvaMed. We recognise the strong value that AdvaMed delivers on behalf of the global industry, and this enhanced collaboration will allow us to work together even more closely to support the industry,” said ABHI CEO Peter Ellingworth. “Together, we will drive positive change in the HealthTech sector worldwide, ultimately benefiting patients by improving access to lifesaving technologies.”

The MOU includes many provisions to improve collaboration between the U.S. and U.K. medtech markets, including:

AI regulatory development
Regulatory convergence
Trade and 3^rd Party Country engagement
National Health Service sustainability initiative

Call to Action…

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AdvaMed Statement on FDA-USAID India Regulatory Session

Fiona Lynch — Tue, 16 Apr 2024 18:50:09 +0000

Global & Trade

WASHINGTON, D.C. – AdvaMed, the Medtech Association, released the following statement thanking the FDA Center for Radiological Health (CDRH) for recently hosting an event in New Delhi to discuss regulatory policies and best practices for ensuring medical technology reaches patients. The event, called “Minds to Markets: Regulatory Considerations in Med-Tech,” advances US-India cooperation on medtech supply chain through greater regulatory alignment.

“India is a critical partner in medtech, and events like this provide valuable opportunities to further align our regulatory frameworks and standards so that we can innovate, grow, and better serve patients in both countries and around the globe,” said Scott Whitaker, AdvaMed President and CEO. “We thank FDA and USAID for organizing this event and welcoming our India Regulatory Subgroup Chair Asok Kumar as a panelist to discuss a range of issues facing the medtech industry in the United States and India. I also want to thank U.S. Ambassador to India Eric Garcetti for attending this important event and recognizing the role medtech plays in the health care system.”

The event, which was held on Friday, April 12, in New Delhi, India, included panels on topics such as FDA’s approach to ensuring the safety and efficacy of medical technology, medtech innovation, and patient access. FDA regulators also discussed regulation of medical devices, the important role of the International Medical Device Regulators Forum (IMDRF), Artificial Intelligence and Machine Learning (AI/ML), innovation in devices, and regulatory harmonization and reliance in practice.

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Call to Action…

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AdvaMed Statement on the World Trade Organization Ministerial Conference

Cody Uhing — Sat, 02 Mar 2024 00:22:58 +0000

Global & Trade

WASHINGTON, D.C. – Today, AdvaMed, the Medtech Association, released the following statement from President and CEO Scott Whitaker regarding the conclusion of the World Trade Organization Ministerial conference in Abu Dhabi:

“We are pleased with the outcome of the WTO ministerial conference, which did not include an expansion of the TRIPS waiver to diagnostics and therapeutics. Expanding the waiver would have jeopardized innovation and undermined future investments in medical technology R&D—investments critical to combatting the COVID pandemic and future global health crises. We are committed to continuing our work with the U.S. government, WTO members, international policymakers, and other stakeholders to develop comprehensive solutions in trade and health that address the regulatory, logistical, and trade impediments that have served as well-documented barriers to access throughout the pandemic.

“We are also pleased that the WTO listened to the overwhelming number of stakeholders who support the renewal of the moratorium on customs duties on electronic transmissions. Failing to renew this 30-year-old foundational agreement would have been devastating to medtech businesses, especially small enterprises, that would have had to navigate new restrictions and tariffs, and in our industry could have limited access to life-saving medical technology for millions of patients worldwide.”

AdvaMed joined other organizations in February to urge the Biden Administration to oppose the extension of the TRIPS waiver to cover diagnostics and therapeutics, as well as to support the extension of the e-commerce moratorium.

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Call to Action…

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AdvaMed Statement on the Sale and Privatization of the Federal Helium Reserve

Cody Uhing — Mon, 22 Jan 2024 15:21:54 +0000

Global & Trade

WASHINGTON, D.C. – Today, Scott Whitaker, President and CEO of AdvaMed, the Medtech Association, urged the White House to delay the sale and privatization of the Federal Helium Reserve until concerns about resulting supply chain disruptions are resolved.

“Helium is critical to the function and operation of key medical technologies patients rely on for their care. For example, it’s used to cool the magnet in magnetic resonance imaging machines. American patients receive an estimated 40 million MRI scans each year to help diagnose strokes, tumors, brain injury, spinal cord injury, and heart problems.

“Only a few countries worldwide produce helium. U.S. manufacturers tend to rely on the Federal Helium Reserve to meet the needs of the MRI machines installed throughout the country. There’s a real risk that these companies, and global companies that purchase our helium, will be forced to seek sources elsewhere. That’s particularly challenging, given the war with Ukraine and crisis in the Middle East, which has spilled over to the Red Sea, a major trade route.

“While innovations to use less helium in medtech are under way, MRI machines are made to last for years as an investment and aren’t easily replaced. AdvaMed urges the White House to delay the sale and privatization of the Federal Helium Reserve until outstanding issues identified by the Compressed Gas Association are resolved. Timely, critical patient care would suffer if helium supplies constricted further.”

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Call to Action…

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AdvaMed Statement on 14th Ministerial Meeting of the United States-India Trade Policy Forum

Fiona Lynch — Fri, 19 Jan 2024 15:11:45 +0000

Global & Trade

WASHINGTON – AdvaMed President and CEO Scott Whitaker released the following statement regarding the 14^th Ministerial-level Trade Policy Forum held in New Delhi, India:

“Reinforcing a strong bilateral trading relationship with India is critical for our countries, and especially for the medtech manufacturers in the U.S. and India. I am glad to see Ambassador Tai and Minister Goyal continue to make progress on strengthening these ties during their most recent Ministerial-level discussions. Most notably, the cooperation between our two countries to diversify and strengthen supply chains and improve trading of high-tech products is welcome news as we continue to recover from pandemic-related challenges.

“AdvaMed and our members are also pleased with the ongoing discussions about Trade Margin Rationalization (TMR) to facilitate patient access to affordable medical devices and the recognition on both sides about the importance of addressing standards and pricing issues for medical devices. We continue to encourage both sides to undertake more in-depth work to foster greater regulatory harmonization and demonstrate progress towards adopting international standards that will reduce barriers to trade and strengthen supply chains.

“AdvaMed also welcomes the launch of recent discussions on bilateral government procurement and is encouraged by Ambassador Tai and Minister Goyal’s plan for further technical engagement between their officials on transparency and procedural fairness.”

Read the joint statement from USTR Ambassador Tai and Minister Goyal here.

Call to Action…

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Global & Trade Archives - AdvaMed

Medtech POV Podcast: Rep. Brad Wenstrup on COVID-19 Lessons, Common Sense in Health Care, and Treating Shooting Victim Scalise

Global & Trade

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Medtech POV Podcast: Rep. Brad Wenstrup on COVID-19 Lessons, Common Sense in Health Care, and Treating Shooting Victim Scalise

AdvaMed Seeks Medical Technology Exemption from All Tariffs

EY 18th annual Pulse of the MedTech Industry Report

AdvaMed Welcomes India, New Member Countries from Latin America, Middle East, Africa to IMDRF

AdvaMed Welcomes APEC Recommendations for Enterprise Integrity and Public Procurement

AdvaMed Signs New MOU with British Medtech Association

AdvaMed Statement on FDA-USAID India Regulatory Session

AdvaMed Statement on the World Trade Organization Ministerial Conference

AdvaMed Seeks Medical Technology Exemption from All Tariffs

Global & Trade

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Medtech POV Podcast: Rep. Brad Wenstrup on COVID-19 Lessons, Common Sense in Health Care, and Treating Shooting Victim Scalise

AdvaMed Seeks Medical Technology Exemption from All Tariffs

EY 18th annual Pulse of the MedTech Industry Report

AdvaMed Welcomes India, New Member Countries from Latin America, Middle East, Africa to IMDRF

AdvaMed Welcomes APEC Recommendations for Enterprise Integrity and Public Procurement

AdvaMed Signs New MOU with British Medtech Association

AdvaMed Statement on FDA-USAID India Regulatory Session

AdvaMed Statement on the World Trade Organization Ministerial Conference

EY 18th annual Pulse of the MedTech Industry Report

Global & Trade

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Medtech POV Podcast: Rep. Brad Wenstrup on COVID-19 Lessons, Common Sense in Health Care, and Treating Shooting Victim Scalise

AdvaMed Seeks Medical Technology Exemption from All Tariffs

EY 18th annual Pulse of the MedTech Industry Report

AdvaMed Welcomes India, New Member Countries from Latin America, Middle East, Africa to IMDRF

AdvaMed Welcomes APEC Recommendations for Enterprise Integrity and Public Procurement

AdvaMed Signs New MOU with British Medtech Association

AdvaMed Statement on FDA-USAID India Regulatory Session

AdvaMed Statement on the World Trade Organization Ministerial Conference

AdvaMed Welcomes India, New Member Countries from Latin America, Middle East, Africa to IMDRF

Global & Trade

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Medtech POV Podcast: Rep. Brad Wenstrup on COVID-19 Lessons, Common Sense in Health Care, and Treating Shooting Victim Scalise

AdvaMed Seeks Medical Technology Exemption from All Tariffs

EY 18th annual Pulse of the MedTech Industry Report

AdvaMed Welcomes India, New Member Countries from Latin America, Middle East, Africa to IMDRF

AdvaMed Welcomes APEC Recommendations for Enterprise Integrity and Public Procurement

AdvaMed Signs New MOU with British Medtech Association

AdvaMed Statement on FDA-USAID India Regulatory Session

AdvaMed Statement on the World Trade Organization Ministerial Conference

AdvaMed Welcomes APEC Recommendations for Enterprise Integrity and Public Procurement

Global & Trade

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Medtech POV Podcast: Rep. Brad Wenstrup on COVID-19 Lessons, Common Sense in Health Care, and Treating Shooting Victim Scalise

Game-Changing Compliance Education for Healthcare Professionals: Healthstream Webinar

AdvaMed Seeks Medical Technology Exemption from All Tariffs

Medical Education & Training Guidance Document

EY 18th annual Pulse of the MedTech Industry Report

AdvaMed Welcomes India, New Member Countries from Latin America, Middle East, Africa to IMDRF

AdvaMed Welcomes APEC Recommendations for Enterprise Integrity and Public Procurement

The Role of Collective Action in Advancing High-Standard Business Ethics Critical to Patient Safety and Innovation

AdvaMed Signs New MOU with British Medtech Association

Global & Trade

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Medtech POV Podcast: Rep. Brad Wenstrup on COVID-19 Lessons, Common Sense in Health Care, and Treating Shooting Victim Scalise

AdvaMed Seeks Medical Technology Exemption from All Tariffs

EY 18th annual Pulse of the MedTech Industry Report

AdvaMed Welcomes India, New Member Countries from Latin America, Middle East, Africa to IMDRF

AdvaMed Welcomes APEC Recommendations for Enterprise Integrity and Public Procurement

AdvaMed Signs New MOU with British Medtech Association

AdvaMed Statement on FDA-USAID India Regulatory Session

AdvaMed Statement on the World Trade Organization Ministerial Conference

AdvaMed Statement on FDA-USAID India Regulatory Session

Global & Trade

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Medtech POV Podcast: Rep. Brad Wenstrup on COVID-19 Lessons, Common Sense in Health Care, and Treating Shooting Victim Scalise

AdvaMed Seeks Medical Technology Exemption from All Tariffs

EY 18th annual Pulse of the MedTech Industry Report

AdvaMed Welcomes India, New Member Countries from Latin America, Middle East, Africa to IMDRF

AdvaMed Welcomes APEC Recommendations for Enterprise Integrity and Public Procurement

AdvaMed Signs New MOU with British Medtech Association

AdvaMed Statement on FDA-USAID India Regulatory Session

AdvaMed Statement on the World Trade Organization Ministerial Conference

AdvaMed Statement on the World Trade Organization Ministerial Conference

Global & Trade