The EY Clinical Trial Fast Lane solution is designed to activate clinical trials in 45 to 60 working days through rapid performance of functional services, process excellence, deep understanding of clinical trial operations, real-time transparency across all involved stakeholders and prompt risk mitigation.

The EY Clinical Trial Fast Lane solution enabled Moores Cancer Center to accelerate activation of its highest priority clinical trials and implement related process improvements to improve clinical trial activation timelines across all clinical trials. As a result, MCC patients had access to these innovative, investigational treatments and therapies up to 11 times faster than traditional timelines for the institution.

Read the full Case Study.

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WASHINGTON, D.C. – Today, AdvaMed, the Medtech Association, released the following statement from President and CEO Scott Whitaker upon the passage of a research and development expensing tax provision critical to medtech innovation in the House of Representatives. The provision, which is part of the bipartisan, bicameral Tax Relief for American Families and Workers Act of 2024, would delay a change requiring businesses to deduct their research and development expenses over five years, instead allowing immediate deduction. Earlier this month, Whitaker urged Congress to approve the provision.

“R&D is critical to the medtech innovation upon which so many American patients rely. The way R&D expensing is handled under current tax law is especially challenging for the small and emerging companies that make up more than 80 percent of the medtech industry. This critical change to tax policy will unquestionably lead to greater innovation on behalf of the patients our industry serves. We appreciate the strong bipartisan vote tonight in the House and hope the Senate agrees that this important tax policy change would be a big step forward for patients.”

Under current law, research or experimental costs paid or incurred in tax years beginning after December 31, 2021, are required to be deducted over five years. The new provision delays the date when taxpayers must begin deducting those expenses over five years until after December 31, 2025.

The five-year deduction requirement is especially hard for small and emerging companies, which are critical to driving innovation and improving patient outcomes. Research and development funding is expensive and hard for small companies to afford, given their narrow operating margins.

In his letter to lawmakers earlier this month, Whitaker cited the example of Alva Health, a small company that wrote that the tax provision, if unfixed, would cause “delays in getting our lifesaving stroke detection product into the hands of patients in need.” He went on to write, “For the patients we serve, who rely on the technologies our industry develops, we are pleased to see this provision to fix the damaging change to Section 174 advance and encouraged by the prospect of timely enactment this year.”

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WASHINGTON, D.C. – Scott Whitaker, president and CEO of AdvaMed, the Medtech Association, today urged Congress to enact a research and development expensing tax provision critical to medtech innovation. The provision would delay a change requiring businesses to deduct their research and development expenses over five years, allowing immediate deduction.

“Research and development is essential to the creation of safe, innovative, and effective medtech devices and diagnostics,” Whitaker wrote U.S. House and Senate leaders. “The process of developing these new therapies and treatments is expensive and challenging for small, emerging companies to afford. Navigating a tax liability over five years produces an undue hardship for these companies, threatening to force many of the most innovative and promising medical technologies to wither on the vine.”    

The research and development provision, under tax code Section 174, is part of the bipartisan, bicameral Tax Relief for American Families and Workers Act of 2024 that passed out of a key House committee soon after introduction.

Under current law, research or experimental costs paid or incurred in tax years beginning after December 31, 2021, are required to be deducted over five years. The new provision delays the date when taxpayers must begin deducting those expenses over five years until after December 31, 2025.

The five-year deduction requirement is especially hard for small and emerging companies, which account for more than 80 percent of the medtech industry and are critical to driving innovation and improving patient outcomes. Research and development funding is expensive and hard for small companies to afford, given their narrow operating margins. In his letter, Whitaker cited the example of Alva Health, a small company that wrote that the tax provision, if unfixed, would cause “delays in getting our lifesaving stroke detection product into the hands of patients in need.”

Whitaker wrote to congressional leaders, “For the patients we serve, who rely on the technologies our industry develops, we are pleased to see this provision to fix the damaging change to Section 174 advance and encouraged by the prospect of timely enactment this year.”    

Whitaker’s letter is available here.

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Accelerated access to novel cancer therapies at Moores Cancer Center

Overview

1. Overview
2. Agenda
3. Speakers

Accelerated access to novel cancer therapies at Moores Cancer Center

AdvaMed Accel and the U.S. Commercial Service have teamed up to host a webinar exclusively for AdvaMed members on the China medical device sector and opportunities for U.S. exporters. Designed with small companies in mind, this webinar, on October 18 at 11am ET, will breakdown the Chinese medical device market, review the current regulatory requirements and pathways, and address I.P. protection in China for U.S. companies.

11:00 – 11:05 am ET	Welcome Remarks, Everett Wakai, Minister Counselor for Commercial Affairs, U.S. Embassy Beijing
11:05 – 11:20 am ET	China Medical Device Market Overview, Chang ZHANG, Senior Principal, IQVIA
11:20 – 11:35 am ET	NMPA Regulatory Requirements and Registration Pathway, Hamish King, Chief Executive Officer, Cisema
11:35 – 11:55 am ET	IP Protection in China,IP Attaché,U.S. Patent and Trademark Office China
11:55 – 12:05 pm ET	Q&A

Meet the Speakers

Hamish King

Chief Executive Officer

Cisema

Everett Makai

Minister Counselor for Commercial Affairs

U.S. Embassy Beijing

Conrad W. Wong

Senior Attorney

U.S. Patent and Trademark Office (PTO)

Chang Zhang

Senior Principal

IQVIA

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Accelerated access to novel cancer therapies at Moores Cancer Center

Overview

1. Overview
2. Speaker

Accelerated access to novel cancer therapies at Moores Cancer Center

The collapse of Silicon Valley Bank (SVB), Signature, First Republic, and Credit Suisse came as a shock to many. While the Federal Reserve and the Treasury Department acted quickly to keep U.S. account holders whole, the repercussions of these collapses remain to be seen. Join AdvaMed for a member briefing on May 18 from 3:00 – 4:00 pm to discuss the current state of the banking system and potential implications for companies and venture capital. Attendees will hear from Michael Peregrine, a partner with McDermott Will & Emery, who will provide an overview of the Federal Reserve findings on SVB, recent case law, and implications for financial institution reporting and oversight requirements going forward. 

This event is free to attend for AdvaMed members. Register here.

Michael Perigrine
Partner, McDermott Will & Emery

Michael W. Peregrine represents corporations, their boards of directors, and individual directors and officers in connection with the full range of governance, fiduciary duty, director liability and leadership issues. Much of Michael’s practice involves advising boards of directors on matters of sensitivity and controversy, often in connection with corporate and fiduciary crises. He is recognized as one of the leading national corporate governance counselors and is a respected interpreter of the law of fiduciary duties.

Michael serves as outside governance counsel to many prominent corporations, including hospitals and health systems, voluntary health organizations, colleges and universities, disease charities, social service agencies, health insurance companies, pharmaceutical companies and financial institutions. Clients regularly seek Michael’s advice on complex and discreet governance matters including—but not limited to—the following:

• General application of fiduciary responsibilities
• Board conduct, composition and culture
• Board and committee structure
• Oversight of corporate legal, risk and compliance functions
• Intra-board conflict and dysfunction
• Application of governance ‘best practices’

Michael is often called upon to advise boards on judicial and regulatory challenges to governance; he also provides strategic counseling related to difficult corporate reputation matters and problematic media coverage. In addition, he frequently serves as special counsel for confidential internal board reviews, investigations and disciplinary matters.

Michael is particularly known for his expertise concerning governance structures arising from mergers, acquisitions and other change of control transactions; he is also widely recognized for his knowledge of nonprofit corporate law and related matters of public policy. As a Senior Contributor to Forbes, he writes about governance, leadership and boardroom culture topics.

Michael is a nationally prominent and widely published thought leader on corporate governance matters. He is the author of both editions of the monograph Conflicts of Interest and the Non-Profit Board published by The Governance Institute. In addition to these monographs and his Forbes.com posts, Michael writes regular columns on corporate governance-related topics for Agenda, CorporateCounsel.com, and publications of The Governance Institute, the American Health Law Association and the National Association of Corporate Directors. He is a regular contributor on corporate governance topics to The New York Times’ “DealBook” feature; Corporate Board Member; The Chronicle of Philanthropy; the Harvard Law School Forum on Corporate Governance and Financial Regulation; Columbia Law School’s Blog on Corporations and the Capital Markets; New York University School of Law’s Compliance and Enforcement Forum; Law360; Corporate Compliance Insights; and Becker’s CEO Report. He is also frequently quoted on governance and compliance topics in The Wall Street Journal, Barron’s and The New York Times.

Michael is also coauthor of the three corporate governance compliance white papers published jointly by the US Department of Health and Human Services’ Office of Inspector General and the American Health Lawyers Association.

In addition to his written work, Michael is the founder and host of McDermott’s Governing Health podcast.

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WASHINGTON, D.C. – Following the introduction of the bipartisan American Innovation and Jobs Act in the U.S. Senate and its House companion the American Innovation and R&D Competitiveness Act, AdvaMed, the MedTech Association, called on lawmakers to quickly pass the legislation which would allow for small companies to deduct their research and development expenses in the year they are incurred. Currently, companies are required to deduct their expenses over the course of five years.

“R&D is critical for medtech companies developing the next generation of innovative treatments and diagnostics, but the R&D phase is also a period of uncertainty and high risk,” said Scott Whitaker, AdvaMed President and CEO. “Recent changes to the R&D amortization policy have exacerbated this risk by subjecting small companies to onerous tax burdens, including on federal grant funds, creating an environment where the most innovative and promising medical technologies could wither on the vine. The bipartisan bills in the House and Senate address this concern by reversing this policy, and we encourage Congress to make this measure a priority to support America’s small businesses, especially those developing the medical technologies that are improving health outcomes every day.”

“Repeal of this R&D tax change is necessary to preserve the ability of many small medical technology companies, the lifeblood of the device innovation ecosystem, to stay in business,” said DeChane Dorsey, Executive Director of AdvaMed Accel. “Changes to the tax code have created challenges for many small companies as they work to limit their tax liability on money given to them by the federal government to innovate technologies that fulfill an unmet need identified by agencies including NIH, NSF, and DoD. The current requirements run counter to the intent of establishing these grant programs and could roll back the clock on researching, developing, and bringing innovations that help patients to market.”

Research and development (R&D) is critical to the development of innovative medical technologies. It represents a major, necessary expense for medical technology companies to develop novel, safe, and effective products to serve patients. Prior to 2022, the tax code recognized the importance of U.S. innovation by allowing medical technology and other industries to deduct their R&D expenses in the year they were incurred. In January 2022 the policy changed requiring a deduction over five years, making it harder for companies to make critical investments in developing the latest in medical technology.

The medtech industry, represented by AdvaMed, is a world leader in developing new and innovative health care technologies, contributing nearly $100 billion to the U.S. economy and employing approximately 400,000 people. AdvaMed Accel represents small and emerging-growth medtech companies, which comprise more than 80 percent of the industry and serve as a key driver of innovation and patient outcomes. These small companies are the hardest hit by the change in tax treatment of R&D expense.

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In 2023, Congress has the opportunity to advance policies that will dramatically improve patient access to the life-changing and lifesaving medical tests, treatment, and technologies that are so critical to improving patient outcomes. As long as there are patients in need, AdvaMed will continue advocating for solutions that will improve the patient experience – and ultimately save and improve lives.

Our top medtech priorities for the 118^th Congress highlight opportunities to address the most important issues facing patients and the medical technology industry today. With these priorities as a guide, AdvaMed will collaborate with leaders and medtech champions from both parties in both houses of Congress to foster greater medical innovation and expand access to medical technologies.

Did You Know?

• Medical technology advancements helped increase life expectancy by more than five years from 1980-2019.
• Access to effective screening helped reduce deaths from breast cancer by 43% since its peak in 1989, prostate cancer by 53% since its peak in 1993, and cancer overall by 32% since 1990.

“America’s medtech companies continue to lead the world in medical innovation, improving lives and patient outcomes through accurate diagnostic testing, and safe and effective treatments. As we look to the future, the medtech industry is ready to strengthen its critical leadership role in meeting the needs of patients—we are ready to roll up our sleeves and work with the 118th Congress on policies that will prioritize and improve the lives of every patient in America, every time they need access to care.” 

––Scott Whitaker, President and CEO, AdvaMed

Top Medtech Priorities for the 118th Congress to Help Usher in a New Era of Innovation on Behalf of All American Patients

To the 118^th Congress:

More than ever before, the critical role the medical technology industry plays in our health care system was on full display throughout the pandemic. Our industry was at the center of the global crisis, developing and distributing billions of Covid tests and every other critical medical technology necessary to treat patients suffering from Covid.

We at AdvaMed, the world’s leading trade organization representing medical technology and device manufacturers, are proud of the medtech community’s incredible effort to meet the demands of the pandemic. But the reality is, it is only a small part of the overall picture of medtech: Everything you see, for example, when you walk into a clinic or doctor’s office or operating room—literally everything but the people and the pharmaceuticals—is medtech and plays an indispensable role in your care.

Whether it is the nearly 50 million surgeries performed annually in the U.S. or the delivery of 4 million babies, advancements in medtech are driving better outcomes, longer and healthier lives, and lower costs. Innovative medical technology is a key driver in increased U.S. life expectancy, which is projected to increase by nearly six years by 2060.

As we enter the 118^th Congress, there is a great opportunity for both sides of the aisle to come together on broadly bipartisan initiatives that will greatly impact patients. Recent polls show health care is a top priority of both Democratic and Republican voters; they want to see their elected representatives work across the aisle to improve access to care and lower costs—two areas in which medtech can play an important role.

And there’s nowhere better for the 118^th Congress to start than right here:

We have identified nine top priorities—from the unique vantage point of the lifesaving medical technology industry—that would have an immediate and long-term impact on patient care. Taken as a whole, they would unleash a new era of life-changing innovation for patients.

From diagnostics to treatment to recovery, patients want to know they are being treated not just by the best doctors and nurses—but with the latest and best medical technologies as well. Working together to turn these policies into law will go a long way toward ensuring every patient feels precisely that way about their care, every time.

We look forward to working with you to pass these initiatives and send them to the President’s desk.

Scott Whitaker
President and CEO
AdvaMed

Improve Patient Access to Breakthrough Medical Technologies

Improving the Medicare coverage pathway through the Centers for Medicare and Medicaid Services (CMS) of breakthrough medtech innovations will benefit patients suffering from a lack of medical alternatives, as well as foster greater innovation. Congress should:

• Pass bipartisan legislation similar to the Ensuring Patient Access to Critical Breakthrough Products Act, introduced last Congress by U.S. Rep. Suzan DelBene (D-Wash.) and the late Rep. Jackie Walorski (R-Ind.), which would guarantee Medicare beneficiaries access to cutting-edge, breakthrough medical innovation by expediting the coverage determination process and improving the availability of breakthrough devices for patients.
• Work with CMS on its Transitional Coverage of Emerging Technologies (TCET) proposed rule to establish a distinct, predictable alternative pathway to national Medicare coverage for emerging medical devices and diagnostics.

Strengthen U.S. Medtech Industry’s Global Leadership Position

The U.S. is the global leader in medtech. Patients worldwide deserve access to the lifesaving, life-enhancing medtech developed by the American industry. Congress should:

• Continue to ensure a level-playing field and better patient access to U.S. medical technologies in China – one of the fastest-growing medtech markets in the world.
• Continue to ensure continuity of patient access to medical technologies in the European Union by addressing serious implementation issues with the EU’s Medical Device and In-Vitro Diagnostic regulations.
• Work with AdvaMed to express to Japan the importance of maintaining stable, consistent medical device policies for the benefit of Japanese patients.
• In trade agreements, secure commitments that underpin medtech global access, such as best regulatory practices, regulatory harmonization, and health care supply chain prioritization and broaden patient access to medical devices, such as those undertaken by the United States-India Trade Policy Forum and the Indo-Pacific Economic Framework.

Secure American Medtech Supply Chain Resilience

The pandemic highlighted the increasing interconnectedness of the global supply chain and the resulting vulnerability to our health care system of significant disruptions. Protecting and prioritizing health care supply chains, both at home and across the globe, are essential to ensuring the timely delivery of patient care. Congress should:

• Work with the Administration to ensure the federal government obtains and maintains sufficient quantities of the key medical technology inputs, including semiconductors, plastics, and medical grade packaging, needed for patient care.
• Continue to press for the prioritization of medical applications in semiconductor chip supply manufacturing and procurement incentives, including mature chips, at the federal and state levels.
• Work with AdvaMed and the Administration to help increase supply chain support through industrial base expansion and enhanced trade with reliable partners.
• Bolster trade agreements to include commitments on medtech supply chain resilience and health care prioritization.

Ensure Patient Access to Accurate Diagnostic Tests

Medtech companies will continue to deliver patients the diagnostic testing products they need and expect. In order to achieve this critical goal, Congress should:

• Enact the bipartisan Verifying Accurate Leading-edge IVCT Development Act (VALID) Act.
• Work with AdvaMed’s coalition of laboratory stakeholders to ensure appropriate Medicare reimbursement rates for diagnostic tests. The flawed implementation of the Protecting Access to Medicare Act (PAMA) created an unsustainable payment system, necessitating congressional action.
• Re-authorize the Pandemic and All Hazards Preparedness Act (PAHPA), and advocate for the inclusion of lessons learned from the response to COVID-19 to prepare for future pandemics and other health emergencies.

Boost Next-Gen Medtech Innovation Through America’s Start-Ups

With more than 80 percent of American medtech companies considered small businesses, they are a key driver of the innovation that improves and saves patients’ lives. Ensuring their ability to bring their safe and effective medical devices to market is critical to improving patient outcomes. Congress should:

• Pass payment policies that promote adoption of innovative technologies, including TCET and other payment reforms.
• Work with AdvaMed to monitor FDA progress and rollout of the TAP Pilot to ensure compliance with MDUFA V requirements.
• Protect federal funding of research and development through programs like SBIR/STTR.
• Continue to preserve tax policies that encourage investment in small medtech companies such as provisions for qualified small business stock and net operating losses.
• Ensure that policies coming out of the Federal Trade Commission regarding non-compete agreements do not place small companies at a competitive disadvantage.

Strengthen Regulatory Process to Ensure Latest Medical Technologies Reach Every Patient

MDUFA V was a historic agreement, bringing greater predictability, consistency, and accountability to the entire device review process. Congress should:

• Work with AdvaMed to monitor FDA success in meeting increased hiring targets for medical device reviews.
• Ensure that additional resources support streamlining the review process such that improved performance targets are met for regulatory decisions on product submissions.
• Monitor FDA success in implementing provisions of the Consolidated Appropriations Act of 2023 including: predetermined change control plans, certificates to foreign governments, data transparency, and CLIA waiver provisions.

Close the Care Gap for Underserved Communities

The gaps in care and outcomes between those served in our best facilities and those in underrepresented and vulnerable populations are unacceptable. Diversity in medical device clinical trials will help close the gaps. Congress should:

• Pass legislation to accommodate payment for alternative providers (nurses, nurse practitioners, primary care providers) who can support clinical research through use of alternative trial design or alternative data collection methods that are supported, including digital and telehealth technologies.
• Work with AdvaMed to enhance diversity in trials, support legislation to modernize human subject reimbursement and compensation regulations and create safe harbors for financial assistance for human subjects and investigators vis a vis the federal Anti-Kickback Statute.

Protect Sterilization Processes in Order to Protect Public Health

Federal regulations must protect the health care system’s ability to continue serving patients with sterile medical equipment. Congress should:

• Ensure EPA regulations allow the medtech industry to meet growing demand for sterile medical devices in health care settings nationwide, preserving a stable domestic function, complying with and exceeding all local, state, and federal laws on ethylene oxide emissions using sophisticated technology.
• Reiterate to federal, state, and local regulators that patients and communities come first in every aspect of medical technology, including the sterilization of the medical devices necessary for every aspect of health care, from screening to the operating room to post-operative care.

Ensure Tax Law Keeps Pace with Medtech Innovation

The right tax policy will help encourage the research and development that is so critical to medical innovation on behalf of patients in need. Congress should:

• Reinstate the immediate expensing of research and development costs. The Tax Cuts and Jobs Act of 2017 changed expensing timelines to be amortized over a number of years. This change provides a disincentive for investment and makes U.S. businesses less competitive.

Learn more about AdvaMed’s policy work.

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As 2022 comes to a close, we reflect on the significant accomplishments that AdvaMed and its member companies have achieved on behalf of the medtech industry and patients everywhere this year. Because of the hard work of AdvaMed staff and our dedicated member companies, we have advanced public policy beneficial for patients, secured historic funding for innovative technologies, found solutions to supply chain issues, and much more.

1: Medtech Wins in MDUFA V

After two years of congressional negotiations and dedicated work from member companies, AdvaMed secured a clean reauthorization of MDUFA V, which Congress passed and the President signed into law in October. MDUFA V grows FDA’s base funding level to help meet our industry’s increase in device review submissions and provides FDA the opportunity for additional incentive funding. The agreement includes many “firsts” for greater accountability, predictability, and consistency within FDA.

2: Advanced Good Governance Policies with FDA

The FDA oversees many top priorities of the medical technology industry. AdvaMed succeeded in securing reforms to FDA policies, including:

• Clinical Laboratory Improvement Amendments (CLIA) waivers,
• Issuance of Certificates to Foreign Governments for medical devices manufactured outside of the United States in select circumstances,
• Evaluation of third-party research on medical devices used for regulatory decision-making, and
• Allowance of predetermined change control plan submissions to ensure the thorough review of possible changes to a device without burdening FDA resources in future updates.

3: Unraveling Global Supply Chain Shortages

This year, AdvaMed staff serving on the White House’s Joint Supply Chain Resilience Working Group and advising FDA’s Supply Chain Resilience Program worked tirelessly to address the global and domestic supply chain challenges as well as the pressures they place on our member companies and the patients we serve. Team members held numerous meetings with federal government officials and key suppliers including representatives from the semiconductor industry and chemical industry to urge them to prioritize their health care customers who rely on these inputs and materials for their medical devices and work to prevent disruption in patient care.

4: A New Pathway for Emerging Technology

AdvaMed led an ongoing advocacy campaign urging the Centers for Medicare and Medicaid Services (CMS) to create a predictable pathway to Medicare coverage for new and innovative medical devices. In response, CMS has taken steps to develop a proposed rule called “Transitional Coverage for Emerging Technologies” (TCET) by its target date of Spring 2023.

5: The Future of Medtech R&D

AdvaMed’s advocacy for medtech R&D led to the creation of the first ever Directorate for Technology, Innovation, and Partnerships within the National Science Foundation. The $20 billion allocation established grants and incentives for domestic device R&D, manufacturing, and STEM education and placed medical technology as a top strategic priority for investment.

6: Support for Small Medtech Businesses

Following more than a year of AdvaMed and member engagement with congressional leaders, the Small Business Innovation Research and Small Business Technology Transfer (SBIR/STTR) programs, vital resources to small and emerging growth medtech companies, were reauthorized for three years in September.

AdvaMed also worked with Deloitte and our members to update a white paper on the investment ecosystem and stave off changes to the qualified small business stock provisions in the tax code—preserving valuable provisions that encourage investment in these businesses and the recruitment of talent.

7: Addressing the European Union’s Medical Device Regulation Bottlenecks

AdvaMed’s advocacy efforts on the global stage, including in coordination with Medtech Europe, contributed to broad support in the European Union for legislative solutions to resolve the Medical Device Regulation (MDR) bottlenecks, with nearly all EU Health Ministers supporting an extension of the MDR transitional provisions. The proposed three-to-four-year extension still needs to be finalized through the EU legislative process and once implemented, would provide EU patients continued access to critical medical devices.

8: Greater Investments in Domestic Semiconductor Manufacturing

AdvaMed’s advocacy for increased investment in the domestic manufacturing of semiconductors, an essential component of tens of millions of medical devices, contributed to the passage of the bipartisan CHIPS Act, including $52 billion in investments and signed into law in August. Currently, AdvaMed staff is working with Commerce and DOD to steer those investments into chips manufacturing that will benefit our industry.

9: Addressing Racial Disparities in Health Care

AdvaMed’s widely-sourced report, “Approaches to Increasing Diversity in Clinical Research and Addressing Health Inequities,” presented thoughtful approaches to improving representation in clinical research to eliminate health disparities throughout the medtech industry.

10: Medtech Wins at the State Level

AdvaMed’s State Affairs team worked to ensure that right-to-repair mandates exempt critically important medical devices and blocked restrictions on health-related data-sharing. The team protected medical technologies from newly passed PFAS bans and disclosure mandates, in addition to increasing patient access to medical technology, such as biomarker testing. 

“Because of the hard work of AdvaMed staff and our dedicated member companies, we have advanced public policy beneficial for patients, secured historic funding for innovative technologies, found solutions to supply chain issues, and much more.” 

––Scott Whitaker, President & Chief Executive Officer, AdvaMed

The post AdvaMed’s Top 10 Medtech Wins in 2022 appeared first on AdvaMed.

Medtech companies willing to do business in new ways and develop holistic approaches to meet their customers’ needs stand to exceed industry growth forecasts and reap significant revenue rewards. To achieve this growth, medtech companies must move beyond the traditional playbook of incremental product improvements, narrow M&A activity and investment in sales and marketing efforts. This report from PwC – an associate member of AdvaMed – presents three growth strategies to win in this competitive and rapidly changing environment. Each medtech company’s path to growth can draw from any or all of these strategies. The most successful will find the right blend of the three.

Read the full report online.

Download the report.

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WASHINGTON – This week, the Senate and House approved the reauthorization of the Small Business Innovation Research and Small Business Technology Transfer (SBIR/STTR) programs for three years. Since early 2021, AdvaMed and AdvaMed Accel, the division that represents the medtech industry’s small and emerging-growth companies, have been vocal proponents of reauthorizing the programs ahead of their expirations at the end of September.

“Across the medtech industry, small companies are at the forefront of developing new and innovative technologies that improve patient health outcomes,” said Scott Whitaker, AdvaMed President and CEO. “AdvaMed has worked to maintain the availability of the SBIR and STTR programs that offer critical resources for our members to get the next generation of products off the ground. We welcome the news of reauthorization and are grateful for the leadership in the House and Senate for ensuring these programs do not lapse.”

“The federal SBIR/STTR programs are a lifeline for small medtech companies that would otherwise be unable to secure initial funding to advance their innovative ideas in the research and development phase,” said DeChane Dorsey, Executive Director of AdvaMed Accel. “After months of negotiations and advocating on behalf of our small company members, we are pleased to see these vital programs reauthorized.”

Medical technology device development relies on lengthy research and testing. Devices must meet a high bar for safety and effectiveness. Start-ups consisting of a handful of employees cannot sustain paying for months and even years of research and development, and private investors are reluctant to fund testing that might not result in a quickly profitable product. Investors also consider market share and scalability. A product that makes a difference to thousands of patients still might not be attractive enough to investors. 

75 percent of AdvaMed’s 450 members are small companies and comprise the AdvaMed Accel division. In a 2021 survey, 89 percent of AdvaMed Accel member respondents reported having applied for SBIR/STTR grants; 31 percent of their applications were rewarded.

Learn more about SBIR/STTR programs.

The SBIR/STTR programs offer highly competitive grants across 11 federal agencies, from the National Science Foundation to the Department of Defense. For more than 40 years, these programs have provided more than 179,000 awards, totaling more than $54 billion, to U.S. small businesses. 

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