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Industry | Medical Technology |
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Headquarters | Washington, D.C. |
Key people | Scott Whitaker (CEO) Peter Arduini (Board Chairman) |
Website | www |
AdvaMed, or the Advanced Medical Technology Association, is an American medical device trade association, based in Washington, D.C. It is the largest medical device association in the world [1] with U.S. and international members who are medical technology companies (medical devices, diagnostic products, and health information systems) that collectively represents 80% of U.S. medical technology firms in the United States, that produce close to 90% of annual health care technology purchases in the United States and more than 40% globally.[ citation needed ]
Scott Whitaker is AdvaMed’s President and CEO, [2] and its current Board Chairman is Peter Arduini, also serves as the CEO of GE HealthCare. [3]
AdvaMed’s website states that the organization promotes competitive policies that foster the highest ethical standards, rapid product approvals, appropriate reimbursement, and access to international markets. [4]
The Innovation Agenda identifies five core policy pillars: improving the FDA’s regulatory processes, restructuring CMS’s coverage and payment processes, reforming the U.S. tax system to create a level playing field, improving access to international markets, and supporting the maintenance and growth of an R&D infrastructure. [5]
AdvaMed has consistently and strongly opposed the 2.3% medical device excise tax imposed by the Affordable Care Act in 2013, stating that it harms job creation, deters medical innovation needed to save and improve patients’ lives, and inhibits economic growth.[ citation needed ]
In 2015, Congress temporarily suspended the medical device excise tax. While AdvaMed supported the suspension, the association continues to push for full and permanent repeal of the tax. Whitaker has stated that “It’s not enough to delay or further suspend this disruptive tax, even if for a longer period of time. It simply does not give industry the certainty and confidence it needs to make these critical long-term R&D investments. The time is now. We stand ready to help this administration, Congress, and the nation get Americans back on the job." [6]
In February 2017, AdvaMed released data from the U.S. Department of Commerce revealing that the U.S. medical technology industry saw its jobs ranks fall by nearly 29,000 while the medical device excise tax was in effect. [7]
In 2016, the FDA released the first draft of its guidance on applying human factors engineering principles to combination products. It immediately faced criticism from AdvaMed, citing overly burdensome requirements. Seven years later, in 2023, the FDA finalized its guidance and released the final draft. It is intended to complement the FDA's 2011 device guidance and a separate document on "Safety Considerations for Product Design to Minimize Medication Errors." The finalized guidance addresses specific questions that may arise during the development of combination products, focusing on user interactions and clinical trials support. [8]
In July 2024, AdvaMed signed a letter to members of both the House Committee on Armed Services and the Senate Committee on Armed Services opposing Section 828 of S. 4628, the National Defense Authorization Act for Fiscal Year 2025, entitled "Requirement for Contractors to Provide Reasonable Access to Repair Materials," which would require contractors doing business with the US military to agree "to provide the Department of Defense fair and reasonable access to all the repair materials, including parts, tools, and information, used by the manufacturer or provider or their authorized partners to diagnose, maintain, or repair the good or service." [9]
In August 2020, The Advanced Medical Technology Association (AdvaMed) reported that VentConnect is growing its network. The updated MedDeviceNetwork network (MedDeviceNetwork.org) would expand past ventilators and incorporate many emerging medical devices in the current battle against COVID-19 and other potential health crises that America's doctors and caregivers require. [10]
Biomedical engineering (BME) or medical engineering is the application of engineering principles and design concepts to medicine and biology for healthcare applications. BME is also traditionally logical sciences to advance health care treatment, including diagnosis, monitoring, and therapy. Also included under the scope of a biomedical engineer is the management of current medical equipment in hospitals while adhering to relevant industry standards. This involves procurement, routine testing, preventive maintenance, and making equipment recommendations, a role also known as a Biomedical Equipment Technician (BMET) or as a clinical engineer.
Stryker Corporation is an American multinational medical technologies corporation based in Kalamazoo, Michigan. Stryker's products include implants used in joint replacement and trauma surgeries; surgical equipment and surgical navigation systems; endoscopic and communications systems; patient handling and emergency medical equipment; neurosurgical, neurovascular and spinal devices; as well as other medical device products used in a variety of medical specialties.
Medical software is any software item or system used within a medical context, such as reducing the paperwork, tracking patient activity
Abbott Laboratories is an American multinational medical devices and health care company with headquarters in Green Oaks, Illinois, United States. The company was founded by Chicago physician Wallace Calvin Abbott in 1888 to formulate known drugs; today, it sells medical devices, diagnostics, branded generic medicines and nutritional products. It split off its research-based pharmaceuticals business into AbbVie in 2013.
Medtronic plc is an American-Irish medical device company. The company's operational and executive headquarters are in Minneapolis, Minnesota, and its legal headquarters are in Ireland due to its acquisition of Irish-based Covidien in 2015. While it primarily operates in the United States, it operates in more than 150 countries and employs over 90,000 people. It develops and manufactures healthcare technologies and therapies.
Artivion, Inc. is a distributor of cryogenically preserved human tissues for cardiac and vascular transplant applications and develops medical devices. Among its products are human heart valves, which are treated to remove excess cellular material and antigens, and BioGlue surgical adhesive.
ADVA Optical Networking SE was a European telecommunications vendor that provides network equipment for data, storage, voice and video services. It was founded in 1994 by Brian Protiva. On August 30, 2021, it was announced that ADVA and Adtran Holdings would be merging, continuing business under the name Adtran.
Withings is a French consumer electronics company headquartered in Issy-les-Moulineaux, France. It also has offices in Boston, Massachusetts, USA, and Hong Kong, and distributes its products worldwide. Withings is known for design and innovation in connected devices, such as the first Wi-Fi scale on the market, an FDA-cleared blood pressure monitor, a smart sleep system, and a line of automatic activity tracking watches. It also provides B2B services for healthcare providers and researchers.
Scanadu was a Silicon Valley-based company developing next generation tests, devices and services ostensibly to allow users to better monitor their own health. It was founded in February 2011 by Walter De Brouwer and Misha Chellam in Silicon Valley. In mid 2011, Scanadu set up a lab at NASA Ames Research Center in Mountain View, Calif., to help grow the company. It relocated to Sunnyvale, CA in September 2016.
Mazor Robotics was an Israeli medical device company and manufacturer of a robotic guidance system for spine surgery that was acquired by Medtronic in December 2018. Surgeons that utilized Mazor Robotics Renaissance generally specialize in orthopedic surgery or neurosurgery.
Edwards Lifesciences is an American medical technology company headquartered in Irvine, California, specializing in artificial heart valves and hemodynamic monitoring. It developed the SAPIEN transcatheter aortic heart valve made of cow tissue within a balloon-expandable, cobalt-chromium frame, deployed via catheter. The company has manufacturing facilities at the Irvine headquarters, as well as in Draper, Utah; Costa Rica; the Dominican Republic; Puerto Rico; and Singapore; and is building a new facility due to be completed in 2021 in Limerick, Ireland.
MedTech Europe is the European trade association representing the medical technology industries, from diagnosis to cure. It represents Diagnostics and Medical Devices manufacturers operating in Europe. It is born as an alliance of two European medical technology associations, EDMA and Eucomed, representing the European IVD and medical device industries, respectively. It was established with the aim to represent the common policy goals of both organisations more effectively, promoting the interests of its members and of the medical technology industry in general. There are more than 33,000 medical technology companies in Europe. The highest number of them are based in Germany, followed by Italy, the UK, France and Switzerland.
Bertin Nahum is a French-Beninese entrepreneur in surgical robotics. He is the CEO and co-founder of Quantum Surgical based in Montpellier, France. He previously founded in 2002 Medtech S.A; specialized in the design, development and marketing of surgical assistance robots that was sold to Zimmer Biomet in 2016.
Breakthrough therapy is a United States Food and Drug Administration designation that expedites drug development that was created by Congress under Section 902 of the 9 July 2012 Food and Drug Administration Safety and Innovation Act. The FDA's "breakthrough therapy" designation is not intended to imply that a drug is actually a "breakthrough" or that there is high-quality evidence of treatment efficacy for a particular condition; rather, it allows the FDA to grant priority review to drug candidates if preliminary clinical trials indicate that the therapy may offer substantial treatment advantages over existing options for patients with serious or life-threatening diseases. The FDA has other mechanisms for expediting the review and approval process for promising drugs, including fast track designation, accelerated approval, and priority review.
MedAccred is an accreditation program for critical process manufacturing operations in the production of medical devices MedAccred is an industry managed program with the medical device industry having responsibility for all decisions regarding program operations, development, and the decision to award accreditations. The MedAccred program is administered on behalf of the medical device industry by the Performance Review Institute (PRI), a not-for-profit affiliate of SAE International. Participants in the MedAccred program consist of medical device OEMs, contract manufacturers and suppliers who work together to develop industry-wide audit criteria and provide accreditation of critical manufacturing process suppliers to improve product quality.
Janet Woodcock is an American physician who served as Principal Deputy Commissioner of Food and Drugs from February 2022 until February 2024, having previously served as Acting Commissioner of the U.S. Food and Drug Administration (FDA). She joined the FDA in 1986, and has held a number of senior leadership positions there, including terms as the Director of Center for Drug Evaluation and Research (CDER) from 1994 to 2004 and 2007 to 2021.
Andhra Pradesh MedTech Zone(AMTZ) is the medical technology park with Common Manufacturing Facilities & Common Scientific Facilities located in Nadupuru village area of Visakhapatnam, adjacent to the Visakhapatnam Steel Plant. The AMTZ is spread over an area of 270 acres and it has over 10 manufacturing units.
The Bleeding Edge is a 2018 Netflix original documentary film that investigates the $400 billion medical device industry. Written and directed by Kirby Dick and produced by Amy Ziering and Amy Herdy, it premiered at the 2018 Tribeca Film Festival, where it was billed as "the stuff of dystopian nightmares". The film was released for streaming on Netflix on July 27, 2018.
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