What is Your Greatest Challenge?
Regulatory Compliance and FDA Approval
Learning the ins and outs of the regulatory process and getting my product approved through FDA. (We work with members to develop pre-market approval policies that speed patient access to new technologies, ensure reasonable post-market and inspection programs, develop a legislative agenda, and to coordinate on international regulatory efforts.)
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Finding Business Partners or Securing Funding
Finding business partners or securing funding (Through a variety of programs, EGCC members can access senior-level executives from the biggest names in industry in targeted working groups. Additionally, AdvaMed’s partnering programs, company presentations and investor forums offer EGCC members opportunities to showcase the value of their medical technology.
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Obtaining Adequate Reimbursement
Obtaining adequate product reimbursement (AdvaMed works with regulators, law, and policy makers to develop payment policies that support the innovation and use of new medical technologies. We work to improve many aspects of Medicare including processes for covering, tracking (coding) and paying for medical devices and diagnostics.)
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Legal and Ethical Compliance
Understanding proper legal compliance and the Code of Ethics (AdvaMed members encourage ethical business practices and socially responsible industry conduct related to their interactions with health care professionals. Want more information?)
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International Sales and Marketing
Selling in overseas markets (AdvaMed's International department focuses on health care, trade, and medical technology reimbursement issues in Europe, Japan, and a few big emerging markets in Asia and Latin America. We work closely with U.S. and foreign health care and government officials, as well as other international trade associations, to promote the medical technology industry abroad.)
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