B06. The ABC's of R&R (Spoiler alert: we are talking Regulatory and reimbursement in the U.S. market, not rest and relaxation)

Tracks
Reimbursement
Thursday, June 13, 2024
11:15 AM - 12:15 PM
C2.5+C2.6

Chair & Speakers

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Sarah Griffin
Director
Medtechnique Consulting

Chair: The ABC's of R&R (Spoiler alert: we are talking Regulatory and reimbursement not rest and relaxation)

Abstract

Most Australian innovators are keen to launch in the USA. However, the pitfalls are many. This session has 2 experts in US regulatory and reimbursement and will be invaluable information for companies interested in exploring the complex US market. Where do you even begin as a medical device start-up for commercialisation in the US market - regulatory or reimbursement? For a start-up, regulatory and reimbursement are the foundation of a solid business plan. This session expounds on the basics of coding, coverage, and payment for the US healthcare system and regulatory submission strategies that start-ups should be considering at even very early stages to set them up for success.

Biography

Sarah Griffin is the founder of MedTechnique Consulting and has more than 25 years of experience in the medical technology sector including health economics, health insurance, health policy and legislation, medical finance, reimbursement systems and government relations. Sarah’s strengths lie in her strategic approach to market access and the creation of effective reimbursement and health economic strategies and is an expert in preparing complex reimbursement submissions. Since founding MedTechnique Consulting in 2013, she has assisted numerous medical technology companies gain market access for innovative technologies.
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Ms Michelle Lott
Principal And Founder
leanRAQA

The ABC's of R&R (Spoiler alert: we are talking Regulatory and reimbursement in the US market, not rest and relaxation)

Abstract

Most Australian innovators are keen to launch in the USA. However, the pitfalls are many. This session has 2 experts in US regulatory and reimbursement and will be invaluable information for companies interested in exploring the complex US market. Where do you even begin as a medical device start-up for commercialisation in the US market - regulatory or reimbursement? For a start-up, regulatory and reimbursement are the foundation of a solid business plan. This session expounds on the basics of coding, coverage, and payment for the US healthcare system and regulatory submission strategies that start-ups should be considering at even very early stages to set them up for success.

Biography

Michelle Lott is founder and principal of leanRAQA. She's supported 100+ companies with regulatory strategy, regulatory submissions, quality systems compliance, due diligence, technical support services. Michelle served a four-year term on the FDA Device Good Manufacturing Practices Advisory Committee (DGMP). She serves as mentor in residence for several medical device incubators and guest lectures on regulatory affairs. She holds a BS in Chemistry from Troy State University and is a Certified Executive Leader in Regulatory Affairs from RAPS and Kellogg University. Nic is a medical technology consultant in health economics, payer perspective, reimbursement and market access. After finishing school in Boston, he began his career as a payer determining which medical technologies were paid for by Intermountain Healthcare. He started and eventually took public a biotech company . He is presently in health economics and market access at a major medical device manufacturer. Nic consults venture capitalists and start-ups who are working on new life science products, helping them identify what health insurance companies and hospitals want in a technology and for what they’re willing to pay. He is a strategic advisor to medical technology companies and is a guest lecturer at UCSF School of Medicine
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Mr Nic Anderson
Principal and Founder
N C Anderson Consulting

The ABC's of R&R (Spoiler alert: we are talking Regulatory and reimbursement not rest and relaxation)

Abstract

Most Australian innovators are keen to launch in the USA. However, the pitfalls are many. This session has 2 experts in US regulatory and reimbursement and will be invaluable information for companies interested in exploring the complex US market. Where do you even begin as a medical device start-up for commercialisation in the US market - regulatory or reimbursement? For a start-up, regulatory and reimbursement are the foundation of a solid business plan. This session expounds on the basics of coding, coverage, and payment for the US healthcare system and regulatory submission strategies that start-ups should be considering at even very early stages to set them up for success.

Biography

Nic is a medical technology consultant in health economics, payer perspective, reimbursement and market access. After finishing school in Boston, he began his career as a payer determining which medical technologies were paid for by Intermountain Healthcare and was a member of Intermountain’s New Device and Technology Committee (Value Analysis). He left these roles after seven years to start and eventually take public a biotech company in the tissue regeneration space where he served as the Director of Market Access. He is presently in health economics and market access at a major medical device manufacturer. Nic consults venture capitalists and start-ups who are working on new life science products, helping them identify what health insurance companies and hospitals want in a technology and for what they’re willing to pay. He is a strategic advisor to medical technology companies and is a guest lecturer at UCSF School of Medicine and at conferences and symposia around the world where he speaks on clinical trials, HEOR, commercialization and reimbursement. In 2017 Nic was the Expert in Residence at the Dubai 100, a digital health accelerator located in Dubai. Nic’s experience in life sciences spans devices, diagnostics, biotech and digital health. Companies turn to him to understand what trials and health economics will be necessary to obtain market access and reimbursement. On the personal front, he lives in Utah with his wife and kids and is a skier, cyclist and is a forever student of the Austrian School of Economics. Education: BA - Behavioral Neuroscience. Purdue University MA - Bioimaging. Boston University School of Medicine MBA - Business Administration. University of Utah Fellowship - Pierre Lassonde Entrepreneur Center
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