Strategic Entry into the U.S. Medtech Market
Manchester - October 25, 2017
MIDAS, the Medical Alley Association and the Minneapolis Saint Paul Regional Economic Development Partnership (GREATER MSP) are hosting a U.S medtech market seminar in Manchester.
Event Description:
MIDAS, the Medical Alley Association and GREATER MSP are bringing world-class experts from the United States to Manchester on October 25th to speak and meet with companies regarding FDA regulations and approvals for clinical trials, reimbursement, market entry options, and sources of financing in the United States. With a wealth of experience in their respective specialties, these experts have the knowledge and tools that British medical device companies need to chart a successful path to commercialization in the largest medical device market in the world.
Presentations by the experts will be followed by question and answer periods.
In the evening, you are invited to join the U.S. delegation at Etihad Stadium for a Manchester City FC Tour and dinner featuring Dr. Richard Preece, Chief Medical Officer of the Greater Manchester Health & Social Care Partnership. Dr. Preece will be speaking on the devolution of health and social care and opportunities for industry led innovation.
Event Details:
Location:
The Workplace
4th Floor, Churchgate House,
56 Oxford Street, Manchester, M1 6EU
Time:
1:00 pm - 4:00 pm
There is no fee to attend the seminar.
The fee for dinner is £25 per person.
REGISTER HERE
Presenters:
Shaye Mandle, President and CEO, Medical Alley Association
Mr. Mandle has more than 20 years of experience in government, the private sector and academia, leading organizations, public affairs and political activities. From 2011-2014, Mr. Mandle served as the association’s EVP & COO and its VP of Government & Affiliate Relations. Prior to joining The Medical Alley Association, Mr. Mandle served as the Executive Director of the FedEx Institute of Technology at the University of Memphis, where he launched and oversaw the University Office of Technology Transfer and led the University’s corporate partnership, entrepreneurship and economic development programming. Mr. Mandle has also led business development and government affairs for the Reconnaissance and Surveillance Operation of Science Applications International Corporation (SAIC), a Fortune 500 company specializing in defense and homeland security technologies.
Mr. Mandle has served as the chief executive of two industry and economic development organizations, the Illinois Coalition for Science & Technology and the East-West Corporate Corridor Association. Mr. Mandle’s extensive policy and political experience includes leading state and federal political campaigns and having served on the policy staff of former U.S. House Speaker, J. Dennis Hastert and former Illinois Governor Jim Edgar. Mr. Mandle has a Juris Doctor, cum laude, from the Duquesne University Law School and a Bachelor of Arts from Illinois Wesleyan University.

Edward Black, Reimbursement Strategies
Topic: Reimbursement
Edward Black founded Reimbursement Strategies, LLC in 2008 after a career of 25 years in medical and provider network management within the Blue Cross Blue Shield system in the U.S. Mr. Black served on two national advisory boards for the Blue Cross Blue Shield Association responsible for leading consistency in medical, benefit, and payment policy across the system. From 1994 to 2002, he served as the executive director of three managed care business partnerships with large multispecialty clinics for which he was awarded the 1995 Outstanding Contribution to the Healthcare Industry award by the Medical Alley Association.
Today, Reimbursement Strategies offers the full range of medtech/biotech/pharma reimbursement services including HCPCS and CPT coding analyses and new code submissions; medical coverage policy research, analysis and advocacy; payment negotiation; clinical trial optimization for reimbursement and health economics; and medical society liaison for clinical guideline development. Mr. Black is a frequent international lecturer and the company represents clients in multiple international markets including Canada, Ireland, the UK, Europe and Australia. Mr. Black also serves as an adjunct faculty member in the University of Minnesota Master of Science in Medical Device Innovation Program and Reimbursement Advisor to the University Office for Technology Commercialization.

Mary Kay Sobcinski RN, RCRI
Topic: Clinical and Regulatory Strategies
Mary Kay Sobcinski is a Senior Principal Advisor, Clinical Sciences, at Regulatory and Clinical Research Institute (RCRI®). She is a performance-driven clinical strategist and researcher for medical device, biologic, and combination products. She combines her extensive medical product experience, healthcare administration background, and nursing expertise to bring a unique perspective to corporate, clinical and regulatory strategic planning, marketing, project management and problem solving. She is a dynamic and successful leader of highly effective and engaged clinical study and multidisciplinary teams. Mary Kay’s expertise spans the strategic design and development of innovative and successful trial designs including global IDE and IND trial approvals with extensive international regulatory experiences involving multiple negotiations with FDA, Health Canada, notified bodies, and the Therapeutic Goods Administration (Australia). She has held management roles in both clinical and regulatory affairs for medical devices, biologic drug and combination devices. She has authored numerous successful worldwide regulatory submissions for clinical trial and product approvals. Her medical product industry experiences emphasize cardiovascular, neuromodulation, spinal, gastrointestinal and infectious diseases indications. Mary Kay is an adjunct professor in the Master’s in Applied Clinical Research program at St. Cloud State University. Mary Kay is a registered nurse with a Bachelor of Science in Nursing degree from Loyola University Chicago and a Master’s degree in Healthcare Administration from the University of Minnesota.

Chris Schad, Mayo Clinic
Topic: Venture Capital and Innovation
Chris Schad has worked in a variety of leadership positions in clinical and research laboratories after coming to Mayo Clinic in 1986. In his current role as Senior Strategy Consultant, Chris develops and executes the strategy for Discovery Square, a mixed-use urban life-science hub adjacent to Mayo Clinic. This is part of Destination Medical Center, a $5.6B public-private economic development initiative designed to position Minnesota as a global center for the highest quality medical care while attracting high-value jobs and businesses to the region. Chris’ role is to bring new technology companies into Discovery Square where they develop products and services for market and clinical practice, and to support the growth of the entrepreneurial ecosystem of the region.
Mr. Schad has a Bachelor of Science degree in Biology and a Master’s in Business Administration. He is a published author on many peer-reviewed scientific papers, including several as first author. He is an Assistant Professor of Laboratory Medicine in the Mayo Clinic College of Medicine.

Jim Sargent, RQR Partners
Topic: Market Entry Strategies
James (Jim) Sargent is the Managing Partner of RQR Partners, a firm which specializes in providing innovators and investors with commercial guidance beyond the spreadsheet. With over 25 years of experience in global markets leading small, medium and large organizations, Jim has led teams from initial ideation up through full scale global commercialization.
He started his career with Pfizer in sales and then transitioned to Boston Scientific, where he held numerous positions with increasing responsibility over his 20 + years with the company, including a five year assignment where he and his family relocated to Asia Pacific. While in Asia Pacific, Jim was responsible for penetrating new countries, integrating acquired companies, and general management for the Rhythm Management group. He also served as the Chairman of the Medical Devices Committee for the Korean delegation of AMCHAM during his residency in Seoul.
In 2015, Jim used his cultural and commercial experience to form RQR Partners, a global firm focused on developing and evaluating global commercial strategy and investment decisions for new innovations and technologies.
Jim lives in Minneapolis, Minnesota with his wife and two children, and holds a bachelor’s degree in marketing from Syracuse University.
About MIDAS:
MIDAS is Manchester’s inward investment agency, with a strategic aim to secure significant levels of new investment and employment for the city region. This is achieved through the global business marketing of Manchester, targeting key markets and sectors, and the provision of an extensive, free and confidential package of advice and assistance for location consultants and potential investors. MIDAS services are available to national and international companies that wish to relocate to – or expand within – Greater Manchester. Working in partnership with the ten local authorities, MIDAS provides services such as relocation support, assistance in finding property solutions and advice on recruitment and training.
About the Medical Alley Association:
Medical Alley Association serves the individuals and organizations that comprise Minnesota's health industry by influencing policy, fostering connections and providing critical intelligence to improve the quality of health around the world. The Medical Alley Association’s mission is to champion and facilitate an environment that enables health technology and care organizations to innovate, succeed and influence the evolution of healthcare.
About GREATER MSP:
GREATER MSP (Minneapolis Saint Paul Regional Economic Development Partnership) is a private non-profit organization (501C3) dedicated to providing public and private sector leadership, coordination and engagement to grow the economy of the 16-county Minneapolis Saint Paul region. GREATER MSP is advancing a coordinated regional economic development strategy, a coordinated regional brand to promote the region’s assets and a coordinated regional business retention, expansion, and recruitment program to stimulate capital investment and job creation in the region.
