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BMTA Overview

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Overview of Boston MedTech Advisors services

Overview of Boston MedTech Advisors services


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  • 1. Boston MedTech Advisors More Experience. Better Results. www.bmtadvisors.com 1 More Experience ► Better Results
  • 2. Mission Assist medical technology companies and healthcare providers to achieve their business goals by offering ethical, result-oriented, professional and cost effective advice and services. Operating Philosophy  Provide optimal solutions that  Leverage our own experiences, recognize the multi-faceted aspects know-how and relationships for the of today’s healthcare markets and benefit of our clients. the client’s unique business needs.  Establish ongoing relationships  Maximize value by delivering high by aligning our incentives with those quality services at a reasonable of our clients and partners. cost. 2 More Experience ► Better Results
  • 3. Our Clients’ Challenges Value creation is associated with  Healthcare Environment – demonstrated market complex, competitive and acceptance, rather than continuously evolving regulatory clearance  Regulatory Process – intense and lengthy  Reimbursement – constantly evolving rules that affect commercialization and adaptation of new technologies and procedures  Capital – requires more rounds to support extended time-to-market 3 More Experience ► Better Results
  • 4. Clients  Start-ups through Fortune 500 companies  Diagnostic, therapeutic and monitoring medical technologies  Healthcare providers - medical practices, clinics and hospitals  Consumer medical products and services  US and non-US companies  Incubators, technology transfer offices and licensing entities  Academia and research organizations  Investors (private, institutional)  Government agencies 4 More Experience ► Better Results
  • 5. Engagements (sample)* * Including consultants prior relationships 5 More Experience ► Better Results
  • 6. Our Relevant Experience  Many years of working with/within  Established experience in developing the US and European medical and executing marketing and business technology and healthcare systems. plans for new technologies and clinical services.  Relevant background in general management, product development,  Successful track record of financing marketing, reimbursement, early-stage companies. regulatory, clinical affairs and business development in companies  Effective support of companies seeking ranging from start-ups to multi- expertise in US and European markets nationals. and businesses.  Extensive network of industry,  Supporting large number of different- providers, academia, investors and size companies, including pre- and post- business partners. revenue, VC-backed and public entities, US-based, off-shore, multi-nationals  Excellent submission and and academia. communication history with the FDA and other regulatory agencies.  Principals of Boston MedTech Advisors  Successful record of strategizing are entrepreneurs, founding own and implementing reimbursement medtech and healthcare services solutions. companies. 6 More Experience ► Better Results
  • 7. Working with Boston MedTech Advisors  Active involvement by an Expertise and practical solutions in experienced US and the following areas: European teams, dedicated to  Regulatory help you to successfully develop and execute your  Reimbursement business plans.  Clinical studies and evidence  Comprehensive support, development tailored to the needs of early- stage and established medical  Market research and planning technology companies, pre-  Business development and post-market introduction.  Technology assessment  A single source for strategy development, planning and  Financing execution. 7 More Experience ► Better Results
  • 8. Clinical Disciplines (partial list)  Aesthetic Medicine  General Surgery  Neurology  Ambulatory monitoring  Health IT  Orthopedic  Anesthesiology  Hepatology  Patient Monitoring  Cancer Therapies  Home care  Pulmonary  Cardiology  Interventional  Radiology / Imaging  Critical Care Cardiology  Rehabilitation Medicine  In-Vitro Diagnosis  Cryosurgery  Sleep Medicine  Interventional  Dermatology  Vascular Medicine Radiology  Emergency Medicine 8 More Experience ► Better Results
  • 9. Business Development  Identify complementary business opportunities and potential strategic partners  Analyze alternative sales channels  Initiate and facilitate business transactions  Create early US or European presence, including marketing and business development arm for emerging companies  Introduce larger companies to technologies and products augmenting their current business 9 More Experience ► Better Results
  • 10. Reimbursement & Contracting Strategies  Review pertinent reimbursement codes and coverage guidelines for new products and services  Analyze reimbursement impact on product design, sales and marketing strategy  Evaluate the impact of reimbursement issues on regulatory, clinical studies and marketing initiatives, and identify steps to mitigate the effects of payment barriers  Support the development of new reimbursement codes and expansion of coverage guidelines  Develop reimbursement support services for end-users  Provide guidance for contracting with third-party payers 10 More Experience ► Better Results
  • 11. Regulatory Affairs  Analyze the impact of FDA and other pertinent regulatory guidelines on technical development and marketing plans  Develop well-structured and rational regulatory strategies  Conduct pre-submission review meetings with the FDA and other regulatory agencies  Prepare and facilitate regulatory filings, including 510(k), PMA and IDE applications  Support regulatory filings in non-US markets (Europe, Japan, Canada, other)  Registered ‘US Agent’ for foreign medical device manufacturers 11 More Experience ► Better Results
  • 12. Clinical Trials Planning and Management  Identify sites and principal investigators for clinical studies and negotiate study agreements  Develop clinical study protocols in support of regulatory submissions, marketing and reimbursement activities  Prepare IRB and other study support documentation  Provide technical, clinical and management oversight during clinical studies  Clinical site and patient monitoring (including internet-based)  Database development  Data acquisition and processing  Data analysis  Prepare summaries of clinical trials for presentation to regulatory agencies, customers, business partners and investors 12 More Experience ► Better Results
  • 13. Market Analysis and Business Strategy  Assess market potential for new technologies and services  Conduct competitive market research and analysis  Analyze clinical needs, regulatory and reimbursement environments for new technologies, products and services  Identify market opportunities for new technologies and services  Develop marketing and business plans  Evaluate new markets for existing products and services 13 More Experience ► Better Results
  • 14. Financing Support  Work with entrepreneurs and management teams to develop ‘fundable’ business plans and to optimize financing campaigns  Introduce entrepreneurs to VCs and private investors active in the healthcare field  Identify prospective strategic partners, prepare companies to appropriately explore opportunities and support all phases of the process  Support fundraising activities  Conduct due-diligence evaluations of new technologies and services 14 More Experience ► Better Results
  • 15. Senior Team Bios David Barone, MSc, MBA, Principal Over 25 years experience including general, technical and operations management, strategic planning, marketing and business development. Current activities focus on advising and assisting US and off-shore medical technology organizations, ranging from start-ups to Fortune 500 companies, in areas ranging from opportunity analysis, marketing strategy and market development, reimbursement strategies, business development and financing. Prior to co-founding Boston MedTech Advisors, David held senior management positions in a number of medical device companies and has founded, financed and developed a number of healthcare companies. B.Sc., Electrical Engineering, Technion, Israel Institute of Technology, M.Sc., Bio-Medical Engineering and Master, Business Administration, both from Rensselaer Polytechnic Institute, NY. Zvi Ladin, PhD, Principal Over 20 years of experience in the medical industry, government and academia, focusing on developing and managing clinical, regulatory affairs and reimbursement initiatives. A co-founder of Boston MedTech Advisors, focusing on establishing regulatory strategies for therapeutic and diagnostic medical device companies, submission of regulatory applications, including 510(k) and PMAs for products in Class I-III and drug-device combination products and representing companies in negotiations with the FDA and other regulatory agencies. Dr. Ladin taught mechanical and biomedical engineering at MIT and Boston University and served as a scientific advisor to the FDA. B.Sc., Aeronautical Engineering and M.Sc., Biomedical Engineering, Technion, Israel Institute of Technology; Ph.D., Medical Engineering, MIT-Harvard Medical School Division of Health Science and Technology. 15 More Experience ► Better Results
  • 16. Bios (cont.) Michael Imhoff, MD, PhD, Managing Director, BMTA Europe Board certified in surgery and intensive care medicine, with over 15 years of clinical experience in large medical centers and strategic consulting for leading companies in the global medical technology markets, as well as start-ups in the US and Europe. Research areas include trauma surgery, intensive care medicine, patient monitoring, clinical data management, artificial intelligence in medicine and health economics. Dr. Imhoff is an associate professor in Medical Informatics and Statistics at Ruhr-University Bochum, Germany, a reviewer for the German Research Foundation, a member of the editorial boards of and reviewer for several international biomedical journals, and author of over 300 publications and scientific presentations. Medical school: Universities of Bochum and Munster, Germany; PhD, Ruhr-University, Bochum, Germany. 1991 Recipient of the Lederle Prize for Research. Yossi Elaz, BSc, Senior Consultant Background includes senior executive positions in large global medical device organizations, including Siemens Medical Systems, and most recently, a member of Draeger Medical’s Global Management Team. Experience includes overseeing large R&D organizations, product requirements management, operations and business development activities encompassing a diverse range of medical disciplines, including platforms for patient monitoring system, therapy devices and critical care information management systems. Developed a large number of clinical partnerships with leading medical institutions and opinion leaders in US and Europe and has been involved in the evaluation of numerous medical device technologies. B.Sc., Electrical Engineering, Technion, Israel Institute of Technology. 16 More Experience ► Better Results
  • 17. Bios (cont.) Tom Keegan, Senior Consultant An accomplished marketing professional with over 20 years of marketing, technical and clinical experience in the medical industry, Tom held senior management positions in private and public companies, including Haemonetics, UltraCision, Johnson & Johnson Ethicon Endo-Surgery, Smith & Nephew Endoscopy, Endius, and most recently, serving as the Vice President of Marketing for MIS (Minimally Invasive Surgery) Solutions for Zimmer Spine. Tom's experiences include development and implementation of marketing plans, market research and analysis, professional education, marketing communications, pricing strategy and reimbursement development. Tom has been responsible for key areas during the acquisitions and mergers of early stage companies into major corporations, overseeing the integration of sales forces, technology transition and personnel training. Education: Studies in the BA, Marketing and BET, Electrical Engineering Programs at Northeastern University Boston, MA. 17 More Experience ► Better Results
  • 18. Contact Boston MedTech Advisors, Inc. 990 Washington Street Dedham, MA 02026 Ph 781.407.0900 Fax 781.407.0901 Boston MedTech Advisors Europe, GmbH Am Pastorenwaldchen 2 D-44229 Dortmund, Germany Ph +49.231.973022.10 Fax +49.231.073022.31 info@bmtadvisors.com www.bmtadvisors.com 18 More Experience ► Better Results