Overview of Boston MedTech Advisors services

1. Boston MedTech Advisors
More Experience. Better Results.
www.bmtadvisors.com
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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.
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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
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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
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5. Engagements (sample)*
* Including consultants prior relationships
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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.
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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.
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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
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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
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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
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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
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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
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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
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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
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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.
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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.
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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.
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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
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