Howard Edelman Consulting

2116 15th Ave.
San Francisco, CA 94116
Work Phone: 415-271-4730
Cell Phone: 415-271-4730
howardedelman2116@gmail.com
http://www.hedelman.com/

Howard Edelman is a high impact medical device consultant accomplished in all phases of medical product development in a variety of organizational structures from pure start-up to mature organization from product concept to market maturity. Experienced with multi-market, multi-disciplined technical environments with emphasis on innovation, product development, market strategy, all aspects of operations, business development, market development, all phases of execution, operations, supply chain development and management (US and China), manufacturing transfer throughout manufacturing lifecycle, early clinical development, field studies and trial, marketing and sales development. Mr. Edelman often functions as senior level operational consultant for senior management. Broad experience in leading the development of a broad range of medical and biotech instrumentation projects with extensive recent experience in surgery stations, durable medical equipment, and a variety of other device markets.
NOTED FOR:


Market Leadership: Founded and grew VitalWear to the market leader by maximizing the market potential through focused, cost-effective marketing campaigns to key distribution partners underpinned by attractive product reimbursements. Started the Cothera division at United Orthopedic Group and rapidly built and launched a unique, disruptive and innovative product line in the secondary orthopedics medical device market.
Product Innovation: A long history of developing innovative products with sustainable IP positions and high gross margins. At VitalWear and Cothera, supported these efforts by executing effective China supply chains managed by local recruited teams.
International Expansion: Expanded the distribution base at VitalWear and Cothera internationally by completing product CE marking, ISO13485 and other regulatory efforts and building effective representation in the abroad.
Revenue Growth: Continually grew revenues YOY and through the economic downturn. At VitalWear, achieved 27% EBIDTA months in preparation to sell the company. Achieved $10MM run rate at Cothera 18 months post-launch.
Startup Situations: Experience in numerous startups with broad and deep experience across the operation in all areas with multi-market, multi-disciplined technical environments with emphasis on innovation, product development, market strategy, all phases of execution, operations, rigorous QA compliance, supply chain development and management (US and China), manufacturing transfer throughout manufacturing lifecycle, marketing and sales development. Experience ranges from sweeping floors and unloading containers to securing various types of equity and debt financing.
Market Focus: Experience background in medical device and molecular biology instrumentation with product lines generating +$200 million in sales.

SPECIFIC SKILLS:


Management: Budget & Financial Model Development, P&L, Overall Business and Market Planning, Strategy & Execution
All Aspects of R&D: New Product Innovation & Development, Strategic IP Development and Defense
Quality Assurance: Designed, Drafted, Executed, and Operated FDA Audited Quality Systems
FDA: All aspects of FDA Requirements and Approvals, ISO13485 & ISO9001 approvals, recent CE markings, recent 510(k)filings, Health Canada, CFDA
Team Building: Multi-Functional, Multi-National Team Building & Management Recruitment and Management Domestic and Asia
Marketing: Market Analysis, Business Plan Development, Field Study Initiation, Capital Raising Support
Financing: Venture, Angel, Private Equity Due Diligence
Manufacturing: Outsourced Product Development and Management, Outsourced Manufacturing Management, Operations and Supply Chain Development and Management, Transfer, Integration, Sustaining (US & China)

Education and Background:
Boston University, B. S. Biomedical Engineering, May 1983
Université de Paris, Certificat de Langue. Française, December 1989

Awards and Certifications:
10 US PATENTS ISSUED