Expert Details
Medical Devices, Business Development, Regulatory Affairs, Project Management
ID: 732325
Minnesota, USA
Expert has advised a variety of clients on project management as well as quality, regulatory and manufacturing issues, developed market analysis and business plans for his medical device commercialization consulting company.
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 1992 | Degree: MBA | Subject: Strategy / Finance | Institution: The Kellogg School of Management, Northwestern University |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 2004 to Present | Employer: Undisclosed | Title: President; Lead Consultant | Department: Consulting |
Responsibilities:He advised a variety of clients on business development, project management as well as quality, regulatory and manufacturing issues. He developed market analysis and business plans for this medical device commercialization company. Expert led 6 core business critical path projects in regulatory, validation, labeling, remediation and new product development for 5 major multinational device companies. He also developed complete label systems and barcodes for two early stage companies for both FDA submission and manufacturing implementation. Expert implemented 2 Quality Management Systems and hosted an FDA Audit. Additionally, he served as lead Project Manager (12-15 direct reports) for 2 critical FDA Remediation Projects involving validation and labeling. |
|||
| Years | Employer | Title | Department |
| Years: 2001 to 2004 | Employer: Renal Solutions Inc. | Title: Business and Product Developer | Department: Business and Product Development |
Responsibilities:At this Start-up Alternate site home treatment product and service business, Expert led the business market planning, partnering and product development efforts. He re-crafted Market Approach, Product Definition and basic Regulatory Strategy, which resulted in first-round Venture Capital funding with five partners worth over $17 million. Expert also completely restructured and relocated the Product Development Team. Additionally, he secured FDA approval of first product in October 2003. |
|||
| Years | Employer | Title | Department |
| Years: 2000 to 2001 | Employer: Medisystems Corporation | Title: Various | Department: Marketing, Research and Development |
Responsibilities:He held key positions in marketing, R&D and operations, where he developed product positioning and distribution strategy, for this $100-million-dollar high-volume medical disposables manufacturer. He re-engineered channel strategy for more direct access to the customer base. Expert also closed two new national distribution agreements worth $33 million in sales. He implemented an integrated advertising strategy including electronic media and web access to labels and manuals, increased website traffic threefold. |
|||
| Years | Employer | Title | Department |
| Years: 1998 to 2000 | Employer: Hu-Friedy Manufacturing Inc. | Title: Various | Department: Product Development Instrumentation, Compliance and R&D |
Responsibilities:Expert established a new business division for this $70-million-dollar market leader in hand-held dental surgical instruments, where he executed a comprehensive business analysis. He established an ISO/CE-compliant product development process. Expert also implemented a new insert manufacturing process, reducing defect rate over 20%. He successfully concluded research on a phase one SBIR grant from NIH; secured second round of funding at >$750K. |
|||
| Years | Employer | Title | Department |
| Years: 1997 to 1998 | Employer: HemoCleanse Inc. | Title: Various | Department: Marketing and Product Development |
Responsibilities:He worked with market and business development teams as well as product development at this new technology start-up. He played a key role in developing a disease management business plan that ultimately led to $10Mm in funding. Expert developed protocols and directed phase 1 & 2 clinical trials on two unique liver support devices. He also outsourced disposable manufacturing, cutting costs 30%. |
|||
| Years | Employer | Title | Department |
| Years: 1989 to 1997 | Employer: Baxter Healthcare Corporation | Title: Various | Department: Manufacturing Planning; Supplier Management and New Business Development; Marketing and Engineering Hemodialysis Products |
Responsibilities:From 1989-1993, he was responsible for full P+L, marketing, sales and R+D of this independent global business unit. From 1993-1995, he evaluated 16 new business opportunities while managing key suppliers. He directed approximately $100 million in annual purchases, leading numerous negotiations with Japanese, German and Italian key suppliers. From 1995-1996, he led a team of cross-functional senior managers in creating a global manufacturing sourcing strategy for the corporation. He drove $14 million in savings through creative supplier negotiations and commodities financing. |
|||
| Years | Employer | Title | Department |
| Years: 1985 to 1989 | Employer: Haemonetics Corporation | Title: Business Plan Developer | Department: Commercial Plasma |
Responsibilities:Expert developed the business plan for this new division. He was responsible for full P&L, including Marketing, Sales and R&D. He identified a new market and started this new operating division. He took the business from $240,000 to over $10 million in 3 years. This is a $209-million-dollar business today. |
|||
| Years | Employer | Title | Department |
| Years: 1980 to 1985 | Employer: Baxter Travenol Labs | Title: Marketing, R&D Laboratory and Animal trials | Department: New Product Development / New Business CCPD |
Responsibilities:His responsibilities included Marketing, R&D and product laboratory and clinical trials. |
|||
Career Accomplishments
| Associations / Societies |
|---|
| Project Management Institute Regulatory Affairs Professional Society |
| Licenses / Certifications |
|---|
| Regulatory Affairs RAC-US; Project Management Professional |
Additional Experience
| Marketing Experience |
|---|
| Expert is a medical device executive, who has spent 20 years with multiple fortune 500 Global Device companies and a further 12 years with early-stage companies and start-ups. With over 30 years of such varied medical device product development, marketing, and business leadership experience. Expert has led teams that introduced three new to the world devices in Hemodialysis, Blood Processing and Liver Support. He has driven successful new business ventures at Baxter International, Haemonetics, Medisystems and two successful start-ups, HemoCleanse and Renal Solutions. Expert's career accomplishments include: • Successfully launching over 25 new instrument and disposable medical devices • Managing numerous global, multi-million-dollar new product development projects for Fortune 500 medical device companies (PMP Certified) • Leading a $240MM global business for a Fortune 100 public medical device company • Establishing a new division, which grew into a $150MM business within 5 years, for a Fortune 500 company • Authoring Business Plans, Product Development Strategies and Regulatory Strategies for several successful early-stage start-ups • Securing $29MM in Venture funding for startup companies • Implementing 2 complete FDA/CE compliant Quality Systems • Developing manufacturing process systems and supply chain logistics for early-stage companies Expert has an MBA in Business, Management, Marketing, and Related Support Services, from the Kellogg School of Management at Northwestern University, and a Bachelor of Science in Biology, from Western Michigan University. He also completed post graduate work in Bioengineering at the University of Utah. Alongside these educational achievements, Expert has also received Project Management Professional (PMP) certification from the Project Management Institute and Regulatory Affairs Certification (RAC-US) from the Regulatory Affairs Professionals Society. Areas of excellence include: • Product Innovation & Development • Product Launch & Commercialization • Project Management and planning • Financial Planning & Performance • Building / Leading Teams • Collaborative Management Style • Industry Leadership • Fund Raising • Market Strategy • Creating Winning Business Plans • Regulatory and Quality systems Development |