HOW WE HELP

Grounded in a deep understanding of the CDMO / CMO landscape, product development and manufacturing, our focus is on driving value creation in the MedTech and Life Science companies – Strategy Development, Regulatory Pathway, Preclinical Testing and Program Execution.

Deep Sector Experience

Experienced working with private and VC / PE-backed compainies over the past three decades. BSM excels at translating complex issues into strategic, tangible action plans to drive growth in startup and under-performing groups.

Fractional Leadership

Specializing in providing fractional leadership to early-stage and startup organizations, offering flexible, short- or long-term tailored partnerships to achieve product realization and organizational goals.

Rapid Value Creation

Drawing on global expertise in product development, operations / manufacturing, combined with strong business leadership to achieve KPIs and OKRs.

Value Drivers

Strategy

  • Clinical Needs Assessment
  • Product Features & Benefits
  • Competitive Product Assessment
  • Product Realization Strategy
  • Regulatory Risk Assessment

Product Development

  • Plan Creation & Review
  • CDMO / CMO Selection
  • CDMO & Program Management
  • Bench & Preclinical Testing
  • Design Verification & Validation

Regulatory / Quality

  • Regulatory Pathway
  • Risk-Benefit Analysis
  • Clinical Testing
  • QMS Implementation & Management
  • DMR / DHF / Rosl File Creation

Operations / Manufacturing

  • Manufacturing Transfer
  • Process Design & Optimization
  • Lean & Poka-Yoke
  • Operational & Manufacturing Management

Bio

Barry Smith is an accomplished leader with a notable history in the Life Science and MedTech industries. His diverse experience covers the successful management of multi-national and multi-site organizations across North America, Europe, and Asia.


In 2001, Barry's strategic acumen was instrumental as a founding member of a management buy-out team that successfully integrated companies across the United States, Germany, Italy, and China into a comprehensive solution for the on-site gas market.


Predominantly operating in the Life Science and MedTech sector, Barry served as the President & CEO of CIRTEC Medical before creating BSM Medical in 2011. His leadership was pivotal in merging Texcel Medical and Circle Medical in 2009, giving life to a top-tier contract development and manufacturing organization (CDMO). In 2010, CIRTEC successfully executed a liquidity event for its private equity group, yielding a noteworthy 45% IRR under Barry's stewardship.


Barry's multifaceted skill set includes business and product development, technical and operational management, quality systems, and financial management. He excels in translating complex business scenarios into tangible, strategic action plans. His ability to revitalize under-performing companies and foster growth in both startups and mature organizations is notable.


Known for routinely outperforming stakeholder expectations, Barry's board memberships include tenures at Synectic Product Development, CIRTEC Medical, and US Spine. He holds a Bachelors of Science degree in Chemical Engineering from the University at Buffalo.

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Contact Information

BSM MEDICAL

Email: bjsmith@bsm-advisors.com

Mobile: +1 610.766.1090

LinkedIn: BarrySmithMed

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