Director & Partner

Tim Montgomery, CCDS, BA, MBA

Tim is an enthusiastic life science advocate with 20 years of global healthcare experience and a keen understanding of international medical / clinical requirements leading up to product commercialization in the fields of molecular diagnostics, implantable medical devices and research pharmaceuticals (Phases 1a-3b). Tim has Degrees in Biology and Germanic Languages from Indiana and Ball State Universities, post-grad studies at the Wharton Business School (MBA) focus on business collaborations and international business. 

Areas of expertise:

  • FDA / EMA Regulatory Strategy & Compliance
  • Specialized Diagnostics (CDx / DX)
  • Implantable Cardiac Devices & Arrhythmia Technologies
  • Medical Device Development $ commercialization
  • New Product Registration & Global Market Access
  • Remote Patient Monitoring & Digital Health
  • Strategic Partnerships & Business Development
  • Pharma & Biotech Commercial Strategy

Over the previous years, Tim has also attended numerous specialized medical /clinical training sessions in the areas of FDA regulatory requirements for specialized diagnostics (CDx / Complementary Dx), medical devices, new product registration strategies, remote patient monitoring, specialty drug approval requirements.  

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Proven Impact

  • Global Perspective

    Experience across the USA, Europe, and International Markets

  • Cardiac Specialist

    Deep expertise in cardiovascular diagnostics and implantable devices

  • Commercial Leader

    Proven success in business development, partnerships, and market expansion

  • Innovation Driven

    Passionate about advancing technology to improve patient outcomes

Statement of Work

Scope of responsibilities have involved in-licensing arrangements, contracting long-term service and supplier contracts with Biopharma, affiliated laboratories, device manufacturers, support of regulatory initiatives at the NIH (Bethesda) and FDA (D.C.) and academic institutions globally. 

Previous project assignments typically involved detailed in-house consultation with biopharma client project teams to help more fully satisfy their regulatory, internal QC, or scientific requirements for a specific research project, or for a series of drug candidates in pre-clinical testing.