- Predetermined Change Control Plans for Medical Devices
- FDA Expanding Postmarket Surveillance for Medical Devices
- CMS’ Transitional Coverage for Emerging Technologies Pathway
- FDAs Final Rule on Laboratory Developed Tests (LDTs)
- MEDCAC Clinical Evidence Review: Impact on Medical Devices
- Reimbursement Q&A: Medical Device Coding and Coverage
- Implant Devices Performance Requirements
- FDA Draft Guidance Issued on the Use of Clinical Data in Premarket Notification 510(k) Submissions
- FDA Updates on the Breakthrough Devices Program
- CMS Proposal for Transitional Coverage for Emerging Technologies (TCET)
- Final Biocompatibility Guidance: Update on Devices in Contact with Intact Skin
- FDAs Proposed New Rule on Laboratory Developed Tests (LDTs)
- FDA Issued Final Guidance on Digital Health Technologies for Remote Data Acquisition in Clinical Investigations
- New Draft Guidance Document on Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission
- Cybersecurity in Medical Devices
- Use of Real-World Evidence in Support of Medical Device Premarket Submission
- The Transition Towards ICD-11
- From “Approved” to “Covered” – What Medical Device Companies Need to Know
- FDA Review Patterns of De Novo Submissions
- Medical Device Alarms
- Business Development: Expectations and a Bit of Experience
- Successful Delegation – Working with Physician Extenders
- Regulating Medical Spas in Massachusetts – March/April 2009
- Update on State Regulation of Light-Based Device – May/June 2008
- Staying Abreast of Light Therapy Regulations
Regulatory
- 2024 Regulatory Update – CDRH Trends and Key Developments (pdf)
- U.S. Regulatory Affairs, Best Practices (Video)
- Transition to European Medical Device Regulation (MDR): Ongoing Challenges (pdf | video)
- Revamping 510(k): Out with the Old, In with the New
- FDA Initiatives Responding to New Challenges
- New Thinking at the FDA – Back to Basics
- US Regulatory and Marketing Barriers for Medical Devices
- Changes in Regulatory Environment (US) and Implications for Early Stage Medical Device Companies
- Shifting Ground in US Medical Device Regulation – Has the 510(k) Program Run Its Course?
- The New Regulatory Challenges in Europe
- The New Medical Device Regulation and the Clinical Challenges in the EU
Clinical Studies
Healthcare Environment and Reimbursement
- Introduction to the U.S. Healthcare System, the Largest and Most Complex Market (pdf |video)
- Earlier Reimbursement as a Driver of Valuation (pdf | video)
- Pricing of Digital Health Technologies: Considerations, Pitfalls and Opportunities (pdf | video)
- The US Health Insurance Marketplace: Why Planning Your Reimbursement Strategy is Critical for your Company’s Success (pdf | video)
- How Disruptive Innovation Improves Healthcare
- How Should Changes in Healthcare Markets Affect Your Business Plan?
- Value is the New Mantra
- It is All About the Adoption… More Than a Mantra
- Changes in US Reimbursement Environment (US) and Implications for Medical Device Companies
- Trends in Coverage and Reimbursement Policies
- ‘Time to Adoption’ – Reimbursement as a Marketing Strategy Paradigm
- Reimbursement Strategy for MedTech Companies
- Patient Monitoring and Informatics
- October 2024 Newsletter
- September 2024 Newsletter
- July 2024 Newsletter
- June 2024 Newsletter
- April 2024 Newsletter
- March 2024 Newsletter
- February 2024 Newsletter
- January 2024 Newsletter
- Transitional Coverage for Emerging Technologies Newsletter
- June 2023 Newsletter
- May 2023 Newsletter
- April 2023 Newsletter
