Practical Advice for Medical Devices Firms
www.clinipace.com
Managing the New
Reality: Practical
Advice for Medical
Devices Firms
Contents
Managing the New Reality: Practical Advice for Medical Devices Firms............... 1
Understanding Regulatory Pathways and Clinical Development to Ensure a
Successful Commercial Entry ...................................................... 2
Navigating regulatory pathways .................................................. 2
Premarket Notification 510(k) and Premarket Approval ...................... 2
Investigational device exemption ................................................ 3
Importance of seeking feedback.................................................. 3
Designing and Conducting Efficient Clinical Trials ...................................................... 4
Be design intelligent ................................................................ 4
Protocol considerations ............................................................ 5
Use of technology ................................................................... 5
Run a transparent, efficient study ............................................... 5
Establishing clinical efficacy ...................................................... 6
Evaluating the marketplace: Does the market potential justify the cost of
developing a device? .............................................................................................................. 6
Know your target addressable market ........................................... 6
Know the marketplace ............................................................. 7
Understand the reimbursement environment .................................. 7
Coverage decisions by the Center for Medicare and Medicaid Services .... 8
Importance of HCPCS codes in new product reimbursement ................ 8
Charges made through hospitals .................................................. 9
Physician reimbursement ......................................................... 10
Private carrier payment........................................................... 11
References .............................................................................................................................. 12
About Clinipace Worldwide .............................................................................................. 13
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