Building a Medical Device IP Portfolio: A Practitioner's Guide to Claim Strategy, Regulatory Timing, and Aftermarket Control
By Casey Scott McKay ·
This guide builds a medical device intellectual property portfolio as a sequence of decisions tied to the regulatory calendar rather than to prosecution milestones. It starts with the filing rule that governs everything - file before the submission - and the continuation practice that keeps a family live through the approval gap. It then works claim layering across the device, the system, the consumable, the interface, the manufacturing method, and the design, with the drafting that survives eligibility for diagnostics. It covers the aftermarket decision between selling and placing instruments, the repair and reprocessing analysis, software change control where the software is itself the device, promotional review across regulatory and competitor exposure, and the process trade secrets that outlast the patents.
IP and Technology > Patent Counseling Transactions | Guide | Published 28 April 2025 - Updated 4 June 2025 | Casey Scott McKay - marksy.us
Summary. This guide builds a medical device intellectual property portfolio as a sequence of decisions tied to the regulatory calendar rather than to prosecution milestones. It starts with the filing rule that governs everything — file before the submission — and the continuation practice that keeps a family live through the approval gap. It then works claim layering across the device, the system, the consumable, the interface, the manufacturing method, and the design, with the drafting that survives eligibility for diagnostics. It covers the aftermarket decision between selling and placing instruments, the repair and reprocessing analysis, software change control where the software is itself the device, promotional review across regulatory and competitor exposure, and the process trade secrets that outlast the patents.
Keywords: device portfolio strategy · claim layering · consumable claims · interface claims · manufacturing method claims · eligibility drafting for diagnostics · filing before submission · predicate monitoring · continuation practice · design patent filing · placement versus sale · exhaustion control · reprocessing and repair · software change control · promotional review · substantiation file · dual name clearance · term modelling · extension eligibility · trade secret process controls
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