Independent thinking on medical-device development
Current commentary, professional discussion, regulatory developments, opinions and practical observations from the realities of developing medical devices.
Current commentary
Roczen’s 48-week findings provide a practical starting point for distinguishing medication supply, treatment persistence, injection events and clinical outcomes—and designing evidence that supports the intended claim.
Software unit verification is not necessarily dynamic unit testing. What IEC 62304 and FDA actually expect from medical device manufacturers.
Celebrating the SmartPilot–MyTherapy collaboration and its opportunity to connect injection information with useful, personalised support throughout treatment.
The 5 October 2026 standards and guidance update: how FDA’s FY2027 priorities can inform medical-device development and lifecycle planning.
How dependencies, trust boundaries and compromised networks should shape threat modelling and penetration testing for connected medical devices.
Browse by subject
Follow commentary across the connected technical, regulatory and organisational questions facing medical-device teams.
Turn user needs into controlled requirements, verified outputs and defensible development evidence.
View commentary →02Apply ISO 14971 as an active product-development discipline—not simply a collection of forms.
View commentary →03Practical lifecycle guidance for embedded, cloud, mobile and software-only medical devices.
View commentary →04Integrate security into development, risk management, verification and post-market governance.
View commentary →05Produce objective evidence that the product was built correctly—and is the right product.
View commentary →06Define product purpose, architecture, interfaces, performance and traceability across disciplines.
View commentary →07Connect QMS and regulatory expectations with proportionate practice and useful evidence.
View commentary →08Build capable teams, effective governance and the conditions for reliable delivery.
View commentary →Choose what you need
MedTech.blog is one part of a connected set of independent resources from Paul Gardner.
Current commentary, regulatory developments, professional opinion and observations from practice.
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Standards and regulations define expectations, but real projects still depend on interpretation, trade-offs, leadership and professional judgement.
MedTech.blog examines that space openly: what works, what fails, what changes—and what the industry should discuss next.
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