Why we started with CleverSkin24
INSIGHT Why we started with CleverSkin24 A platform becomes harder to believe when the first commercial plan tries to prove everything at once. CleverSkin24 gives us a narrower route: a…
INSIGHTS
Notes from the work.
Practical thinking on medical-device development, evidence, manufacturing, commercialisation and market entry.
Advanced wound-care costs in the UK: why the burden matters
INSIGHT Advanced wound-care costs in the UK: why the burden matters Wound care is often discussed as a product category. For the health system, it is also a repeated workload:…
Starting OEM, regulatory and manufacturing-equipment conversations
INSIGHT Starting OEM, regulatory and manufacturing-equipment conversations Manufacturing is not something we can design on a spreadsheet and validate later. The equipment, package, process, supplier grades and host-manufacturer capabilities all…
Why we built an Advisory Board
INSIGHT Why we built an Advisory Board Founders need conviction. They also need people who are prepared to challenge it. The CleverSkin Advisory Board was built to bring structured external…
The 72-point scorecard system
INSIGHT Why we built a 72-point scorecard A development-stage MedTech company can look busy while still avoiding its hardest questions. That is why we built a 72-point scorecard. The scorecard…
Why we launched an IMS early
INSIGHT Why we launched an IMS early Early-stage companies often postpone systems until they are larger. I think that is the wrong sequence for a regulated product. Complexity appears before…
Why securing the Class I position for the first product matters
INSIGHT Why securing the Class I position for the first product matters The most important regulatory decision is not always how broad a product can become. Sometimes it is how…
International interest and government dialogue
INSIGHT International interest and government dialogue We have had interest and discussions involving stakeholders in Indonesia, Vietnam, the Philippines, Canada, India, Kuwait and Germany, including government-linked and institution-linked conversations. I…
Early route-building in Turkey, Saudi Arabia and Brazil
INSIGHT Early route-building in Turkey, Saudi Arabia and Brazil A country on a pipeline is not a market-entry strategy. The route becomes real only when we understand who carries regulatory…
MEDICA 2025 and the start of CleverSkin’s public journey
INSIGHT MEDICA 2025 and the start of CleverSkin’s public journey MEDICA 2025 mattered because it moved CleverSkin from internal development into external challenge. That is a different test. A team…