Rob Wakeford, Author at MDIN https://www.mdin.co.uk/author/rob-w/ Medical Device Innovations Tue, 04 Aug 2026 13:02:54 +0000 en-US hourly 1 https://www.mdin.co.uk/wp-content/uploads/2025/02/Printable-resolution-Without-text-e1740048902397-150x150.jpg Rob Wakeford, Author at MDIN https://www.mdin.co.uk/author/rob-w/ 32 32 From first concept to Article 117: a rugged autoinjector https://www.mdin.co.uk/rugged-autoinjector-article-117/ Tue, 04 Aug 2026 12:55:06 +0000 https://www.mdin.co.uk/?p=2205 A rugged autoinjector taken from initial concept through to EU MDR Article 117, with the technical documentation built as the design developed.

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]]> Proof of concept for a custom-fit wearable support device https://www.mdin.co.uk/custom-wearable-support-device-proof-of-concept/ Tue, 04 Aug 2026 12:31:07 +0000 https://www.mdin.co.uk/?p=2182 Proving a scan-to-device workflow for a custom-fit wearable support device, from proof of concept through initial prototypes to a defined regulatory route.

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]]> HelloCath: from an idea to tested prototypes and a regulatory route https://www.mdin.co.uk/hellocath-concept-prototypes-regulatory-route/ Tue, 04 Aug 2026 12:31:06 +0000 https://www.mdin.co.uk/?p=2181 Concept development, several rounds of silicone prototypes, technical drawings and a mapped regulatory route for an early stage bladder care venture.

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]]> Proof-of-concept vs prototype: which build do you actually need? https://www.mdin.co.uk/proof-of-concept-vs-prototype-medical-devices/ Tue, 04 Aug 2026 08:06:15 +0000 https://www.mdin.co.uk/?p=2149 “Can you build us a prototype?” is probably the most common opening question we get, and about half the time a prototype isn’t actually what the project needs next. The words get used interchangeably, but in device development they describe different builds that prove different things, at quite different costs. Picking the wrong one wastes […]

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]]> What actually goes in a medical device technical file? https://www.mdin.co.uk/what-goes-in-a-medical-device-technical-file/ Tue, 04 Aug 2026 08:02:49 +0000 https://www.mdin.co.uk/?p=2147 Every medical device on the UK or EU market has a technical file behind it. It’s the evidence pack that shows your device does what you claim, and that you can show your working. Without one you can’t place the device on the market, and in my experience a thin or muddled file is one […]

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