Case study · SaMD & clinical trials

Building a certified medical device software function, from zero to clinical trial

As VP of Technology, built Closed Loop Medicine’s core software engineering capability from scratch — recruiting and managing the technical team, establishing delivery rituals and procedures fit for medical device development, and defining the technology strategy and product architecture behind the company’s first certified SaMD.

Client

Closed Loop Medicine

Role

VP of Technology

Stage

2018–2023 (4+ years)

Focus

Team building · Architecture · Compliance

The challenge

CLM needed a software engineering function built from the ground up — one capable of designing and delivering certified medical device software (SaMD) for Insomnia and Hypertension dose management, to IEC 62304 and ISO 13485, while running live clinical trials.

The approach

Recruited and managed the technical team, and established the delivery rituals, policies, and procedures required for medical device development — then defined the technology strategy and product architecture underpinning CLM’s regulated software products.

Established, managed, and oversaw the software engineering function, including procedures for developing software to meet regulatory requirements for medical devices (IEC 62304, ISO 13485).

Led creation of an innovative technology platform for drug dose optimisation, resulting in the submission of several technology patents.

Successfully managed the operation of three clinical studies, including one of the few UK studies to continue through the COVID-19 pandemic.

The outcome

Drove successful delivery of CLM’s first digital treatment for Insomnia dose management, from inception through to clinical trial deployment — meeting applicable Medical Device standards (ISO 13485, IEC 62304) throughout.

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