Assessing a diagnostic device for technical due diligence
The client wanted to invest in a point-of-care (PoC) diagnostics device for home use with disposable assays. They asked us to review two technologies to assess readiness level, key risks and recommend mitigations.
The key to performing technical due diligence is to assign staff experienced in the practicalities of medical device engineering in a regulated ISO13485 environment. We started by selecting key staff: a project manager with many years of electronics, software development and technical due diligence experience, a consultant with experience in PoC diagnostics device development, fluent in the language where the client was based and a human factors consultant specialised in usability engineering.
Following staff selection, we took time to fully understand critical aspects of the proposed diagnostic device and our client’s expectations. We visited two suppliers of the technology targeted by our client and evaluated the technology readiness level (TRL) of the device. We identified that the TRL of key aspects of the consumable was not mature enough.
Our assessment also allowed us to identify that plans to achieve CE marking were optimistic. We provided a more realistic scenario that was close to what happened and significantly later than the supplier had planned.
Often in due diligence work other parties are involved such as regulatory staff and those undertaking commercial due diligence. During this project, we made sure to liaise with these parties to get a cohesive conclusion on issues that overlapped with those disciplines.
Our final presentation to the client focused on the technology and the organisation, highlighting risks and recommended mitigations. Our presentation was supported by a report detailing the evidence that underpinned our conclusions.
The success of this project was based on Team’s focus on detailed medical device development. We only work on medical devices, so we’re knowledgeable about technological developments in the drug delivery, surgical and diagnostic market. This focus allows us to have deep and effective relationships with our clients, suppliers and the industry.