Technical due diligence of an on-body delivery system

Assessing a platform device for design robustness and suitability for commercial manufacture

Our client wanted to license a complex on-body delivery system for use as a platform device. Assembling a core team of drug delivery device development experts, we conducted a rigorous technical due diligence programme on a target product that was close to market. Delivering a robust report, we helped the client assess both the device’s design robustness and suitability for commercial manufacture, and the quality and completeness of the Technical File, allowing them to make an informed decision on whether to proceed.

Drug delivery | Due diligence

Planning the due diligence approach

We carried out an initial planning meeting with the client to agree both the scope of the technical review and to identify and address any sensitivities, for example ensuring the necessary confidentiality was maintained for the target company. This allowed us to establish the appropriate team and set clear processes for document access and review, to ensure our client received a clear and thorough assessment.

One of the things to ensure success in any technical due diligence programme is creating an environment which facilitates effective collaboration. Assessments such as these partially come down to subjective judgement of processes and techniques and how they have been applied – often by highly experienced development teams – relative to industry best practice. It is therefore important and hugely beneficial if all parties are happy to have open and constructive discussions.
Chris Hurlstone, Director of Drug Delivery, Team Consulting

Risk-based due diligence

We followed a risk-based approach to ensure we provided a comprehensive review of the key areas that mattered most to our client. This covered areas such as:

Requirements capture (including capability of the target technology in comparison with existing competitor products)
Software development process
Design for manufacture and assembly
Risk management
Design verification

Map of world highlighting locations in UK, Europe and US

Remote review across multiple sites

To ensure a fast and flexible approach, we carried out the review remotely. This enabled the core teams and additional contributors to gather regularly, including between the US-based client, European sites, and Team in the UK.

The assessment took place through a combination of technical file review via e-room and sharing of specified files, design reviews with senior management and technical leads from the target company, alongside separate discussions between Team and our client.
Mark Di Cioccio, Managing Consultant QA/RA, Team Consulting

Medical software review

As the on-body delivery system contained software, this formed a key part of the technical audit. We reviewed the software development against the requirements of IEC 62304, including how the software classification was justified for the given application. We also assessed the software architecture, software detail design and the verification methods.

One area that required a deeper investigation was the software risk analysis, not because it was incorrect but because the methodology applied was different to established industry best practice. This meant it took a more detailed level of review to assess its effectiveness and the robustness of the conclusions drawn.
Stathis Louridas, Director of Systems, Team Consulting

Person looking at finite element analysis on computer screen

Design robustness review

To determine the robustness of the device design and engineering, our due diligence team looked at how the engineering analysis approaches had been carried out, including the use of finite element analysis, math modelling and tolerance analysis. This included determining the appropriateness of the approaches taken, such as the dimensional and process capability data used for the tolerance analysis. We also reviewed the way in which theoretical tools were used to support and supplement empirical methods such as development and verification testing.

Medical device lab technicians looking at a screen

Assessing the technology as a platform

Our client was interested in the technology as a platform, rather than for one specific application. To help inform their decision making, we reviewed how well the performance characteristics and capabilities of the pump technology were understood and demonstrated.

Industrialisation process review

Suitability for commercial manufacture was a key concern for our client. We carried out a detailed review of the device design for manufacture and assembly and the status of the industrialisation process, given the target production volumes. This included detailed discussions around the approaches taken, such as for the manufacture, assembly and testing of electro-mechanical subsystems.

We also reviewed the tool validation status and the level of qualification of the assembly lines, considering the potential for automation on stages that were currently manual in nature.

Working to regulatory standards

Throughout the technical due diligence process we assessed how well the target company met the requirements of core medical device standards, including:

ISO 14971 – Application of risk management to medical devices
ISO 13485 – Quality management systems – requirements for regulatory processes
ISO 11608 – Needle-based systems for medical use
ISO 10993 – Biological evaluation of medical devices
IEC 62366 – Application of usability engineering to medical devices
IEC 62304 – Medical device software lifecycle processes
IEC 60601 – Medical electrical equipment requirements

Outcome

We provided the client with a detailed report into the current development status of the target product, discussing how closely the company’s description aligned with our findings, as well as our assessment of design robustness and suitability for commercial manufacture. The report was risk-based and highlighted any potential “showstoppers” which would need to be addressed prior to licensing, as well as priority areas for ongoing improvement. This allowed the client to make an informed decision on whether to proceed.