Due diligence of a generic inhaler platform

Challenge

Team Consulting carried out a highly confidential due diligence and technical audit of a generic inhaler platform. The aim was to support a client’s decision on whether to procure both the technology and the company.

Approach

We performed a detailed review of the target company’s technical file documentation, to ensure due process had been followed and appropriately implemented. Drawing on our team’s medical device expertise, we also reviewed the device design itself, to assess performance, robustness and readiness for high volume manufacture. This analysis was then used to determine suitability for submission via the 505(j) regulatory pathway. Finally, we assessed the target company’s overall capabilities, quality systems and tools.

Outcome

We presented a detailed summary report to our client, to support them in making a multi-million pound decision on a company buyout.

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Sector
Drug delivery

Services
Medical device due diligence
Technical audit

Client
PharmaCo

Booklet titled Due Diligence Report

Performing due diligence on a company and technology

Our client asked Team to perform technical due diligence on a target company and its generic inhaler platform. We were tasked with examining the progress the company had made in their development, its current status and the standard of the work supporting it. In addition to this, we were asked to review the company itself, taking into account its people, systems and capabilities, to assist the client in considering a company buyout.

What is essential for effective due diligence of this type is having a team with the right expertise and experience, in order to swiftly and effectively review and assess large amounts of information and data. Our core team averaged over 25 years’ experience in medical device development, allowing them to quickly and deeply understand the work that had been done and identify areas of uncertainty and risk.

Chris Hurlstone, Technical Director, Team Consulting

Commercially sensitive approach

Understanding that the platform was still in development and commercially sensitive, we limited our approach to a small expert team with confidential access to the required information. This group was then able to draw on the wider, specific knowledge and experience of Team’s subject matter experts where required.

Identifying development risks

As part of the full due diligence process, we identified risks to the development of the generic inhaler platform and how well the target company was equipped to resolve them. In some cases assessments such as these are informed by hard evidence, whereas in others they are based more on experience and judgement. On this project, we engaged in open discussion and exchange of views with the engineers and designers carrying out the development, which was extremely helpful in establishing a representative view.

Our team had a strong understanding of industry approaches and methodologies across capabilities and disciplines, allowing them to assess the performance robustness of all aspects of the design. Having a clear knowledge of the specific regulatory requirements and needs for compliance was also essential to determine whether the development was on track for approval via the chosen pathway.

Brennan Miles, Head of Drug Delivery, Team Consulting

Review of company systems and competencies

We conducted a review of the target company’s systems and personnel, including the quality of the tools they were using and how effectively they were being applied. Many different processes and techniques can be applied to develop innovative medical devices, within a clearly defined framework or regulations and standards. Our team was able to provide an objective view on where industry best practice was being applied and where we felt there were some areas in need of further consideration.

Outcome

We generated a comprehensive technical report summarising our activities, findings and recommendations, which we presented to and discussed with the client’s team. This allowed them to take a final decision on their route forward.

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