Medical device due diligence

Our long history in medical device development gives us a deep understanding of what it takes to develop outstanding products that are technically and commercially viable and compliant with medical regulations. With a strong track record and a multitude of industry awards, we are often asked to help clients qualify an opportunity, minimize risk and maximize their chance of success.

We can help you conduct effective due diligence whether you are an early-stage investor, a growing organization, or a large corporation preparing for potential funding, licensing or acquisition. Our specialists can design and deliver programs ranging from broad assessments across multiple areas of device development to deep dives into specific areas of concern.

Quality and regulatory due diligence

We can review your chosen regulatory strategy and planned approval pathway, e.g., UK CA, EU MDR/IVDR, US PMA/IDE/510(k). Our team can also provide independent assessments of your design and development processes against the regulatory requirements for quality management systems, primarily ISO 13485 Section 7.3 and 21CFR820.30.

Standards compliance assessment

We appreciate that interpretation of standards requirements – particularly for novel and innovative devices – is not always straightforward. This is why our consultants sit on a number of industry panels and working groups, including the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS) and ISO TC84 device for administration of medicinal products and catheters. Team often carries out standards compliance analysis against key industry standards and we have highlighted a selection of commonly encountered standards below:

• IEC 60601 – Medical electrical equipment requirements

• IEC 62304 – Medical device software lifecycle processes

• IEC 62366 – Application of usability engineering to medical devices

• ISO 10993 – Biological evaluation of medical devices

• ISO 11608 – Needle-based systems for medical use

• ISO 13485 – Quality management systems – requirements for regulatory processes

• ISO14971 – Application of risk management to medical devices

• ISO 20072 – Aerosol drug delivery device design verification

• ISO 10555 – Intravascular catheters

• IEC 61010 – Measurement, control and laboratory equipment

Technical file and design history file review

Core to many due diligence projects is a review of technical and design history files. We assess existing content, how it has been produced, by whom it has been produced, and identify gaps or documentation that needs improvement. Our consultants consider the application of design and development planning, design controls, alongside the scope, methodologies and application of risk management and human factors engineering. In addition, we can review in detail the output from core technical development activities, such as engineering analyses and device test programs, to ensure that they reflect state-of-the-art industry best practice.

Overall, we report on whether your documentation meets the needs of regulatory submission. We check that documentation reflects a rigorous process to develop, understand, specify and manufacture a robust, high-performing product that meets your needs.

Manufacturing due diligence

Team has a deep understanding of device manufacturing, including design transfer and production scale-up. We know where the risks and difficulties are often encountered. As part of our due diligence offering, our consultants can deliver a detailed assessment of the status and robustness of the manufacturing strategy and systems for your product.

Our team can help you identify the manufacturing risks or gaps and support you in planning for success. Our support includes:

• Expert review of Design for Manufacture (DfM) and Design for Assembly (DfA)

• Review of process risk analyses

• Supply chain evaluation including supplier selection,

• Assessment and review of process equipment validation and qualification plans and reports.

Commercial due diligence

Assessing commercial opportunity is key to deciding whether to acquire or license a product or technology. We can support you in establishing answers to the following questions:

• Is the opportunity well defined? Is this the right product for the market?

• Are the proposed development strategy and project plans realistic and appropriate?

• Are technology readiness levels what they claimed to be? What are the residual risks?

• Are target manufacturing costings achievable for the chosen production strategy and volumes?

• How technically sound is the intellectual property (IP) portfolio? We can assist in finding, interpreting and navigating through the technical aspects of existing IP.