Medical Device Developer and CRO Relationships: Key Value Drivers and Performance Indicators

Over the last decade, there has been a change in the nature of outsourcing relationships. Associations between sponsor companies and service providers have evolved from one-time contracts to long-term strategic alliances. In addition, with constant updates in regulations in the medical devices industry, innovator companies are increasingly opting to partner with experienced contract service providers in order to successfully navigate the evolving regulatory environment. Presently, due to lack of in-house expertise to comply with the regulatory requirements, innovator companies are often required to outsource various supply chain processes / operations to contract service providers. CROs that claim to offer regulatory affairs management services usually possess expertise and technical knowledge to support clinical research and the approval of medical devices.

Key Considerations for Selection of Key Performance Indicators (KPIs)

It is important to note that the contracts of sponsor companies with CROs can be evaluated based on a number of (up to 100) of KPIs; however, as per the general industry perceptive, having too many KPIs does not help the sponsor to assess the performance of the company more efficiently. In fact, operating with poor KPIs reduces the chances of success. Therefore, it is critical for a sponsor to differentiate between these parameters, to find a partner that is most suitable for their operations. Figure 7.1 highlights the key attributes related to the selection of a good KPI.

Figure 7.1 Key Attributes for Selection of KPIs

Source: https://www.optimizesmart.com/understanding-key-performance-indicators-kpis-just-like-that/

Some of the main parameters that need to be considered for the selection of KPIs are mentioned below:

• Distinction between KPIs and performance indicators: As iterated earlier, it is important for a sponsor company to be able to distinguish between PIs (performance indicators) and KPIs in order to establish contracts with different CROs. In general, sponsor companies shortlist 5-7 KPIs, amongst hundreds of performance indicators to evaluate the partners that best fit their needs.
• Number of KPIs: As per the opinions of senior stakeholders in the industry, there should only be around five to eight KPIs related to a service contract. It is worth highlighting here that these KPIs are supported by a number of performance measures (PMs). In addition, the number of KPIs is directly related to the number and the nature of strategic objectives that the sponsor company / organization has for the outsourced services.
• Relationship between sponsor and partner: It has been observed that several collaborations dissolve due to lack of proper communication, understanding and transparency between the partners. Hence, it is important for both the parties to mutually execute a practical communication plan and decide critical aspects of the project in the presence of both the sponsor and the CRO to minimize confusions later during project execution.