By Nicholas Smith
You have made the decision to enter into the development of an IVD system solution for your customers. You have learned that inviting an OEM partner into your project could be beneficial to reduce risks and fill expertise or skill gaps, but you are still hesitant. What are the key elements that you should consider to ensure the success of the collaboration?
How you interact with your OEM partner is critical
Knowledge of the market, voice of customer, incremental product feedback and early stage demonstrations are all activities that bring the right insights to the project. Providing clear cut inputs to craft project requirements is the first factor for success. On the contrary, poor, incomplete, or misunderstood translations of customer needs to product requirements are a major cause of OEM failures. In a multi-process development, introducing changes requires re-engineering, costly design modifications and delays in scheduling. For this reason, including the voice of the customer early and throughout the concept phase is critical.
Continuous and diligent monitoring of specifications from concept phase through to reliability testing ensures that risks are identified at an early stage and are mitigated rapidly and efficiently. A lack of continual due diligence and feasibility often results in quality issues and missed requirements which can lead to schedule delays.
Bringing an IVD instrument to market includes possible technology risk, cost overruns, schedule delays and missed end-user targets. Using a risk based development approach from the concept stage through feasibility, design, verification and validation up to product launch constantly ensures that any deviation from the requirements, the time line or the budget are identified and addressed in a timely fashion.
Both parties bring to the development journey their particular skill set and expertise. It is important to make sure that resources and skills for systems modeling, application software and integration are available and ready to flow into the project. Selecting the appropriate resources is part of the OEM engagement. Failure to leverage key partner resources on both sides may affect development and cause inefficiencies in the project.
In addition to process and know-how, consider your culture and your OEM partner’s – how do you interact and collaborate together? Culture can directly impact ultimate effectiveness and the success of relationships. Make sure you are speaking with the same definitions to ensure good communication. What is the definition of success? Make sure both teams clearly understand this.
Simultaneous development of instrument and assay often leads to moving requirements or missed insights which in turn cause delay, cost overruns and may eventually cause a joint system development to fail. On the other end, early integration of a customer’s assay into the system development process ensures a clear cut definition of inputs, stable requirements and an increased chance of success. This favors an efficient feasibility phase where all critical elements of the assay can be integrated and tested.
Quality processes and regulatory compliance should be considered early in the development phase. Improper traceability or lack of quality controls and documentation may have severe consequences in regulated markets such as IVD. The Tecan Regulatory Affairs team is well versed in the complex and varied directives for all major regions and can support you as needed. Our uncompromising attitude to quality is ingrained in the culture of our company and shapes everything we do.
Download the checklist for evaluating the fit between your company and an OEM partner.