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By Nicholas Smith
You have made the decision to enter into the development of an IVD medical device 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?
Seven key factors for a successful OEM partnership
1. Good insight into the customer’s requirements
Choosing an OEM partner who knows the market and understands your customer is essential. On top of this, it is important to find a partner who can incorporate regular and incremental feedback into the development process and is able to demonstrate prototypes at an early stage. This can give you the confidence that your project is on track from the very outset. Providing clear cut input to craft project requirements is the first factor for success because poor, incomplete, or misunderstood translations of customer needs are major causes of OEM failures. In the multi-process development required for lab automation of in vitro diagnostics, 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.
2. Consistent focus on risk identification and mitigation
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 testing can result in quality issues and missed requirements which can lead to schedule delays.
Bringing an IVD medical device 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 timeline or the budget are identified and addressed in a timely fashion. With a good OEM partner, risk monitoring goes beyond the development phase into lifecycle management. It is important that if unexpected events occur you can rely on the support and expertise of your OEM partner to make the necessary adjustments and adapt to the new situation.
3. Use your partner’s technical strength and innovations
Both parties bring their particular skill set and expertise to the development journey. 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 IVD project. In the era of digitalization there are many new technologies—like state-of-the art software and digital twins—that can make instrument development faster and mitigate risks. Your OEM partner should be able to demonstrate that they have a strong grasp of innovations in the OEM space.
4. Local partner presence, language and cultural understanding
In addition to process and know-how, consider both your own organization’s culture and that of your OEM partner. How well will you interact and collaborate together? Culture can directly impact effectiveness and the success of relationships. Make sure you are speaking with the same definitions to ensure good communication. It is important that you and your OEM partner can come to a clear agreement on the definition of a successful lab automation project from the very beginning.
5. Early integration of customer assays
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 testing phase where all critical elements of the assay can be integrated and tested quickly because they have been considered early on in the process.
6. Strong regulatory insight and understanding
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 in vitro diagnostics. Ask whether your OEM partner has a Regulatory Affairs team that is well versed in the complex and varied directives for all major regions and can support you as needed. This will help make sure that there are no regulatory surprises as you bring your product to market, and will ultimately guarantee the quality of your product.
7. Sustainable partnerships
For climate conscious businesses that value sustainability, manufacturing can be an especially difficult process. Manufacturing and logistics have traditionally had a relatively negative effect on the environment, so it is important to consider how your OEM partner has adapted their business to be more sustainable. If you value sustainability in your business, it is important that your OEM partner shares those values so that you can be confident that your project will not negatively impact the environment.
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