By Nicholas Smith
You are considering an Original Equipment Manufacturing (OEM) partner to support you in bringing your idea to market. The planned IVD device may require components, robotics and modules. You may need integration into an existing platform or the development of a completely new customized system. What else should you take into account when selecting an ideal OEM partner?
Transparency is the life blood of a true OEM partnership
Every partnership has two sides and each must work together to reach success. In this case, there is the OEM partner and an OEM customer. Would any OEM partner fit with any OEM customer? There are several success factors that OEM customers and OEM partners need to consider to develop a successful OEM partnership.
Both parties should be willing to adopt a win-win approach, where risks (financial, time, technological …) are identified in a transparent manner and are mitigated throughout the program in a spirit of partnership. Clear definition of ownership and responsibilities (e.g. who is responsible for verification, validation, who is the legal manufacturer ...) at a very early stage ensures a well-defined set of deliverables. This in turn ensures that both parties’ expectations are met.
A development program usually does not end at launch but moves into life cycle management where manufacturing, supply chain, service, etc. are addressed. For this reason, it is important to make sure that both parties are ready and are prepared to enter into a lasting relationship.
As a strong foundation on which to base the definition of requirements, the OEM customer understands the market and end-user customer needs best. In a relationship, the responsibility must be taken to translate those needs into adequate requirements. Providing regular Voice of Customer (VOC) challenge to the proof of concept, the prototypes, and the final products will confirm that the requirements set are correct and give the confidence that you are developing the right solution for your end-user customers.
The OEM partner should have sufficient knowledge of the relevant market to understand your business and turn your end-users requirements into the appropriate specifications. When selecting an OEM partner, consider if this potential partner has developed and manufactured similar products or systems for your target market in the past. Do they have technology that meets the needs of your end-user customers?
Tecan has a proven record in life science and IVD markets, proposing platform solutions (Freedom EVO®, Fluent® platforms), robotics and pumps (Cavro and Sias product portfolio), consumables and accessories for many types of laboratories all over the world. Over 80% of the top 30 clinical diagnostics companies have Tecan built inside. With over 10,000 OEM units shipped to serve clinical diagnostics and over 100,000 components built into clinical diagnostics devices, Tecan is an OEM leader in the IVD space.
A development process is complex and can be a risky journey which requires a variety of complementary technical (mechanical engineering, motion control, fluidics, software, engineering, assay integration …) and supporting skills (regulatory, quality …).
Among other capabilities, system engineering and integration expertise are critical and their importance should not be minimized. Hence, look for an OEM partner that can fill any skill gaps that you may have. Additionally, within the partnership, you and your OEM partner can leverage each other’s core competencies, e.g. instrument (partner) and assay (customer). Co-development, co-feasibility and check points in the program schedule de-risk simultaneous assay and system development.
In addition to complementary capabilities, both parties should ensure that there is a well understood assignment of key partner resources. An inefficient use of resources, inadequate selection of skills, or lack of diligence in selecting resources are all important factors which can increase timeline and cost risk.
Product technology gaps may result in slower technology readiness or an increased technology learning curve. When selecting an OEM partner, consider what off-the-shelf products they offer which may broaden your own product pipeline. For instance, development of new components, modules, robotics or platforms as initial steps in the development of a full complex system often brings additional risks which are difficult to mitigate. Integrating already developed and tested elements reduces risk and can lead to faster technology readiness.
Maintaining compliant processes and recording all documentation into an internal Design History File (DHF) are key elements of good development practices for the selected OEM partner. Both the OEM partner and OEM customer must practice active joint review of deliverables throughout the OEM development.
Using a mutually agreed risk-based development approach and joint continuous monitoring from the concept stage through feasibility, design, verification, validation and product launch constantly ensures that any deviation from the requirements, the time line, or the budget are identified and addressed in a timely fashion.
In addition to the process and know-how, consider the culture of the partner company - how it interacts and collaborates. These directly impact ultimate effectiveness and 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. Do you want to launch in a region where you will need technical support in additional languages? Be sure that your partner can support this.
Bring us your specific requests and find out why Tecan is a successful OEM partner in the IVD market.
Talk to an OEM partnering expert today to find out more.