By Nicholas Smith
The In Vitro Diagnostic (IVD) medical device market is one where new and advanced applications are appearing every day. Equipment expertise and regulations are becoming increasingly complex to the point that a diagnostic company may not be able to keep pace and bring their platform solution to market in a timely manner with the appropriate support level required by the customer.
IVD instrument development requires a breadth of experience. This is not only in concept, design, engineering and development, but also in manufacturing and support. High technical risks, cost overruns, schedule delays and missed end-user targets are just some of the inherent risks. A risk based development approach from the concept stage through feasibility, design, verification, and product launch can be used to minimize these risks.
It is possible to build a process to reduce project risk
Critical to the development process is the concept phase where user needs are translated into system requirements and further into specifications. The more specifically the user needs and requirements are described, the more precisely the specifications will be defined. To ensure success, several iterations of concept and modeling by experienced and knowledgeable concept engineers are often required. Indeed, a successful concept phase implies that technical, market and end user understanding are gathered simultaneously. It also safeguards against changes in design, enables faster speed to market and provides a foundation for accurate program scheduling and cost estimates.
Implementing integrated product concept and development in a company may be a challenge due to a lack of resources or expertise. On the one hand, the resources required may be not available as they are dedicated to your other projects. Alternatively, one can have technology gaps, performance or specification weakness. Finally, the need can be skills such as regulatory support, quality, and process definition, all of which are specifically required in a regulated environment. No matter the necessity, internal and external collaboration are key to a successful instrument development. This is the reason why many companies are considering OEM partnership today.
Tecan offers knowledge across the development process from concept and design, engineering and development to manufacturing and support including product life cycle, regulatory, quality, and service. Our design and engineering teams complement yours to develop and manufacture customized components or complete systems or platforms. We understand the values that each side brings into the project. Hence a personalized concept team will work closely with you to form a strong and long term relationship. This concept team possesses the applications expertise and market knowledge that matter to your project and will propose workflow automation and systems that will meet your customers’ needs.
With over 30 years of fluidics and system engineering expertise in components, modules, platforms, and complete systems, Tecan has capabilities that can extend yours in the areas of hardware engineering, system and assay integration, or software applications. Over the years, our concept team has grown their skills and expertise to propose customized solutions in both established and emerging life science and diagnostic markets. Where appropriate, we can work with you to define your presence even in new and emerging markets
Quality processes and regulatory compliance must be considered early in the development phase. Lack of traceability, quality controls or documentation may have severe consequences in the IVD space. Tecan ensures quality processes and documentation, as well as regulatory compliance for the requirements of FDA, CE marking, and other directives (e.g. RoHS Directive, REACH Directive, WEEE Directive, amongst others). Our Regulatory Affairs teams are well versed in the complex and varied directives for all of the major regions we serve and can support you as required. Our uncompromising attitude to quality is ingrained in the culture of our company and shapes everything we do.
Tecan is the partner of choice in the IVD industry. We are a market leader in the automation of complex customized systems in the strictly regulated diagnostic market. Talk to us about your specific requests and let Tecan empower you to take the lead in your markets quickly and cost-effectively.
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