Engage the Experts Early
When OEMs – especially those in the highly regulated medical-device market – team with their suppliers early in the design process, they can reduce the risk of project errors and delays – and increase their likelihood of getting their product to market when they expect.
Brian Ream, Principal Field Applications Engineer, Sensors
The challenge facing original equipment manufacturers (OEMs). Regulations from the US Food and Drug Administration (US FDA) and European Conformity (CE) require OEMs of medical devices to use a risk-based design approach over the entire design cycle – from design inputs through final verification and validation testing. In managing this process, OEMs often overlook one supplier who can help them mitigate design risk: their sensor supplier. This typically occurs when the new medical device features innovative, proprietary functionality. In these cases, some OEMs are reluctant to share design information externally with suppliers until late in the design process. For Medical OEM project managers and designers, their sensor suppliers – specifically the supplier’s product experts – can play an important role when developing new products. When these sensor product experts are involved in the product’s design from the beginning, they can help the design team avoid critical risks, because these experts often have significant knowledge about the sensor's performance, and are often intimately involved in the product’s enhancements over several years. They will readily know what the product can do – and what it cannot.
This depth of knowledge is critical when you think about the many iterations a design can take during the typical product life cycle. The design path – from concept to sourcing to release to revenue generation – is anything but straight. As situations develop that require the design team to rethink your concept, they need to reconsider vendors and identify new product risks – quickly. The design path can quickly become more circuitous, which means the development timeline can easily surpass delivery dates, which can in turn delay expected revenue streams. When you add in the need to schedule clinical testing or address issues to comply with US FDA or CE regulations, the need for more experts involved in the process early on becomes a clear strategic advantage to meeting the expected goals and delivery dates.
Involving Experts Early
Delays are part of every new product development process, even when the best engineers and project planners are involved. By involving product experts early, these delays can be quickly addressed. On a previous project to build a temperature-control sensor for a critical microprocessor controlled process, the OEM engaged our sensors experts during one of the later project stages. By the time the OEM contacted us for product, the design had been finalized. This caused problems later in the project. Because temperature control was crucial to ensuring the processor’s proper performance, our team opted to design dual sensors, as a way to provide redundancy in this critical operation. Based on a drawing of the dual NTC thermistor design, our engineers chose our most accurate and stable glass encapsulated sensor. This sensor provided ±0.1°C accuracy of the full range of temperatures that the microprocessor was expected to see. Our sensors were then incorporated into a thermally isolating non-metallic housing that exposed the sensors to the airstream around the microprocessor for fastest time response. The drawing called for flying leads with no connector. Everything was clearly documented on our drawing.
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We then manufactured the FAI (first article inspection) sensors successfully and delivered these to the customer. It was then that we received their call: Their instruments were failing at a high rate during the initial production build; this product release was in jeopardy. Upon investigation, it turned out the products we supplied with flying leads were sent off-shore for assembly into an assembly utilizing shielded cable molded into an integrated connector. In the course of the cable attachment operation, the glass sensors were being physically damaged, causing significant out-of-tolerance temperature measurements. During our visit to the customer’s site, which included a Failure Analysis / Corrective Action (FA/CA) session, one of OEM’s senior design engineers wanted to know why this damage was occurring. Our team explained that it was not because of the potential fragility of the glass sensor we designed and the parts built with exposed sensors. Rather, it was that we were not involved in determining the end use, and as a result, were uninformed about potential design shortfalls. From the information we gained during this meeting, we were able to redesign the sensor into a protective housing and integrate the cable and connector directly into our assembly. This assembly was then fully tested and certified to the required ±0.1°C tolerance. Not involving our product experts from the project’s launch resulted in required rework that delayed the project’s completion by two months, which in turn delayed the product’s release to market. This entire slippage, along with product-scrap costs, could have been avoided if our product experts had been involved in the initial design stages.
Maximizing Product Performance
As with all standard medical sensor products, sometimes the existing specifications will not meet the new product’s design requirements. The earlier these specifications are identified, the easier it is for suppliers to develop the products needed. At TE, our engineers work closely with our customers to define their product needs and customize our products to their specifications. The “Same as Except” class of products enables us to easily implement minor modifications to existing standard platforms. This requires minimal non-recurring engineering (NRE) and volume commitments. This class of product also streamlines the design verification and validation process, since the majority of product specifications remain the same as our existing validated standard product platforms. There are times when the standard products – or Same as Except products – will not accommodate a design’s unique performance requirements. In these cases, our engineers – as part of our enterprise effort to deliver Extraordinary Customer Experiences – team with our customers to develop a unique solution specifically tailored to the unique design requirements. Projects of this sort start with mutual non-disclosure agreements (NDA) to protect both party’s interests and allow for the exchange of key design ideas. In our work, higher NREs and volume requirements are typical, especially for sensor products designed for a medical product’s unique performance requirements. In these cases, our part numbers are unique to our customer’s product and are considered fully proprietary to our customer.
Early collaboration leads to better results. When OEMs – especially those in the highly regulated medical-device market – team with their suppliers early in the design process, they reduce the risk of errors and delays – and increase their likelihood of getting their product to market when they expect. With product design hurdles rising, in light of revisions to IEC 60101-1 and other standards, it is increasingly crucial for OEMs to collaborate with each of their supplier’s product experts early, especially when electrical systems are a crucial part of the solution offered.
Advancing Medical Technology
TE worked with medical device designers to create a sensor that monitors the ideal temperature and humidity levels within a newborn’s incubator. Precisely maintaining this critical environment is just one of the many ways we’re advancing medical and healthcare technology.