Company insight
■Turnaround time (relative to the order’s size)
■Tooling cost considerations ■Non-recurring engineering fees (if applicable)
4. Prototype development This is where the rubber starts hitting the road and you’ll get your first real-world glimpse of what the final product will look like. It’s also another layer of review. Your manufacturer will use the CAD, BOM, and other product documents from the design phase to create physical prototypes. This is an important moment in development as you’ll be able to interact with a physical version of your product before committing it to production. With these initial samples, you’ll be able to look at the critical-to-quality elements such as the biocompatible materials used or conduct preliminary tests for functionality and performance. The prototype phase is also where you can make major tweaks or adjustments as needed.
6. Product qualification/certification testing phase
Another layer of review, qualification and certification testing is designed to prove the sensor’s ability to work safely and accurately in its intended environment. This type of testing ensures that your medical device meets all applicable national, international, and industry standards set by the FDA, CE, or the EU’s MDD. It’s often completed by independent third parties, who review a wide variety of elements such as: ■Radiofrequency emissions ■Electromagnetic compatibility ■Environmental conditions, including temperature and humidity resistance.
■Materials safety/biocompatibility ■Power usage / efficiency Documentation and reporting processes are also critical components of the product certification process. Manufacturers must provide extensive documentation and data to demonstrate
Another layer of review, qualification and certification testing is designed to prove the sensor’s ability to work safely and accurately in its intended environment.
5. Sample performance review A step up from a prototype, a sample is the next closest thing to the final version of the product. Just like with the prototype version, you will review the sample for performance, functionality, and quality – but at a much more detailed level. More specifically, you’ll evaluate: ■The accuracy of the sensor in detecting and measuring data
■The consistency and reliability of the sensor’s performance over time
■The durability of the sensor against the rigours of real-world use without breaking or malfunctioning.
■Ease of use and user-friendliness so that it’s intuitive and straightforward for medical professionals to use.
■The size and fit of the device into its intended application.
This is the last best chance for you to make adjustments to your sensor without impacting the project’s timeline or budget drastically.
that their prototype medical sensors meet all necessary standards and regulations. This includes detailed technical files, labelling information, user manuals, and other data that demonstrate compliance with regulatory requirements.
7. Full production
After all of the above steps have been successfully completed, your sensor is now ready for full production! That means your sensor manufacturer will now produce the sensors according to the agreed-upon quality, quantity, and timeline. It’s also important to note that during full production, manufacturers need to continuously monitor their manufacturing processes for product consistency and quality control purposes.
This is a key step in producing a high-quality medical sensing solution that meets all regulatory requirements and customer expectations.
Medical Device Developments /
www.nsmedicaldevices.com
How long does it take to make a custom medical sensor Next to “How much does a sensor cost?” this is a question we field a lot – understandably so. In general, the process outlined above takes about a year and a half to complete. That timeline however can be affected by several factors: 1. Your level of readiness – In most cases those we work with come to the table knowing many of the key details about the sensor they need, such as sensitivity, size, and intended lifespan. Others, however, are still in the early stages of their own product development and are a ways off from getting deep into the specifics of their sensor needs. In the case of the latter, it’s simply going to take a longer time to get through the initial stages of conceptualization and development as sensor specs are still being ironed out in real-time. 2. Supply chain conditions – As we all learned during the pandemic, the global supply chain is extremely delicate. Though it’s (mostly) recovered from the extremes it faced during lockdowns, it’s still fragile. That said, no supply chain is impervious to outside factors causing disruptions – for instance, severe weather one day can create delays that span several weeks.
3. Meeting compliance requirements – Like the devices they’re installed in, medical sensors need to meet certain requirements in order to be approved for use. Depending on where you’re located, this could mean extra rounds of testing and evaluation. In some cases, it could mean travelling to the testing facility or having an inspector come on-site.
Custom sensor creation for medical devices, worth the wait While creating a custom sensor for your OEM medical device doesn’t happen with the snap of your fingers, the last thing you want is a component that fails to meet performance expectations. Therefore, working with a sensor manufacturer on a custom solution through each step of the production journey will help ensure that the product you receive is more than up to meeting the demands of its application. ●
www.amphenol-sensors.com 77
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