When a new custom sensor for your medical device is needed, chances are you needed it yesterday.
Custom components don’t appear overnight. And the likelihood of a sensor manufacturer having one that precisely matches your device’s specifications and performance requirements — ready in volume — is extremely low.
The reality is that medical sensor technology, especially when tailored for a specific OEM application, takes time to conceptualize, design, validate, and manufacture at scale.
Here’s what the development process looks like when bringing a custom sensor to life.
When it comes to creating a customized sensor solution for medical devices, the #1 thing to be aware of …
Actually, there are two #1 things: It takes time and it's an involved process.
Because a sensor that's created for your OEM medical device is completely unique, the process to make it is essentially cooking from scratch.
What does the process of developing medical sensor technology for acustom sensor solution look like?
In a general sense, there are seven steps to developing a custom medical sensor with a sensor manufacturer:
As the first step in developing medical sensor technology for your device, this stage is the most important. Setting the stage for what you'll create, you'll go over all the details of your sensor and its application. This includes elements such as:
With an understanding of what the final product should look like, the sensor design team gets to work on distilling that vision into an actual engineering drawing. After the drawing is completed, we'll send you a copy of it for your review. In almost all cases, there's an element of back-and-forth to further refine your sensor's plans.
In a certain respect, this is like going over proposed schematics for a custom home – you'll be looking at a very detailed plan.
In addition to the sensor's dimensions, you'll have other elements to review, such as material selection, wiring diagrams, and other finer points of the sensor's assembly.
And chances are you'll likely need a few rounds of tweaking and adjustment to get a design that meets – and exceeds – expectations.
Having an agreed-upon design with the specifics for your sensor, your sensor manufacturer will draw up a quote.
The quote should include a breakdown of:
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.
A step up from a prototype, a sample is the next closest thing to the final product.
Just like with the prototype, you'll review the sample for performance, functionality, and quality – but at a much more detailed level. More specifically, you'll evaluate:
While it's possible to make changes to the sensor before the final step, this is the last best chance to make adjustments without impacting your project's timeline or budget drastically.
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:
Documentation and reporting processes are also critical components of the product certification process. Manufacturers must provide extensive documentation and data to demonstrate that their prototype medical sensors meet all necessary standards and regulations. This includes detailed technical files, labeling information, user manuals, and other data that demonstrate compliance with regulatory requirements.
After all of the above steps have been completed, your sensor is 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.
Next to "How much does a sensor cost?" this is a question we field a lot – understandably so.
In general, developing custom medical sensor technology takes about a year and a half to complete. That timeline however, can be affected by several factors:
Developing custom medical sensor technology for your OEM device does not happen overnight. Yet when performance, reliability, and regulatory compliance are on the line, shortcuts are not an option.
By working closely with a qualified sensor manufacturer through each stage of development, you gain a solution engineered to meet the precise demands of your application. The time invested in the process supports long-term performance in the field.
Connect with a medical sensor engineer to discuss your application requirements and development timeline.