The speed at which medical wearables have become commonplace is quite remarkable. So too are social media-fueled tales of consumer frustration with defective products.

From the vantage point of InterTech’s deep bench of test engineering talent— arguably the most experienced product testing engineers in the world— these product failures are predictable whenever design and manufacturing teams mistake the GRR of test instruments with the overall GRR of test solutions. Inadequate test fixturing to manage the elasticity of products or simulating real-world temperature and pressure conditions that a wearable device must operate in are just two of the common reasons why leak testing and functional testing of wearables is off.

Showcasing Test Technology for Medical Products Market Share.

Get a tour of test technology being used by many of the world’s leading medical device manufacturers for rapid prototyping and optimized production processes.

-- MICROSCALE LEAK TESTING —find leaks as small as a 0.5 micron hole

-- IP 67 and IP 68 COMPLIANCE —safeguarding electronic components of wearables and other dust/moisture sensitive devices

—ERGONOMIC ERROR-PROOFING TEST FIXTURES

—AND MORE!

To schedule a one-on-one in-depth consultation with an InterTech Test Engineering Specialist at the Assembly Show, call 847-679-3377.

In this column we answer questions from InterTech customers and also take on some misleading information that manufacturers of Brand X leak detectors have been disseminating.

Send your questions to sales@intertechdevelopment.com.

Question: The GRR of test instruments is all important to ensuring that dust-sensitive electronic components do not result in defective medical products being released to clinical settings?

Answer: NO! Test instruments are only one contributor to GRR. Test fixtures—and especially those that allow human errors — can have significant negative impacts on GRR. Documented GRR of test instruments is an inadequate quality control metric. The GRR of the entire test SYSTEM— fixturing and test methods —can make or break the GRR of test instruments.

Achieving IP 67 or IP 68 standards for dust and moisture are good examples. InterTech’s test engineering specialists became aware of how human error and poorly conceived test fixturing were undermining GRR for dust and moisture sensitive test and assembly operations. InterTech’s solution was to re-think and carefully engineer test fixtures and poke-yoke test and assembly methods for IP67/68 compliance. Now, leaders in global medical device manufacture are using the InterTech TechPress™ for audit testing to meet IP 67/68 standards.

TechPress eliminates variability in testing introduced by human operators having to handle difficult to actuate toggle clamps prone to overclamping or underclamping and/or inconsistent clamping force over the full range of stroke. TechPress enables a consistent sealing force applied against a positive stop. Both the errors introduced by operator fatigue and also operator injury common when toggles require adjustment are eliminated.

InterTech’s deep bench of test engineering expertise can help your team focus on the GRR of the entire test system, and not just the test instrument. To schedule a no-cost consultation on best-match test technology and methods for your unique application requirements contact 847-679-3377.

For all the medical product designers who KNOW their work meets the standard of museum quality perfection….

There actually IS a museum that is devoted to showcasing work like yours— where someday your products might also call a display case home. It’s the International Museum of Surgical Science, the FIRST and ONLY museum of its kind in the world.

When you visit Chicago for the Assembly Show, you’ll find a fascinating recount of surgical and other clinical history told via the tools of the trade— now and before. Always rich in special event programming, the Assembly Show coincides with the museum’s focus on the more gory aspects that are part and parcel of the surgical trade— BOO!

While in town please accept our invitation to also visit for an in-depth and no-cost consultation with staff at InterTech’s Test Engineering Lab while you are nearby. Call 847-679-3377 to schedule an appointment.

InterTech’s patented MicroScale Leak Testers are increasingly being used by leading global manufacturers of wearables and other leak sensitive biomedical devices. These rapid ROI test instruments enable prototypes to be thoroughly tested and vetted before new products’ release.

Why is MicroScale leak testing important and how does it work? Read this InterTech Design Engineering Report for details.

InterTech Test Instruments are Built to High Quality US Standards

•  No Tariff Impacts on Your Order
•  Reliable Delivery
•  Factory Service ALWAYS Available

Get Test Solutions Customized to Your Application Call InterTech at 847-250-0450 or email sales@intertechdevelopment.com