}?>

Case Study: Confidential Multi-bay POC MDx

Opportunity

Initial Defect Rate: 50%

When Invetech took over production from a major contract manufacturer, the stakes were high. The facility was facing an FDA major non-conformance, and half of the product output was defective—a staggering 50% defect rate that threatened both compliance and reputation.

Invetech set out with an ambitious goal: to bring this defect rate down to industry-leading standards through a series of innovative design changes.

Over five years, we meticulously transformed the production process, one phase at a time. 

A detailed photo of a DNA microarray chip, used for genetic testing and research, with a scientist's hand manipulating the chip with tweezers.

Solution

Final Defect Rate: <1%

When Invetech first inspected their production line, a critical issue surfaced. A significant portion of the product was failing due to an overlooked process flaw: a heat-intensive step in manufacturing was distorting rubber components, leading to a staggering 50% defect rate. This discovery presented a clear challenge but also an opportunity for breakthrough.

To address the issue, Invetech embarked on a comprehensive redesign. Recognizing that rubber couldn’t handle the heat, the team selected a resilient, foam-based material engineered to withstand much higher temperatures without compromising integrity. This change became a pivotal improvement, but it was only the first of many. Over the next five years, Invetech systematically refined each production component, pushing toward an ambitious goal of zero defects.

This commitment paid off. By overhauling materials and processes, Invetech achieved an unprecedented 0% defect rate, transforming their approach to manufacturing and setting a new industry standard in product quality.

More Case Studies

Below are a selection of case studies highlighting the range of problems we’ve solved to deliver innovation and business value for our clients.

Life Sciences & Biotech

Not all innovative or complex technology is used in the clinic, but these systems benefit from many of the same principles used.

Read More →

Mid to High Throughput Instruments

Whether we support the entire product or take lead on a subsystem, full instrument architecture is critical to success.

Read More →

Benchtop & Distributed

Translating technical workflows of an assay into an automated process performed within a device.

Read More →

Custom Process Automation

Transition from clinical to commercial scale manufacturing with our production-ready manufacturing and automation solutions.

Read More →