CASE STUDIES

Haemonetics®: TEG® 6s Hemostasis Analyzer System

This next generation instrument brought the client’s breakthrough technology from the clinical lab to the point of care for life-saving results.

Client: Haemonetics Corporation

Product: TEG® 6s Hemostasis Analyzer System

Awards

Good Design Award 2016 for medical and scientific product design

Regulatory Requirements

EMC, RoHS (IEC 61010, IEC 61326, RoHS Directive 2002/95/EC, and ISO 15223), UL, FDA

Expertise Used

Fluidics, Optics, Design for Manufacture, Usability/HFE, Contract Manufacturing

Bringing Breakthrough Technology from The Lab to The Point of Care

Real-time awareness of a patient’s blood clotting ability, or hemostasis, in an emergency or surgical setting is crucial for doctors to be able to maintain patient coagulation equilibrium. Oftentimes, hemostasis analysis is completed in a hospital’s central laboratory, separate from the surgical theater. This arrangement wastes valuable time by requiring operating room staff to leave the surgical theater to access these critical test results.

Haemonetics, a healthcare company dedicated to providing innovative blood management solutions, partnered with Invetech to design and manufacture the TEG® 6s Hemostasis Analyzer System. This system is a compact diagnostic instrument that provides clinicians with rapid, comprehensive and accurate identification of a patient’s hemostasis condition in a surgical theater, laboratory, or point of care setting.

The TEG® 6s Analyzer was introduced to the market on July 31, 2014 and is now in full production by our contract manufacturing team. The instrument went on to win the Good Design Award in 2016 for its compact, minimalist design with all-in-one cartridges, resonance and sensing algorithm, large touchscreen, and user-friendly interface.

Featuring an innovative, all-in-one cartridge, the TEG® 6s system delivers the same quality test results without the complicated test preparation process. The instrument allows clinicians to drive personalized, clinically and economically sound treatment while also allowing them to make decisions with confidence.

“As a tool that helps make better treatment decisions that lead to reduced risks, complications and costs, the TEG® 6s system has been very well received by clinicians and laboratories in the US and around the world.”

Jill Robinson

Program Manager, Global Marketing and Communications at Haemonetics

Applied New Optics Technology Application

For the first time in a hemostasis analyzer, the TEG® 6s Analyzer introduced a resonant frequency technology with optics analysis. The blood sample is suspended and its coagulation is measured by its response to vibrations over a wide spectrum of frequencies. This response is then analyzed using a series of algorithms and appears to the end user as an easy-to-read result on the instrument’s touchscreen display – a design upgrade from the external data processing required by the previous version. Having the algorithms function correctly given the processing constraints of the embedded system within the instrument presented various challenges. 

To optimize the development process, we created a framework on a PC that exactly replicated how the algorithms are calculated by the instrument’s firmware.  In doing this we could tune and debug the system by reprocessing test files captured on both the instrument as well as synthesized files for rarer, out-of-range cases. During this process, we were also able to make improvements such as speeding up the key matrix operations by two orders of magnitude.

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An early version of the TEG® 6s Analyzer being evaluated in a surgical theater.

Gathered User Insights to Create Better Solutions

Throughout the instrument’s development, prototype units were deployed into local hospitals to gather user feedback that we translated into appropriate design modifications. Examples of these modifications include rearranging how data is displayed on the touchscreen, color coding test results, and adding a timer to the screen while tests are being conducted.

We also worked closely with Haemonetics’ service team, who interact directly with the Haemonetics’ end users and know the everyday issues that arise after an instrument has been released. The flow of information went both ways: while we listened to their observations on potential issues their customers might have, they became familiar with the TEG® 6s Analyzer so that they could better service it once it was launched.

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User insights were gathered and integrated into the design of the TEG® 6s Analyzer to create a sleek and user-friendly instrument.

From Concept Development to Contract Manufacturing

Our contact manufacturing team worked directly with our engineers early in the instrument development process. Through this collaboration, our contract manufacturing team helped create a product design that would be easier to assemble and eliminated risks associated with the assembly and manufacturing processes.

During the design development stage, we developed a preliminary production process and completed a PFMEA (Process Failure Mode Effects Analysis)—something typically done after a product has already been developed. In doing this early, we were able to refine the product’s design while it was still being created as opposed to making time-consuming changes to the manufacturing processes later on to account for any design-related assembly issues.

Making these design changes and addressing potential manufacturing issues up front allowed us to transfer the design and ramp up for production very quickly, enabling the client to meet their desired launch date. Developing the assembly process early on also allowed several issues to be eliminated that would have impacted the delivery or quality of the instrument.

In addition to the collaboration between our design, development and contract manufacturing teams, tools from the Fortive Business System (FBS) also made a positive impact on the instrument’s time to market and quality. Leveraging FBS tools enabled us to decrease the manufacturing time from two days to one day, while maintaining the high level of quality required for a Point of Care platform.

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We integrated feedback from our contract manufacturing team into the TEG® 6s Analyzer’s design to mitigate the risks associated with manufacturing processes.

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Our processes brought the TEG® 6s Analyzer’s manufacturing time down from two days to one.

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