Diagnosing, curing problems in vital medical equipment

The pivotal role of diagnostics in the medical field can’t be overstated – in fact, information gained from diagnostic tests is responsible for more than two-thirds of all medical decisions. Additionally, errors in diagnoses affect more than 12 million Americans each year, and, in many cases, cause serious harm to patients. Improving the accuracy of diagnostic methods will help improve patient care, contribute to ongoing health, and can limit spending on healthcare. One way to improve diagnostic testing is employing more accurate diagnostic testing equipment.

The role of in vitro diagnostics
In vitro diagnostic (IVD) devices are vital pieces of medical equipment performing tests on various samples taken from the human body, such as swabs of mucus from inside the nose or blood drawn from a vein. IVD devices can quickly detect numerous medical conditions and can also be used to cure, treat, or prevent diseases. But how does this technology work?

A blood analyzer is one type of IVD that spins very quickly to separate blood cells from the fluid portion of the blood, creating a serum or plasma. The device detects molecules in the blood or counts and identifies the shape and size of blood cells to garner valuable information.

This process can test blood cell and protein counts or identify illegal drug use, blood type, the presence of antibodies, among several other applications. Many medical professionals would agree a critical area of patient safety, healthcare quality, and cost savings that hasn’t been adequately addressed by the healthcare sector is the process of reducing diagnostic errors in such machines.

Given the critical importance of accurate test results, blood analyzers are understandably regulated by the U.S. Food and Drug Administration (FDA). So, when one reputable IVD device manufacturer began to experience failure issues with one of their highly sought-after blood analyzers, they needed to quickly find a reliable cure for the problem and turned to a partner they knew and trusted.

Diagnosing the problem
The IVD company has a successful 75-year history, trusted by hospitals, healthcare networks, blood banks, and labs worldwide. Their equipment supports more than 1 million tests every day, impacting more than 800,000 patients across the globe.

DFF Corp., a contract manufacturer in Agawam, Massachusetts specializing in medium- to high-volume production of precision machined components, had previously worked with this manufacturer for several years – first with smaller machine components and then larger sub-assemblies.

For the assembly in question, the IVD company designed their blood analyzer in partnership with a different manufacturing company holding the rights to the design. When management realized the machine had a higher than desired failure rate, they looked for another company and turned to DFF, which is known to help clients with design improvements and possesses the experience, equipment, resources, and knowledge to offer sound recommendations to improve products and processes while reducing costs.

Complicated testing process
One major hurdle for redesigning equipment as critical to public health as blood analyzers is the number of meticulous requirements and regulations surrounding the machine’s accuracy. The testing process is comprehensive, so each analyzer’s capabilities must be documented to prevent false positives or false negatives; every individual test the blood analyzer can perform must be qualified. If the design is changed, the analyzer needs to be tested and proven capable of detecting the elements it was able to detect prior to the alterations.

Reverse engineering a solution
A team at DFF reverse engineered the 300-part assembly, diagnosing a design modification that would improve accuracy, and meet FDA regulations.

Engineers made certain simplifications to the original assembly, containing parts and sub-assemblies found to be unnecessary, decreasing the number of parts while significantly improving overall accuracy.

Now, after several years of operation, the blood analyzer has essentially no failure rate, proving a streamlined process with a trusted partner can result in a better design. The customer can now mass produce at double the volume with a 10x improvement in accuracy.

The value engineering partnership
DFF’s value engineering process offers a systematic approach to provide necessary functions while improving overall cost points for a project. Its team of engineers frequently recommends cost-saving substitutions of materials and methods, without sacrificing any functionality. The team accomplishes this using design for manufacturability (DFM), design for assembly (DFA), additive manufacturing (AM), and geometric dimensioning and tolerancing (GD&T) services.

DFF takes this value engineering responsibility so seriously that it’s enshrined in its business name: DFF stands for Defect Free Flow.

About the author: Frank Garaughty is an Engineer at DFF Corp. and can be reached at 413.786.8880 or fgg@dffcorp.com.