When new assays or diagnostic tests are ready for commercialization, there can be tremendous hurdles to overcome, including significant investment in the infrastructure for automated manufacturing and test equipment and hiring and retaining highly trained personnel, as well as implementing high-end quality management systems. In addition, FDA, ISO, GMP, and other approvals or certifications may be required. This article examines the requirements for manufacturing these complex diagnostics as well as the critical factors to consider when selecting a manufacturer.

Computed tomography (CAT or CT) imaging is an incredible tool doctors use to help detect and diagnose patients noninvasively. Using specialized x-ray technology, the device has the ability to image cross-sectional areas of the body, and it provides greater details than conventional x-rays. Today, Positron emission tomography (PET) is employed to detect tissue conditions on a molecular level using radioisotopes ingested by the patient and detected by highly sensitive sensors in a PET machine. A PET scan measures important body functions such as blood flow, oxygen use, and sugar (glucose) metabolism to help doctors evaluate how well organs and tissues are functioning. PET scans are used in several applications such as cardiology, oncology, and neurology. According to the National Institute of Biomedical Imaging and Bioengineering, combination PET/CT scanners are the primary imaging tool for identifying most cancers worldwide.

Most medical diagnostic and testing equipment involves some type of enclosure, cart, or cabinet that serves as a user workstation or protects sensitive electronics, controls, and hardware. Although not as sophisticated as the actual diagnostic device itself, these enclosures are nevertheless critical to the use and overall service life of the finished product.

Depositing small, repeatable volumes of fluid in assembly applications spans a diverse range of industries. The ability to deposit precise amounts of material is an ever-increasing necessity for manufacturers, particularly when assembling electronics and medical devices. These fluids must be dispensed reliably, accurately, and with consistent repeatability in dosage and placement. The precise positioning and quantity of the fluids deposited is integral to the assembly, function, quality, appearance, and viability of the final products being manufactured.

High-speed machining is typically used in medical equipment manufacturing where machinists often work with exotic alloys and harder metals like titanium.

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In a series of procedures carried out by a team at Imperial College London at St Mary’s Hospital, researchers have shown for the first time how surgeons can use Microsoft HoloLens headsets while operating on patients undergoing reconstructive lower limb surgery.

For patients, high-quality orthopedic components mean that implants can be kept for as long as possible, reducing or even eliminating the need for further procedures down the road. In order to ensure the level of quality required, many orthopedic device manufacturers use high-precision air gaging during development and in production.

As technology becomes increasingly mobile and information becomes more readily available, consumer demand for immediate answers continues to rise. This demand is coupled with the concurrent growth of health-conscious consumer attitudes. Mobile apps that report traffic delays, artificial intelligence software that listens to and interprets commands, and wearable electronics that track activity and sleeping patterns — these programs are all geared toward consumers who are invested in gaining rapid information that they can use to make everyday decisions.

Digital design tools — computer modeling and realistic simulation — have emerged as key contributors to success in medical device product design and manufacturing, and increasingly in the pharma industry as well. Many of these tools have been used in the aerospace, automotive, construction, and other industries for decades. While life sciences applications are in the earlier stages of development, they are beginning to produce often astounding results.

The need for thermal management continues to increase in the medical industry. Active thermal management is critical for applications such as patient core temperature management, skin cooling, medical device cooling, and laboratory equipment cooling. Medical device designers need highly efficient and compact cooling systems that can be integrated into their systems, often with the option of battery power for mobility.