The medical device industry is unparalleled, where innovation in technology meets the understanding of the human body to treat diseases and disorders. Medical devices vary greatly, from simple diagnostic tools to complex and life-saving equipment such as pacemakers and ventilators. These technologies fall into many different categories based on the diagnosis, treatment, and prevention of disease, but one commonality between these diverse applications is clear: the patient. And when considering patient-centered design of medical devices, whether it’s a handheld interventional device, a benchtop drug infusion pump, or a wearable biometric sensor, usability, functionality, and quality are paramount.
Traditionally, medical device design and manufacturing has been severely limited by the constraints of traditional electronics manufacturing. Benchmark’s medical team’s dream has long been to leverage our miniaturization technology to design the electronics around your medical device, as opposed to having to design your product around the electronics.
Today, in the spirit of Moore’s Law, electronics have been rapidly shrinking and once rigid and planar printed circuit board assemblies (PCBA) no longer dictate the geometry of a medical device. Instead, the electronics can now be engineered to conform to the best overall device design based on the product requirements in usability, functionality, efficacy, durability, environment and more. Device manufacturers are leveraging miniaturization techniques and processes to both improve the efficacy of existing products as well as to develop new and often disruptive devices. To borrow a term from the defense industry, SWAP-C refers to optimization of size, weight, and power, as well as cost. Recently, these same benefits are being realized in medical device design and manufacturing.
Some recent examples of miniaturization clearly demonstrate the value to this design strategy. The Medtronic Micra™, the world’s smallest pacemaker, is what’s known as a transcatheter pacing system (TPS) which, in step with other recent transcatheter technologies like aortic or mitral valve replacement, can be delivered using minimally invasive techniques and resides entirely inside the heart. Related to gastrointestinal health, the market of swallowable cameras known as "pill cameras” are now manufactured by about a dozen companies. These are used to image regions of the GI tract, including the esophagus, stomach, small intestine, and colon offering a less invasive alternative to certain endoscopies. Miniaturization has not only positively impacted implantable devices. Miniaturization has increased the quality and effectiveness of other medical devices including handheld and mobile imaging systems, surgical robotics, and in-vitro diagnostics.
While one major aspect of miniaturization in electronics is the ever-shrinking size of components and integrated circuit (IC) packages, there are several technologies and techniques at work. There have been recent innovations in electronic substrates that have broadened what is possible in designing and manufacturing PCBAs through techniques like high density interconnect (HDI), three-dimensional heterogeneous integrated circuits, flexible and formable substrates, high layer count lamination processes, and novel additive and subtractive processes for reducing trace line width and space geometry. Possible elements of HDI designs include the use of blind and buried vias (microvias), coreless construction, embedded bare dies and components, and high-performance substrate materials.
The positive impact of these advancements include radically smaller devices with increased effectiveness and reliability.
Challenges in Miniaturization
While the benefits of miniaturization in medical device design are easy to see, historically there have been limitations and challenges to adoption in the medical arena. Miniaturizing electronics demands smaller components, which creates new requirements in material handling, testing, manufacturing process and automation. If you’re employing microelectronics in your design, you must consider that few traditional electronics manufacturers possess the often-costly equipment and capabilities to support processes like wire-bonding, die attaching, laser welding, and precision alignment techniques. If your device must be manufactured in relatively high volumes, process automation may be needed where manual assembly or alignment aren’t possible. This is often an unexpected and not insignificant source of additional cost in bringing a new device to market.
This is why it’s important to involve manufacturing experts as early in the design process as possible, to ensure that the manufacturing strategy is in line with the product design. There are many unique capabilities required to effectively design and manufacture miniaturized devices and it’s often challenging to find them all from one partner or align multiple partners.
Benchmark is a Miniaturization Leader in Medical Technologies
Benchmark used this set of challenges as a blueprint for our next generation medical design, engineering, and manufacturing offering. Benchmark Lark Technology is a global leader in circuit miniaturization, using a proprietary semi-additive manufacturing process to fabricate ultra-high-density circuits in boards of 10+ layers known as 3-dimensional heterogeneous integrated circuits. Lark has a unique capability to make these circuits with several types of substrates including liquid crystal polymer, which many medical device manufacturers see as an excellent material due to its flexibility and near-hermetic properties. Our experienced medical product design and manufacturing teams are able to incorporate this technology into new designs or work with customers to reduce the size or improve the form factor of existing designs. No other design and manufacturing partner has Benchmark’s depth of experience working with medical technologies, our proven track record for FDA regulated products, and breakthrough miniaturization technologies.
Benchmark’s medical technology team can now use our miniaturization technology to design the electronics around your medical device as opposed to having to design your product around the electronics.