The most innovative medical engagement solution in the world; safe, secure, qualified and out performing consumer systems is produced in Minnesota. From concept to leading designer and production of high performance digital systems, this has been a singularly unique process.
There are millions of ideas that consider making specialty high-speed, complex digital hardware yet there are very few cases of manufacturing success to market qualification. In the medical market where the barriers are higher, qualifications more stringent and hardware performance demand uncompromising, there is a lower than 1% success rate. We’re not talking pumps, monitors and specialty one purpose technologies like scanners but more demanding general purpose systems for patient and staff engagement. In this space, of the millions of concepts, only one has made it to market. This is a short review of that path.
For GeaCom it started with an idea to address the most urgent and meaningful challenge in global health today; efficient equity and enhanced efficacy. Something that can bridge the gulf between caregiver and those seeking care without eliminating the vital human factor. A system based on Communication & Information Theory Empowered technologies. The hardware must be capable of sophisticated human interactions in any language, literacy, culture and more while being encapsulated in a compact, human factors designed and safe package. This means something new to the world. A product with digital sophistication, design complexity and subtlety in its creation.
In the early days it was simple cardboard and wood designs to test the physical manifestation against human factors and pleasant flowing lines. A measure of proper handle diameters for all sizes, angles for rheumatoid arthritis patients, a screen neither too big nor too small and testing, testing, testing using the closest facsimiles available. Ultimately, as research narrowed the field the first 3D print models were made with space for Populated Circuit Boards (PCBs). We learned the optimal size, shape and weight. This was a multiple year process of research, testing, sourcing and applying.
With a clear idea of PCB sizes (in this case to fit behind a display) it was time design an electronics system that met interoperability requirements while offering the vital CITE enhancements, all while exceeding stringent regulatory standards of the medical market. Electronic emissions were addressed, operation within old and new infrastructure considered, forward looking standards designed to, new levels of memory availability to support the millions of interactions put into service and power systems that never interrupted vital engagement with the patient. Some technology that was generally available and some that was totally new to the world and special became part of the design. It turns out anything new, even moderately different is many factors more difficult to bring “to life”. GeaCom started with “bread boards”, moved to open hardware technologies, graduated to specialty evaluation modules (EVMs) and started the path to producing PCBs from the ground up.
Utilizing the assistance of component makers like Texas Instruments, Micron, Sierra Wireless and many, many others, then leveraging the experience of quality board manufacturers and finally engaging global component consolidation firms a Supply Chain Integration Partners, our journey to production of marketable product was well on the way. The initial Bill of Materials (BoM) is now defined. Even at that stage there was much to learn and the program hadn’t even come half way to fruition. The arduous task of design, test, revision is one not to be taken lightly. Many high performance digital PCBs go through as many as a dozen revisions before achieving stable performance (each revision takes months). Technical considerations such as ground planes, impedance, heat, vibration and more were meticulously identified, refined and perfected. Unique features such as cascading power systems, circuit protectors, environmental adjustments, antenna tuning and power management is a long process that can’t be shortcut.
Certifications then become the next big challenge. UL, UN, CE, FDA, FCC, PTCRB and more are all long, expensive processes. Simply attaining certifications for lithium batteries and transport is a protracted process. The antenna systems for WiFi, cell network and private networks is a highly specialized and fine tuned process that alters design with cascading effect to all levels from silicone up. A process of record keeping to meet demanding requirements is also a major endeavor that takes thousands of expert person hours. Small decision mistakes at this stage cost months and millions so much care must be taken to gain the best insights and advice. Once certifications are achieved then the design enters “frozen state” and the process of efficient manufacture lies ahead.
With PCBs in proper state the process of finalizing mechanicals (plastics) begins. Fine tuning for pinch points, pressure points is achieved through ongoing destructive testing. Assembly considerations come to play as the time to produce in labor, when high volumes are in play, dwarfs the time/cost of refining at this stage. When the final design of each mold is determined highly complex release drafting and mold angles are determined with cycle time in consideration. Any ‘double shot’ molds are highly tuned and tested before finally sending the design for FDA grade steel cut (a process that takes months). Once cut, the the specialty plastics sourcing and on-press refinement begins.
With mechanicals, Bill of Materials and PCBs defined, the writing of specifications and testing procedures can be performed. The Specifications are 1000s of pages of definitions of details on requirements of manufacture, sourcing, qualified machine use, assembly procedures, inline testing like “bed of nails” & circuit probes and operational testing before boxing and shipping.
Thousands of hours of research, 10s of thousands of hours of design and redesign, 100s of thousands of hours building and testing and millions of dollars of expenditures. This brings us only to the point of market entry. The actual process and detail can fill several books. While working on this there was plenty of criticism and conjecture but not time to stop nor desire to reconsider. When finally the product reached market readiness, we did look up and found GeaCom alone as the only qualified producer of North American made medical grade engagement technology. We stand alone as the world’s only manufacturer of product in this segment and leader in portable power management, CITE and FDA technologies. Inline with this accomplishment GeaCom registered patents and established key trade secrets to protect its innovations from theft and copying.
I’d be pleased to address any questions or inputs from readers and will expound on the other aspects of bringing vital innovations to market with complex platforms.