Heart disease is the leading cause of death in the United States, claiming more lives than all forms of cancer combined. Our customer is a global leader transforming cardiac care. The company’s medical grade electrocardiogram (EKG) products detect normal heart rhythm or atrial fibrillation (Afib) anywhere, anytime in just 30 seconds – all in a portable, affordable device. With the devices, patients can analyze and manage heart conditions quickly, conveniently and cost-efficiently. The customer’s newest product, takes its advanced technology to the next level, providing the most detailed insights on a patient’s heart ever seen in a mobile, pocketable device.
As the first cost-effective, non-invasive, smartphone brand-agnostic solution that achieves 6-lead EKG recordings, the product needed to instill patient confidence in the product’s accuracy, reliability and effectiveness. The product design also had to be manufacturable at scale, using the highest quality materials and components, while meeting globally recognized (including FDA and FCC) standards. In addition, the product would need to meet cost targets and sustainability requirements.
Our customer’s product vision was brought to life by their R&D team and PCH’s world-class engineering and manufacturing expertise. PCH worked closely with them to realize the product’s robust technical and user experience requirements.
Because PCH and our customer had worked together on two previous EKG products, PCH had a good understanding of their expectations and workstyle.
PCH worked to realize the product’s functionality and enhance its reliability and manufacturability – all the while adhering to the industrial design intent.
In approaching the design of the device, our customer sought to create an inspired,
new-to-the-world solution — a timeless new hardware product. Our customer envisioned using high-quality materials coupled with innovative assembly methods to create a discreet, premium medical device. The design was conceptualized with the belief that simplification and purity in materials and assembly were key to providing users moments of joy in daily use.
At the early stages of the project, PCH and our customer consulted with PCH’s manufacturing engineering team regarding sourcing, tooling, and assembly requirements. PCH’s guidance regarding the manufacturing feasibility and risks associated with each design option was crucial in choosing the design direction, enabling our customer to choose an optimal design while being certain that it could be engineered and manufactured at scale. Once the design options were narrowed, PCH began prototyping the device.
PCH engineers built, iterated on and tested the primary design concept at PCH’s state-of-the-art prototyping labs in San Francisco. Functional builds were made to understand and test the primary industrial design concept, assembly process, total part-count, features, functionality, and reliability.
During the prototyping phase, PCH found that the industrial design, which called for a height of 7.0 millimeter (mm), would not fit the necessary components and battery. With very little internal body space, the device had to enclose a removable gasketed battery door. Ultimately, PCH found a solution that slightly increased the device height to 7.15mm.
It was also critical to streamline assembly for mass production while adhering to global guidelines (such as the FCC in the United States) for medical wireless products.
Throughout the project, PCH brought its in-depth knowledge and deep experience in engineering, product development, manufacturing at scale and supply chain management to deliver a robust solution for our customer.
Our customer recognized the value of establishing strong partnerships between design, engineering and manufacturing experts at the earliest product concept phase. This close working relationship proved essential in not only delivering our customer’s product vision and robust technical and user experience requirements, but also in creating a beautiful high-quality product that meets global standards and cost target for a consumer product.