Medical device design spans many engineering and technical disciplines, such as mechanical design, automation, controls, and supply chain. Also, it is a highly regulated industry that serves the majority of the population, which creates high visibility and a high production volume of refined products. When developing medical device designs, it is imperative for the team to keep current on market trends, to comply with the current regulatory landscape, and to employ an expedient development process to products that customers and end users want.
Medical devices are trending toward miniaturization and modular device designs. This movement allows patients to use equipment from the doctor’s office at home. The small devices are less cumbersome for patient use, increasing the likelihood that they will use it as the doctor recommends. Product developers are also simultaneously ruggedizing and reducing the product design cost, improving product durability while making the products more portable.
Another trend is an uptick in large device manufacturers merging or acquiring one another. Boston Scientific is a notable example of the buyer in several recent acquisitions (NxThera, nVision Medical, Millipede), and there have been mergers between Medtronic-Covidien, Abbott-St. Jude Medical, and Zimmer-Biomet. The increased revenue streams and capital from these deals facilitate long-term R&D investment and could improve economies of scale for the manufacturers.
These M&A’s do create a vacuum that startups can fill. The increasing size of large manufacturers/suppliers creates more strict boundaries between which products they want to provide, and which products they don’t. If there are devices that are not available, a smaller company may be able to supply the system/device more easily than getting a large firm to adapt its product strategy.
A final trend is the increased use of Common Procedural Terminology (CPT) codes for medical procedures and the Healthcare Common Procedure Coding System (HCPCS) for disposable medical devices. These codes allow users (and manufacturers) to know precisely the product used for billing/claims purposes, and they also provide data to measure treatment outcomes and cost. Using these codes also empowers medical device manufacturers to develop highly targeted ROI justifications in their development pursuits.
REGULATORY DESIGN CONSIDERATIONS
Understanding and incorporating current regulatory standards is a critical element to medical device product design. ISO standards such as 60601 (medical electrical equipment) and 62304 (medical device software) are examples of standards that impact Syncroness’ product design expertise. Additionally, ISO 13485 (medical device quality management systems) provides a tremendous value to customers, giving them the confidence their design partner is developing products consistent with industry best practices to assure quality, and documenting appropriately.
THE SYNCRONESS ADVANTAGE
Two examples of the types of systems Syncroness develops are Class II electromechanical medical devices for cardiac monitoring and rehab and in-vitro diagnostic systems. We have developed an automated system to process blood samples, and have designed the product’s software, electrical, and mechanical components. We’ve also created high-volume disposable products, with a concentration around design for manufacture.
To manage the main aspects of these product types, we adopt an Agile project management approach, employ continuous improvements, and conduct internal audits. We apply Agile not only for software-focused efforts but also for hardware pursuits as well. These steps ensure progress continues forward, frequently reviewing with the customer’s internal team while maintaining process integrity with a time-sensitive development cycle. We also grow our base of expertise by sending team leads to seminars and continuing-education training.
Syncroness has over 20 years of experience in medical device design and is an immediate value injection to our customers. Our ability to rapidly develop products, processes and project management style, quality assurance, and regulatory expertise add confidence and transferrable skills to our development partners. We can provide full-scale medical device design development, from initial concept and ideation to transfer to manufacturing, giving our customers the support they need to supply the market.