In a relatively short span of time, medical instrumentation has run the gamut in dimension, size, scale, complexity, automation and application. Evolving from huge instruments that occupy the majority of a laboratory and require hours or days to process, to handheld point-of-care analyzers that provide instantaenous results, medical technology has made huge strides.
If you're in the medical device business, you realize that you too must evolve to stay in step with the rapidly changing market - or get left behind.
Every step matters
Whether you need engineering and design services, contract manufacturing, or both, the intricate steps required for a smooth transition from design to manufacturing are crucial. There are no shortcuts if success is your goal.
As Sam Brusco states in a Medical Design Technology article, "Medical equipment hasn't always looked as pretty as it does now; medical engineers didn't have the advanced design and manufacturing techniques to work with quite yet." What is the secret to success for a smooth transition from development and design to manufacturing? Is it as simple as designing for manufacturability or has the process grown as complex as the instrumentation itself?
As Michael Kallelis, executive director of business development at KMC Systems states in a Clinical News Journal article, "A well-designed product that struggles in manufacturing is of limited value to a company's goals. Likewise, a product that lingers in development and misses its commercial launch date will struggle to achieve its targeted ROI. For a product to be a commercial success, the ideal situation is for the instrument to be conceived, developed, designed and built in a seamless process by one, multi-disciplined company."
KMC Systems adopted a dual heritage of engineering and contract manufacturing for the medical and life science markets early on. "This is KMC's strong value proposition," Kallelis said, "which is not typically found in other firms."
Engage early and often
Engaging an outsourcing partner early on in the development phase adds value for the OEM as the manufacturer can integrate both the design and development of the medical device to suit the needs of the end user instead of providing off the shelf solutions. Even if you utilize in-house resources for engineering and development and intend to outsource manufacturing, it's best to engage with your manufacturing partner before the project is ready to hand off for manufacturing - and keep the communication open.
Recently featured in an article for AACC's annual meeting, Robert Silva of KMC Systems states "To bring new innovations to market, a certain degree of invention may be required to break barriers and solve complex challenges." Allowing for design flexibility and discussing the options of design early on drives the product to market with a quicker turn around time and is more cost effective. With the collaboration of the engineering and manufacturing teams, the challenges and options of design have been dealt with early on in the process with technical issues addressed and executed seamlessly.
If the objective of the medical device is to be more functional with a reduced product size and cost, or if the device is meant for the patient's home rather than a hospital, use ability and security are of high importance. The complexity of either scenario requires a dedicated problem solving team.
The collaboration from design to manufacture results in productivity, boosting customer confidence, and market acceptance. This is what KMC Systems offers, as a specialty engineering firm with proven success as a contract manufacturer for over 35 years.
When is a project ready for manufacturing? Download this Manufacturing Readiness Review for a helpful checklist.