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Small Walt Question: My company is developing a complex disposable cartridge for a point-of-care technology, and will hire a medical contract partner to design and  manufacture the instrument itself. At what point should we engage a medical device contract manufacturer?Answer
Small David Question: I want to implement  a lean medical product manufacturing philosophy into  my business. What are some of the  challenges we can expect to  face? Answer
Small Ed Question: The pressure to introduce new medical devices to market quickly and cost-effectively is constant. What strategies can I employ to commercialize my product in a strict timeframe? Answer
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Medical Instrument Development

KMC Systems Medical Product Development

Serving the medical industry for more than thirty years, KMC Systems is an industry-recognized provider of medical product development, design, manufacturing and field support services. Through open communication and collaboration with our customers, and by applying our expertise and proven processes, the KMC360® Total Product Lifecycle Management Program mitigates development risks, reduces cost and speeds time to market. 

To see how KMC Systems turns smart ideas into brilliant reality, download our Total Product Lifecycle Chart

Medical Product Lifecycle Chart

Our customers rely on our extensive experience and proven success record in medical device development. The medical product development stage in the KMC360® Program is a key element in the total medical product development life cycle. During the staged medical device development process, our systems engineering team evaluates concept feasibility and architecture requirements with simulation tools in a virtual prototype environment to reduce development risk before investing resources in product design. 

KMC systems engineers provide resources that guide our customers through the medical product development process, addressing requirements definition, hardware/software architecture concepts, risk management and hazards analysis, as well as system verification and validation, during the product development stage.

We have developed and refined our medical product development process through our broad experience resulting in a nimble, compliant and efficient approach to medical device product development with results that comply with FDA 21 CFR Part 820, ISO13485, ISO 14971, and ISO 9001.

Interested in KMC's Medical Device Development Services? 

Download the KMCDevelopment Sheet