KMC Weighs in on In-Vitro Diagnostic Design and Development Trends.

IVD Instrumentation Development MPO

In a feature article by Medical Product Outsourcing (MPO)entitled “More Usable, by Design”, Jim Stommen writes that fewer bells and whistles are included in new in-vitro diagnostic design. He goes on to say that “doing more with less gets the royal treatment and cost-control and functionality reign as King and Queen.”

Stommen interviewed a number of product developers across the medical device spectrum to ascertain the challenges seen in their space. He found a common theme amongst most for the need to address “usability” in today’s new medical instrumentation designs.

Usability Requirements 

Bob Evans from KMC Systems, Inc. pionts out the importance of defining user requirements early on in the IVD product design and development process, “There is more awareness by our customers to develop usability requirements from user research methods.  Consideration and inclusion of these requirements while developing instrument specifications and program plans are necessary elements for robust design input documentation. This lays the foundation for not only complying with FDA guidelines but also meeting the user’s needs” with in-vitro diagnostic design and development. 

This is particularly true, Evans said, with developing today's complex in-vitro diagnostic instrumentation. In other words, when user requirements and instrument specifications are clearly defined in the development stage, medical contract manufacturers can avoid the infamous "tree swing dilemma". 

ivd diagnostics article - define user requirements

Marc Dubreuil, director of business development at Farm Design, a longtime product development firm headquartered in Hollis, N.H., cited the emphasis on usability of devices, saying he “wouldn’t necessarily call it new, but the focus is much greater than ever before.”

What is new, he said, is that instead of technology being pushed into the market, “a lot of large medical OEMs are starting to figure out that it’s easier to find out what users want and need and then supply that need as opposed to just pushing technology. That being said, new technology gives them added differentiation, added value, things like that. But usability is by far the biggest focus in design today.” 

Today's IVD instrumentation design requires greater flexibility, lower cost
Evans also stated in the MPO article that today's in-vitro diagnostic instrumentation needs to be smaller and more flexible while providing faster throughput and lower development and instrument costs. (See KMC's product portfolio here.) 

You may also be interested in this post: 3 Strategies for Assessing IVD Medical Product Development and the White Paper on IVD instrument development.

KMC IVD Development White Paper  


Topics: KMC Systems, News, IVD instrument development program, In Vitro Diagnostics, ivd product development, ivd instrument development, medical contract manufacturing, proven process, in vitro diagnostic device design, medical device, IVD Business Strategy Conference