The KMC 360 rapid product development program was used in the development of the SurgiQuest AirSeal device for minimally invasive laparoscopic surgery.

Many contract manufacturers use rapid prototyping (RP) as a valuable tool in product development. But while RP is important in and of itself, a holistic approach is needed to ensure medical devices are introduced to market quickly and cost-effectively. A holistic approach called “rapid product development” (RPD) combines people (rigorous communication), processes (documentation, testing, and control), and technology (off-the-shelf tools) to support these goals. RPD is a relatively new and proven process that streamlines design and manufacturing. Additionally, it ensures devices are manufactured with less error and more cost efficiently.

Our new KMC 360 program supports this approach for contract design, manufacture, and maintenance. Basically, the program centralizes all outsourcing to support OEMs and start-ups throughout the entire medical device and instrumentation product lifecycle. A key component is a flexible stagegate process that lets a product enter a contract manufacturer’s design and development cycle at any time.

People

Developing a complex device or instrument involves large teams of engineers and thus requires many cross-disciplinary efforts. To reduce the chance for errors, rigorous communication is necessary to ensure all team members understand the processes, technologies, and risks.

To ensure good communication, our KMC 360 program involves regular crossdiscipline seminars. Electrical engineers educate mechanical and software engineers while mechanical engineers teach system engineers about design practices. This sharing of knowledge helps multidisciplinary teams understand factors such as how each part of an automated instrument functions as a system.

In addition, we have created a rapid-product-development laboratory. Designed with employee input, the lab provides a dedicated, functional space for hands-on activities such as design, prototyping, and debugging, as well as conference areas for impromptu meetings and video conferences with customers. In addition, we use employee surveys and improvement workshops to keep the creative juices flowing, give new ideas visibility, and create an exciting environment in which employees, business, and innovation thrive.

Processes

Certain factors are key to support rapid product development. First, the quality system established by the manufacturer to ensure products meet FDA standards must be flexible, yet structured enough to apply the right amount of control at each development phase. A onesize- fits-all quality system might ensure control but can be overkill in the prototyping phase. A better approach is to put alternative procedures in place that provide options. For example, programs can scale back quality control for prototypes that will not be used in human trials when the primary objective is a feasibility demonstration. This provides a more flexible and overall quicker product-development approach.

Also important is speed. Paperless approval systems combined with the flexible stage-gate process provides appropriate documentation control with significant time savings. In addition, process workflows help avoid errors, thereby bringing the product to market faster.

Technology

In the past, methods for configuring, debugging, and testing software in a medical device involved using many different low-level debugging utilities. Companies can streamline software development by developing libraries of proven verified software code and electronic controls that can be reused in future projects. KMC Systems, for example, has created its own proprietary EC Diagnostics, or “ecDiag” software to facilitate the reuse of software code that controls common commands. This one common language can be leveraged in development, manufacturing, and fieldservice applications, eliminating months of custom software design.

Developing reusable software and hardware components also gives the engineering team more time to focus on special challenges in the design of a system. It also helps reduce risk in the development phases because a platform is already established. Finally, it provides standardization that serves as a backbone for engineering, manufacturing, and service teamwork throughout product lifecycles.

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