How Innovative Process Design May Impact the Medical Device Industry.

The Medical Device industry is no longer a “well-kept secret” for job seekers. In fact, the term Medical Device has been given its own category on most jobbing sites and has become one of the best employment prospects.

The introduction of the Innovative Design Process can improve current Research and Development (R&D) jobbing opportunities. The Innovative Design Process is meant to bring products to market faster as well as offer quicker optimization possibilities.

The medical device industry has its own International Organization for Standardization (ISO) standard. ISO is essentially lists of best practices and requirements. For candidates new to medical devices field, reviewing ISO 13845 would be beneficial. ISO 13845 is intended to facilitate harmonized medical device regulatory requirements for quality management systems. Interestingly, ISO 13845 adds additional requirements to ISO 9001 while eliminating some others.

ISO 13845 provides a valuable framework for R&D departments. This framework can be used as a solid template even for companies who choose to stay certified only in ISO 9001. However, ISO 13845, true to other ISO standards or best practices, does not dictate a complete methodology that must be used to achieve these standards or requirements. There is flexibility. Flexibility, also heavily promoted by Lean Thinking models, is a positive for R&D. Most business philosophers would agree that you can’t really govern the creative process.

This brings us to the Innovative Design Process. Innovative Design Process, also known as Innovative Design Engineering or Innovative Design Thinking borrows heavily from Design for Six Sigma (DFSS) and Lean Thinking. Similar to DFSS, innovative design processes, use a variety of models and is primarily for product development and optimization as opposed to service issues. Similar to Lean Thinking, Design Process, is dedicated to simplifying and speeding up the process by reducing waste and using critical thinking tools to analyze the impact.

Generally, Design Process models begin with the big picture. This is already a variation of typical problem solving models since many popular models such Define-Measure-Analyze-Improve-Control (DMAIC) dedicate a significant amount of time to understanding and gaining consensus before the process begins. Design Process starts with the watermark. This is what we are trying to build or this is what we are trying to optimize. If making the watermark is considered Step One, then Step Two would be the creative process. Step Two ranges from brainstorming through prototype development. Next, in Step Three, the prototype or the improvement is enhanced. The final step, focuses on application. In this case, application means getting the proper endorsements from compliance organizations.

Novices can think of overall design process or thinking as occurring in four steps – Watermark, Creation, Enhancement, and Application or WCEA©. As noted, there are several other models, some much more sophisticated in the “Create” phase of this simple methodology. This is due to specialized case tools needed to create and optimize products. But, overall WCEA© is an easy way to digest the overall concept.

How does WCEA© or any other Design Engineering Process model improve the medical device industry? This is simple. Creation as well as optimization requires new thinking, fresh designs and the ability to construct something from an idea. These types of activities bolster employment opportunities, offer better market share and contribute to global visibility.