The objective of this study is to show a methodical product development process that is infused with innovative elements in strategic locations, which facilitates product quality, technical breakthroughs, speed to market, and how this method can create a system of development involving all stakeholder groups. This process fosters an understanding of advantageous times for ideation activities and reiteration activities to occur. Due to a lack of industry knowledge and practice regarding design, the sub-categorization of steps in this process will lead to understanding of the tasks, costs and timeframes involved in the design phases. The intention of this process definition is also to build an understanding of which functional groups should be involved in research, ideation and design, and develop an understanding of how these groups should collaborate, and which should be responsible for certain product decisions. Although many similarities exist among current development methods, common misconceptions and process deficiencies are prevalent. Innovative aspects of the process are commonly misunderstood, and are often completely lacking or applied at an inefficient juncture of the process. Other times evaluation and research phases are left incomplete, leaping directly to the mechanical development process phase. This causes earlier steps to be done after engineering work is underway, which creates inefficiencies in the process. There is also evidence of a large gap of misunderstanding about what the nature of the design phase really is, which causes it to be left out of the process altogether or ill-applied during the process. We conducted an examination of current studies and process information from medical device companies and evaluated them for the exclusion or placement of key innovative elements. Common similarities were discovered, and a modified development process description was created with the inclusion of elements useful for optimizing innovation and reducing redundancy. Some of the detrimental commonalities include a lack of detail in the research and ideation phases of the process, the tendency for companies to skip around in the process and impeding the ability to hit critical dates, and involving groups and disciplines in the process at incorrect times which stifles innovation and causes bottlenecks. The revised process involves designers in evaluation, research, marketing, engineering, validation and production, finding that it pulls all groups together, linking them to a single process. We found that this model of product development can provide results that will improve performance and acceptance of new medical devices, while increasing innovation and help to uncover breakthrough concepts. Key factors in this process include the practice of planning innovation into the process in the proper places; having a design team involved in all phases to increase product quality; and expending sufficient effort in the highly misunderstood areas of the process. It is also shown that success is achieved if product decisions are made around design criteria derived from the process, with a design team involved in making these decisions. Continued iterations must occur during the appropriate phases, and when the process is followed, bottlenecks are removed, streamlining takes place, innovation can occur, and customer needs are more fully met in the product, increasing overall product quality and launch success.
A CONTROL LIST FOR THE SYSTEMATIC IDENTIFICATION OF DISTURBANCE FACTORS