New study details how too many companies allow medical device design controls to dominate product development, provides practical ways of incorporating business demands, Strategy 2 Market reports
Chicago, IL -- (SBWIRE) -- 07/23/2015 -- Strategy 2 Market, one of the world's leading Product Development Strategy consultancies, published at the company's website a new report focusing on a common medical device development problem. Through analyzing the New Product Development Process at a number of leading medical device companies, Strategy 2 Market consultants have discovered that many organizations rely overly much on established design controls, failing to properly account for business factors in their processes. The important new Strategy 2 Market report details how medical device companies can identify and overcome this problem, thereby greatly improving the viability and overall value of the products they develop.
"Companies that operate in the high-stakes world of medical devices area understandably inclined to stress the importance of the FDA's design controls," Strategy 2 Market Partner Kathy Morrisey observed, "While these controls are important and valuable, they cannot be allowed to dominate any product development process. Our new report will help companies avoid this common problem and understand how best to integrate business concerns into their processes."
In an effort to bolster the safety of many medical devices, the federal Food and Drug Administration publishes an extensive set of so-called "design control" requirements that must be observed by companies that design, produce, or market them. Detailed under section 820.30 of Title 21 of the Code of Federal Regulations, these design controls provide detailed guidance regarding everything from the creation of a basic design plan to the use of feedback systems for ensuring adherence to a range of best-practice dictates.
The new, free Strategy 2 Market online report details how many medical device companies fall into the trap of allowing these requirements to overwhelm the entire process of New Product Development. While they are valuable and contribute to the safety of new medical devices, the controls are entirely divorced from the business requirements and market realities faced by the companies that follow them. The new Strategy 2 Market report provides some proven methods for avoiding this potentially dangerous trap and successfully integrating business elements into the medical device product development process while still faithfully observing all of the relevant design controls.
As such, the new report is an excellent example of the valuable kind of work regularly undertaken by Strategy 2 Market experts. Founded by industry veterans Mary Drotar and Kathy Morrissey, Strategy 2 Market helps companies in a wide range of industries improve their product development processes from start to finish. Whether that means better coordinating the efforts of a variety of internal teams and departments through the product development process or finding ways to consistently derive more revenue from new products at market, Strategy 2 Market supplies valuable, informed insights, guidance, and strategies to clients.
About Strategy 2 Market
Providing the best in product-development consulting services since 2002, Strategy 2 Market helps client companies improve their processes, coordination, effectiveness, revenue levels, and more.