Can Medical Device Engineers and Quality Control Staff Get Along?

Posted in Quality Assurance by Qmed Staff on September 26, 2013
In a medical device company office, tensions can run high, thanks to tight deadlines, rabble-rousing shareholders, and regulatory pressures. However, conflict doesn’t always come from outside a company; in some cases, internal strife can impact productivity and employee morale. At medical device companies, conflicts often emerge between engineers and quality control professionals, according to a white paper from Master Control.

The goal of product development professionals (like engineers) is to get a product to market as quickly as possible. Engineers and their support teams are the driving force behind new, innovative medical devices. On the other hand, quality professionals work to ensure that upcoming devices don’t face regulatory delays or potential recalls.

In some cases, compliance activities can impact a launch, delaying the entry of a product to market. Since timing is pivotal in the fast-paced medical device market, a roadblock put up by quality professionals can be a frustrating experience for many engineers. In some instances, a quality group can take on the aura of a policeman or other authority. That being said, quality groups help shield companies from litigation and regulatory setbacks.

Bridging the gap between the engineering and regulatory assurance worlds can help improve a device firm's decision-making abilities. Engineers who need to work with QC procedures should have a role in the development of these processes, recommends the Master Control white paper. By giving engineers a window into the world of quality professionals, it’s possible to create compliance structures that are effective without being too rigid.

This article received the following comment from regulatory affairs professional George M. Samaras, PhD, of Samaras & Associates (Pueblo County, CO).
In my opinion the argument is both specious and wrong-headed. After 15 years of working with industry, since I left the FDA, and 10 years of working with industry prior to going to the FDA, this completely misses the point. The goal of product development professionals is NOT “to get a product to market as quickly as possible”. That is the goal of sales & marketing and the senior executives (who invariably come from sales & marketing) and who are principally driven by commissions. The goal of product development professionals, like engineers, is to design/develop the best product possible; that is what motivates them and, if not pushed, they would NEVER get the product to market because of infinite, never-ending refinements and improvements. The goal of quality professionals is to ensure that the product is fit for use, will not result in recalls, and not result in enormous product liability settlements or judgments that damage the company (but do not affect commissions) and, ultimately, cost jobs. In both my consulting practice with manufacturers and my expert witness work with plaintiffs, the common root cause has always seemed to me to be sales & marketing ignoring product development and quality and pushing regulatory to submit less than complete safety and effectiveness data, to take the product to market as quickly as possible … so that commissions and bonuses can begin to accrue. That is not a tension between product development and quality nor is it an indication of low regulatory affairs competence; it is simply a demonstration that product development, quality, and regulatory affairs are nearly always less influential in the organization … and that greed trumps concern for our colleagues and our fellow citizens. There is certainly nothing new about that nor is it unique to the medical device industry!

Check out the recent live poll on Qmed of our mostly-engineering-based audience, which reflects concerns regarding the regulatory affairs / quality control: