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Ask the Experts is a series of reader questions answered by industry advisors. Send us your questions.
Question: In complying with regulatory requirements, how and why should device companies avoid a “check-the-box” mentality, as opposed to a scientific-based approach?
Answer: Facilitating a check-the-box mentality as the foundation for robust design controls and ensuing regulatory compliance seems simplistic and understandingly appealing. It promotes a culture of guaranteed reproducibility and repetitive success. But this mentality that some medical device designers and regulatory people advocate can become a crutch that leads to failure. Developing innovative designs by repetition is counterintuitive.
All humans are fallible. When it comes to solving complex problems with many variables, such as the basic medical device design control process and the purposely aligned, many-faceted-regulatory-process, the incompetency and laziness from always “checking a box” can lead to disorder and a marked lack of productivity.
Familiarity can breed complacency. A checklist attitude can lead to feeling comfortable with the wrong answers and wrong approaches to validate the safety and efficacy of a device that will ultimately be used on human beings in an O.R. When we, figuratively speaking, check boxes to get the job done, genuine relationships, measurement and documented evaluation become not only difficult to manage but can foster an outcome devoid of competent decision making. In a way, it’s an intellectual shortcut that reduces understanding and knowledge to a set of mental checkmarks on a list—again, figuratively speaking. I see it as a form of intellectual laziness that avoids real understanding of the issue, and any real accountability for a decision. Mentally, these design engineers are “done” and can now move on to the next scenario without reconsiderative thought. This is a dangerous precedent to rely on when it comes to taking creative thoughts in the form of concept and feasibility and developing functionally safe medical devices for human use.
We are professionals and people who are supposed to study, know, comprehend and perform based on scientific and regulatory understanding. This is no time for scientific avoidance just to pontificate the “we-need-to-get-that-product-to-market-and-I-mean-now” approach.
For starters, top management must be committed to a science-based engineering approach. The use of process owners to organize and delineate documented methods for getting from point A to point B will augment the compliant infrastructure used to formulate decision-making at the human requirement level of design and development. To avoid checking the box, managers must encourage employees to use the right engineering tools and make them part of the formal quality management system. The building blocks should include the following:
- Basic decision analysis
- Risk analysis
- Cost-benefit and cost-effectiveness analysis
- Controlled optimization
- Simulation prototyping and human factors’ decision scenarios
- Synergistic alignment of manufacturing operations development, statistical inference, management control and software development
By focusing on the strength of this type of decision-making as a unit of science-based analysis, technical decisions will then provide a documented framework for understanding human health-related problems and cutting edge innovation.
A combination of a repetitive learning and inspired check-the-box mentality—with more adaptive and flexible problem solving techniques—is part of operating out-of-the-box. Basically, there is a time and a place for a check-the-box process with the concurrent use of an engineering and science-based approach to medical device design and development.
The truth is that simply collecting data and checking the box is just not good enough.
The mere existence of a completed check sheet doesn’t equate to sustained, significant process improvement and innovation. Intuitively, a scientific-based approach can only thrive when employees have a clear understanding of the expectations and standards that company’s leaders commit to. Management must recognize and encourage innovation, creativity and initiative.
John Gagliardi has had success over the past 45+ years in the medical device and pharmaceutical industries because of his practical approach to process-orientation and business. He has been actively involved in research and development, quality assurance, training, operations, process architecture, FDA inspections and regulatory affairs. Mr. Gagliardi specializes in building systems in a compliant and business-ready manner. Mr. Gagliardi can be reached by email.
MidWest Process Innovation, LLC
