In its State of Medical Device Product Development & Quality Management Report 2021, Greenlight Guru explored how medical device companies approach quality. The report is based on the responses of more than 300 survey respondents employed in engineering, quality, regulatory, and operational roles by medtech organizations from around the world.

MD+DI asked Jon Speer, founder of Greenlight Guru, to answer a few questions on medtech company “quality culture” and some of the challenges that professionals encounter. Speer has more than 22 years of industry experience, and his firm offers medical device quality management (MDQMS) software.

Your report, 2021 Benchmark Report: State of Medical Device Quality Management and Product Development, seems to suggest that it is important for medical device manufacturers to develop a culture of quality that permeates all company functions rather than just checking off items on a to-do list before the product heads out the door. Can you elaborate on what this means?

Speer: We believe that there are two ways to view quality… You can view it as a box you need to check for legal and regulatory compliance, or you can make this an integral part of your product development process. What we’ve seen is that companies that follow the latter path dramatically outperform companies that are just interested in checking that compliance box.

For example, 19% of companies who say quality is a “checkbox” activity say they can’t demonstrate closed-loop traceability (CLT) compared to 7% of companies who view it as a strategic advantage. And 67% of companies who view quality as a strategic advantage can demonstrate CLT today, compared to 42% of “checkbox” companies.

The report reveals that some medtech companies’ employees feel that their company leadership does not buy in into a quality culture. How common is this, and what can employees do?

Speer: Unfortunately, it’s far too prevalent in the medical device space. One-third of all respondents disagree with the statement “Quality is woven into my company’s culture.” In an industry where the consequences are life and death, that is way too high.

If you’ve found yourself in one of these organizations, it is really challenging to push a quality culture from the bottom up. It is vital for the importance of quality—true quality and not just lip service—to be a top-down initiative that permeates throughout the company. It has to be a core value of the company. And it’s really hard because doing so requires a great deal of conviction and discipline.

Are there certain job functions or departments that can suffer when there is not a quality culture? What are the benefits to those departments and the company once there is a quality culture?

Speer: For sure. Quality departments in many medical device companies have been villainized. Why? Quality (the department) is charged with establishing and maintaining the QMS. But when the company lacks a true quality culture, Quality is often viewed as the “bad guys” for attempting to uphold and ensure adherence to company policies and procedures.

Does building a quality culture come down to budget, or are there other factors that are necessary?

Speer: It’s really more of a mindset issue rather than a budgetary item. If a company has been operating for any significant period of time without an emphasis on a quality culture, it is really difficult, but not impossible, to shift. A lack of quality culture often becomes a breeding ground for counter and subcultures to grow. Once that happens, there is often a lack of trust throughout the organization.

One survey respondent reported that compliance is separate from product development. Can you explain why a quality culture should matter during product development?

Speer: I totally understand this response. Many companies interpret “quality” to be synonymous with “compliance.” As such, systems and processes that are implemented are skewed heavily towards rigorous compliance. Yes, compliance has importance. But compliance should not be the driving force. Compliance should not be the determining factor in how and what is done to ensure quality.

Your report explores the benefit of purpose-built QMS tools. Can you offer a general definition of what this means and why it matters?

Speer: Purpose-built, in this context, means that a solution has been designed specifically for the medical device industry. The solution has built-in critical aspects of compliance and has been adapted per the medical device industry regulations. As such, this allows users more freedom and flexibility to focus more on quality throughout the total product lifecycle.

How do you think the COVID-19 pandemic lockdowns as well as emergency efforts to meet healthcare product needs impacted a quality culture? Will there be lasting implications?

Speer: This is really too soon to know, because in many respects, we are all still in this state at some level. However, I do believe that lockdowns have helped surface shortcomings and issues that are counter to quality.

How will the future transition from QSR to ISO 13485 impact the industry, and what can companies do now to prepare?

Speer: I think there will be an impact and that it will be pretty steep in the beginning. The QSR has been in effect since 1996. And the outcome will be better for the entire industry. Why? I believe that many medical device professionals are seeking consistency and predictably from regulatory bodies and auditing organizations, and I think FDA transitioning to ISO 13485 is a huge step towards that end.

Greenlight Guru’s online survey was fielded between October 6 and October 20, 2020. To download the full State of Medical Device Product Development & Quality Management Report 2021, please visit https://www.greenlight.guru/state-of-medical-device.