Yes, Quality and Regulatory Roles Do Involve Creative Problem Solving

I have often sensed that many people in our medical device industry have the perception that the nature of work in a Quality/Regulatory role is not creative. Unlike R&D or Marketing, where new products are created, and new ways to serve the customers are imagined, there is no such creative output in a Quality/Regulatory function.

Having worked in all these functions in my >20 years of professional life, I am going to challenge this perception. But a lot depends on how we view our role and how we show up.

When I shared this view in a LinkedIn post, the response was overwhelming and it led to a lot of good discussion!

Here are a couple of insightful comments from colleagues -

I found the concept of regulatory freedom to operate shared by Mike Pogose to be quite insightful.

If you are not able to access the marketplace, you don't have a product. The notion of safe and effective will appear deceptively simple to the inexperienced. Yet, if you are not able to present a persuasive argument to the regulatory authorities, you cannot achieve this regulatory freedom to operate. The type and amount of evidence generation needed to make this argument varies across different regulatory jurisdictions. A deep knowledge of global regulatory requirements, and a lot of creative thinking is needed to help develop an effective market strategy.

A creative problem solving approach is also required for accelerating product development as suggested by Edwin Bills, ASQ Fellow, RAC in his insightful comment. Developing medical devices, especially those aiming to solve challenging therapeutic or diagnostic problems, involves many trade-offs to ensure a favorable benefit-risk balance without over-engineering the product. Quality professionals help facilitate these decisions during design and development, and later during transfer, scale-up and steady-state manufacturing through creative problem solving in the context of regulatory requirements.

However, this effort is not broadly recognized by their cross-functional peers, especially in large organizations with mature products and stable technology.

It is not uncommon to find a templated approach to new product development and launch in these situations. There is a common belief that line extensions and incremental innovations to expand the intended use do not generally present difficult Quality/Regulatory questions to be resolved through creative thinking. The role of a Quality/Regulatory professional is generally seen as a supporting role in executing/maintaining the current strategy.

But this is not true, and we have to challenge this mindset.

Early-stage or start-up medical device companies require intense focus on quick market-entry and cost-effective execution. These organizations are generally resource-constrained. Quality/Regulatory professionals wear multiple hats and get directly involved in daily problem solving, no matter if it relates to their core expertise or not. As a result, their contribution is generally seen by their peers through these interactions, but it still requires a gentle reminder once in a while!

How do you make sure you are seen by your peers as doing creative work?

Tiina Tyni offered a powerful insight about an effective way to communicate the business value of our role:

Tactics such as talking the language of the top management or whoever professional you're communicating with can make a difference. Adapt your message to include terminology, numbers, market share, etc. that are on the other party's radar. And don't forget to make a case of the benefits that you bring or the successes already accomplished.

This is very good advice.

As QA/RA professionals, we are comfortable talking the language of regulations, but not the language of business.

The result is that we appear to focus more on what will not work, rather than what will. The perception we unknowingly create is that of a gatekeeper, rather than that of a problem-solver.

Now, it is clear to those of us who know the world of QA/RA that achieving and maintaining compliance also involves a lot of creative problem solving. However, it is up to us to help our colleagues understand how we proactively facilitate a compliant solution to difficult business problems.

This requires us to change how we interact and communicate on a daily basis.

See your role as a problem-solver, not a gatekeeper.

The first step is to see our role differently in the context of the business goals.

When someone is proposing a new approach to a tough problem, instead of saying "you can't do that because of xyz regulation", say this: "you cannot do it this way, but here are 10 other ways you can"

It is our job to have a deep understanding of the what of the requirements to help figure out the best how for our business.

When we only highlight what is not acceptable from a compliance point of view, we only partially do our job. If we help our colleagues figure out the how, then we will be seen as problem solvers, not gatekeepers.

Learn to speak the language of business. Especially if you are in a leadership position.

This does not mean you have to go get an MBA!

Remember that business operates to grow revenue and make a profit. Reducing or avoiding cost of compliance is expected. It really does not add any direct value to the either the top line or the bottom line. It is considered to be a cost of doing business.

You will get no credit for ensuring compliance, but you will certainly be held responsible for non-compliance. Don't be seen as only a cost-center!

Instead, find opportunities to go beyond compliance where your contribution will add to the top line or bottom line in a more tangible manner. Here are a few ideas:

1. Find ways to reduce product development cycle time by simplifying your procedures, cutting down documentation requirements and optimizing verification/validation testing using a risk-based approach. How much would a 20% increase in R&D productivity be worth to your business in additional new product sales in the next 5 years?
2. Find ways to reduce time to market by ensuring completeness and accuracy of your submission package so you can quickly receive market authorization by the FDA. Did you know that those in the lower 20th percentile take less than half the average time for a 510k decision? How much would a 30-day reduction in FDA decision be worth to your business in new sales?
3. Find ways to improve customer experience by identifying product or process improvement opportunities. Higher customer satisfaction means fewer complaints and a higher chance of adopting your next generation new product. It builds brand recognition and loyalty. How much would an extra point of brand loyalty be worth to the long term revenue growth potential for your business?
4. Find ways to improve your safety signal detection process by implementing advanced analytical methods. Complement it with an efficient business process to cut down the noise and to select only the right signals for timely action. How much would an early, smaller scale corrective/preventive action be worth to your overall operational productivity?
5. Find ways to communicate your results in business terms to not only to those outside your function, but also to your team members. When team members feel connected to the business results, they feel inspired, motivated and empowered. They have fewer reasons to find other career opportunities. How much would higher retention of your team members be worth to your own continued success?

These are only a few examples I have personally seen in my experience. I am sure that you can come up with many more opportunities in your specific business environment.

However, creativity is a choice. It is up to us.

In his recent book, The Practice, Seth Godin shares this incredible insight:

Lost in all the noise around us is the proven truth about creativity: it's the result of a desire - the desire to find a new truth, solve an old problem, or serve someone else. Creativity is a choice, it's not a bolt of lightning from somewhere else.

To some extent - and this is just my feeling - we have to take responsibility for the current state of affairs, especially in large organizations. If our Quality/Regulatory functions are seen only as compliance-driven gatekeepers, and not as creative problem-solvers, we have to first reflect internally. How are we showing up to our colleagues in other functions ? What it is that we do, or don't do, that is either creating or reinforcing this perception? How do our own team members feel about it? What should we be doing to create a change?

So friends, let us make this choice. Let us learn from the best and get to know the regulatory requirements better than anyone else. But then, let us use this know-how to help our organizations find creative solutions to tough problems.

I think we can do it. What do you think?