Bob Yocher has more than 38 years of experience in the medical products business and has long been an active RAPS member volunteer. He has served on the board of directors, as chairman of the RAPS Boston Chapter and as chairman of the RAPS Fellows Selection Committee. Although he is now retired, he continues to be involved. He is currently on the RAPS Affiliate board of directors and will serve in a newly created role as part of RAPS’ Executive Development Program this year. Bob will be one of two experienced regulatory experts there to help participants connect the business concepts they will learn to real-world regulatory scenarios.
I spoke with Bob as part of our new interview series in Regulatory Focus called ‘Focus on…’ where we talk with regulatory leaders, thinkers and influencers from a variety of backgrounds. In addition to conversing with them on a range of regulatory-related topics and learning from their experience and insight, in this series we also want to get to know them a little as people. During our conversation, Bob shared his thoughts on topics including why you should get out of your office more, how to be a good mentor and one common phrase that is a pet peeve of his. Following is an edited transcript of our interview.
You have served in many different roles throughout your career. What have been some of your favorite experiences?
I have been very fortunate to work on a lot of different medical breakthroughs both on the pharma and the medical technology sides, most of which were the first of their kind. Believe it or not, my best experiences were not finding out I got them approved. The most rewarding and best experiences were actually meeting and getting to know a lot of the patients and families who benefited from them. Those moments helped make all the long hours, the constant and sometimes overwhelming pressure a little more rewarding.
In my most recent role with a ventricular-assist device company, we had a well-known country-western singer come in and play live, whereas before he was so short of breath, he couldn’t even speak. And now he’s performing again and recording again. That was one of the more dramatic experiences, but I’ve been involved in everything from treatments for rare, orphan diseases—seeing children that are thriving and growing instead of literally dying—to, as I said, the country-western singer. It’s just been a broad variety of different kinds of patients.
Are you at liberty to say who the singer was?
Without his permission, I won’t.
The role of a regulatory professional is complex and not well understood by a lot of people outside the profession. How do you explain what you do to someone unfamiliar with the regulatory world?
I explain it’s sort of a unique career that’s a blend of medicine, law and science. The task at the end is to get innovative products through the complex and expensive process to get to market by proving that the product is safe and that it works to not only regulators like FDA or their counterparts around the world, but more importantly, to doctors and healthcare providers, the patients themselves and even insurance companies. But then keeping the product on the market is a whole other set of challenges, and most of regulatory is taken up by the latter rather than the former.
How has the regulatory profession evolved most significantly since you started?
Back then, we were either called scientists or quality professionals. I grew up with the profession, basically, and in the early days, I used to pride myself on knowing the regulations themselves forward and backward. Nowadays, it’s not as necessary with the instant information available from smartphones and computers. Everything’s at your fingertips, so it’s not a big deal to actually know the regulations. What is still important though is critical thinking—connecting the dots, analyzing complex patterns of data, translating those complex issues into everyday, simple language in a persuasive form to either obtain an approval, to move a product toward approval or to keep it on the market.
The next biggest change that I’ve seen is in the complexity of the products. It used to be if you knew basic sciences you were all set. Now with areas like computational biology, artificial intelligence, molecular genetics, interconnected devices and security threats, as a few examples, it’s gotten a lot more difficult.
It’s also changed in that regulatory used be this bunch of nerds who sat in the corner, didn’t talk to anybody and were often looked at as the so-called “sales prevention force.” Then, over the years, many, many companies failed because of difficulties getting products approved. One of the biggest and first things you have to do is get an approval. So regulatory now has, as we say, gotten a seat the table in management.
This May, you will serve as a regulatory liaison for RAPS’ Executive Development Program, an intensive business skills training program for rising regulatory professionals and aspiring leaders. How do you think regulatory executives benefit from cultivating strong business skills?
They’ve got a seat at table now, so along with their teammates from sales, marketing, legal, reimbursement and market access, they get to be part of the group that makes the overall business plans. Most of your team members now at that table are business-oriented, so you need to understand their language, their needs, their drivers, and explain how you can help them move the company toward its goals. Our business is a really a high risk, high reward industry. It’s very expensive and very risky, and regulatory approval is one of the main hurdles. You want to make sure that the RA person(s) not only is experienced in regulatory affairs, but also knows what the needs of the company are. And therefore, you need to know some basics about business.
How do you think companies benefit from having regulatory employees who understand business principles?
It’s ‘big risk, big reward.’ There is a lot of money on the table. It takes a long time to develop a product. During that time, you’re not making money. You’re spending crazy amounts of money nowadays on things like clinical trials, and if you have a misstep, you could not only lose the money, you could also lose the company. So, you need to have your best people on the job and that includes regulatory.
What do you think are the one or two most critical business skills for regulatory professionals to develop and why?
It’s hard to limit it to one or two because it really depends on the company, the industry, whether it’s a start-up or a large, established company. But for all companies, I think you need to understand the market forces. If you don’t know what the market forces are or how to work within them, you’re not going to get very far. Understanding value-based leadership, because that’s the idea the board operates on. That’s what your CEO and everybody in the c-suite works on. In middle management, it’s really about understanding the other departments. What are their values? How do I build value for them? Because it’s a continuous chain. It’s sort of like a bucket brigade. Everybody has to pass the bucket, and nobody can spill it. So, understanding what drives the different layers and what drives the different departments is crucial.
What other skills are essential for regulatory leaders and why?
To me, I think critical thinking skills are actually the definition of what a regulatory person does. Critical thinking is approaching problems in a consistent, systematic way to arrive at the best possible solution under the circumstances, without introducing biases, personal or otherwise. It’s understanding the links between ideas, connecting the dots if you will, seeing the big picture, determining the importance and relevance of the different arguments and ideas and recognizing the weaknesses. You’ve got to know both sides of the argument because it’s likely that regulators will challenge you. If you’re not prepared, you’re not going to move the product forward. You’ve got to identify inconsistencies and errors in reasoning and be prepared to adjust.
Another critical skill is influencing others, and that requires the soft skills that hopefully by middle management, you’ve already learned—things like active listening, good writing and negotiating skills.
What is a common mistake you have seen regulatory professionals—at any professional level—make, and how can they avoid it?
I would say not getting to know customers and their needs and wants. This includes internal customers—marketing, legal, reimbursement folks, manufacturing, engineering—because you can’t influence them unless you know what makes them tick. I think a lot of regulatory people stay in their cube or their office. They stare at the computer eight hours a day, and they need to get out more, talk to others and get to know them and what drives them.
Have you mentored someone? If so, what do you feel each of you learned from the experience?
Oh yeah, lots. I would say to other people, ‘when you’re mentoring and coaching, it’s not to give them the answers.’ Ask questions about them, understand how they think and get them thinking critically. Guide them on their journey to make their own decisions, so when you’re not there, they think logically and use those critical thinking skills. Help them learn to make decisions they feel proud of, and that are not necessarily the same as your decisions. When I see people grow, I really enjoy seeing how they develop and become much more aware and willing to listen to others. I would say ‘let your beliefs guide you, but you have to listen to the other person.’
What commonly used buzzword do you purposely avoid using and why?
Well, it’s “regulatory science.” Yet you’ll see it in government documents, you’ll see it in industry documents and in news media. It used to drive me nuts. I’ve seen dozens of different definitions for it that vary widely, and there is, in my belief, no such thing. A scientific approach to regulatory is a little different from regulatory science.
What inspires you?
I truly enjoy helping others. Obviously, my family inspires me. My faith inspires me. But just helping others. Besides working in the industry, I’ve been teaching and trying to give back for many, many years both through being involved in organizations like RAPS and ASQ, etc., but I also, taught graduate school for a long time, and believe me, it’s not for the money because you get virtually nothing. It’s really to get young minds to start questioning and thinking.
What are you passionate about other than work or family?
Now that I’m retired, I do a lot of fishing and boating, and I travel. And although I did a lot of traveling in my career, all I could tell you about is hospitals, airports and factories, so now I’m going back to those cities and enjoying the beauty of them. I’ve been retired three years and I’ve made several trips to Europe. This year we are going to the Asia-Pacific region. Unfortunately, I’m going to miss the RAPS Convergence in Vancouver this year. I’m going to be over there for three months traveling to a number of different countries.