Advancing the Regulatory Profession in Utah


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One doesn’t need a degree in economics to enumerate the factors that contribute to a thriving business sector. Among other building blocks, you need capital investment, supporting infrastructure, favorable business climate, entrepreneurs and leaders and a motivated, educated workforce. State and local government agencies across America keep these in mind as they strive to foster growth. In this respect, the medical technology industry flourishing with Silicon Slopes in Utah is no different.

According to a University of Utah analysis commissioned by the Utah Governor’s Office of Economic Development (GOED) and a local trade organization called BioUtah, our state offers well over 20,000 jobs in the medical device/pharmaceutical sector alone (a subset of the life sciences industry), with approximately a 2:1 split in favor of medical devices/equipment jobs. (1)  This represents an impressively strong sector in a state with a smaller population. The report also states that between 2002 to 2017, the average job growth rate of Utah’s life sciences industry was 3.3 percent per year, compared to 2.1 percent in all other industries in Utah. (2) This supports the fact that the industry is both robust and resilient.

A recent study showing that the state of Utah offers well over 20,000 jobs in the #meddevice and #pharma sectors and also a significant average job growth in those jobs is evidence that the #lifesciences in Utah are robust and resilient, says @MCMasterControl #RAPSorg http://bit.ly/2JrYnaA

In fact, Utah is outpacing other states to a surprising degree. The report further states that, “A nationwide study of biopharmaceutical and medical device employment observed 26.2 percent job growth in Utah from 2012 to 2016, exceeding the 21.9 percent growth for the state’s life sciences industry as a whole during that period. Utah’s growth in biopharmaceutical and medical device employment was above that of every other state from 2012 to 2016. By 2016, Utah was the 13th largest employer in the U.S. in these two life sciences categories, biopharmaceuticals and medical devices.”(3)  This gives Utah the fastest-growing biopharmaceutical and medical device sector in America in recent years.

So, our medtech business climate is excellent. Of the building blocks listed above to support a booming industry sector, Utah has all of these, and this helps explain the favorable statistics cited in the University of Utah study — great news for state and civic agencies who work to promote growth. However, Utah is in no way exempt from the supply and demand realities of the regulatory affairs profession labor market. Ours is a highly regulated industry and is becoming more so with each passing year. Regulatory affairs (RA) has emerged as a durable profession to help medtech companies keep pace with a global maze of laws and regulations.

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Yet, there have long been fewer RA professionals than the industry needs to support a thriving life sciences business sector. As such, life sciences companies vie for precious talent, even among Utah’s previously mentioned sizeable “motivated, educated workforce.” Though the weak supply and strong demand for such professionals drives up compensation, filling this void remains one of the dilemmas perplexing our industry.

Like our colleagues in medtech firms worldwide, we ask ourselves, “How do we lure this talent to Utah?  Alternatively, how can we show engineers and other professionals who are already working within the Utah life sciences industry that regulatory affairs is not only a lucrative career but a fascinating and constantly challenging line of work?” We need a mechanism to disseminate this idea at the local level, with convincing data to support it. Similarly, we need a way to support those already in this profession to navigate that maze of regulations and to network with their colleagues.

Enter RAPS, the Regulatory Affairs Professional Society, easily the largest and most influential trade organization supporting our vocation. Since 1976, RAPS has grown with the profession, now comprising more than 15,000 members in over 80 countries, with our share living and working in Utah. (4) RAPS is known for its fine repository of educational materials and its annual global Convergence conferences as well as for its many local chapters. Excellent programs are offered by RAPS, but until now, not much targeted activity has been driven at the local level in Utah, because we have not developed our own local chapter, turning instead to RAPS headquarters for information and guidance.

Utah RAPS members have long congregated in Salt Lake City bagel shops and during seminar breaks to muse that we should form our own local RAPS chapter. Boston, Atlanta and San Francisco, and many other localities have bustling chapters. Why shouldn’t we? Our business sector can sustain it. We have the constituency, and we have the unmet need.

So, this year, a core group of committed RA professionals changed “maybe someday” into “let’s make it happen.” After several months of careful planning, we launched the RAPS Utah Chapter this autumn, with an official announcement at BioUtah’s annual LifeSciences Summit this month. By all accounts, our projection was right that this would be successful, with chapter membership already approaching 500 even as we first announced our existence. We are planning for this growth to continue at an aggressive rate.

Our RAPS Utah chapter goals are simple but formidable to help attract and nurture regulatory professionals in this region. The new RAPS Utah chapter offers regulatory professionals an opportunity to network online and in person in order to learn directly from our peers how best to approach the increasingly complex and constantly changing global regulatory jungle. I have been in this profession for over 20 years, and I have never known regulations in my industry to relax. They alternately stabilize and increase in burden and complexity, and not always for foreseeable reasons. Keeping up with this changing landscape is a constant challenge. RAPS Utah is committed to the goal of assisting our members in their professional efforts to meet this need.

Through seminars, educational programs and social activities, we offer RA professionals a chance to meet and learn from each other. We will partner with GOED, BioUtah and other relevant associations to present outstanding educational programs, social activities, study groups and guest speakers. And yes, we will continue to meet in the bagel shops and to chat in the hallways of seminars, not as competitors but as regulatory colleagues with the common goal of advancing our profession. In this way, our chapter opens up local access to global knowledge through electronic and face-to-face dialogue. Now we can discuss approaches to new regulations directly with our colleagues — which increases our knowledge and promotes professional development. Our profession does not flourish by remaining silent within the walls of an office cubicle. It flourishes through dialog, study, consultation and constant learning. Supported by RAPS headquarters, this is what our chapter offers.

More specifically, we have mapped out a networking mixer for January, a “hot topic” seminar in the spring, local group meetings for those who wish to study for the Regulatory Affairs Certification (RAC) exam, and other projects. Hot topics for our profession include the looming changeover in Europe from the governance of the Medical Device Directive (MDD) to a newly-implemented and notably more onerous system of European Union (EU) laws called the Medical Device Regulation (MDR). We’re also looking into the growing questions of cyber security and data privacy, as well as other topics of concern. Our chapter membership is made up of local RAPS members, and therefore, their particular professional concerns are what will drive the benefits that our chapter offers.

Utah is host to one of the fastest-growing #lifesciences communities in the U.S. Join with us in congratulating the RAPS Utah Chapter on its founding, and for attracting more #regulatoryaffairs experts to the profession worldwide, says @MCMasterControl #RAPSorg, says @mastercontrol http://bit.ly/2JrYnaA

Though our base is in Utah, and, along with the majority of our constituency, in the Salt Lake Valley in particular, we’ve set our sights more broadly than our state borders. We welcome members from Missoula, Montana, to Tucson, Arizona, to our RAPS chapter. The stronger our chapter becomes, the higher quality our educational opportunities will develop, and with that also come better networking opportunities, global speakers, targeted projects and many other benefits.

This is certainly not the only trade group supporting the life sciences industry in our area. So, why would RA professionals get involved in another organization? Because there could hardly be a more appropriate team to join than the RAPS Utah chapter. It is designed to support precisely what we do for a living, and in the region where we work and reside. Our planned opportunities to learn from each other and thus to advance our successes will be unsurpassed.

Utah’s life sciences sector is energizing. We are host to the fastest-growing life sciences community in the United States. Physicians, scientists and entrepreneurs spin startups out of our universities which, backed by venture capital, grow into stable companies. Meanwhile, the corresponding demand for qualified, motivated regulatory affairs professionals to support these companies continues to climb, both here in Utah and worldwide. Couple a rapidly-growing medtech industry with an excellent local quality of life, and you have a recipe for happy RA professionals. That pool of talent is what our new RAPS Utah chapter aims to assist, promote and support.


References


1) Levi Pace, PhD, Joshua Spolsdoff, MS. “Economic Impacts of Utah’s Life Sciences Industry”. Kem C. Gardner Policy Institute, University of Utah, August 2018. p. 2.

2) Ibid.

3) Ibid., p. 9.

4) http://www.marketwired.com/press-release/-2211023.htm. Accessed September 21, 2018.



2018-bl-author-robert-wohlfarthRobert M. Wolfarth holds a double bachelor of arts in international economics and Russian language from the University of Texas. After six years of foreign policy/defense/intelligence work for the U.S. Congress in Washington, D.C., he moved into the medical device industry where he has served for over 24 years, mostly in orthopedics and cardiology. In Utah, he has been director of regulatory affairs and quality assurance for Amedica Corp., principal project manager for Edwards Lifesciences, and is currently senior manager for regulatory affairs at Merit Medical Systems. He has held an adjunct faculty position at Utah Valley University teaching graduate-level regulatory affairs, served on the Life Sciences Committee for the Utah Innovation Awards,  and received a Certified Quality Auditor designation from the American Society for Quality (ASQ). Wolfarth currently serves as chairman of the RAPS Utah Chapter. Outside of work, he has held many positions in his community, including serving as president of his homeowners association, sitting on several boards of directors, and editor of several journals. Wolfarth is a very active Freemason (Grand Master of Freemasons in Utah in 2017) and Shriner, has published many articles internationally, and has traveled to over 30 countries. A single father, he adopted a girl and a boy in China.



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