James A. Dunning, Principal, QPC Services LLC07.26.18
Does the title of this column strike a nerve? Does it seem crass or disrespectful to combine “selling” with “regulatory compliance”? I ask these rhetorical questions because I have found that many regulatory professionals feel this way. I chose the topic of this column rather carefully, but deliberately, not to aggravate potential readers, but to drive a bit of atypical thinking about how best to communicate regulatory requirements and the value of compliance. I want this column to initiate further thought, discussion, and maybe even research about effective communication regarding regulatory compliance.
I have found that most regulatory professionals do not consider themselves salespersons, since many find the act of sales to be foreign or unfamiliar to them. In short, they just don’t think it is their job to sell anything. Here is my counterpoint to this position: We are all either sellers or buyers in today’s business world because important concepts that require action must be sold in order for them to achieve the appropriate level of importance in organizations. Regulatory compliance is not an exception.
Many, if not most, regulatory specialists believe organizations should drive regulatory compliance because it’s the right thing to do. It is necessary to compete in the medtech industry. While this is the way it should be, it’s not always the case. There are countless companies of all sizes, with products ranging widely in terms of complexity, benefits, and risks, that have struggled with compliance issues. The reasons for these struggles are varied and complicated, but a company’s standpoint on regulatory compliance is a major contributing factor. Regulatory professionals play an important role in helping companies appropriately value compliance. This valuation starts with communication about the importance of regulatory compliance, and a part of this communication is “selling” this value to the organization.
Regulatory experts would greatly benefit from taking a sales course to become more familiar and competent in selling intangibles within an organization. Some sales training courses that I like are Dale Carnegie and Sandler Training (I have no financial ties to either one). I recommend these two simply because they helped me learn more about the sales process.
The ability to sell is an important skill for regulatory professionals to develop. Here’s why:
An additional benefit of regulatory compliance salesmanship is the reduction in frustration within companies regarding this topic. Good sales folk can help organizations “get it” when it comes to compliance.
The medtech industry operates in a dynamic regulatory environment, and fairly rapid rule changes will continue for the foreseeable future. I encourage all regulatory professionals to focus on developing their sales ability because it will make their jobs easier and help organizations better sustain regulatory compliance.
James A. “Jim” Dunning’s consulting career began in 2001. He has provided quality and regulatory consulting services for various companies ranging from Fortune 500 medical device firms to startups. Dunning’s passion, however, lies with startups and small companies, especially those in regulatory distress. He has amassed significant experience in preparing 510(k) applications, developing complete Quality Management Systems, providing Quality System Training, and advising on quality, business, and leadership issues. Dunning is a senior member of the American Society for Quality (ASQ) and a member of the Regulatory Affairs Professional Society (RAPS). He can be reached at jdunning@qpcservices.com.
I have found that most regulatory professionals do not consider themselves salespersons, since many find the act of sales to be foreign or unfamiliar to them. In short, they just don’t think it is their job to sell anything. Here is my counterpoint to this position: We are all either sellers or buyers in today’s business world because important concepts that require action must be sold in order for them to achieve the appropriate level of importance in organizations. Regulatory compliance is not an exception.
Many, if not most, regulatory specialists believe organizations should drive regulatory compliance because it’s the right thing to do. It is necessary to compete in the medtech industry. While this is the way it should be, it’s not always the case. There are countless companies of all sizes, with products ranging widely in terms of complexity, benefits, and risks, that have struggled with compliance issues. The reasons for these struggles are varied and complicated, but a company’s standpoint on regulatory compliance is a major contributing factor. Regulatory professionals play an important role in helping companies appropriately value compliance. This valuation starts with communication about the importance of regulatory compliance, and a part of this communication is “selling” this value to the organization.
Regulatory experts would greatly benefit from taking a sales course to become more familiar and competent in selling intangibles within an organization. Some sales training courses that I like are Dale Carnegie and Sandler Training (I have no financial ties to either one). I recommend these two simply because they helped me learn more about the sales process.
The ability to sell is an important skill for regulatory professionals to develop. Here’s why:
- Regulatory compliance is intangible for the most part, though there will always be exceptions (zero 483 U.S. Food and Drug Administration inspections, for example).
- It is difficult to establish a return on investment for regulatory compliance.
- Many regulatory professionals don’t know how to help companies “get it” regarding compliance. And they cannot really clarify what “it” is, because typically they are communicating within their peer group.
- Many regulatory specialists incorrectly assume that medtech companies will automatically value compliance appropriately because they are comprised of smart and competent people. This just isn’t the case, for the same reason many professionals don’t automatically comprehend the value of selling the concept of regulatory compliance.
- Sustainable regulatory compliance requires action, and the timing of these actions is important. The actions typically are in response to changing regulatory requirements, take more time and resources than anticipated, and should start sooner rather than later.
An additional benefit of regulatory compliance salesmanship is the reduction in frustration within companies regarding this topic. Good sales folk can help organizations “get it” when it comes to compliance.
The medtech industry operates in a dynamic regulatory environment, and fairly rapid rule changes will continue for the foreseeable future. I encourage all regulatory professionals to focus on developing their sales ability because it will make their jobs easier and help organizations better sustain regulatory compliance.
James A. “Jim” Dunning’s consulting career began in 2001. He has provided quality and regulatory consulting services for various companies ranging from Fortune 500 medical device firms to startups. Dunning’s passion, however, lies with startups and small companies, especially those in regulatory distress. He has amassed significant experience in preparing 510(k) applications, developing complete Quality Management Systems, providing Quality System Training, and advising on quality, business, and leadership issues. Dunning is a senior member of the American Society for Quality (ASQ) and a member of the Regulatory Affairs Professional Society (RAPS). He can be reached at jdunning@qpcservices.com.