James A. Dunning, QPC Services09.08.16
I am still surprised when I encounter small medtech companies that consider regulatory functions to be “paperwork” or an “administrative” task. In many cases, the top management in these companies believe the regulatory function is not truly valuable, and the regulatory function and sometimes even the quality assurance function are in place only because of regulatory requirements such as the U.S. Food and Drug Administration’s Quality System Regulation, or ISO 13485 requirements for a quality management system. They simply do not see the business case for the regulatory function.
Regulatory and/or quality affairs officers find it difficult, at best, to work for managers who don’t value the regulatory function. These companies also easily fall prey to regulatory compliance problems. Neither are ideal situations for anyone, yet these scenarios continue to exist, defying logic. Most medtech firms are comprised of well-educated professionals who know how to get things done. But the regulatory function often is not held in high esteem, even when its role is intended to help the company maintain regulatory compliance. It’s mind-boggling.
Trying to determine the reasons for corporate indifference to regulatory function is going to be difficult, but I’ll give it my best shot. In the spirit of full disclosure, I acknowledge that I have not performed a formal, rugged, peer reviewed study of undervalued regulatory function, nor have I any inside knowledge of medtech leadership psyche. But I find the undervalued regulatory function to be such a common occurrence, it merits attention.
There are obviously risks associated with implementing the following recommended remedies. Not all medtech companies are the same, and small firms are not miniature versions of their larger counterparts. Also, financial capabilities differ between medtech companies. All these factors must be considered when developing a remedy for undervalued regulatory function.
Let’s consider some of the reasons for the undervalued regulatory function:
The table on the next page lists the remedies (a brief description) along with a deeper dive into the proposed solution.
It is common for the regulatory function to be undervalued, but in my experience, this can be changed within most companies. The key is understanding why the regulatory function is undervalued, and responding in a positive way to improve the situation.
James A. “Jim” Dunning’s consulting career began in 2001. He has provided quality and regulatory consulting services for various companies but his passion 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. He can be reached at jdunning@qpcservices.com.
Regulatory and/or quality affairs officers find it difficult, at best, to work for managers who don’t value the regulatory function. These companies also easily fall prey to regulatory compliance problems. Neither are ideal situations for anyone, yet these scenarios continue to exist, defying logic. Most medtech firms are comprised of well-educated professionals who know how to get things done. But the regulatory function often is not held in high esteem, even when its role is intended to help the company maintain regulatory compliance. It’s mind-boggling.
Trying to determine the reasons for corporate indifference to regulatory function is going to be difficult, but I’ll give it my best shot. In the spirit of full disclosure, I acknowledge that I have not performed a formal, rugged, peer reviewed study of undervalued regulatory function, nor have I any inside knowledge of medtech leadership psyche. But I find the undervalued regulatory function to be such a common occurrence, it merits attention.
There are obviously risks associated with implementing the following recommended remedies. Not all medtech companies are the same, and small firms are not miniature versions of their larger counterparts. Also, financial capabilities differ between medtech companies. All these factors must be considered when developing a remedy for undervalued regulatory function.
Let’s consider some of the reasons for the undervalued regulatory function:
- Top management does not have prior medtech experience.
- Investors do not hold regulatory performance in high regard.
- Regulatory professionals in the company do not have any other functional work experience.
- Top management does not know how to assign value to regulatory compliance.
- Top management hubris
- Regulatory professional arrogance
- Lack of a regulatory function within the company
- Lack of vision, mission, and values
- Reason: Top management does not have prior medtech experience. Remedy: Regulatory personnel finds ways to inform top management about the regulatory environment in which the company must operate, and how to efficiently comply with regulatory requirements.
- Reason: Investors do not hold regulatory performance in high regard. Remedy: Top management, in collaboration with regulatory and financial officials, communicates the business advantage of efficient regulatory compliance.
- Reason: Regulatory professionals in the company do not have any other functional work experience. Remedy: The regulatory group establishes a professional development program that includes working in other functions in order to make their personnel more well-rounded.
- Reason: Top management does not know how to assign value to regulatory compliance. Remedy: The regulatory group works with top management and the finance group to establish a value for regulatory functions.
- Reason: Top management hubris. Remedy: Not sure there is one. This may just be unavoidable.
- Reason: Regulatory professional arrogance. Remedy: Better integration into the team
- Reason: Lack of a regulatory function within the company. Remedy: Outsource.
- Reason: Lack of vision, mission, and values. Remedy: This solution rests with top management itself.
The table on the next page lists the remedies (a brief description) along with a deeper dive into the proposed solution.
It is common for the regulatory function to be undervalued, but in my experience, this can be changed within most companies. The key is understanding why the regulatory function is undervalued, and responding in a positive way to improve the situation.
James A. “Jim” Dunning’s consulting career began in 2001. He has provided quality and regulatory consulting services for various companies but his passion 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. He can be reached at jdunning@qpcservices.com.