James A. Dunning, Principal, QPC Services LLC01.30.19
It’s that time of year again.
Time for a calendar change. Out with the old and in with the new. Time for another 12-month journey into the unknown.
It’s also time for new beginnings—a period that can be simultaneously fun, exhilarating, scary, and nerve-wracking. In the medtech world, these fresh starts can be particularly stressful, as they often lead to a new round of regulatory inspections. These reviews can vex even the most established companies due to the changing nature of the industry. Change can stress regulatory compliance, and consequently, the state of inspection readiness.
Here are some examples of changes that can stress the state of regulatory compliance and inspectional readiness (listed in no particular order):
Mergers can be trouble for regulatory compliance because they almost always include changes in management personnel, organizational structure, product category/volume, product transfers, quality management system (QMS) policy/procedural changes, and increased workloads in training, change control activities, and qualification/validation. Mergers also tend to change the vision, mission, and beliefs of the operating model used by the combined companies. These changes can make stakeholders more anxious about their futures with the new entity, especially when the merger leads to personnel cuts. Bottom line: All these challenges can create a perfect (stress) storm for regulatory compliance.
Acquisitions are much like mergers but usually are not quite as involved because one company is being “added” to an existing QMS. Nevertheless, acquisitions are easier in theory than in practice; like mergers, they can raise the stress level in organizations (and stakeholders) due to the uncertainty they create about the company’s future direction and mission. Management, however, must remain focused and handle all the significant changes occurring to the purchasing firm.
Most medtech executives would agree that new products are a positive facet of business. But new products can certainly stress regulatory compliance professionals because they often involve new manufacturing processes or require the creation of new, previously unfamiliar product categories that have unique mandates. Moreover, new innovations can feature new technologies that must be addressed within the QMS. New products also increase workloads on training, change control, and other support systems, adding to regulatory compliance executives’ anxiety levels. Adding to the stress is the potential modification to existing facilities or the acquisition and/or building of new facilities to manufacture the new product(s). Another trouble spot is the additional personnel that may be required to develop new products, and the fact that some of these new hires may need to be skilled or experts in areas with which the organization is unfamiliar. The cost of new products can also stress an organization financially, adding to the sense of urgency felt within organizations. A sense of urgency is a good thing, but it can be a headache for regulatory compliance.
New markets often come with new regulatory agencies and mandates that might be unknown to the organization. Thus, the QMS may need to be significantly revised to comply with the new standards. Although industry harmonization is endorsed by many global supervisory bodies, exposure to new regulatory agencies and requirements can nevertheless put a strain on regulatory compliance.
Regulatory changes are an obvious hassle for regulatory compliance. It seems as if these changes are constantly occurring, thanks in part to the innovation taking place within the medtech industry. Such rapid technological advancements and the general evolution of regulatory requirements can make it difficult for companies to stay abreast of the latest mandates.
Loss, addition, and/or movement of key personnel is another discernable source of regulatory compliance stress. Everyone is replaceable; yet, when essential workers are furloughed or fired, it can leave an empty hole in an organization. There usually are people within companies that contribute to the QMS and associated level of regulatory compliance in ways that are not always captured in job descriptions or QMS tools. The loss of these workers can have a greater-than-expected effect on the organization, and the surprise impact of the loss can strain regulatory compliance efforts. Conversely, adding key personnel can sometimes trigger anxiety in regulatory compliance professionals, especially when the new personnel are placed in decision-making positions within the company. Typically, this does not happen intentionally, and the decrease in regulatory compliance status may take some time to identify. Even when identified, though, the cause of the decrease may not be linked to additional key personnel. Movement of personnel can affect the regulatory compliance status just as much as the loss or addition of key workers. Moving a new employee into a key new role can add unanticipated stress to the QMS and result in a lower level of regulatory compliance status.
New competition can stress regulatory compliance as well. Here’s why: The player handling product categories typically has integrated newer technology and/or lower costs into a medtech firm’s invention(s). Often, these players focus on delivering unmet stakeholder needs to the market. In response, established companies may push themselves to develop products faster; improve their innovations, processes, and customer service; and lower manufacturing costs to maintain market share. Such improvements are positive, but the changes required to achieve them can burden the QMS and subsequently the state of regulatory compliance as well.
In most regions of the world, success is generally measured by business performance (i.e., financial performance). When business performance decreases or does not meet expectations, the organization drives changes (or attempts to drive changes) to improve its overall functioning. In these cases, regulatory compliance can unintentionally be overlooked, or at the very least, be undervalued as an overall success factor.
New control or support systems such as an Enterprise Resource Planning system can certainly improve operational performance and enhance the QMS; integration of these systems, however, can have a negative impact on the state of regulatory compliance. Often the transition takes longer than expected, prompting companies to implement temporary stopgap measures to avoid noncompliance. Yet sometimes these temporary measures are extended so frequently that they begin to break down, and consequently, reduce the level of regulatory compliance.
The changes I’ve discussed are inevitable. But they’re not insurmountable obstacles, and they don’t necessarily have to become stressors to the regulatory compliance system. To keep anxiety levels low, regulatory professionals should consider:
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.
Time for a calendar change. Out with the old and in with the new. Time for another 12-month journey into the unknown.
It’s also time for new beginnings—a period that can be simultaneously fun, exhilarating, scary, and nerve-wracking. In the medtech world, these fresh starts can be particularly stressful, as they often lead to a new round of regulatory inspections. These reviews can vex even the most established companies due to the changing nature of the industry. Change can stress regulatory compliance, and consequently, the state of inspection readiness.
Here are some examples of changes that can stress the state of regulatory compliance and inspectional readiness (listed in no particular order):
- Mergers
- Acquisitions
- New products
- New processes
- New markets
- Changes in regulatory requirements
- Loss, addition, and/or movement of key personnel
- New competition
- Business performance (financial)
- New control/support systems
Mergers can be trouble for regulatory compliance because they almost always include changes in management personnel, organizational structure, product category/volume, product transfers, quality management system (QMS) policy/procedural changes, and increased workloads in training, change control activities, and qualification/validation. Mergers also tend to change the vision, mission, and beliefs of the operating model used by the combined companies. These changes can make stakeholders more anxious about their futures with the new entity, especially when the merger leads to personnel cuts. Bottom line: All these challenges can create a perfect (stress) storm for regulatory compliance.
Acquisitions are much like mergers but usually are not quite as involved because one company is being “added” to an existing QMS. Nevertheless, acquisitions are easier in theory than in practice; like mergers, they can raise the stress level in organizations (and stakeholders) due to the uncertainty they create about the company’s future direction and mission. Management, however, must remain focused and handle all the significant changes occurring to the purchasing firm.
Most medtech executives would agree that new products are a positive facet of business. But new products can certainly stress regulatory compliance professionals because they often involve new manufacturing processes or require the creation of new, previously unfamiliar product categories that have unique mandates. Moreover, new innovations can feature new technologies that must be addressed within the QMS. New products also increase workloads on training, change control, and other support systems, adding to regulatory compliance executives’ anxiety levels. Adding to the stress is the potential modification to existing facilities or the acquisition and/or building of new facilities to manufacture the new product(s). Another trouble spot is the additional personnel that may be required to develop new products, and the fact that some of these new hires may need to be skilled or experts in areas with which the organization is unfamiliar. The cost of new products can also stress an organization financially, adding to the sense of urgency felt within organizations. A sense of urgency is a good thing, but it can be a headache for regulatory compliance.
New markets often come with new regulatory agencies and mandates that might be unknown to the organization. Thus, the QMS may need to be significantly revised to comply with the new standards. Although industry harmonization is endorsed by many global supervisory bodies, exposure to new regulatory agencies and requirements can nevertheless put a strain on regulatory compliance.
Regulatory changes are an obvious hassle for regulatory compliance. It seems as if these changes are constantly occurring, thanks in part to the innovation taking place within the medtech industry. Such rapid technological advancements and the general evolution of regulatory requirements can make it difficult for companies to stay abreast of the latest mandates.
Loss, addition, and/or movement of key personnel is another discernable source of regulatory compliance stress. Everyone is replaceable; yet, when essential workers are furloughed or fired, it can leave an empty hole in an organization. There usually are people within companies that contribute to the QMS and associated level of regulatory compliance in ways that are not always captured in job descriptions or QMS tools. The loss of these workers can have a greater-than-expected effect on the organization, and the surprise impact of the loss can strain regulatory compliance efforts. Conversely, adding key personnel can sometimes trigger anxiety in regulatory compliance professionals, especially when the new personnel are placed in decision-making positions within the company. Typically, this does not happen intentionally, and the decrease in regulatory compliance status may take some time to identify. Even when identified, though, the cause of the decrease may not be linked to additional key personnel. Movement of personnel can affect the regulatory compliance status just as much as the loss or addition of key workers. Moving a new employee into a key new role can add unanticipated stress to the QMS and result in a lower level of regulatory compliance status.
New competition can stress regulatory compliance as well. Here’s why: The player handling product categories typically has integrated newer technology and/or lower costs into a medtech firm’s invention(s). Often, these players focus on delivering unmet stakeholder needs to the market. In response, established companies may push themselves to develop products faster; improve their innovations, processes, and customer service; and lower manufacturing costs to maintain market share. Such improvements are positive, but the changes required to achieve them can burden the QMS and subsequently the state of regulatory compliance as well.
In most regions of the world, success is generally measured by business performance (i.e., financial performance). When business performance decreases or does not meet expectations, the organization drives changes (or attempts to drive changes) to improve its overall functioning. In these cases, regulatory compliance can unintentionally be overlooked, or at the very least, be undervalued as an overall success factor.
New control or support systems such as an Enterprise Resource Planning system can certainly improve operational performance and enhance the QMS; integration of these systems, however, can have a negative impact on the state of regulatory compliance. Often the transition takes longer than expected, prompting companies to implement temporary stopgap measures to avoid noncompliance. Yet sometimes these temporary measures are extended so frequently that they begin to break down, and consequently, reduce the level of regulatory compliance.
The changes I’ve discussed are inevitable. But they’re not insurmountable obstacles, and they don’t necessarily have to become stressors to the regulatory compliance system. To keep anxiety levels low, regulatory professionals should consider:
- Being an active part of the change process. Regulatory professionals are often seen as resistant to change (frequently without due cause), but hard work, focus, and collaboration can reduce this perception and thereby enhance their influence. The age-old axiom “if you are not part of the solution, you are part of the problem” applies here. Work hard to be seen as part of the solution, and help the organization focus on regulatory compliance throughout the change process.
- Listen. Regulatory professionals are most effective when they listen to others in their organizations. It is tempting to speak up too quickly, but take a breath and listen. This is the best way to get other professionals in the organization to listen to the regulatory expert both as an individual and as part of a group. This mutual level of listening within the organization will result in a better understanding of the stressors presented by the change(s) the organization is experiencing.
- Speak up when necessary. Most medtech companies work hard to maintain compliance, but regulatory professionals have a responsibility to identify situations where amenability could be adversely affected. Don’t hesitate to speak up in these situations.
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.
