COVID Strategy for Regulatory and Quality Professionals and Their Leaders
By Bryan Brosseau, Founder and Principal Consultant, Brosseau Consulting LLC | 05.20.20
Great challenges and changes are being wrought by the SARS-CoV-2 virus and mitigation efforts to control its spread. The changes have been relatively sudden and impact every aspect of personal and professional life. While these changes seem abrupt and drastic, it is the profound and lasting nature of this pandemic that will most greatly impact the operations governed by quality management systems (QMS).
The SARS-CoV-2 virus is also driving society to question the value of existing work practices employees have long taken for granted. Such great disruptions not only bring loss and change but also opportunity. With some foresight and strategy, the regulatory and quality units of medtech companies can harness these changes to make their organizations stronger and more compliant. There are actions that both companies and their employees can take to smooth the transition and achieve competitive advantage but they must begin now.
Executive Management
As part of strategic planning and headcount maintenance efforts, companies should consider how they can leverage personnel resources to reduce the negative impact of SARS-CoV-2, improve QMS efficiency, and increase portfolio value.
While the memory of this worldwide pandemic experience is still fresh, medtech firms would do well to consider business continuity measures that reduce risks associated with natural disasters, supply chain disruptions, personnel preparedness, and portfolio relevance. Where possible, they should implement measures immediately and then refine those actions for future security. Evaluating protections against single suppliers or complex supply chains is a good example. Business continuity certification (ISO 22301) can prepare medtech firms for future disruptions and may bolster organizations’ standing with clients who understand the value of such certification.
Executives should provide direction to their organizations on cleaning up and clearing out QMS cobwebs and resolving compliance issues. Some of the ways companies can achieve that include:
New revenue streams may be realized through evaluating new and temporary regulatory measures for products or potential products. Existing resources (personnel, suppliers, and infrastructure) might position organizations to expand their current portfolios, at least temporarily; one way to achieve this is using products presently on the market in new applications or for new indications under an Emergency Use Authorization from the U.S. Food and Drug Administration. Such resourcefulness demonstrates a commitment to the greater good and helps employees round out their skillset and adeptness at product development. Leveraging existing or new suppliers also can help round out a QMS team’s experience and skillset, with importers, contract manufacturers, partner organizations, service providers, and distributors all helping to improve compliance.
Individual Professional Opportunities
Societal shutdowns and shelter-at-home orders worldwide have significantly increased the number of remote workers, forcing companies to interface through teleconferencing. Although it may seem impersonal and fraught with technical challenges, the work-from-home reality is giving employees a new sense of independence and flexibility as they communicate with colleagues and customers via email, chats, and videoconferencing. Experts predict many employees will continue working remotely even after the pandemic is under control, staying fully tethered to their corporate kinfolk through mobile phones, laptops, and other devices. Such a change would certainly eliminate work commutes, adding valuable time to employees’ busy schedules. Workers could use the time for professional growth by perhaps volunteering their time, within the industry or outside healthcare. There are numerous organizations trying to help with medical device shortages, and other efforts that employees can support from home. These opportunities serve a dual purpose: They help others but also workers to establish lasting relationships and build their professional resumes.
Companies should take advantage of this time in lockdown to identify solutions to new QMS challenges or process improvements with an eye on technologies for remote work.
Quality Management System Challenges
Several QMS elements may be difficult or even impossible under existing processes. Companies should consider how they can adapt to ensure QMS roles are maintained under increased remote operations. Remote work is also increasing the need for digital training; thus, companies would be wise to implement new training methods for distance learning or seek new virtual training opportunities for their employees. Many organizations are offering free online training or training programs that were previously only available on-location and requiring travel.
Supplier management processes may require modification for remote assessment. As the workforce transitions to a more pronounced use of telepresence, medtech firms should consider how telepresence may improve supplier relationships and supplier oversight with less travel and expenses. Identifying and implementing new tools for conducting supplier audits such as augmented reality and telepresence tools and apps would certainly be welcome strategies in the current environment. Companies can obtain ideas on useful techniques and tools from the regulators—specifically by consulting guidance for remote auditing, including those for MDSAP1 and Notified Body2 auditors.
Companies with paper-based quality management systems are now experiencing one of the drawbacks of physical document and record storage. The struggles associated with paper-based systems can be overcome with adoption of technology. Planning an electronic or off-the-shelf QMS or implementing one on the heels of a stay-at-home order may seem like daunting tasks. However, a company-tailored 21 CFR Part 11 compliant solution will greatly improve the QMS for future efficiency.
In the current state of the workforce, companies must not forget about their operations teams. Checking in through various remote methods—smart glasses, FaceTime, or Zoom—can be useful in maintaining a presence even if managers cannot be physically present. Medtech firms might consider setting up a designated quality station where operations personnel and on-site quality personnel working with operations can interact with off-site quality resources. Managers can assign shifts with quality personnel to staff the virtual quality station.
Lastly, companies should stay abreast of various regulatory changes prompted by the SARS-CoV-2 pandemic. For example, the EU MDR has been delayed by one year, and there are various exemptions from regulatory requirements right now to address medical device shortages. Forging new relationships and partnerships with internal stakeholders and external resources to evaluate new revenue opportunities would be prudent as the pandemic continues. Such opportunities allow organizations to pivot to new challenges and may even help keep colleagues employed with new revenue streams.
Summary
It does not need to be said that this is a challenging time. And, the workload and work habits many have assumed under these challenges may cause the recommendations discussed in this column to seem exhausting or even impossible. But any effort, idea, or motivation may help, and every opportunity must be considered to keep medtech’s lifesaving, life-improving, and health-sustaining products available. For that is why so many people have dedicated themselves to this industry.
References
Bryan Brosseau’s experience has been forged in almost 20 years in the medical device and biologics industries. With a varied and in-depth knowledge of quality and regulatory requirements, he hones in on the necessary requirements of a project to ensure quality and compliance without impeding progress. Brosseau Consulting LLC manages quality management systems for numerous companies and has obtained regulatory approvals for products across a wide range of therapy areas. Brosseau received his bachelor’s degree in biology from the University of Georgia, maintains a Regulatory Affairs Certification (U.S.) from the Regulatory Affairs Professionals Society, and is a certified ISO 13485:2016 Lead Auditor.
The SARS-CoV-2 virus is also driving society to question the value of existing work practices employees have long taken for granted. Such great disruptions not only bring loss and change but also opportunity. With some foresight and strategy, the regulatory and quality units of medtech companies can harness these changes to make their organizations stronger and more compliant. There are actions that both companies and their employees can take to smooth the transition and achieve competitive advantage but they must begin now.
Executive Management
As part of strategic planning and headcount maintenance efforts, companies should consider how they can leverage personnel resources to reduce the negative impact of SARS-CoV-2, improve QMS efficiency, and increase portfolio value.
While the memory of this worldwide pandemic experience is still fresh, medtech firms would do well to consider business continuity measures that reduce risks associated with natural disasters, supply chain disruptions, personnel preparedness, and portfolio relevance. Where possible, they should implement measures immediately and then refine those actions for future security. Evaluating protections against single suppliers or complex supply chains is a good example. Business continuity certification (ISO 22301) can prepare medtech firms for future disruptions and may bolster organizations’ standing with clients who understand the value of such certification.
Executives should provide direction to their organizations on cleaning up and clearing out QMS cobwebs and resolving compliance issues. Some of the ways companies can achieve that include:
- Remediating for QMS compliance to new or revised regulatory requirements (EU MDR)
- Addressing languishing QMS elements such as CAPA, NCR, or complaints
- Empowering employees to seek out opportunities for preventive action and process improvement
- Hosting a Lean Six Sigma project for an employee or student from outside the organization
- Evaluating the company training plan to determine where additional training is warranted, if a more risk-based approach is required for regulatory compliance, or to evaluate new methods for verification of training effectiveness
New revenue streams may be realized through evaluating new and temporary regulatory measures for products or potential products. Existing resources (personnel, suppliers, and infrastructure) might position organizations to expand their current portfolios, at least temporarily; one way to achieve this is using products presently on the market in new applications or for new indications under an Emergency Use Authorization from the U.S. Food and Drug Administration. Such resourcefulness demonstrates a commitment to the greater good and helps employees round out their skillset and adeptness at product development. Leveraging existing or new suppliers also can help round out a QMS team’s experience and skillset, with importers, contract manufacturers, partner organizations, service providers, and distributors all helping to improve compliance.
Individual Professional Opportunities
Societal shutdowns and shelter-at-home orders worldwide have significantly increased the number of remote workers, forcing companies to interface through teleconferencing. Although it may seem impersonal and fraught with technical challenges, the work-from-home reality is giving employees a new sense of independence and flexibility as they communicate with colleagues and customers via email, chats, and videoconferencing. Experts predict many employees will continue working remotely even after the pandemic is under control, staying fully tethered to their corporate kinfolk through mobile phones, laptops, and other devices. Such a change would certainly eliminate work commutes, adding valuable time to employees’ busy schedules. Workers could use the time for professional growth by perhaps volunteering their time, within the industry or outside healthcare. There are numerous organizations trying to help with medical device shortages, and other efforts that employees can support from home. These opportunities serve a dual purpose: They help others but also workers to establish lasting relationships and build their professional resumes.
Companies should take advantage of this time in lockdown to identify solutions to new QMS challenges or process improvements with an eye on technologies for remote work.
Quality Management System Challenges
Several QMS elements may be difficult or even impossible under existing processes. Companies should consider how they can adapt to ensure QMS roles are maintained under increased remote operations. Remote work is also increasing the need for digital training; thus, companies would be wise to implement new training methods for distance learning or seek new virtual training opportunities for their employees. Many organizations are offering free online training or training programs that were previously only available on-location and requiring travel.
Supplier management processes may require modification for remote assessment. As the workforce transitions to a more pronounced use of telepresence, medtech firms should consider how telepresence may improve supplier relationships and supplier oversight with less travel and expenses. Identifying and implementing new tools for conducting supplier audits such as augmented reality and telepresence tools and apps would certainly be welcome strategies in the current environment. Companies can obtain ideas on useful techniques and tools from the regulators—specifically by consulting guidance for remote auditing, including those for MDSAP1 and Notified Body2 auditors.
Companies with paper-based quality management systems are now experiencing one of the drawbacks of physical document and record storage. The struggles associated with paper-based systems can be overcome with adoption of technology. Planning an electronic or off-the-shelf QMS or implementing one on the heels of a stay-at-home order may seem like daunting tasks. However, a company-tailored 21 CFR Part 11 compliant solution will greatly improve the QMS for future efficiency.
In the current state of the workforce, companies must not forget about their operations teams. Checking in through various remote methods—smart glasses, FaceTime, or Zoom—can be useful in maintaining a presence even if managers cannot be physically present. Medtech firms might consider setting up a designated quality station where operations personnel and on-site quality personnel working with operations can interact with off-site quality resources. Managers can assign shifts with quality personnel to staff the virtual quality station.
Lastly, companies should stay abreast of various regulatory changes prompted by the SARS-CoV-2 pandemic. For example, the EU MDR has been delayed by one year, and there are various exemptions from regulatory requirements right now to address medical device shortages. Forging new relationships and partnerships with internal stakeholders and external resources to evaluate new revenue opportunities would be prudent as the pandemic continues. Such opportunities allow organizations to pivot to new challenges and may even help keep colleagues employed with new revenue streams.
Summary
It does not need to be said that this is a challenging time. And, the workload and work habits many have assumed under these challenges may cause the recommendations discussed in this column to seem exhausting or even impossible. But any effort, idea, or motivation may help, and every opportunity must be considered to keep medtech’s lifesaving, life-improving, and health-sustaining products available. For that is why so many people have dedicated themselves to this industry.
References
Bryan Brosseau’s experience has been forged in almost 20 years in the medical device and biologics industries. With a varied and in-depth knowledge of quality and regulatory requirements, he hones in on the necessary requirements of a project to ensure quality and compliance without impeding progress. Brosseau Consulting LLC manages quality management systems for numerous companies and has obtained regulatory approvals for products across a wide range of therapy areas. Brosseau received his bachelor’s degree in biology from the University of Georgia, maintains a Regulatory Affairs Certification (U.S.) from the Regulatory Affairs Professionals Society, and is a certified ISO 13485:2016 Lead Auditor.
