Business Assurance
Business assurance refers to the set of strategies, processes and activities undertaken by a manufacturer to ensure the sustainability and resilience of the business, whilst achieving its objectives, safeguarding its assets, and mitigating risks. Central to business assurance are systems that monitor and manage risks effectively to instil stakeholder confidence in the brand and products.
PMS data in any business area provides a valuable source of insight to guide decisions and continual improvement, for example, related to customer experience, product design, and satisfaction with the products; essentially all ingredients required to stay ahead of competitors. For MD manufacturers, there are also regulatory requirements to identify potential issues or trends that may require corrective actions. This data is critically important to support informed decision making for business assurance and provide metrics to monitor the impact of investments in product design, including information and branding for that product.
Regulatory approvals are often seen as pivotal points in a business plan, opening markets as well as releasing investment. Financial, operational, compliance, risk, customer and market data are routinely integrated into the business assurance process. The contribution of technology data is usually around market launches, rather than the deeper contextualisation that is provided in the regulatory development and PMS.
PMS best practice
Despite the diverse regulatory landscape for PMS, there are some best practices. These include having robust plans that reflect the actual product risks determined by the manufacturer and are proportionate and timely. As PMS plans are dynamic, the feedback loops are best designed so that regulatory and business decisions can be made on timely and relevant data. Where PMS aspects are performed externally by service providers, businesses need to consider the extra internal analysis of the data, including raw data, and verification of the results, to ensure that the service meets and continues to meet their requirements.
It is worth considering regulatory PMS actions in the context of similar business assurance activities. General customer satisfaction surveys give the opportunity to develop customer relationships and can help improve customer satisfaction. However, regulatory PMS surveys are becoming increasingly outsourced, breaking the connection between the manufacturer and user, as well as potentially missing input that could help find new improvements or applications for the products. The same applies to literature reviews, which were once conducted in house and the analysis used to verify the continued suitability of the research questions and objectives that need to be addressed. Now, external providers provide a more generic service requiring the manufacturer to take care to ensure that in house analysis addresses the company-specific requirements. From a business perspective, the literature review could be extended beyond the regulatory requirements to cover aspects important to business sustainability and resilience.
In analysing PMS data, there are specific competencies required to ensure regulatory compliance. Where this service is provided externally, the regulatory requirements will be met, but the implications of the data to the wider business that could be determined from an in-house cross-disciplinary team will be lost. Indeed, integrating PMS into business assurance is a practical and effective way to ensure top decision makers stay informed and engaged with the products their company makes and the associated risks of those products.
The effectiveness of PMS hinges on the adept application of diverse strategies tailored to the unique characteristics of the manufacturer’s products and business. Both proactive surveillance methodologies such as real-world data analysis or reactive measures like complaint handling and trend analysis can provide valuable business insights.
Shifting Focus to Business Assurance
Despite its undeniable importance, PMS often encounters resistance within organizations due to the cost and misconception that the data is only valuable for regulatory approval. Resource constraints, regulatory complexities, and the perceived disconnect between compliance efforts and business strategy contribute to the reluctance in embracing PMS as a strategic imperative. Overcoming these barriers necessitates a paradigm shift, reframing PMS from a purely regulatory requirement to an integral component of proactive business risk management and assurance strategies.
Conclusion
In conclusion, PMS is integral for regulatory compliance, patient safety, and business assurance. By moving beyond the regulatory confines and embracing PMS as a strategic imperative, manufacturers can navigate complex regulatory landscapes, fortify their market position, and ultimately deliver safer and more efficacious MDs to consumers. Through continuous learning and adaptation of best practices, manufacturers can unlock the full potential of PMS as a catalyst for sustainable growth and industry leadership.
