Once a medical device product is placed on the market, a range of activities ensue to ensure its continued safety, efficacy, and regulatory compliance. These activities include post-market surveillance, regulatory compliance, marketing and sales, customer support, and continuous improvement.
Marketing and sales
Post-market, the focus also shifts to marketing and sales activities to ensure the product reaches its intended users and performs well in the market.
Sales Enablement: Building and training a commercial team on the technical aspects of the device, its benefits, and its proper use ensures that they can effectively communicate with healthcare professionals and potential buyers. Identifying, onboarding and monitoring distributors is also an ongoing process as companies expand their presence in different markets.
Market Research and Feedback: Gathering feedback from users and stakeholders helps understand market needs and how the device performs compared to competitors. This can inform marketing strategies and future product development.
User training and support
Providing robust customer support is vital for the success of a medical device. This includes:
User Training: Offering training sessions for healthcare providers to ensure they understand how to use the device correctly. Technical support teams are also available to troubleshoot any issues that arise. Applications specialists can be vital in forming long-term relationships with customers.
User Support: Providing ongoing support to users on technical troubleshooting, maintenance and account management through helpdesks and customer service organisations.
Service and maintenance
Service and maintenance ensure the reliability, safety, and longevity of medical devices. These activities encompass routine inspections, preventive maintenance, repairs, and updates, which collectively help minimise device downtime and ensure optimal performance.
Preventive maintenance involves regular, scheduled inspections and servicing of medical devices to identify and address potential issues before they result in failures. This includes checking for wear and tear, calibrating instruments, updating software, and replacing parts. By following manufacturer-recommended maintenance schedules, healthcare facilities can ensure devices remain accurate and reliable, preventing unexpected malfunctions during critical procedures.
Corrective maintenance addresses issues that arise during the device’s operation. This involves troubleshooting, diagnosing, and repairing faults to restore the device’s functionality. Quick and efficient corrective maintenance is vital to minimise downtime and ensure that medical devices are available for patient care when needed.
*Calibration and Validation: Regular calibration and validation are essential to maintain the accuracy and precision of medical devices. These processes ensure that devices perform according to their specifications and regulatory standards. Calibration involves adjusting the device to ensure its readings are accurate, while validation ensures it operates correctly within its intended use environment.
Post-Market surveillance
One of the most critical post-launch activities is post-market surveillance (PMS). This involves continuously monitoring the device’s performance in the real world. Manufacturers collect and analyse device use data, including adverse events, malfunctions, and complaints. This data collection can be facilitated through various means, such as user feedback, clinical follow-up studies, and registries.
Regulatory compliance
Maintaining regulatory compliance is an ongoing process. Even after the device is on the market, manufacturers must comply with local and international regulations. This includes:
Quality Management System (QMS) Maintenance: Ensuring that the QMS, often certified under ISO 13485, remains effective. Regular internal audits, management reviews, and continual improvements are crucial.
Regulatory Updates: Keeping abreast of changes in regulations and standards is essential. Manufacturers must ensure their products and processes comply with new requirements, which may involve additional testing, documentation, or modifications to the device.
Continuous improvement
Continuous improvement activities aim to enhance the device based on feedback and technological advancements.
R&D Updates: Incorporating user feedback, PMS data and the latest technological advancements into future device versions. This can involve software updates, hardware improvements, or entirely new models.
Process Optimisation: Analysing and optimising manufacturing processes to improve efficiency and product quality and reduce costs
Conclusion
The lifecycle of a medical device extends well beyond its market release. Post-market surveillance, regulatory compliance, marketing, sales, service, customer support, and continuous improvement are critical to ensuring the device remains safe, effective, and competitive. These efforts help safeguard patient health and maintain trust in the manufacturer’s brand.