Arena, a PTC business, outlines the role a successful cloud QMS can help medical device manufacturers achieve commercialisation success in a volatile market.
Delivering safe and effective medical devices ahead of the competition is difficult for today’s manufacturers as they navigate evolving customer demands, increasing product complexity, supply chain disruptions, and more stringent industry regulations.
With product teams and supply chain partners more dispersed than ever, it’s imperative that everyone involved in the design, validation, production, and certification process has complete visibility into the latest product information so they can stay on track with compliance requirements and other key deliverables. Yet, many companies manage product and quality processes using manual, paper-based systems and lack a single source of product truth to ensure quality and streamline compliance.
In this article, we explore some of the product development hurdles that medical device manufacturers typically face in getting products to market. We also reveal how an enterprise quality management system (eQMS) solution can help companies meet their compliance goals and achieve commercialisation success.
Product development challenges for medical device manufacturers
Regulatory compliance
As FDA, ISO, EU MDR, and other regulations across the globe become more stringent, manufacturers are having to gather extensive technical data to ensure patient safety and demonstrate compliance. And although the different regulations share the same basic principles, manufacturers still need to monitor them closely to keep up with the ongoing changes and intricacies that impact their business.
Design controls
Companies must establish effective design controls to verify that devices perform according to their intended use. To ensure accurate controls, the design history file (DHF) and device master record (DMR) must be managed in context of each other and the entire product record.Because traditional paper-based systems and document-centric QMS platforms leave quality records, design files, bills of materials (BOMs), and other key components of the product record disconnected, teams lack full visibility and traceability, which leads to errors and inconsistent information. These design control issues often result in audit citations and derailed product launches.
Training management
An employee training program is essential to demonstrating adherence to FDA, ISO, safety, and other standards. Regulatory agencies focus on a training management system to determine the company’s ability to follow its documented business policies and procedures. For instance, as part of an inspection, the FDA will first review a medical device company’s training records to assess whether employees are following current good manufacturing practices (cGMPs).
Documenting, testing, and tracking that employees are properly trained is a heavy burden for those responsible for executing the program, especially when using manual, paper-based systems, or a siloed solution. Without training record management automation in place, companies are prone to compliance risks and unnecessary administrative costs.
Requirements management
Requirements management is the process of documenting, analysing, tracing, prioritising, and agreeing on product requirements and then controlling and communicating changes to relevant stakeholders. This process occurs throughout new product development (NPD) and leading up to new product introduction (NPI).
Requirements are typically:
- Design constraints
- Testable
- Interface-centric (what the product is perceived to be)
- Mostly about what the product should do
According to LNS Research, 91% of organisations still use spreadsheets and electronic documents to track requirements. Since these ad hoc solutions are not tied to the product record, cross-functional teams lack full visibility into quality issues, customer needs, design defects, and other dependencies that impact NPI. Reliance on multiple disconnected systems also results in more work and increased risks to launch schedules and profitability.
As the demand for more sophisticated products continues to rise, manufacturers need a more unified system to track requirements that span mechanical, electrical, and software disciplines and keep everyone on the same page.
Document management
Centralised storage, tracking, and management of all product and quality documentation is necessary to meet the demands of today’s highly regulated environment. Medical device companies must maintain vast amounts of documentation including standard operating procedures (SOPs), specifications, engineering drawings, and policies as part of their QMS. However, these documents are often stored in different systems and multiple locations, making it difficult for dispersed teams and supply chain partners to identify the latest version and conduct reviews and approvals in a timely manner. During audits, it is also difficult to quickly compile requested information and demonstrate proper revision and document control.
Driving commercialisation and compliance success with cloud QMS
Today, more and more companies are moving away from traditional paper-based systems and leveraging digital technologies to better manage and track their new product development and introduction (NPDI) processes. By embracing cloud-based eQMS solutions, companies can eliminate data silos and communication barriers to quickly resolve quality issues and drive continuous improvement.
Advanced solutions like Arena’s product centric QMS connect product and quality records in a single electronic system. This enables organisations to establish strong design controls and gain greater visibility and traceability over corrective and preventive actions (CAPAs), DHFs, DMRs, SOPs, requirements, and other quality processes that are critical to meeting regulatory requirements.
Teams can leverage quality templates to easily develop post-market surveillance (PMS), clinical evaluation, and corrective action reports as well as other documentation necessary for a technical file submission. The platform also provides an automated system to create employee training plans, assign training records, and generate progress reports to help reduce compliance risks and eliminate reliance on a separate disconnected training system. Because automated change processes and revision controls are applied to all product and quality information, companies have greater success in passing audits and meeting their commercialisation milestones.
To learn more about how a product-centric QMS helps medical device companies streamline NPDI and achieve compliance goals, read Arena’s customer success stories at: https://www.arenasolutions.com/wp-content/uploads/Customer-Success-Story_Potrero-Medical.pdf?utm_source=referral&utm_medium=display&utm_campaign=Med+Tech+News+Summer+2022&utm_content=protrero+customer+story&utm_content=Select+Type&audience=life+sciences
