I’ve seen firsthand the impact that medical devices have on people and their loved ones. In 1975, advancements in hip and knee replacements enabled my dad to walk again after being bed ridden for years from Juvenile Rheumatoid Arthritis. The medical device industry continues to boom and change the lives of people. Thanks to a combination of America’s aging population and new technology, companies are making notable strides in improving the quality of life through carefully designed devices.
However, in one of the most heavily regulated industries around, getting these new medical devices to market is not easy.
For good reason, medical devices undergo much testing and scrutiny by regulatory agencies before they’re delivered to consumers, but the company’s responsibility doesn’t end there. Manufacturers are held to high quality standards and must follow strict guidelines when making their products and responding to quality issues. These processes and standards are often very complicated as regulations continually evolve.In response, medical device manufacturers are starting to use specification management software to help navigate these ongoing changes and complex requirements. To understand exactly how this is achieved, you need only look as far as three of the biggest compliance issues plaguing manufacturers.
1. Corrective and Preventive Action Processes
The lack of process surrounding corrective and preventative actions, also referred to as CAPA, ranked as the number one compliance issue among medical device manufacturers. This is largely due to the fact that these procedures have not been well established by companies or were improperly documented.CAPA processes should be integrated into supply chain procedures, not treated as an afterthought in the product development stage. Specification management software helps medical device manufacturers get a 360-degree view of their processes and properly document all procedures - all tied to the spec-level for visibility and traceability.
2. Complaint Follow Up Procedures
The second most commonly cited compliance issue involves complaint follow up procedures. Companies are required to follow strict follow up procedures when consumers raise complaints or concerns. And this process should be well documented once a product hits the market (ideally well before). Complaints can result in recalls, lawsuits, or the outright seizure of the product. One of the most powerful features of Specright’s Specification Data Management™ platform is the ability to log and associate customer complaints to individual specs or Bill of Materials. To assist in complaint follow up procedures, companies can dial in on each product’s specifications to see what materials were used, where they were sourced, and other intricate details that can expedite answers.
3. Written Medical Device Reporting
A lack of written medical device reporting represents the third-most cited compliance issue and encompasses a wide spectrum of data. For example, companies are required to document key product descriptions and important terms like “malfunction” or “cause or contributed to.” The omission of critical information can result in fines and corrective action from regulatory agencies.By using specification management software, companies can better track the data required for each product to maintain consistency and compliance. Furthermore, this crucial data is available to stakeholders and partners from anywhere at any time, as one clear and concise single source of truth.
How to Achieve Greater Compliance in the Medical Device Industry
Specright’s specification management software provides insights at the spec level so that manufacturers can always keep a finger on the pulse of their products and processes. From documenting materials between multiple vendors to ensuring all products are made to the correct specifications, Specright is helping companies take control of their data beyond the bill of materials and drive efficiency across the supply chain. Compliant products simply get to market faster, meaning customers who rely on them can purchase and use them sooner. Like my dad’s story, medical devices really do have the ability to change people’s lives.And when their quality of life increases as a direct result, it’s hard to ignore the boost in reputation and revenue your company receives in response.To learn more about how Specright works for real-world companies today, watch our customer testimonials.