Medical manufacturing organizations face a lot of challenges when it comes to innovation. They need to work within an extremely regulated environment. While moving from one manufacturing process to the next one, they need to demonstrate that they adhere to controlled, structured, and repeatable processes. They necessarily show that their products are up to app safety, fitness, and security standards before using them in any kind of medical procedure along with PLM software.
The issue is that most medical device manufacturing companies are not set up in such a way that they can meet these challenges in an effective way. Or they might lack the expertise. They handle their compliance metadata with systems comprising of pens and papers and filing cabinets. If they get the software to manage the workflows, it will likely handle only one part of the process. It means they will need different software solutions for every stage of the product lifecycle. It is an expensive and time-consuming process.
Introducing Product Lifecycle Management (PLM)
Product Lifecycle Management Software is the answer to all of these challenges. Enterprises that bring in the software become the cornerstone to their quality, compliance, and engineering processes. It acts as a central hub for all the data throughout the value chain. And is available for stakeholders not only inside the company but also for those who are outside the organization.
Oracle Agile PLM solutions offer engineering intelligence to stakeholders during the manufacturing process and later into the product stage. It incorporates regulator workflows and the product engineering lifecycle. With the intelligence of this tool, businesses can identify valuable insights assisting them in making the products and manufacturing process better. Along with managing the products’ lifecycle, it brings a number of extra benefits for medical device manufacturers, including:
- At each stage of the manufacturing process, it matches the product parts to needs.
- Streamlines the revalidation process and boosts opportunities to reuse material through the online catalog of parts.
- Administrates compliance requirements that are segmented by product category, market, region, and more.
- Ensures that engineering, marketing, quality, and compliance teams have bespoke views of correlated engineering data drawn from the accurate record systems.
In this way, the software acts as a hub for the quality and regulatory frameworks of the company. It saves money and enables faster work, and you won’t need a paper or pen in sight. Thus, PLM offers a competitive advantage to companies.
The Importance of PLM Software in the Medical Device Industry
Different companies around the globe in the medical device industry are relying on PLM to achieve their digital transformation goals, drive down costs, and speed up development times. By implementing PLM into your business and utilizing data for decision making, enterprises can see a dramatic impact in the following ways:
- 35%-time reduction in the compliance process.
- 90% increase in the first-time-right quality results.
- 30% acceleration in time to market.
- 95% reduction in issue fixing time around non-conformance.
As you can see from these numbers, PLM is revolutionizing the medical device industry and offering patients better outcomes.
Increase Efficiency and Reduce Time-to-Market
PLM software enables med device companies to link compliance requirements with specification and engineering data. It helps to fully keep a record of all of their activities from the initial concept to retirement. It combines reporting, traceability, and compliance management capabilities to help medical device manufacturers address strict regulatory and quality requirements. Thus, enhancing the demanding time-to-market pressures. PLM facilitates tracking of all of the product data throughout the lifecycle and improves data accuracy. It decreases your costs of both compliance and non-compliance, along eliminates the need for manual data entry.
Quality by Design
PLM helps companies to take a more insightful and modern approach to ensure medical device quality management. It helps in identifying and resolving quality issues at the earliest in the product design and manufacturing processes. This design and manufacturing quality approach support heightened levels of innovation, faster production rates, and a prominent reduction in costs of goods.
Thus, helping organizations maintain the highest levels of safety and quality associated with every medical device created. When you embed quality data with analytics throughout all phases of product design and development. Along with core preventive and corrective actions and change control procedures, true product innovation within the medical device industry becomes a reality.
PLM software efficiently helps medical device companies to implement intelligent design and manufacturing processes. It offers you a platform where you can ensure reduced risk, enhance quality and create collaboration between manufacturing specifications, production targets, and requirements.
If you haven’t investigated the power of PLM in the medical device company yet, contact Xavor Corporation. From the initial idea to the announcement, our PLM solution will streamline your regulatory, engineering, and quality processes, saving a lot of your money and time.