Category: Life Sciences

28 Nov 2017

White Paper: Optimizing Medical Device Development with Full Regulatory Compliance

How to Integrate Quality Throughout Your Product Lifecycle

A variety of factors are vital to the long-term success of a company and a product line, including price/cost, time-to-market, and more. But in this age of global communication—particularly in this era of social media usage, when an opinion or comment can go viral—one of the most important priorities for any company is product quality. That’s especially true for medical device manufacturers—companies whose customers’ lives often depend on the quality of the manufactured product.

The challenge many manufacturers face, however, is maintaining quality, as well as traceability and transparency, not just at one point in the product lifecycle, but throughout. That challenge is often compounded by siloed design, production, and change systems that don’t easily share information with each other or provide accessibility to all stakeholders in the process—something that impacts more than just the product itself.

As a new paper from Dassault Systèmes, “Optimizing Medical Device Development with Full Regulatory Compliance,” notes:

Quality information must be highly visible throughout an organization to ensure that any and all decisions…are informed in a timely, efficient, and accurate fashion.

Unfortunately, even when companies know that quality is so important, they don’t always make it the focus, as they scramble to get products to market or as different teams struggle with poor cross-functional communication. And that’s a problem. As the article points out:

Achieving product quality is a multidimensional challenge and failure to manage quality in an integrated way throughout the total product lifecycle jeopardizes a company’s profitability and reputation.”

The ideal solution is total transparency of the product lifecycle across functions, organizations, teams, stakeholders, and more. And that’s exactly what a PLM system—an enterprise-wide, cross-functional solution that provides a “formalized, systematic approach for managing all aspects of product quality, reliability, and risk”—can deliver.

PLM platforms also help organizations optimize design controls, communication, and product/technology reuse. By handling requirements management for both mass-market manufacturing and specialized, configure-to-order business models, as well as requirements validation through simulation and systems engineering, PLM solutions enable manufacturers to maintain traceability of customer needs being met throughout the lifecycle, from concept to design to finished product feature. In addition, search tools and integrated processes such as quality management solutions save manufacturers money and ensure communication and transparency organization-wide.

In short, a platform-based PLM solutionbreaks down organizational boundaries so companies can achieve the ultimate goal of increased patient safety while delivering innovative healthcare breakthroughs.”

To learn more about how a PLM solution can help your organization, download the whitepaper:

14 Oct 2017

Use Simulation to Power Innovation in Life Sciences

Cardiovascular disease is the leading cause of death worldwide. Surgical intervention, including the use of balloon angioplasty and stent insertion, remains a life-saver for many patients. Stent designers and manufacturers are continually searching for the most efficient way to produce their product to the highest standards of quality.

By refining designs early in the conceptual process, computer simulation is helping leading medical device companies understand the in-vivo performance and surgical delivery of coronary stents to further optimize device behavior for better patient outcomes.

View the benefits of realistic simulation in the infographic.