How PLM Solutions for Medical Devices Deliver Compliant, Market-Ready Solutions

In a truly global landscape, the medical device supply chain may be the single most complex one for manufacturing entities to navigate. With health care representing one-fifth of the U.S. economy, there is tremendous demand for state-of-the-art technology that can improve health outcomes, whether it’s through early diagnosis, more accurate blood pressure readings, or any number of other health solutions that medical devices have made possible. How quickly and effectively the medical device industry can get these products to market can be life-changing — quite literally.

But the pathway to distributing medical devices is a difficult one due to the costs of production, stiff competition from rival developers, and increasingly strict medical device regulation from oversight bodies. Medical device manufacturers must routinely clear numerous hurdles and regulatory requirements in order to bring their products to market, as well as expand into other geographies.

Product lifecycle management — and, by extension, PLM solutions — can make your journey to the market more of a straight line. Here’s a breakdown of what product life management is all about and how it helps solve medical device manufacturers’ biggest pain points by improving quality management.

First things first

Product lifecycle management is a process that represents the entirety — hence the term “lifecycle” — of a product’s existence. To consumers, a product’s life may seem like it begins when they first purchase the item. But to the manufacturer, the product lifecycle begins much earlier, starting at conceptualization and concluding at retirement, with development, product launch, and servicing and support representing the three phases in between. All product-based industries use some iteration of product lifecycle management, including toy companies, automakers, industrial machinery developers, home appliance manufacturers, and more.

When it comes to the stages of product lifecycle management, both the names and the number tend to vary, depending on the industry and what is being produced. The activities that occur within those phases can also be different. Generally speaking, though, there are at least five. Let’s dive into these stages a little further:

  1. Conceptualization: The conceptualization phase is the seminal one. Ideation happens here, as well as requirements guiding the features and functionality of the product.
  2. Development: Development is where ideas are put into practice. In this stage, the product is designed and validated, analysis is performed, and prototypes are created. This allows stakeholders to provide feedback on what, if anything, needs to be changed about the product design before moving on to mass production. “Design for X” is also critical in the development process. “X” means manufacturability, quality, compliance, and other governing parameters. Examples of relatively recent regulatory requirements for medical manufacturers include Unique Device Identifier (UDI) and EU MDR.
  3. Product launch: Here, feedback on refinements is implemented and the product design goes from prototype to ready for purchase. Stakeholders collaborate with marketing entities to assist with getting the product to the market. The product design goes from prototype to ready for purchase. Additionally, commercial and regulatory requirements now come into play, which if not met, can impair the launch and sale of your products.
  4. Servicing and support: Producers may offer supplementary services to end-users on an as-needed basis, such as troubleshooting and support to ensure the product works as intended and is delivering the correct results. And with regulated products, various regulatory agencies have requirements relative to how long product information must be maintained, what acceptable archive processes are, and other factors in the data retention area.
  5. Retirement: This is the stage where the product is phased out because it’s reached its endpoint. It no longer works, buying trends have shifted, or improvements in technology have rendered it obsolete.

Product lifecycle management software is a tool that helps manufacturers organize product development so creations find their way to the actual marketplace, not just the marketplace of ideas. With product lifecycle management software in place, manufacturers have more visibility and control over all the phases and stages that a product goes through over the course of its life. Product lifecycle management software makes it easy to track data, share product data with other stakeholders, and make more informed decisions regarding development, marketing, pricing, and compliance across the supply chain, thanks to unifying many disparate processes.

Effective product lifecycle management is essential to medical device companies

Without a plan and the right technology, product lifecycle management is fraught with risks. According to Inc., as many as 95% of products that are newly released wind up being pulled from the market because they don’t sell well. There are also unique challenges facing medical device manufacturers in particular. In addition to financing development, medical device developers must adhere to strict quality control measures and regulatory compliance protocols established by major oversight entities — both in the healthcare industry (such as the American Medical Association) and the federal government (such as the Federal Drug Administration). Because the bar is so high, estimates suggest that only 45% of medical devices wind up being approved, according to a study published in the medical journal BMJ.

Product lifecycle management software helps medical device companies successfully bring their creations to market by supplying them with the added visibility, efficiency, and project delivery capabilities critical to product development.

The medical device lifecycle is a little different
The process of bringing medical devices to market typically takes longer than it does with other products that don’t have as many regulatory structures. This is one reason the medical device lifecycle runs longer than with other products. The phases are similar, though, and include:

  1. Concept: In the ideation phase, a medical device is conceptualized, its capabilities are defined, and funding options are explored.
  2. Planning: Similar to the general product lifecycle management workflow, the planning component for medical device manufacturers involves creating a prototype of the device – a design based on the needs of health care practitioners or patients – and a strategy to market the device. This stage also ensures that users’ needs align with technical requirements.
  3. Design: In the design stage, engineers and manufacturers collaborate to mass-produce the medical device in question. This process is informed by feedback from users, technical documentation, design verification, and initial studies verifying that the device is safe and effective to use.
  4. Validation: The validation process for medical device manufacturers is significantly more complex than for many other types of manufacturers. Medical device companies conduct clinical studies to corroborate the soundness of their devices and must comply with extensive regulations and documentation requirements before their products can be marketed to the general public or health care providers.
  5. Launch: Once approved by oversight entities, the medical device is marketed and sold to hospitals, clinics, patients, or other intended users. The launch phase may also include training and support if technical know-how is required.
  6. Post-market: The post-market phase represents any point after which the device has gone to market and become available for use. During this phase, medical device manufacturers continue to monitor product safety and may conduct additional marketing and customer research initiatives in the hopes of increasing future sales.

PLM software solves medical device manufacturers’ challenges

Because the medical device supply chain includes multiple players in addition to manufacturers and end-users, a lack of transparency across the landscape can present quality issues during every phase of product lifecycle management.

PLM software helps break down walls so there is easier coordination. Oracle Cloud PLM is one such solution that allows for increased visibility and agility. By leveraging Oracle Cloud PLM, every stage of a product’s lifecycle is centralized, from conceptualization to planning, design, validation, and more. Because Oracle Cloud PLM is built on a SaaS model, the solution is automatically updated with the latest features, functions, and best practices that help you manage your current devices and roll out the next big thing.

Whether you’re looking to streamline your product launch, make the regulatory compliance process easier, or improve the quality of your product lifecycle management, Inspirage can help make it all possible. We partner with companies to break down barriers and identify opportunities to drive better performance. Contact us today to learn more about Oracle’s PLM platform and our innovative Medical Device solutions.

Michael Torek | Key Contributor

Michael Torek is the global Practice Lead for Inspirage’s Innovation and PLM practice. Michael has over 20 years of professional experience in business management and consulting roles. Prior to Inspirage, he had PLM leadership responsibilities within the consulting organizations of both Oracle Consulting and the Agile Software Corporation.