Developing a medical device is an investment that continues well after manufacturing and marketing. The obvious task is to create a device that safely meets the end-users' needs and continues to do so over time. What’s often neglected is what happens afterward.
It’s essential to consider the long-term picture during design, both in order to protect your device and its users, and to ensure proper support throughout its lifecycle.
The relationship between a medical device and its user doesn't end once it's on the market—in fact, in many ways, it is just beginning. Postmarket support is a crucial component of the medical device design and development process. Let’s explore why.
Considering Your Medical Device’s Long-Term Picture
Designing a medical device is a long-term investment. Manufacturers must think beyond the initial details of the device and consider the device’s entire lifecycle. This means considering how the device will be used in the future, as well as how software or user needs may change over time. Postmarket support helps manufacturers stay connected to their purpose and update the device on-demand to meet evolving needs.
Consider the analogy of planning a vacation. You can spend months researching and planning every detail of your departure, but if you don't think through what will happen once you get there, have a way to get home, or if your plans get derailed, then time, money, even lives, could be at risk.
Thorough postmarket support is like having a solid plan both for the vacation itself and for getting home. It ensures that your device remains effective and safe, and that users have the support they need if something goes wrong.
To design a medical device that continues to meet the end-users' needs, one must consider the future from the start. This means thinking beyond the launch and developing holistic solutions from inception to end-of-support. Such an approach helps manufacturers understand how the device will be used in the future and how user needs may evolve over time.
In other words, the manufacturer must consider the "what-ifs" and plan for all possible outcomes. Postmarket support consists of two major phases: Postmarket Surveillance in conjunction with Sustaining Engineering, and end-of-life.
In the postmarket surveillance phase, manufacturers monitor their devices to identify and address any issues that arise post-launch. This can include monitoring keywords, message boards, medical journals and other media, and universities to stay informed about potential issues. Manufacturers also must actively address cybersecurity concerns and provide software updates and bug fixes to ensure that the device remains secure and effective.
In this phase, quality management involves ongoing risk analyses, field support from on-site technicians in the hospitals, homes, and clinics where the device is actually being used, preventive and corrective actions, and recalls. Recalls may be necessary if the device poses a risk to patient safety, and manufacturers must follow a detailed notice and reporting process.
While postmarket surveillance focuses on collecting information about the device post-launch, sustaining engineering is what manufacturers do with that information. This process includes analyzing returned products, quality analysis, writing and delivering software updates, providing customer support, and performing maintenance tasks.
Sustaining engineering ensures that the device remains effective, safe, and up-to-date with the latest technology, industry standards, and user needs. It also helps manufacturers identify trends, patterns, and potential issues, allowing for proactive improvements and reducing the risk of device failures or recalls. Last but not least, it lays the groundwork for future development, informing next-generation design for subsequent models thanks to lessons learned by surveilling and sustaining the current product during deployment.
Medical Device End-of-Life
Eventually, all devices reach the end of their useful life. This is triggered by two possible scenarios: an individual device is deemed irreparable, or the Manufacturer of Record simply no longer supports its model type.
When an individual device is deemed irreparable, it may be replaced with another device of the same make and model, a comparable make and model, or a newer make and model if such exists. In any case, this is the end of the road for that particular device.
The other possible outcome is that the Manufacturer of Record decides it will no longer support the device. When a Manufacturer of Record takes this route, there are typically three phases of notice that occur:
Initial Notice: The manufacturer of record is typically required to provide an initial notice of its intent to discontinue the medical device to the relevant regulatory agencies and/or distributors well in advance. The industry’s convention is to provide a minimum lead time of 3 years (although the exact timeframe may vary based on contractual obligations, availability of viable alternative devices, and so on). This notice will include information on the discontinuation and any alternative devices that may be available.
Notification to Users: Once the manufacturer of record has provided initial notice, they must notify users of the affected medical device, including healthcare providers and patients. This notification typically includes information on discontinuation, any alternative devices, and guidance on how to manage the affected device.
Final Notice: The final notice phase occurs when the Manufacturer of Record has ceased all support and services related to the medical device. This notice will include information on the date that support and services will be discontinued, any remaining inventory of the device, and any alternative devices that may be available.
If this is the case, individual medical devices may still be viable or reparable, and may be sold in secondary markets as pre-owned or refurbished. The Manufacturer of Record has little to no ability to prevent this from happening, and needs to plan as far back as the Design Phase to mitigate the new set of risks represented by secondary market appropriation.
Beginning with the End in Mind
There is so much to consider throughout medical device design and development, but just as in the vacation analogy, a lack of consideration for all possible future developments, wrong turns, and unforeseeable issues sets a device up for immense problems from the beginning.
These considerations are why a holistic approach to research and development is vital. This means going beyond the obvious and considering every possible outcome. It means exploring potential risks and addressing them proactively. Not considering postmarket support during research can lead to small hiccups or a complete waste of resources. It can also lead to huge issues much later, affecting the device's reputation and, most importantly, user safety. Therefore, manufacturers must identify and plan for all possible outcomes throughout design and development.
When you begin developing a medical device concept, it is impossible to predict its path years into the future. However, by taking a holistic approach to research and recognizing the importance of ongoing support, Velentium builds devices that are able to withstand the test of time.
Velentium’s process considers present timelines and future concerns concurrently and ensures holistic solutions from inception to postmarket. With Velentium, your concept is in good hands the whole way.
Reach out to Velentium today to begin your medical device’s journey through the design and development process.