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Prepare to be Obsolete!

How to proactively manage medical device obsolescence to extend the life of your product!

We have talked a lot about how the medical device landscape is changing. From digital product strategies and better understanding your new users to rapid technology advancements and requirements for interoperability and connectivity, each new future trend adds to the complexity of designing and developing medical devices right now. While it is critical to understand and plan for trends, it’s important not to let current issues get lost in the pursuit of new strategies. One topic that often flies under the radar is how OEMs should address obsolescence in this new landscape. While obsolescence has always been an issue facing OEMs, its impact on the complex medical devices developed today is dramatically different than what it was even just five years ago.

So what’s driving this change? Today’s systems approach to device development, driven by the need for smart, connected products means that replacing a single part is no longer an easy option. The entire system has to be evaluated. To complicate matters further, consumer electronics integrated into many medical devices have a typical lifecycle of only 18 months whereas a typical medical device is on the market in excess of a decade. So not only are OEMs facing system-wide effects of obsolescence, they are potentially facing the same issue every one to two years.

While managing obsolescence is inevitable, it doesn’t have to be a struggle. By doing your homework in the early stages of development and having a strategy in place for obsolescence, you can reduce your risk and control costs throughout the product lifecycle.

The Foundation of your Obsolescence Strategy

The key to successful obsolescence strategy is to address obsolescence at the front end of development (and not just act after you receive an end of life notice) taking into consideration technology forecasting and business case planning in order to execute the most cost-effective solution. When determining your obsolescence strategy, here are a few key things to remember:

  1. Your Product’s Future
    Before you can create an obsolescence strategy, you need to clearly identify the goals of your device. In other words, not what your device can do at launch, but what you would like it to do five or ten years from now in terms of feature or performance enhancements or even potential cost reductions. Why is this important? The goals of your device will help shape the priorities of your obsolescence strategy. For example, because products are often released without being totally functional and capabilities are usually phased in, companies can meet their obsolescence needs and roll out improvements simultaneously, saving time and money.
  1. User Value Drives Success
    In a previous article, we talked about the importance of knowing your user. But knowing them is just the first step. You also need to know what they want and expect out of your device today and throughout the product lifecycle. If your medical device is on the market for 15 years, will your users want the same functionality and features then as they do now? Probably not. User requirements will change over time. Those future requirements will guide your obsolescence strategy. You need to prioritize the features that provide the most user value and build in the flexibility to adapt to changing preferences. This is a critical point. Yes, device efficacy must be there, but the fact your device does what it claims to do is a given. Your users ultimately determine the success of your product in the marketplace.
  1. The Necessary Evil: Regulatory Compliance
    Any change to your medical device design requires regulatory scrutiny. Altering or replacing a critical component often means notification and re-certification with the FDA (and potentially your 510(k) submission). For example, updating something as simple as a touchscreen could mean new software, and therefore additional verification and validation testing. Proactively identifying potential alternatives and pre-planning for their regulatory impact will save you valuable time later on, so having regulatory expertise to guide you throughout the lifecycle will be invaluable.
  1. Data and Connectivity
    Digital medical devices are becoming more the norm these days than traditional medical products. Managing how your connected device data is captured, stored and transferred is important to protecting your users’ trust and complying with HIPAA. Unfortunately, the rules and regulations for this type of data is still being updated and changed all of the time. Regulatory expertise and the ability to update your device as necessary to comply will be critical.

Obsolescence can affect everything from system support and product safety to reliability and performance. But even more important to you, it affects your bottom line during a time when your device should be most profitable. Creating a plan for obsolescence will be significant and knowing what to keep in mind will guide you. Think of your obsolescence strategy as preventive maintenance for your product. You choose to either invest the time and money in an obsolescence management plan now or be forced to pay later.

Lisa Walker
Chief Operation Officer

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