Considering a revision to a current device? There is a lot to consider, but in the end the potential benefits of a second (or later) generation device may be well worth it. There are many reasons why your company might choose to pursue a second-generation, or Gen2, product. You may have received requests for additional features from the clinical end users; there may have been some advances in technology that will permit significant cost re-engineering; there could be changes in the reimbursement structure that may be taken advantage of or there may be changes in infection control practice that demand a redesign. No matter the reason, there are opportunities, pitfalls, and questions to consider.

What's your strategy?

Much of the path leading to a Gen2 release has to do with the product strategy. For example, are you trying to retain market leadership or to gain share, or are you trying to be cost competitive? Regardless of which strategy is guiding development, the business case for a Gen2 release tends to be built on much more solid ground than the initial release. This is because by the time the question of Gen2 is raised, there tends to be a good deal of quality data, both internal and from the market, to help guide decision-making.

The first thing you want to do is to collect as much market data as possible. This entails going out and speaking to your sales force and any other customer-contact staff that you have. What kinds of feedback have they been getting from your customers? What would your sales staff like to offer their customers in the next generation? Field staff is often solution-focused, and are often aware of market changes before such data are published. As your on-the-ground foot soldiers, they can also give you a good idea of what the competition has been promising their customers. Your sales force will have some firm opinions around features and price points. Pay attention to what they tell you about unmet customer needs. This is important for your initial understanding of opportunity in the market. Of course, doing a competitive landscape analysis to look for expanded market opportunities is also a good idea.

Make sure you collect internal information as well. Talk to the technology and engineering people in your company. Have there been advances in material or design? Can the device now be cost engineered? Can it now work as a platform for future products? Don't forget that your quality and manufacturing people might have a wealth of information for you in the history of device failures, both in the field or in manufacturing. If you have had any service complaints, take a look at them. Find out why these failures have happened. They are typically design related, which will provide you with an excellent starting point as you search for a more robust solution. And, of course, don't forget to look at the warrantee and repair data.

Info in, now what?

Once you have collected this disparate information, it is essential to assemble a cross-functional team to evaluate it. The group should be flexible enough to assimilate the data and experienced enough to take a holistic perspective in their evaluation. There should be enough information for the group to generate some promising but rough concepts that will allow you do some modeling.

There should be enough data on the Gen1 device for the team to do some ROI modeling based on what is known about likelihood of adoption, cost of goods, and manufacturing costs. This scenario planning should leave you feeling confident about your predictions once the decision is made to proceed with Gen2 development.

Here are a few more things to keep in mind:

• Since you have a functioning Gen1 device, you may potentially sidestep questions of clinical efficacy as you move through your regulatory path. You can't skip verification testing, though. Consider whether you intend to change your labeling, or whether you are changing the design, performance, or materials in a way that could change the safety or efficacy of the device. Risk assessment practices can be extremely helpful in answering these questions. Not every change triggers the need for a new 510(k), but make sure the decision not to file is well documented, and has a solid rationale.

• Make sure you are up-to-date on any potential regulatory hurdles. What might look like a quick and clear path to market may be muddied by anything from political concerns at the FDA to another product in your category or company currently being under investigation. Take time to search the FDA's databases of MDRs, warning letters, and recalls for any relevant information. Find out if the FDA has prepared a Total Product Life Cycle Product Code Report listing the types and frequency of device problems reported for a given type of product.

• Ensure that your user needs are up to date. Think about the needs across the entire product lifecycle - from purchasing to maintenance and storage. Ideally, you will ensure that your needs list is complete by either observing users of your current generation, a competitor's product - or at least interviewing users of both.

• Evaluate the human factors engineering. The opportunity to improve the fit and feel, as well as the overall usability of your device is critical. Improved usability can make a real difference in the impact that your device has in the market place. Take your design engineers into the field so that they may see how well real users are able to use the current device under real conditions.

Taking an already successful product and improving it is no easy task. There is a lot of information to sort through and some hard decisions to make. And there is always the temptation to say, “Well, it was successful in the first version, so maybe we should leave well enough alone.”

However, the rewards will be there for those that do their homework and make the right improvements. Take advantage of all of your inputs, ensure that they are properly leveraged by your development team, and you should have a clear winner on your hands.