User Needs

As you continue your 2020 product development activities, we wanted to provide our thoughts on some of the most-common pitfalls our staff has seen, broken down by phase of the Design Control process. Over the next few weeks, we will provide our rationale, and some simple mitigation for each.

We start first with User Needs.

The design review waterfall

Pitfall 1: Failure to adequately benchmark the competitive landscape to establish minimum requirements.

What you don’t see or don’t know can lead you astray.

In this Age of Information, it’s easy to surveil the market and collect comparative details about products. Your team must take a deeper dive into research and create a way to compare each product’s strengths and weaknesses. A Competitive Matrix is a great tool for this. If you’re not sure how to do it, or comfortable doing it, email us, and we can send you a template

When working on more complex systems, you may even want to benchmark a specific function of a competitive device to ensure you don’t try to reinvent the wheel.  You may even find that their solution is easier to implement or maybe more cost-effective.

Pitfall 2: Consulting only a few key users to shape your product’s design.

  You may have a few willing and outspoken users or customers. Maybe you’re lucky to have a few enthusiastic healthcare professionals in your stable, willing to share their take on what’s missing in the market. This is great, but the danger is assuming that a small but capable minority can reasonably speak for all customers and use cases. An echo chamber doesn’t help you design a product to meet the needs of the market. Seek as many opinions within your timeframe as you can. Better yet, do some market research before you progress to the next phase (Design Inputs).

Furthermore, with the new FDA regulations in effect for Home Use and Usability, documenting your approach to gathering and reporting on the collected data is needed for any product under development.  Finding a team that knows the level of rigor needed for your specific product can reduce your workload while maintaining compliance with these new regulations.

Pitfall 3: Failing to challenge a perception that your new product solves real-world problems any better than existing products.

Most folks are aware of the “me-too” philosophy of product development. Duplicating another product without adding something new or different to the offering is a missed opportunity. It also hastens the market’s progress towards commoditization and lower prices/profits. Do your company a favor (and your competitors)—ask yourself if you can do something better. If your answer is no, then consider taking more time to find out the angle that allows your product to boldly stand up in the market. The easiest place to start is with your sales team.

Next time, we’ll discuss avoiding common Design Input pitfalls (and how to get your product out of one!).

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Design Inputs

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The Five Greatest FDA Myths