ISO 13485:2016
DEVICE DEVELOPMENT

Do the Research!

At Nectar, all of our projects begin with a Research Phase where we focus on the areas that will help shape our design requirements. However, the research is not limited to this first phase, as it continues throughout the entire project. Each project is different and unique, so we are obliged to get an accurate and holistic view of the entire landscape.

Though User Experience (UX) underlines our entire development process, we are cognizant of not being too myopic with a user centric philosophy. The user is extremely important, but there are also other key aspects to consider in order to create a truly successful product. In this article, I will cover the general areas of research that we investigate.

Current Company / Product

When improving or redesigning an existing product, it makes sense to start with understanding what will be designed or replaced. To do this, we read existing documentation (user manuals and marketing materials) and interact with the current product or technology. This analysis provides a basis to measure successes, failures and pain points.

Understanding the company or client we are designing for helps set many expectations. Each entity has its own ethos, market focus and branding, so the final product needs to be in line with all of these factors. The client will also have valuable information on the other research areas to be discussed in this article (competition, intellectual property, compliance, and users).

Competitors / Marketplace

Similar to a sports team, preparing for success requires a proper survey of the competition and playing field. Scouting the competitors will help paint an accurate picture of the product landscape. If properly executed, the researcher will be able to identify the biggest opportunities in terms of selling points, competitive advantages, market trends, and ways to differentiate the product. This is especially crucial in a homogeneous market.

A researcher can quickly get a solid grasp on the climate by simply browsing company websites. He can typically find user manuals and marketing materials, which he processes and comparatively analyzes against the client’s own products.

“Not only can you learn best practices from competitors, but you can also learn to avoid the mistakes they make.”
-Inc.com

Comparisons, Inspirations, and Analogs

Looking at similar products in different verticals enables out-of-the-box ideation inspiration. This type of research can assist in minimizing ‘reinventing-the-wheel’ concepts. Seemingly disparate fields can provide surprisingly applicable concepts.

Case Study:

For a recent project in the medical field, we were trying to come up with space efficient door designs. We found some great ideas looking at garage doors and kitchen remodels. Especially in the kitchen remodel area, the requirements of space efficiency and accessibility of supplies translated perfectly.

Having existing and tangible reference points also facilitates communication amongst the team. We often discuss our concepts internally using the analogous term e.g. ‘garage door concept.’

Technology, Legal, and Relevant Standards/ Practices

Technology

We don’t just leave the technological research to the engineers. Everyone on the team ought to have at least a general grasp of what we are working with functionally. Doing some high-level research on applicable technologies will help streamline brainstorming and ideation when the time comes.

Heuristics & Best Practices

From the User Experience standpoint, being conscious of human factors and ergonomics is particularly important when dealing with physical products. We keep a copy of Dreyfuss’ The Measure of Man and Woman  and Nielsen / Norman’s 10 Usability Heuristics close by at all times for quick reference. For example, if we are going to be designing something for a standing user, it is helpful to know the height, reach distance, line of sight and other factors for the relevant percentile users.

Intellectual Property & Compliance

Researchers cannot ignore Intellectual property and compliance are areas. The team must be cognizant of these areas throughout the entire development process.  We often rely on specialized field and legal experts to explain the intricacies of each area.

Ideally we want to avoid a legal battle stemming from patent issues. Even if we come up with a great idea or solution, it may not be viable because it infringes on an established patent.

Compliance can also put unique constraints on a project. In the medical field, there are often extra sets of standards that must be met, including sanitation, reliability and emergency/fail state operations.

Understanding these issues early on helps us avoid potentially disastrous paths.

Users/Stakeholders

Proper user research means understanding all of the stakeholders, not just those who will be using the products.

Client

We have found that getting a conversation going with sales and marketing teams early on can offer some very important insights on not only the current products and competition, but also the end users. These teams already have valuable understanding of what their customers like and where they stand compared to their competitors. These teams can also provide information on current and target demographics, from which we develop user personas.

Buyers / Vendors

It is important to remember that the users who buy the product are distinct from those who use the product. This is especially common when dealing with commercial or medical products.  In this sense, a designer must consider the value proposition to the buyer, and what features will influence their decisions.  This notion may also be relevant if there is a third party or middleman who will be selling the product.

End users

The most important users are typically the end users – the more exhaustive and extensive research on these users the better. One of the best ways to understand the end user is to observe them in their environment. This method uniquely reveals many of the subtleties of interaction that would not otherwise be evident. It also reveals the pain points that users face.

The researcher will document his observations with handwritten or digitized notes and video recordings (when appropriate). These recordings often serve as a basis for usage storyboarding.

Interviewing the user is also a very powerful research method. The users are typically eager to share common impediments as well as suggestions on how to improve on the product. We prepare questions beforehand, though many more inevitably arise while observing the users in action.

There are numerous other user research methods that could be discussed, but I will save those for a dedicated post.

Conclusion

Research is a crucial process in product development, especially for creating an optimal User Experience. Covering as many bases as possible ensures a solid foundation to design upon. Proper research especially helps minimize risk from unnecessary rework further down the line.

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Nectar is an award-winning design & engineering consultancy with a specialization in medical device development. We are proudly 13485 certified, we adhere to the highest industry standards. Nectar has been an industry leader in Southern California for over 25 years. Our proven user-centered design process has facilitated the successful launch of hundreds of products in the market.
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