User-Centered Design and the Medical Device Start-Up

PRODUCT DEVELOPMENT INSIGHT

During the past several years, a substantial number of medical design programs have been initiated by start-up companies. Start-ups are a natural place for such innovation because the companies are characterized by high-risk and high-reward profiles. In almost any hot industry, start-ups attract venture capital (VC). According to market research provided by VentureOne, a VC firm, U.S.– based investments rose 8% in 2006, the highest in five years.¹

The increased interest in medical design is not surprising considering the number of baby boomers and their demand for new and innovative medical devices. Venture capitalists invested a record $1 billion in U.S. medical device companies in the second quarter of 2007. That is 58% higher than the second quarter of 2006.² The increased need for personalized healthcare products is leading to opportunities for medical device entrepreneurs.

As venture funding funnels its way into development programs, start-up companies are likely to be at the forefront of providing end-users with medical products geared to their lifestyles. However, for these companies to succeed, they must channel their limited resources into the most-critical needs. One such need is to design products specifically for the user.

With market pressures such as limited funding and time, start-ups need to maximize their development path by initiating user-driven (or user-centered) design principles. Usability is critical to any product in the healthcare industry. The inclusion of user-driven design enables the team to put specifications on the design parameters, avoiding costly feature creep.

Feature creep is often driven by an OEM's growing wish list, or by designers themselves, as they see opportunities to improve the product. Feature creep is the mistaken belief that one small feature will add zero incremental cost to a project. In all products, there is a temptation to keep adding new features; however, it is important to maintain focus on what the users really need. User-driven design protects against such temptations and also enables the design team to quickly confirm that product concepts address unmet needs in innovative ways.

Start-Ups and the Market

User-centered design focuses attention on user needs and is a process used by traditional Fortune 500 companies. But start-ups differ from Fortune 500s in a number of ways. The obvious differences are in size and in the amount of funds available for product development. However, another difference, not always addressed early on, is that start-ups lack seasoned marketing teams that have access to customer feedback.

Fortune 500 companies spend a great deal of time with customers. They collect feedback and refine ideas in a multifunctional team environment with customer interaction. Fortune 500 firms have dedicated marketing teams that interface with the users and provide a loop back to the design team, conveying issues and concerns facing its customer base. The marketing team also facilitates key meetings between the users and the design team for first-hand observation. This user knowledge is very important.

In contrast, most start-ups are founded on an entrepreneur's idea for a new technology. Some strive to meet an unmet user need. These unmet needs are usually identified by the initial inventor, rather than by a panel of customers. The entrepreneurs often include only a few key people that have a preset perspective on why the product is needed and why it will succeed.

By definition, an entrepreneur is a person who undertakes and operates a new enterprise or venture and assumes some accountability for the inherent risks. The entrepreneur is the primary product champion, the one voice that has driven the idea past the due-diligence phases of VC funding. This person has likely been consumed by the product idea for a long time and cannot help but develop a set opinion on the design and feature set of it.

But even start-ups should take users into account at the outset of the design process.

When embarking on the development path, it is critical to test the product idea on users to gain outside user feedback. Such real-world experiential feedback is critical in determining or validating features important to the device. It is important to test these assumptions with an unbiased group, whenever possible.

User-Centered Design

There are many aspects to user-centered design, and these should be considered as a product is evaluated for human factors, interface design, and industrial design. Most important is to identify the relevant use conditions and to understand all key users. User-centered design helps establish and maintain a process for understanding the environment, understanding how users apply the product, and ensuring that the user's needs are addressed. The chief difference from other design philosophies is that user-centered design helps to optimize the product around how people want or need it to work, rather than forcing them to change work habits to accommodate the system or product. This approach aids the development team in creating a product with the potential to increase market demand and sales because people are more likely to adopt a device that they find easy to use.

The level of design support and the costs required for a design varies depending on the depth and cross-section of people who are interviewed or studied, the device's classification level, and the intended use environment. However, from a very basic level, user-centered design can be an integral part of the design process with minimal effects on budget and time. In many cases, a few carefully selected test users can provide a good base for validating ideas. The cost and time spent on user-centered design is usually recouped because it prevents changes or product redesign late in development. For this reason it is crucial that a start-up use this process if it is operating on a tight budget or schedule.

User-centered design enables a designer to become the user advocate and to serve as the bridge between engineering, manufacturing, and marketing. In general, there are some typical tasks that a user-centered design system should accomplish. These include identifying users, getting meaningful feedback, documenting use environments, developing user scenarios, performing competitive analysis, and conducting usability testing.

Identify the Users of the Product or System. Spending time with the users can help designers find the unmet needs that the entrepreneur may not have expressed in the initial product concept presentation to VCs. Suppose, for example, that a new medical instrument can analyze and detect rare cells in blood. All of the focus would be centered on the technology and getting it to market. But how is this new instrument going to fit into its environment? In what area of a lab does it belong? How does the technician manage the blood from the lab? Talking to end-users can help answer these questions. In this case, the technicians are the main users, but there may be secondary users that need to be addressed, such as service or maintenance personnel. Their responses may be simple (such as finding out users want space on the product for sticky notes) or serious (such as finding out they need to stack a printer on top of the unit).

Get Meaningful Feedback. Finding out what people want is very important for start-ups in particular, because early-stage companies do not always have entrenched marketing, voice-of-the-customer (VOC) data, or other feedback channels. Established companies use VOC approaches so that the marketing groups can get feedback based on existing products. The downside of VOC is that the information rarely leads to dramatic breakthroughs, but rather encourages incremental improvements. This is primarily because most people have a hard time visualizing or describing better ideas. It is far easier for them to see ideas and then express a like or dislike.

Both start-ups and established companies should invest the time to visualize product ideas for the users to evaluate. Visual ideas help foster early interaction with the users so that companies become familiar with the users' needs. Such insight is critical to the success of the product.

Observe Users in Their Work Environment. An important part of design research is shadowing the user, much as a social anthropologist would do. This includes conducting interviews that ask users what they do and what their experience is with the subject matter. In many cases, the user is a highly trained surgeon, nurse, or technician. But the user could also be a patient.

For start-up device companies launching a new product, it is particularly important to explain the proposed new product. Designers should be prepared to set the stage of what the firm believes the product can do, and then evaluate responses while participants are working with the device. Video ethnography is a good tool to document this experience. Ethnography is a research method founded on the idea that a system's properties cannot necessarily be accurately understood independently of each other. Video ethnography could include sending a small team to videotape the users in their environment without much distraction. The video can be viewed and analyzed by a larger team during the course of development. Such data can also be used by start-ups to demonstrate corroboration of users to its VCs through the various gates. A key to doing design research is to develop a personal relationship with and interest in the people being interviewed. Engaging the users will increase their desire to create a feedback loop for continuing design reviews.

Develop User Scenarios. A great way to address a large population is to create virtual characters and daily-use scenarios. If the product is meant for general use, developing fictional characters can aid in product development and help identify users and their lifestyles. Typical examples of virtual characters might include the following:

These are generalized examples with certain assumptions. Ideally, real people are needed to form an idea about product use. But these characters help start-ups understand that products need to fit in the users' lifestyles, not the other way around. The scenarios help justify the appropriate interface, aesthetics, and form of the product.

Conduct Analogous and Competitive Products Analysis. Another simple task that can help in the design process is to compare analogous and competitive products. By listing the competitive products and breaking out their feature sets, designers can create a baseline of features to compare with the new product. Equally, the use of analogous products can stimulate the thoughts of the team by borrowing ideas from other market segments.

Focus on Usability Testing and Discuss Concepts and Prototypes. Concept visualization is one of the most important aspects in uncovering users' unmet needs. Once a product has a user set, it is important to come back to them during the design process and validate the designs.

Users are often more responsive when given a prototype that can be evaluated in person. By comparing multiple concepts and prototypes, users can compare their earlier expectations with the real thing. Prototyping is often the key. The first prototypes can just be foam models for simple evaluation. Each phase has its appropriate prototype level and can be matched with use and available budgets.³

Understanding the User

Users often demand that the product be extremely simple and intuitive to use. For example, the boomer market is an important driver in medical innovation. Boomers expect medical devices to span the gap between medical equipment and consumer products. Questions that start-ups should ask include the following:

Understanding users is critical to the development of the product's interface, form factor, and appropriate use of aesthetics. Such design research is an inexpensive way to validate that the design meets its users' needs. Designers are engaged with the users for short periods of time. The money spent can be as basic as the cost for travel, time on-site, and a videotape. For patients, a small honorarium may need to be provided. Doctors and nurses are often willing to donate their opinions and time to a project that has the potential to improve their work.

Conclusion

It can be difficult to marry the needs of the manufacturing process with the needs of the user. Medical device start-ups should consider that their product may require high-volume manufacturing (a significant topic that is beyond the scope of this article). At the same time, users want simple and elegantly designed products that are easy to use. In addition, start-ups need to understand that, by definition, the user's unmet need may not be known prior to the research.

By getting the design team up to speed quickly and confirming the design direction throughout the program, user-centered design helps increase speed to market and can help avoid costly design changes. Design-centered research helps refine the initial idea and tailors it to fit the environment and users' needs. This approach can also assist a start-up in validating the idea as it navigates through the various rounds of VC funding.

Tor Alden is principal and owner of HS Design Inc. (Gladstone, NJ). He can be contacted at [email protected].

References

1. “U.S. Venture Capital Investment Continues to Grow, Up to 8% to $7.4 Billion in Second Quarter of 2007,” from PR Newswire [online] (23 July 2007 [cited 31 July 2007]); available from Internet: www.money.cnn.com/news/newsfeeds/articles/prnewswire/NEM03623072007-1.htm.

2. Brian Gormley, “Medical Devices, ‘Web 2.0' Firms Drive Venture Investment,” from MarketWatch Inc. [online] (23 July 2007 [cited 31 July 2007]); available from Internet: www.marketwatch.com.

3. Bill Evans, “Design Research Part 2: Refining User Interfaces,” Medical Device & Diagnostic Industry 29, no. 7 (2007): 44–51.

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