Imagine yourself as an engineering manager at a decent-sized medical device company. You have a team of engineers working with you who know their jobs pretty well. They’re a good mix of young, energetic people still early in their careers and a couple of more experienced, “old-school” types who have been with the company a long time and enjoy passing on their knowledge. It’s a good team, and they’ve released quite a few improvements to your product line over the past few years.

Fig. 1 – Brainstorming is a great way to open up fresh thinking and drives the team to more creative solutions.

One day, your product manager pays you a visit with a new idea for a device that would complement your product line and help with some procedures that your current products can’t perform. It’s a great concept, but it’s never been done before. You challenge your team to come up with a design. They take a couple of months and create a prototype, but it just doesn’t do the job. They’ve used a lot of the same ideas from the current product line, but the new application has some constraints and requirements that are tough to accommodate.

This is a pretty common scenario, and it doesn’t matter whether the existing product line involves cardiovascular catheters, drug delivery pumps, or joint replacement systems. A stable, focused development team often has trouble stepping outside of its comfort zone to innovate.

Many medical device companies specialize in particular types of products. They incrementally improve these devices to make them more effective, less expensive, or easier to use. Often, the experience of the development team guides engineering solutions toward conventional, standard ways of doing things—standard because they represent a known, optimized solution to a particular problem and its set of constraints. But sometimes the standard— even when it’s been historically successful— is not the best solution.

Teams Are Built Around Relevant Experience

Development teams become effective because companies hire the right people and because the members of the team gain collective experience working on projects together. When it’s time to hire, companies search for people with “relevant experience” in their particular device specialty so they can get up to speed quickly and maximize their contribution. Then, as team members collaborate on projects, they learn from each other and build tribal knowledge. Over time, this leads to a consistent knowledge base within the company.

In medical device development, it’s not unusual for an engineer to work on a few generations of products within a particular family (e.g., stent delivery catheters for coronary or peripheral arteries, suture passers for knee or shoulder repair). But the net result can be a development team that restricts its focus to a narrow set of design options and has a tendency to ignore solutions they haven’t already tried. The team may be working with blinders to innovation. This brings me to the point of this article: that exposing a team to a new development experience can help unlock more innovative thinking.

Innovation Requires Thinking Differently

Removing blinders—or even realizing you have them on—can be difficult. Every design has requirements and constraints that drive an engineer to a particular solution. When engineers have deep experience in a particular area it means they’re familiar with the constraints they’ve faced in the past, and that experience may lead them to the same solutions that have successfully addressed those constraints. It’s like a marble rolling around in a bowl: the path of least resistance leads to the same place every time.

In an attempt to foster innovation, companies often involve different functional disciplines early in the new-product development process. Marketing, product management, engineering, industrial design, and manufacturing all have different perspectives on product outcomes, and each can provide valuable input. However, in an organization that produces narrow categories of products, even this seemingly diverse group of people can share the same blinders.

The team in our example has been optimized to deliver refinements to a particular product line. They understand the components and manufacturing processes that produce their devices, but all of their devices are slight variations on the same theme. They aren’t used to thinking about different applications or device constructions. It’s like the difference between swimmers and cyclists: both are good athletes, but they have strengthened different muscle groups in ways unique to their specialization.

Engineers and designers with broader and more varied experience have the ability to see beyond the confines of the product category in which they work. They can challenge assumptions and conventional wisdom while seeing similarities with devices from other product categories in which they’ve worked. To stretch the athlete analogy, they are the decathletes—not the absolute best in any single event, but capable in each event, and their creative “muscles” are ready for all of them.

There are pitfalls, though. Without sufficient specialized knowledge, engineers with generalist experience can still make junior-level mistakes when it’s time to implement a great idea. Deep knowledge in particular areas may be necessary to optimize a final design. To stretch the analogy a bit further, true decathletes will at least know the heights that are attainable in the pole-vault, even if they can’t reach that height themselves.

Harnessing the Creative Generalist

So, how does a team with blinders get past them to innovate? Clearly, firing the entire team is a drastic and unproductive strategy. Tribal knowledge and specialized experience have value, so they shouldn’t be abandoned. A great alternative is to look outside the team and bring in a resource with a track record of creative collaboration to help generate new ideas. Here are a few key steps:

First, identify external resources with broad experience and a history of providing creative solutions. This could be a medical device development consultancy, a contract manufacturer with engineering capabilities, or even other teams within the same company. General experience is key, but you should also look for people who can help guide the innovation process.

There are a variety of ways to approach finding innovative solutions, but the most successful processes encourage the team to consider every concept, no matter how crazy it may seem. Even wild, seemingly impossible ideas can spark feasible breakthroughs. An experienced consulting team will be able to figure out which methods are the most promising for a given problem.

Fig. 2 – A pilot build guides the client to design validation and helps troubleshoot manufacturing issues.

To avoid a major hit to team morale, make it clear that bringing in outside help is not a reflection on capabilities, but necessary to help remove blinders. Assess your team’s thoughts on this. Are you better off bringing in outside help just for ideation, or would the team appreciate the learning experience of working with consultants for the entire development process?

Encourage team collaboration. Development consultants and contract manufacturers are used to working with a variety of clients, and the best of them will provide an inspiring experience as they guide the client through the process. (See Figure 1)

Provide the real product requirements, not just the results of previous design optimizations. To find viable solutions, an engineer needs to thoroughly understand all aspects of the problem. This is where tribal knowledge is critical to the process. However, it’s important to think about and describe the details and constraints of the actual problem, not past solutions. For example, it’s a good idea to describe the delicate anatomy around a target surgical site, but requiring a particular shape and size of surgical tool is often overly constraining. Development consultants will often ask questions about very specific requirements to make sure they understand the basic needs of the product.

Minimize constraints, without going too far. Try to eliminate as many constraints as possible, particularly those that lead directly to previous solutions. But leave important constraints in place or you risk solving the wrong problem. Creative thinking is the result of tension between requirements and constraints. Keep the constraints real, and seriously consider how valid they are when challenged. Minimizing constraints will result in a wider variety of initial concepts, and constraints may be added later to help with down-selection.

Avoid “polluting” the contributions of outside team members by giving them time to develop new ideas before sharing existing concepts. They may come up with some of the same solutions, but their lack of prior knowledge should lead to a wider range of concepts.

Keep an open mind to the unconventional. Resist the urge to say, “That can’t be done.” Most innovation experts agree that it’s important to avoid down-selecting concepts too quickly. Explore a wide variety of ideas and let people build on them, recombine them, and refine them before narrowing down to a solution. Use important constraints to help select the best concepts. Be sure to get key stakeholder input before narrowing too far. And finally, the value of concept preference testing with representative users cannot be overstated.

Use the best resources, whether internal or external, to complete the design. In the final phase of any project, the devil is still in the details, and final implementation is where specific experience pays off. Novel designs can be risky, so give them the best chance to succeed by applying rigorous engineering standards. A lot of great technologies are abandoned simply because a prototype was poorly engineered due to the developer’s lack of experience. At a minimum, make sure that prototype designs are reviewed by people with relevant experience so that they can challenge the design details. (See Figure 2)

Consultants are sometimes criticized for sweeping in, solving a problem, and then leaving the core team to maintain a design they don’t fully understand. To make sure a project ends successfully, involve the internal team in the entire design process, have them check and challenge the work being done so that they understand it, and be sure that the final design is properly documented and reviewed.

Fresh Thinking Can Help Remove the Blinders

Consultants learn from every project they work on, adding depth to their product development knowledge, broadening their experience, and enhancing their capabilities. Working with a consultancy or other outside resources can be an enriching experience for any development team, because it introduces them to new methodologies for getting work done and a fresh perspective on creative exploration. Exposing your team to a new group of collaborators and a more open-minded ideation process can help them understand their own limitations and put them on a path that yields innovative development results.

This article was written by Robert Charles, Design & Engineering Manager, Farm, Hollis, NH. For more information, Click Here  .