Part 1 addressed how to go about developing the best and most powerful partnership between a medical product manufacturer and an outside design firm. In Part 2, we addressed how to approach the research stage. Now the topic moves to the aspect of how to go about forming a good design partnership.
When manufacturers consider the use of an outside firm for product development, they typically think of the design phase (“We could have them design the product…”). Some manufacturers exclude the outside firm from the research phase. In later phases, the manufacturer or another entity may take over the regulation work, or the transition to regular production. Typically, the product owner almost always owns the product launch phase. But the outside design firm is always involved in… well, design.
In the most effective partnerships, the manufacturer and outside firm begin with research (see the second column in this series for why this is so). But by the time the partners reach the design phase, they need to be able to define more than just the product concept. They also need to be clear about the manufacturer’s profile and the objectives and constraints that provide context for making decisions throughout the remainder of the project. Two areas are worthy of special focus as the teams prepare for design:
* the manufacturer’s assessment of the Speed/Cost/Quality triangle
* the manufacturer’s expectations for collaborative vs. turnkey development work
The manufacturer’s internal team needs to clearly assess itself--and its organization--due to the fact that any development project is comprised of three interacting legs, much like a triangle. The legs are Speed, Cost, and Quality, and the value assigned to any one leg affects one or both of the other legs.
The often-frustrating reality of product development is that “we can’t have it all.” To go faster, cost almost always increases (and sometimes quality decreases). To save money, it is usually best to go slow, because speed is almost always financially inefficient in the complex scrum of product development. No organization can afford to assign unlimited value to any one of the legs (e.g., maximum speed no matter the cost).
This reality is not a barrier to effective partnership. But it does require that the partners have a clear understanding of the manufacturer’s profile. The window of opportunity for a new product may be finite, or the manufacturer’s budget cycle may require a “Go/No Go” decision on design feasibility by a certain date, which can factor into the speed valuation. The estimated market value for the product--and, therefore, its pricing--certainly affects the Cost valuation, but so can the manufacturer’s budget for tooling or launch, or the company’s profit-margin expectations. Many factors affect the Quality valuation, from the regulatory demands on the product to the customer profile to the company’s organizational culture. The partners need to clearly understand these dynamics if they are to work effectively through product design.
Fortunately, even this understanding can be gained through partnership. It’s common for an internal team to lack a clear grasp of its own situation. The team may not have fully considered the implications of “Speed, Cost, and Quality,” or its organization’s priorities. But the outside design firm knows it needs to round out this profile of the manufacturer, and can help the internal team accomplish this. Once the partners have worked together through the research phase, the outside firm likely has a clear, objective view of the manufacturer, and knows exactly what to ask to clarify the manufacturer’s profile.
That profile also encompasses the method of partnership during design. For a large, traditional manufacturer with multiple projects happening simultaneously, it may make sense to spend the money for a turnkey approach. In this arrangement, the outside design firm takes the research and attempts to develop an almost-complete product design without much manufacturer involvement, then returns to discuss the design--or even the prototype--with the client.
But increasingly, particularly in small- to medium-size medical device manufacturers, close collaboration is the key to success. Eric Sugalski, the founder of Boston Device Development, a product development firm that has worked extensively with first-generation medical-device products, finds it best to stay in close contact with the client during the design phase.
“We prefer to have weekly check-ins and impromptu phone calls,” said Sugalski. “We consider ourselves an extension of the internal group.”
He pointed out that close collaboration is not only critical to developing a good product, it’s also critical to actually getting the product to market.
“It’s not just about how good and compelling the product is,” he said. “There are so many stakeholders involved in getting the product to market that we need to have their buy-in. They need to know their ideas and feedback have been considered seriously in order to get to the next step.”
It’s in the back-and-forth of such design efforts that the complementary nature of the partners is most operative. Robert Sheldon, a principal with Product Council, a design firm based in Chicago, says that’s one thing he likes about working with medical-device clients.
“In their eyes, we are the experts at what we do,” explained Sheldon. “There is a mutual respect that fosters a healthy collaboration.” He also thinks the result is better products, adding, “Medical-device clients trust our user-centered design process, which consistently produces the best solutions.”
Sheldon contrasts that with consumer product companies, which tend to prefer pure market-driven or technology-driven approaches, and generally have many opinion-contributors and stop gates--which often lead to mediocre solutions with few innovations.
Sugalski points to the evolution of medical device companies as reason for the particularly complementary fit between manufacturers in the industry and outside design firms.
“Many of these companies have grown through acquisition, and have purchased smaller firms after the early risk stage. They’ve shifted toward more of the downstream activities,” he said.
This often leaves the client, particularly the company that wants to move fast in product design, needing a unique set of capabilities from the outside design partner. Sugalski calls these “hacker” skills, or the ability to produce something fast and cheap just to prove the concept. Later the partners will have to transition into much more rigid quality control and regulatory processes. But the best design approach to such projects may be short sprints with rapid iterations.
That was the approach taken by Boston Device Development and ZSX Medical when they partnered to develop Zip-Stitch, a laparoscopic surgical device for hysterectomies that solves an old problem in a new way. They used a “breadboard” approach to product design: make something functional, try it, revise it, repeat. The result was a fast development from back-of-the-napkin idea to prototype, with strong, positive feedback from surgeons.
“The rapid iteration approach allowed us to get through the development process really quickly,” said Sugalski. “We wouldn’t have learned nearly as much without iteration, and we wouldn’t be as far along as we are.”
It was a process well-suited to ZSX Medical. That’s the key; slow or fast, iterative or monolithic, collaborative or turn-key, any effective design partnership always requires self-awareness.