“Collaborating with [Smithwise] rapidly accelerated our progress,” Mazzucco says. “In a period of 5 months, we built 10 functional prototypes that are currently being evaluated by key users and other stakeholders.”

Sprinting at Startup Speeds 

Smithwise, formerly Boston Device Development (BDD), is a company that primarily works with VC-backed startups in the development of first generation devices, collaborated with ZSX Medical in the making of the Zip-Stitch, a novel laparoscopic instrument. BDD drove a process that more resembled software development than the typical “waterfall” medical device process. Using development methods similar to agile development, the collective team engineered the device, built 10 functional prototypes, and gained market feedback – all in five months.

Accelerating time to market is a pressure that most industries are feeling now more than ever. Web software sprints are measured in days, and many consumer products only last for a single season. While perhaps not to the same extreme, medical device companies also feel pressure to deliver results quickly. With fierce competition in the marketplace and uncertainties around evolving medical practices, medtech companies must seek out increasingly narrow market window opportunities. Given the current state of device development, there are cues that medtech could be taking from parallel industries.

Test the Market Early
Rather than pursuing the design of the final manufactured product, the BDD-ZSX team focused their early development efforts on producing a functional device that could be used to quickly obtain feedback from physicians and other key stakeholders. Because the Zip-Stitch incorporated a new technology, there was uncertainty around its perceived value with target clinicians. Rather than trying to perfect the technology and build a device ready for production, the team sprinted to get to a beta version in the hands of users. “You can have a really cool technology, but if it doesn’t address a pain point,” says ZSX founder Dan Mazzucco, “then doctors and hospitals won’t buy it.”

 Through this rapid customer-focused approach, the team gained critical insight. This new knowledge informed architectural and feature-level design changes early and enabled the team to adapt and pivot directions to meet customer needs. Had the team focused on perfecting the technology, these market realizations would have been reached at a much later and more expensive phase of development. 

Don’t Wait On Design Inputs
The traditional waterfall process advocates for the creation of an exhaustive list of design inputs before entering design mode. The challenge in developing first generation products is that teams often do not know what questions to ask, let alone what inputs to define. Design inputs emerge through the concept development process. Only by digging into the details of a design will a team realize the tradeoffs, risks, and constraints. “Trying to fully define inputs before developing concepts is like trying to write a recipe for a meal without tasting any of the ingredients,” says BDD founder Eric Sugalski. 

Learn Through Breadboards; Confirm Through Prototypes
“Prototypes and breadboards,” Sugalski explains, “are terms that are interchanged quite frequently in product development, but we believe there are distinct and important differences.”

 Breadboards focus on key features or functionalities that need to be proven at an early stage. These are often focused on a small subsystem, isolated from the rest of the product. As Sugalski elaborates, “For our team, breadboarding is part of the engineering process. As soon as we have an idea that we want to advance, we conduct a rapid design-build-test of that isolated feature or functionality. Our 3D printing and machining capabilities allow us to work through these ideas in hours, instead of weeks. We breadboard throughout the engineering process to de-risk key technical areas. Taking cues from scrum and agile software development, we bake breadboarding into the engineering process to learn, iterate, and reach the desired functionality.”

 Prototypes, on the other hand, are the embodiment of all features and functionalities that comprise an integrated product. “We launch prototyping after we have fully vetted the key technical risks through isolated breadboards. For us, prototypes are functional units that can be verified through bench testing. Our expectation is functionality, since we have worked out the bugs during prior breadboarding iterations,” Sugalski explains.

This distinction was critical in the success of the Zip-Stitch effort when preliminary breadboards, focused on the laparoscopic jaw mechanism, did not meet performance expectations. Fortunately, the team realized this shortfall only weeks into the development process. “It took us 4 cycles of parts to build this critical feature correctly,” says Sugalski. “Because we took a breadboarding approach and resolved this key feature early, the design process continued to move forward efficiently. If had we waited until the full prototype of the system was built, we would have discovered this flaw too late to correct it without significant setbacks.”

Augment Capabilities with Partners
With two fulltime employees, ZSX Medical is, by definition, a lean startup. Rather than growing a team of in-house resources, they collaborate with outside companies on key parts of the development process. As Mazzucco explains, “Our needs will change over the course of this process. While I may have a need for engineering talent now, I will not have the same needs a year from now when we are in production.”

Collaborating with BDD has allowed ZSX to expand their capabilities quickly. Not only did they gain access to engineering resources, but also access to a full supply chain, development processes, and experience in device development. Building these capabilities from scratch would be very difficult to reproduce under a rapid timeframe.

The results have been tangible. “Collaborating with BDD rapidly accelerated our progress, Mazzucco says. “In a period of 5 months, we built 10 functional prototypes that are currently being evaluated by key users and other stakeholders.”

As medical device companies continue facing time-to-market pressures, operating as a lean startup may be the best route forward. Identifying key risks, sprinting toward solutions, and pivoting based on market feedback may be essential for a two person firm to survive, but even the most well funded groups can gain an edge with these lessons.

See the article as it appeared in Medical Design Technology.


Ergonomic mockup used in laparoscopic simulator:

Handle breadboard evaluating cam profiles:

Prototypes are the embodiment of all features and functionalities that comprise an integrated product:

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