1. Understand the problem the product is trying to solve. Working with surgeons can be challenging. They’re very smart, and usually come into a project with an idea of what they would like the final product to look like. Great, right? The drawback is that, often, these surgeons are capable of making anything work during surgery, and their solution may not be everyone’s solution. The key is to take a step back and focus on basic engineering design principles. Having a full understanding of the problem the proposed product is attempting to solve is critical for the development of a product that will be widely accepted by the medical community.
2. Work in a cadaver lab. There is no better way for engineers to develop products than by getting their hands dirty. Bone models only go so far in helping understand the anatomy, and understanding the constraints imposed by soft tissue goes a long way during the development process. Cadaver labs also allow a working partnership between the engineer and the surgeon. Surgeons can try things outside of the norm without causing harm and spawn their own creative thinking. The direct communication and free thinking between engineer and surgeon in a lab is often an innovation breeding ground. With the overlapping clinical and engineering knowledge, these two can walk out of the lab with a sense of where the idea is going, and perhaps even a concept that just needs to be drawn up in CAD. If another day is available, maybe a prototype can be printed overnight and tested in the lab the next day.
3. Observe procedures in an operating room. Observing procedures and seeing how things work first-hand can help a design engineer understand how the surgery is performed and how the product they are designing will be used. Oftentimes, the procedure is performed in a much different method than described, and the engineer can learn through observation. Other considerations often overlooked can be brought to light as well, such as the interaction between the product and surgical scrub tech or nurses.
4. Partner with the marketing team through end-user inputs. One of the strongest product development tools is an appropriate level of tandem collaboration of the marketing and engineering personnel with the end users. It is common for marketing to be on the front lines of communication with users, but engineers should also have an overlapping relationship with users once the project kicks off to offer a different perspective. The onus is on the product development engineer to ensure appropriate correlations are communicated back to marketing, so there is a better understanding of the product’s physical and performance characteristics.
5. Work closely with a prototyping team. The prototyping team should be considered an extension of the development group. If they are brought into the development process early, their immense manufacturing experience can be leveraged to ensure a smooth transition process to production. Never underestimate the knowledge the prototyping department has for the manufacturing of products; they can offer valuable information on available manufacturing processes.
6. Maintain a good relationship with manufacturing facilities and partners. For a successful product launch, process design is just as important as product design. Working with manufacturers during the design phase to incorporate process design can affect the time and costs of both manufacturing and inspection. It is also beneficial to work with a supplier with a wide array of manufacturing capabilities; this lends itself to matching the best possible manufacturing process to the design and to work with high-tech machines to manufacture a variety of designs while also ensuring consistency. As pricing pressures increase in the total joint, trauma, and extremities markets, Design for Manufacturing and Design for Inspection must also be considered.
7. Review the design inputs. All of the preparation steps leading up to this should provide a solid base of design inputs. Check that they are thorough enough to ensure the user needs are covered while the downstream associated methods of verification and validation can be executed.
If these steps are followed, the chance for a successful product rollout with a seamless transfer into the market is greatly enhanced.
Arley Perez is a senior product development engineer at Orchid Design, a design and development division of Orchid Orthopedic Solutions providing physicians, entrepreneurs, OEMs, and emerging companies with efficient solutions to complex medical device challenges. His development and project management experience is focused on knee, hip, and extremities sports medicine. Email him at firstname.lastname@example.org.