Sew Much on the Line 
Though compliance is not normally part of the new product development process, Madelyn Archibald’s unique sewing skill set came in handy for the Bioventus PROcuff rotator cuff repair bio-implant design team.
Bioventus has a mission to help patients lead active lives, which is carried out through our cultural principles of caring, learning and results. Ms. Archibald, a Compliance Specialist in Bioventus, has truly exemplified these cultural values to help Bioventus achieve its patient-centric mission.
The PROcuff team needed some creative help to finalize new design prototypes for the surgeon team working with them to evaluate as part of the final design process. The PROcuff team – Kara Segerstrom and Mitchell Vanderlaan (below left) – had design ideas ready for prototyping but ran into a hurdle that at first seemed insurmountable … the team needed to find a vendor who could sew their design together in a very short time period. At first, the team thought of working with a tailor in the Durham area because of the sewing skillset needed to assemble the new design. During discussions, the team discovered Ms. Archibald is a skilled designer who actually has an impressive clothing line of her own.
The team approached Ms. Archibald for help, and she immediately came to the rescue, sewing the first prototype idea that very night and giving it to the team the next day. Talk about caring, results and learning in one day!
Next, Ms. Archibald was asked to make modifications to several other prototype designs, which required her to spend evening hours sewing a quite complex medical device to be used for a design lab; meaning, the prototype needed to be durable enough to withstand the rigors of a surgical procedure conducted in a cadaver lab. This design help by Ms. Archibald was no small feat, and the result was truly indicative of our Bioventus culture. 
The PROcuff team delivered three prototype versions to its surgeon design team and conducted a lab that helped the team finalized their direction for the PROcuff implant. This direction was needed to help the team submit necessary design dimensions for the required testing and validation protocols from the FDA for product submission, called a 510(k). Without Ms. Archibald’s willingness to learn why PROcuff helped patients, how the implant was intended to be designed and assembled, the team would not have been able to execute a needed design lab in such a tight window. One of our Design Surgeons, Dr. Scott Hacker (right) used the prototype that Ms. Archibald assisted with during a lab in San Diego, California in May.
Ms. Archibald delivered beyond what the team expected, which will go down in the team’s history as one the turning points for our program and has now helped us realize our objective of producing a design by the end of this year for the FDA to review so we can address patients with shoulder rotator cuff repairs later next year.