PAVmed is a multi-product medical device company with a mission to advance products from concept through commercialization faster and with less capital expense than others in the industry. In 2017, the company was working with a contract medical device manufacturer to develop a disposable, minimally invasive surgical device to treat carpal tunnel syndrome.
The goal of carpal tunnel surgery is to cut the transverse carpal ligament, which relieves compression of the median nerve in the wrist. Traditional carpal tunnel surgery is effective, but invasive, requiring a two-inch long incision. This causes more pain and scarring than a less invasive method would, with recovery taking several weeks to several months or more.
PAVmed’s new device, named CarpX™, would offer an easier, faster, less invasive alternative to traditional carpal tunnel surgery. It would have the potential to reduce postoperative pain and accelerate the patient’s recovery. PAVmed also believed CarpX™ could decrease costs by shifting procedures from the operating room to a less expensive setting.
With CarpX™, a physician would advance a balloon catheter with integrated bipolar radiofrequency (RF) cutting electrodes over a wire under ultrasonic guidance to position it in the carpal tunnel in the wrist. When activated, the balloon would create space within the tunnel, protecting the median nerve from the electrodes and creating stabilizing tension across the transverse carpal ligament. The electrodes would use very short bursts of RF energy to precisely cut the ligament from below, relieving nerve compression without damaging other structures.
In 2018, the device had gone from concept through several design and development iterations into verification and validation testing, where it repeatedly failed due to various design flaws. PAVmed’s manufacturing partner was unable to address the issues quickly enough to meet PAVmed’s aggressive timing and financial goals. Sage was engaged to get the project back on track and deliver what was needed to obtain FDA 510(k) and CE mark approvals for the product.
PAVmed chose Sage for a two key reasons: First, Sage is a lean, flexible company with highly experienced engineers known for their ability to creatively solve complex engineering problems and develop solutions quickly. Additionally, the company has a low-volume manufacturing facility in-house, which is rare in the product development consulting industry and a key differentiator from other firms, most of whom must rely on external contract manufacturers to produce devices for testing.
Most firms that are willing to do low-volume manufacturing are larger companies focused on high-volume contract manufacturing. Rarely do they have the developmental speed, acuity, and creativity embodied in Sage’s team. Sage would be able to quickly and easily produce the limited quantity of devices needed for verification and validation testing, eliminating the dependency on an external contract manufacturer, which would streamline the process and reduce costs.