Sage’s Medical Device Engineering Expertise Propels an Innovative Breast Cancer Tumor Localization System from Design to Commercialization

For a surgeon to effectively remove a non-palpable breast tumor, a radiologist must first mark its location and margins. Since the 1970s, the most common procedure used for this purpose has been wire localization: Radiologists place fine, thread-like wires near the tumor using a needle and image guidance. They remove the needle, leaving the wires extending outside the patient’s body. The wires are then taped to the skin to keep them in position while the patient is transported from the radiology suite to the surgical suite for tissue removal.

With wire localization, the radiology and surgical procedures must happen on the same day in the same facility, which creates scheduling challenges. Patients with exposed guidewires must be physically moved from the radiology suite to the surgical suite, and if a marker moves or is pulled out during transportation, there’s a risk that the surgeon may not remove the entire tumor. The procedure can also be an upsetting, uncomfortable procedure for patients who are already under significant stress.

An alternative existing procedure involves the radiologist placing small, radioactive seeds adjacent to the abnormal breast tissue to mark its location. The surgeon then uses a sterile Geiger counter to locate the seeds, facilitating tumor location for surgical excision. While this procedure eliminates the need for same-day procedures and the risk of shifting wires, the complex regulations associated with storing, tracking, and using radioactive seeds increases the burden on the hospital.

Health Beacons was founded in 2008 to develop a simpler, less-intrusive, precise approach to localizing the margins of non-palpable breast cancer tumors using radio-frequency identification (RFID) technology. Their vision was for the radiologist to implant miniature RFID tags using a needle and image guidance to delineate the tumor’s envelope. In surgery, the physician would then use a handheld device and probes with RFID sensors, which would locate the tags and guide the surgeon to the target tissue during dissection. When located, the reader would also present the tag’s unique ID number, so radiologists could provide the surgeon with information about the tumor’s location relative to each individual tag, which would improve accuracy during removal.

Without exposed guidewires, the patient could go home after placement of the RFID tags and return on the day of surgery, eliminating same-day scheduling challenges and reducing patient stress. And the use of precise RFID technologies could reduce the localization’s margin of error, which could also reduce the need for additional surgeries.

To realize their vision, Health Beacons’ founder hired Sunrise Labs, who engaged Sage for their medical device engineering and industrial design expertise to help bring what would eventually be called the LOCalizer™ from design to commercialization. Sage would design and develop the handheld reader and two probes: a large RFID probe integrated into the reader to identify gross tag location and a separate, single-use surgical probe, which plugs into the handheld reader, to pinpoint precise tag location during surgery. Sage also had the industrial design expertise needed to create an ergonomic, aesthetically pleasing form-factor and elegant user interface.

The LOCalizer’s™ handheld reader had to meet a number of technical and ergonomic requirements: Its body needed to house an RFID circuit board, display screen, speaker, battery pack, and large, powerful loop-shaped radio frequency probe. The display screen had to be bright and easy to read, presenting a tag’s unique ID number and its distance from the probe in millimeters. These components each required physical space. Additionally, the device needed to be durable, and the large sensor had to be securely held in place to ensure accuracy, which meant incorporating structural components that also took up space. But because it would be handheld and operated, the device and its controls had to be ergonomically sized and configured.

Sage had to develop a space-efficient, ergonomic design that would meet these technical and structural requirements. To do so, they iteratively collaborated, exploring options and negotiating tradeoffs. Working with Sunrise Labs, Health Beacons’ founder, and manufacturing partners, they found and allocated sufficient physical space for the electronic componentry and created thin-walled injection molded components to provide the necessary structural support, ultimately creating a small, ergonomic device that could be easily operated during surgery.

Sage’s team formed an effective partnership with the founder of Health Beacons on this highly technical project. They were a central entity collaborating with Sunrise Labs, Cirtronics (who manufactured the handheld device), and Next Phase, (who manufactured the surgical probe) — communicating design information and ensuring all documentation met the requirements of multiple quality systems. And they streamlined the end-to-end process by meeting strict budget and timeline requirements to keep mechanical and industrial design off the product’s critical development path.

Health Beacons’ LOCalizer™ wire-free guidance system provides surgeons with the precision they need to effectively locate and remove breast cancer tissue. There’s no need for the hospital to handle and expose patients to radioactive material. And patients no longer must experience the challenges associated with multiple same-day procedures or the risk of wires moving during physical transportation. The LOCalizer™ has advanced women’s healthcare by offering an improved patient experience and turning a stressful experience into one that is simpler and less intrusive.

When Sage was engaged to develop the system, Health Beacons’ founder had an innovative idea and an early prototype. Sage was quickly able to create a viable product architecture for the handheld reader and surgical probe. They were an integral part of the team throughout the end-to-end product development lifecycle — from design through testing and manufacturing, and finally, to market launch.

The LOCalizer™ received FDA 510(k) clearance in 2017, and in 2020, Hologic, a global medical technology company and champion of women’s health, acquired Health Beacons. Sage played a pivotal role in this success story by leveraging the team’s deep medical device engineering and industrial design expertise, ability to solve complex problems, and collaborative, flexible, creative approach to working with clients and partners.