Nearly half of the world lives on less than $8.30 per day. So, when a person residing in a low- or middle-income country breaks an arm or leg, it can easily send the whole family spiraling into poverty. SIGN Fracture Care International, a non-profit humanitarian organization, enables a patient with a fractured bone to stand in one day, leave the treatment center in one week, and be back at work or school in one month. To date, SIGN has teamed with surgeons to heal more than 467,000 patients in 61 countries.

SIGN: Rebuilding Patients’ Lives

Founded in 1999, SIGN manufactures low-cost surgical instruments and implants to stabilize fractured bones. These devices can be used in the most basic treatment settings, including those without X-ray machines or electrical power. Not only does SIGN donate the instruments and implants, but it also donates training and education to empower doctors in the communities they serve. By working with teaching hospitals and hosting educational conferences worldwide, SIGN equips surgeons to heal patients within their own local communities.

As a non-profit, SIGN doesn’t calculate return on investment in dollars but rather in the number of patients whose quality of life and productivity have been restored after a serious injury. At the same time, SIGN relies completely on donations from private donors, organizations, and foundations, so it needs to operate at the highest level of efficiency and produce the most instruments and implants possible with the available funding.

To drive innovation and efficiency across its design and manufacturing operations—and enable devices to be delivered to remote regions with precision and timeliness—SIGN relies on a combination of three-dimensional (3D) design and enterprise resource planning (ERP) software.

Creating Innovative Medical Device Designs

Since 2001, SIGN has used SolidWorks 3D CAD software from Dassault Systèmes to innovate and develop products suitable for highly resource-constrained settings, empowering surgeons to effectively treat orthopedic trauma patients in their local communities. The non-profit relies on the software to design both its surgical instruments and implants, guiding them from conceptualization through creation, validation, and delivery to patients via its network of orthopedic surgeons.

SIGN takes advantage of SolidWorks’ capabilities to import and model anatomy, conduct finite element analysis (FEA) simulations, and render models for surgical technique manuals. The non-profit also utilizes the software’s product data management (PDM) functionality to manage change control within the constraints of the highly regulated medical device industry.

Terry Smith, SIGN’s engineering manager, observed that SolidWorks has been integral to the team’s product design process, noting, “Without it, we wouldn’t be where we are today.”

Driving Efficiency and Cost Savings

In 2023, SIGN implemented Dassault Systèmes’ DELMIAWorks ERP system to manage its manufacturing processes and move to paperless workflows.

“We have transitioned from paper-based manufacturing processes to paperless processes,” notes Bob Schmitt, manager of regulatory affairs at SIGN. “For instance, previously our job travelers were actual paper folders of documents, whereas now they are digital documents accessible to all staff and operators. At the work centers, our operators work in front of two screens: one showing the device drawing and the other the inspection requirements. They no longer have to shuffle through folders to get the most current information and specifications.”

“The same can be said of our inspection records,” Schmitt observes. “Now, in-process and final inspections are digitally recorded in the ‘Quick Inspections’ module along with the calibrated inspection instruments used to accept product.”

Shelly Foster, logistics and operations analyst at SIGN, adds, “Converting to digital data processes and controls are saving 20 or more hours a week by reducing errors and streamlining pre- and post-production checks. Saving 10 minutes each on 1,500 folders really adds up over time and lets me focus on other aspects of my job.”

Ensuring Quality and Compliance

As a medical device manufacturer, SIGN is registered with the Federal Drug Administration (FDA) and certified for the International Standards Organization (ISO) 13485 quality management system (QMS) standard. The ERP system now plays a central role in both ensuring quality and streamlining compliance with these organizations.

“ISO 13485 and FDA auditors now prefer evidence-based audits over the older narrative-based format, so having ready access to comprehensive device history records is critical in demonstrating regulatory compliance,” Schmitt explains. “The ‘DELMIAWorks Assembly Lot History’ report and the Inspection Sample Log report together serve us well in capturing these highly regulated inspection results.”

Additionally, rigorous calibration and documentation of inspection equipment is fundamental to quality inspections and essential in supporting ISO 13485 and FDA regulations, such as Title 21 CRF Part 11 covering electronic records and signatures. Today, SIGN uses its ERP system to automate and streamline these processes.

“We use the DELMIAWorks quality modules to trigger and document all of our in-process and final inspections as well to schedule and document all of our gauge calibrations,” Schmitt says. “Before we went digital, the inspection processes produced more paperwork, required more double checks, and used more storage and retention resources than perhaps any other processes in the business. Now, all that is done on the system, and all the storage is digital. The savings have been tremendous. In addition, to ensure compliance with electronic signature regulations, we use the CRF Part 11 features of the system to require dual digital signature authentication.”

Conclusion

For more than 25 years, SIGN has been on a mission to bring equality to fracture care around the world. Aided by its 3D design and manufacturing ERP software, the non-profit is delivering on this vision with state-of-the-art medical devices that can be delivered quickly and cost-effectively to even the most remote and under-served communities around the world.

Steve Bieszczat is responsible for DELMIAWorks brand management, demand generation, and product marketing. Prior to DELMIAWorks, he held senior marketing roles at ERP companies IQMS, Epicor, and Activant Solutions. Bieszczat’s focus is on aligning products with industry requirements as well as positioning DELMIAWorks with the strategic direction and requirements of the brand’s manufacturing customers and prospects. Steve holds an engineering degree from the University of Kansas and an MBA from Rockhurst.