Getting new medical devices designed, tested, manufactured and ultimately approved by government regulatory agencies, such as the U.S. Food and Drug Administration (FDA), is a grueling and very time-consuming process fraught with many challenges. Any tools that can help medical device manufacturers overcome those obstacles can make the difference between getting a breakthrough product to market and abject failure.
Medical Device Hopes to Better Diagnose Fertility Issues
As couples are putting off starting families until later in life for a myriad of reasons, there has been a rising number of infertile women seeking the help of technology to help them conceive. In fact, globally one in every six couples now face infertility issues. According to the CDC, nearly 1.5 million cycles of In-Vitro Fertilization (IVF) are performed worldwide every year. Better treatments starts with better diagnostics.
The Center for Advanced Medical Learning and Simulation’s (CAMLS) Tampa Bay Research & Innovation Center (TBRIC) collaborates with physicians and medical device manufacturers to help them meet these challenges in order to get the latest advances in healthcare into practice. To support its collaborative development programs, CAMLS needed an integrated 3D development platform with extensive design and simulation capabilities to accelerate the production of innovative medical devices and procedures.
According to Chief Engineer Mario Simoes. “Our mission is to work with physicians and manufacturers to accelerate development of innovative medical devices and procedures,” Simoes says. “To achieve our objectives, we need robust yet integrated design and simulation capabilities—ranging from structural and thermal analysis to fluid flow and mold-filling simulation—to streamline the development and accelerate the availability of new diagnostic equipment.”
Using SOLIDWORKS design, analysis, mold-filling simulation, product data management, and technical communication software solutions, CAMLS worked with CooperSurgical, Inc. to develop the ABBI™ (Air Bubble Based Infuser). The device uses saline infused with air bubbles to provide a better approach for conducting ultrasound exams of the uterine cavity and fallopian tubes to determine potential fertility issues.
“Using SOLIDWORKS, we were able to cut development time by 30 percent,” Simoes says. “Medical device development takes more time than designing other types of products because we have to validate every step, both in software and through the production of prototypes to support usability studies to comply with U.S. Food and Drug Administration [FDA] requirements. The combination of integrated SOLIDWORKS tools and the ability to conduct testing all within the same facility shortened the process and accelerated time-to-market.”
Read the entire CAMLS case study to learn how researchers and engineers at CAMLS put SOLIDWORKS Solutions to work to accelerate the design, testing and manufacture of ABBI, a single-use device that facilitates two procedures as part of an initial female fertility evaluation: a sono-HSG for tubal patency and an SIS for uterine structure.
To learn more about how SOLIDWORKS Solutions can be used to help bring medical devices to market stat, click on the banner below.