Interview with Chad Price, CEO of Mako Medical
As the demand for artificial knees, hips and other joint replacements continues to grow due to the aging population, technology companies have tried to make the process of designing these devices faster and cheaper. One company, Mako Medical, has developed software that can streamline the process of designing new implants. In this interview, chad price mako medical CEO, explains how artificial knees and other joint replacements differ from most other types of medical devices and how his company’s software can speed up their development. He also discusses how the FDA has tried to help manufacturers reduce the time it takes to bring a new device to market by implementing a digital submission system that allows for pre-review review modules.
What is Mako Medical?
Mako Medical is a software company focused on helping medical device manufacturers improve the design and manufacturing process of artificial joint implants. The company’s cloud-based software solution creates a digital representation of every manufactured joint and is used in conjunction with 3D printers to simulate and test the performance of new implants. Artificial knees and hips are among the most common types of joint replacements, accounting for over a million procedures every year. Manufacturers have tried to speed up the process of designing new implants by using computer-aided design (CAD) software to streamline the design, simulation and testing process. Mako Medical’s software, which was developed at the Massachusetts Institute of Technology, is aimed primarily at reducing the time it takes to design these implants.
How does your software work?
Mako Medical’s implant creation software allows manufacturers to create digital representations of new artificial joints by importing CAD models and scanning physical parts. The software then lets engineers simulate the performance of the implant inside a virtual patient and carries out virtual testing procedures that can take days or weeks in a lab. The software also allows engineers to create a cloud-based library of all the parts used in the manufacturing process so that other designers can access and recreate their designs. The software’s key feature is its simulation capability.
Why is speed so important when designing artificial joints?
The ability to quickly design new implants is crucial because many patients are waiting for joint replacements. In the United States, for example, there are almost 400,000 people who need a new knee but aren’t getting one because there aren’t enough surgeons to perform the procedure. Many other patients are waiting longer because the government isn’t investing enough in the healthcare system to make sure there is enough room in operating rooms and surgeons have enough time to do the procedure.
The FDA’s digital submission process for medical devices
The FDA has tried to help address the challenges of designing new joint implants by trying to let manufacturers submit their designs digitally. Digital submissions let manufacturers submit their designs on computers instead of paper, which can make the process easier and faster. The FDA has also tried to make it easier for manufacturers to submit their designs digitally by creating an online repository of pre-review review modules (PRVM).
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