Enabling Medical Device Innovation through Simulation

[Music] imagine your medical device is up for an FDA resubmission due to a manufacturing defect or a process change and you have a solid 30-day deadline from the FDA what-if simulation helps you respond to the FDA inquiry within one week and if simulation saves you a substantial amount of time and money by cutting down on building and testing ANSYS simulation has helped many medical companies script these very success stories in the next few minutes you'll see groundbreaking solutions from ANSYS contributing to medical research patient safety and the advancement of the medical devices industry advanced 3d physics simulation for Mance's can predict device performance and solve biomedical engineering challenges saving costly empirical testing with ANSYS tools you can solve complex multi physics problems and perform numerous what-if tests and investigations where experimentation or clinical trials are costly time-consuming or difficult a huge benefit of using simulation is product reliability the FDA is participating in developing regulatory grade computational models that can help with medical device submissions here's a sample guidance document published on reporting methods for modeling and simulation that can help you comply with stringent regulations and pave the way for FDA approval according to the FDA the major reasons for recall are defects and device design software and other components to eliminate or significantly reduce recalls it's valuable to simulate medical devices since it can increase their reliability and enhance their performance consider insulin pumps they are one of the most recall plagued medical devices an insulin pump system has many components an infusion set the pump itself cannula needle display antenna and housing ANSYS multiphysics simulation can be used to detect failure modes and analyze complex interactions among components a patient may not receive in slin if the flow pass is obstructed due to catheter kinking this is one of the primary modes of failure of insulin pumps mechanical and fluid flow analyses from ANSYS can help you detect and prevent this failure from occurring you can also use ANSYS tools to design wireless systems on the insulin pump these solutions enable efficient wireless communications mechanical reliability and proper functionality all components need to work together as a cohesive system here you see a complete system model controlled by embedded software full system simulations help you identify and resolve integration issues early in the design cycle you can also look at the statistical behavior of device performance by exploring the entire design space leading to innovations and best possible device designs you can accelerate all of these simulation techniques using high performance computing ANSYS has gained insight into the industry's need to evaluate how medical devices such as the insulin pump device work in conjunction with the human body as such ANSYS is collaborating with the FDA and medical device industry and has developed an extensive library of human body models representing various body types to be used to predict safety and efficacy by way of virtual clinical trials one example is the creation of a standard computational coil model for MRI compliance of implanted devices MRI compliance testing is a complex multiphysics problem requiring time-consuming and costly measurement techniques the FDA has determined that simulation can be used to identify worst-case scenarios to decrease the number of test points needed for submission ances consulting and training services have allowed many medical device engineers to adopt our simulation workflow quickly creating custom apps is an example of how we democratize simulation here's a custom medical app called endo knot that works in tandem with ances mechanical to assist surgeons and interventional lists in decision-making and planning endovascular procedures treatment for aortic aneurysms requires inserting guide wires and eventually stents to regulate blood flow guide wire insertion deforms vascular walls knowing the amount of deformation the possibility of wall rupture can be predicted ances tools can predict deformation of the 3d vascular models giving surgeons valuable information to know what could happen before and while they were performing medical procedures before we go there's just time to leave you with a testimonial from dr. Paul Morris cardiology doctor and research fellow at Sheffield Hallam University he uses ances computational fluid dynamics and describes the value simulation offers to the medical devices industry the simulation allows us to simulate the blood flow through the coronary arteries and actually predict and compute those changes in blood pressure and flow rather than having to measure them directly by putting a wire down the artery which is much more invasive and much more expensive I think simulation can be used to help explain treatment selection to patients in the future we've been looking at using our coronary artery models to predict how someone might respond to a stent and different stenting strategies so we can't you prepare those Nullah C's before we see a patient's and select the best treatment option for that particular patients anatomy and physiology well before we actually deliver it and importantly advanced simulation from ANSYS enables you to reduce recalls and deliver better medical care to patients worldwide thanks for watching you

Channel: Ansys

Views: 6,629

Keywords: Medical device simulation, implantable medical device simulation, wireless medical devices

Id: IrpbbPOehEc

Length: 6min 9sec (369 seconds)

Published: Thu Oct 05 2017