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R&D Workshop: Medical Device Development - Tissue Effects Simulation
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10/17/2018
When: Wednesday, October 17, 2018
8:00-9:30am
Where: NITA Training Center
1685 38th Street
Suite 200
Boulder, Colorado  80301
United States
Contact: Daniela Blagoeva
(303) 952-6092


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Summary:

Medical device innovators struggle with delays and cost overruns when developing products using animal and tissue experimentation. By modeling the tissue effect of the medical device, you can use computer simulations to bypass most of that and get new life saving technologies to market months faster, so they can help more people and have a positive impact on your bottom line.

 

Simulation of the interaction between your medical device and the patient’s tissue allows you to design to the desired medical effect, test modifications before prototypes are built, and capture the subtle effects of these design changes rather than losing them in the noise of tissue testing.

 

The FDA has recognized the value in simulation data and has issued written guidance regarding computational modeling study design, elevating it to the highest level of FDA strategic priority.  The door is now wide open to work in partnership with the FDA to address safety and efficacy questions using simulation results.  This reduces physical testing requirements as much as 50%.

 

Simulation also provides compelling visualization of complex ideas or hard to grasp concepts and can be used to quickly communicate the value of your device to customers or other non-technical audiences.

While computational modeling was once only the domain of large companies and universities that could afford the cost to develop professional expertise and maintain large computer systems, today’s cloud-based computational power can now be applied to your more complex problems.  Computational modeling and simulation are now within reach of even a small start-up to speed the time to market.

 

This presentation will demonstrate how computational modeling and simulation slashes development time through virtual prototyping; reduces regulatory testing prior to release; and allows you to clearly communicate technological advantages to your medical device – with measurable benefits to your bottom line. A Q&A session will follow the presentation.

 

Key Takeaways:

·        Modeling and simulation significantly reduce time to market for medical device development

·        Modeling and simulation reduce the regulatory load required by the FDA

·        Data visualization is an effective tool for communicating complex concepts

·        Data centers and cloud computing puts computational modeling and simulation within reach of a company of any size.

Arlen Ward

Arlen Ward is an industry-leading modeling and simulation expert and provides consulting services through System Insight Engineering LLC to medical device companies of all sizes.  Arlen has more than 16 years of experience modeling medical applications with Covidien and Medtronic and is trained as a mechanical engineer. Arlen received his PhD from Colorado State University, where his research focused on using computational modeling and simulation to improve the performance of energy-based tools in urological surgery.  Arlen has 19 issued US medical device patents and is a licensed Professional Engineer in the State of Colorado. Arlen’s focus is to leverage modeling and simulation to streamline product development cycles by shortening prototyping time and speeding up regulatory approval.

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