Advanced Energy Surgical Devices

Energy-Tissue Interaction


Device Safety & Regulatory Evidence

Expert Simulation At Every Stage Of Your Design

Focus your project on the best possible version of your medical device faster and more efficiently than traditional testing methods. From ideation and feasibility to generating regulatory evidence, finite element analysis and multiphysics model development will save you time and money.

Validate ideas in record time

with virtual prototyping

Break the never-ending cycle of building and testing prototypes that aren’t getting you any closer to product launch. Know what design works and the energy delivery needed to achieve it- before the first prototype touches tissue.

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Launch your device faster

& boost your bottom line

Shorter design cycles lead to earlier product launches with more innovative devices. The earlier launch gets you to peak revenue faster, significantly impacting your bottom line. How much more could you accomplish if you were launching devices twice as fast as today?

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Generate valid scientific evidence

for regulatory submissions

The guidance and standards for using simulation results as valid scientific evidence for the FDA and other regulatory bodies clear the way for faster device approvals. Simulation saves on preclinical testing requirements and provides insight into device performance in healthy or diseased tissue or in human patients or animal models.

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Deliver the best possible device

with confidence

Using simulation will enable you to gain insight and understanding into your device’s energy physics, resulting in increased patient safety and treatment effectiveness. Getting safer and more effective devices in the hands of clinicians means better outcomes for patients around the world.

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The Insight Process

We work with your engineering team to identify the challenges that are best suited for simulation. Your device technology and our simulation expertise are a powerful combination.

Custom computational model development brings the right pieces together to advance your project, making sure the key interactions are included without unnecessary complexity.

Optimization of your medical device based on tissue effect allows for thousands of iterations to be evaluated to zero in on the best design.

With the insights provided by computational modeling and simulation your informed design decisions move the project forward significantly faster than using traditional design processes.

Why System Insight Engineering?

Find out from our clients

Please take a moment and read what a few clients of SIE have to say about our company, the benefits of using simulation, and the real impact that's had on their bottom line. In every case, regardless of device, each customer has cut cost and time to market significantly. Simulation can save you real time and real dollars, in the race to bring your device to profit. Please do not hesitate to contact us to discuss specifically how simulation and modeling can benefit your firm.
  • "[SIE's] simulation helped us to avoid having to run animal studies and tissue pathology to demonstrate the same outcome at a MUCH lower cost."
    - Chief Operating Officer, Y Combinator Startup
  • “That’s some space-age voodoo you have there! Your ability to simulate real stuff in a real way is very impressive."
    -Principal R&D Engineer, Med Device Electronics Consultant
  • “You have delivered in six weeks what we paid another consultant to do for two and a half years!”
    - Sr. Director of Clinical Research, Women’s Health Company

A better way of testing

As medical device development complexity and regulatory requirements increase, the timeframe for development and the budget to complete the work struggle to maintain pace. Evidence-based medicine requirements increase the need to quickly and clearly convey complex physical interactions to non-technical audiences in an environment of constant distractions. Computational modeling of devices and their interaction with tissue can be leveraged to minimize these issues.

Medical device simulation allows your organization 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 regulatory bodies to address safety and efficacy questions using simulation results.

Using computational modeling and simulation tools in medical device development slashes development time through virtual prototyping, reduces regulatory testing prior to release, and allows you to clearly communicate the technological advantage to your product – with measurable effects to your bottom line.
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