White Paper: In Silico Standard Testing

This white paper has the aim of shedding light on the concept of In Silico Standard Testing for medical devices and highlighting its benefits, with an emphasis on the orthopedic and cardiovascular sectors.

Introduction?

With the very rapid evolution of science and technology, medical devices are becoming increasingly sophisticated and innovative. The safety and quality assessment is one of the most crucial procedures in the medical device development lifecycle, according to the Regulatory Affairs Professionals Society.??

In silico approaches offer a great chance to improve safety, efficacy, timeliness, and cost effectiveness of medical device standard testing?

Summary:?

The need for In Silico Standard Testing?

Potential weaknesses in design variables and their effect on design performance can be recognized in advance and addressed sooner in the design process before prototyping, leveraging computer-aided design and numerical simulations, while potentially successful products can be verified more quickly than with traditional testing. For example, In Silico Standard Testing can be used for worst-case assessment within a series of different sizes of the same implant design to reduce the physical test burden.

In Silico Standard Testing: Benefits and challenges ahead?

Among the main expected benefits of In Silico Standard Testing we list:

• Minimizing the need for physical pre-clinical testing, following a Reduce, Refine and Replace approach;
• Lowering development costs and time-to-market, leading to reduced costs and wider access availability of device-based treatments.
• Enhancing the quality of medical devices released into the market resulting in increasedtreatment efficacy and patient safety through reduction in device failure.

Establishing credibility represents an important challenge for In Silico Standard Testing. Moving in this direction, industry, medical and research groups, regulators, and academia have collaborated on the development and release of ASME V&V 40 standard, providing a framework to establish the credibility of a computational model used for medical devices

InSilicoTrials.com cloud platform for In SilicoStandard testing. InSilicoTrials engineered an integrated cloud platform to perform in silico testing for implants, assessing for example mechanical safety and electromagnetic compatibility in a virtual environment, in line with recognized standards and regulatory guidelines.?

In Silico Standard Testing for the cardiovascular field: Self-Expandable Valve Radial Force Test and Standard test suite for balloon expandable devices.?

In Silico Standard Testing for the orthopedic field: ASTM Standard Test for Finite Element Analysis?

In Silico Standard Testing for MRI Safety:? NuMRis: a tool created during a research collaboration with the FDA?

InSilicoTrials.com is the first cloud platform offering a collection of M&S tools to perform In Silico Standard Testing for medical devices. The proposed tools allow manufacturers and points-of-care to easily assess mechanical safety and electromagnetic compatibility of generic and custom devices before prototyping, preventing risks and criticalities for the patient, and helping to accelerate time and reduce costs of device development.

Read the entire white paper here.