Med-Tech Executives and Regulators Share Insights on the Value of Computational Modeling & Simulation
AXENDIA, Inc. today announced the release of a new research report, "The Value of Computational Modeling & Simulation in the Medical Device Industry." The research examines how innovative medical technology (Med-Tech) companies are using computational modeling and simulation (CM&S) as digital evidence throughout the product life cycle and evaluates its potential to accelerate the introduction of high-quality medical products to support improved patient outcomes.
YARDLEY, Pa., June 8, 2022 /PRNewswire-PRWeb/ -- AXENDIA, Inc. today announced the release of a new research report, "The Value of Computational Modeling & Simulation in the Medical Device Industry." The research examines how innovative medical technology (Med-Tech) companies are using computational modeling and simulation (CM&S) as digital evidence throughout the product life cycle and evaluates its potential to accelerate the introduction of high-quality medical products to support improved patient outcomes.
It also provides a roadmap to the successful implementation of CM&S to drive improvements and accelerate new product introductions in a timely and cost-effective manner while supporting regulatory compliance.
AXENDIA conducted a series of in-depth interviews with medical device industry executives who led their companies' use of CM&S at various points throughout the product life cycle, supplemented by reviews of FDA, industry, and academic articles, presentations, and regulatory documents. AXENDIA's analysts used first-hand accounts and publications to identify the benefits and perceived obstacles to the wider utilization of CMS in the medical device industry.
Regulators around the world are encouraging the use of CM&S. The European Medicines Agency is actively working to enhance the use of CM&S across the product life cycle. For its part, the FDA has identified the use of CM&S as a CDRH and Agency-wide priority and recognizes its value as a regulatory tool with the potential to reduce the cost and enhance the scope of device evaluation. Digital evidence is already being successfully used to support regulatory submissions. In addition, the use of validated digital evidence and digital twins can reduce the burden on physical testing in vivo studies as well as streamline manufacturing to accelerate new product introductions.
This research report was made possible by support from Ansys, Kalypso, and PTC. These companies supported this research report to increase the understanding of the value of computational modeling and simulation in the medical device industry.
AXENDIA retained full editorial control during the execution, analysis, and compilation of this research report.
NOTE TO EDITORS
Detailed findings from this Voice of the Customer Report, as well as graphics, will be available for your use with proper attribution. For additional information, to request the report or to schedule an interview or briefing with our analyst team, please contact Robyn Barnes at 1-267-352-4801.
About AXENDIA
AXENDIA is a leading analyst and strategic advisory firm focused exclusively on the Life Sciences markets. The company provides strategic advice that enables its clients to prepare for, adapt to and overcome disruption. AXENDIA conducts primary quantitative and qualitative research that clients leverage to support their strategies and enables them to make informed decisions based on their unique needs. Industry stakeholders and regulators have relied on AXENDIA for trusted advice on business, regulatory and technology issues, and trends based on trusted sources. AXENDIA serves the entire life science ecosystem, ranging from start-ups to Fortune 100 companies including life science organizations, technology and service providers, and regulatory agencies. For more information, visit http://www.axendia.com.
Read AXENDIA's blog: Life-Science Panorama.
Media Contact
Robyn Barnes, AXENDIA Inc., 1 267-352-4801, [email protected]
SOURCE AXENDIA Inc.
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