Dassault Systèmes is a science-based company providing technology solutions for innovation. We draw on various branches of science – mathematics, biology, chemistry, physics, geology – to break down silos of knowledge and find the most innovative, sustainable solutions for the future. Subscribe to this channel featuring content for those who develop and bring BioPharma and Medical Device therapies to market for the advancement of human health. 

Current MedTech product development methods are falling short of meeting the rising demand for rapid therapeutic solutions that are safe, effective and withstand stringent regulatory scrutiny.  
During the past decade, the FDA has been exploring and advocating for the increased use of Computational Modeling & Simulation (CM&S). However, there have also been obstacles in leveraging CM&S to its fullest potential. Beyond the agency’s ongoing development of CM&S regulatory review processes, medical device manufacturers face their own roadblocks in adopting CM&S technology due to legacy processes, vendor selection, and implementation decisions.  
Unified Modeling and Simulation (MODSIM) from Dassault Systèmes is providing a new paradigm for improving collaboration, process efficiencies and left shifting the value of simulation into the design process. 
In this presentation, learn how to easily implement a virtual (in silico) MODSIM approach to better manage the conflicting needs for usability, engineering, manufacturability, and cost.

Easily Shift From Traditional MedTech Product Design to Modeling and Simulation

Time to move pharma manufacturing to the next level!
- 34% product quality improvements
- 30% reduced manufacturing costs
- 28% reduced unplanned downtime
- 25% increased throughput

Pandemics, shifting drug prices, government healthcare mandates, regulatory requirements, calls for consumer customization—challenges such as these have driven pharmaceutical & biopharma processors to look at ways to streamline operations and reduce costs to manufacture faster. One of the ways this is happening is through modular manufacturing, which allows organizations to produce a variety of products from a single facility with faster changeovers, increased flexibility, and improved overall equipment effectiveness.

Register to watch this discussion on how the Virtual Twin of biomanufacturing processes and recipes, as well as the Virtual Twin of buildings, equipment and single-use kits, can help Life Sciences companies and CMOs to implement modular and flexible drug manufacturing and accelerate industrialization, scale-up and tech transfer, leading ultimately to more sustainable drug manufacturing.

The Virtual Twin of Processes and Equipment to Support Modular Biomanufacturing

As demands for faster delivery of personalized medicine and medical devices increase, manufacturers must have the agility to pivot to new products to meet market needs. To remain competitive, they need to answer the question: "How can I innovate rapidly while ensuring high-quality products and regulatory compliance - all while remaining cost-effective? Discover the capabilities industry leaders gain when leveraging the digital twin. From generating better quality and product outcomes to optimizing the production line flow virtually before deploying physical resources—manufacturing excellence is yours.

Accelerate Manufacturing and Time to Market in Life Sciences

Whereas traditional “waterfall” Engineering provides an intuitive and instructive linear workflow of design activities and defines clear deliverables, it struggles to cope with the iterative and integrative nature at the early stage of conceptual or basic designs. It also fails to cope with the complexity of multidisciplinary concurrent design. The fact that the current practice in Medical Devices industry still heavily relies on documentation is another hurdle to ensure cross-disciplinary consistency, requirement traceability, change impact assessment and knowledge capitalization. 

Model-Based Systems Engineering has strong capabilities to address complex systems (and system of systems), by using models from the ideation. It provides a deep understanding of the contexts and behaviors for the full project lifecycle, allows a clear and methodic cascading and tracking of requirement to downstream activities, with a full control of the interfaces and change impact analyses, fulfilling the stringent Quality Management requirements.

Develop Safe and Effective Medical Devices with Model-Based Systems Engineering

Keeping patients motivated and engaged is key to medical device clinical trial success and the critical factor in making that happen is being able to improve the patient experience. Learn how industry can facilitate, engage and improve our approach to the medical device patient experience to sustain engagement throughout the trial and beyond. How can medical device companies drive patient engagement in clinical development? How can we understand the patient journey and how can it impact trial design, outreach, and overall engagement? How can technology facilitate patient engagement?

Driving Patient Engagement in Medical Device Clinical Development

See a human heart simulation and its capabilities to represent difference patient disease states. Through the use of electrical, structural and fluid flow physics, learn how this technology is shaping the future of precision medicine.

Using Modeling And Simulation In Medical Device Development

Many citations by the FDA include findings with respect to insufficient or lack of information in the Design History File. These findings include incomplete or absence of design verification and design validation documentation, discrepancies between the final design outputs and the Device Master Record (DMR), not following the procedures to make the device per the DMR, and incomplete or inaccurate production data of incoming, in-process and finished products. Learn how to eliminate these challenges and ensure compliance with FDA regulations, ISO quality standards and other global regulatory requirements.

Accelerate The Delivery Of Innovative, Safe, Compliant Medical Devices

Making Drug Delivery More Effective

See a living heart human model and its capabilities to reduce run-away product development costs while improving patient outcomes. Through the use of electrical, structural and fluid flow physics, learn how this technology is enabling defensible simulation-based decision support and evidence for in silico clinical trials.

Reducing Time and Cost of Physical Testing

Learn how human body simulation is applied to the design of imaging and medical devices, specifically electromagnetic simulation processes to reduce product development costs.

Designing Safer Imaging And Medical Devices

The European Union Medical Device Regulation (EU MDR) governs the production, distribution of medical devices in Europe, and compliance is mandatory for companies who wish to sell medical devices in European markets. These regulations have significant implications across the medical device product lifecycle including product design & development, commercialization and post-market surveillance.
From a business perspective, medical device & technology (or MedTech) companies may face challenges such as resource constraints, a lack of familiarity with the regulation, and the need to update older products to comply with the EU MDR. On the technological front, medical device manufacturers may struggle with disjointed and siloed systems, particularly in light of the EU MDR's requirement for comprehensive, data-intensive total product lifecycle management.

Navigating the EU MDR as a Medical Device Manufacturer

Medical Device

Medical Devices

Med Tech

European Medical Device Regulation

Quality Management

Regulatory Compliance

Digital Transformation

Product Lifecycle Management

Regulations

Get powerful life science insights from influential experts. Connect with thought leaders and colleagues to get the most up-to-date knowledge on strategies and initiatives to accelerate the transformation of U.S. and global health care from a volume- to value-based marketplace.

Navigating the EU MDR as a Medical Device Manufacturer

Presented by

About this talk

More from this channel