Bringing Innovative Medical Devices to Market Faster with SOLIDWORKS

Written by: Dassault Systemes UK Ltd | Published:

Medical equipment manufacturers face increasingly demanding regulatory requirements that raise the costs and risks of product development. Success in this challenging environment requires faster innovation with shorter design and validation cycles that reduce both time–to–market and engineering costs while simultaneously supporting regulatory compliance standards. Learn how you can create life-changing medical products while navigating the challenging regulatory environment.

INTRODUCTION TO MEDICAL EQUIPMENT MANUFACTURE

Today, medical equipment manufacturers face increasingly demanding regulatory requirements

that raise the costs and risks of product development. Stringent federal Food and Drug

Administration (FDA) regulations (21 CFR Part 11) require careful and comprehensive

documentation of your work, such as maintaining a design history file with the analysis

(simulation) results that provided the basis for each design decision. Without the proper data

management tools integrated into the early development process, your projects are at greater risk

of not meeting FDA requirements.

To manage product development risk, many medical device manufacturers are moving away from

high-end point solutions for mechanical and electrical design, analysis (simulation), product data

management (PDM), and technical communication and toward integrated product development

platforms that address all of these functions. This approach can increase the chances of

success because it accelerates validation of innovative design concepts and automates design

documentation, providing you with the flexibility and agility you need to comply with regulatory

requirements and mitigate risk.

Success in this challenging environment requires a faster process of innovation with shorter

design and validation cycles that reduce both time-to-market and engineering costs. You can

greatly reduce build-and-test cycles by quickly analyzing the performance of many design

concepts in software, then separating out the viable concepts for further testing, trials, and

development. Using integrated design analysis tools, you can more efficiently evaluate the

performance of a design under a wide range of usage, handling, and storage scenarios, such as

determining what will happen when a surgeon drops a surgical instrument on the floor, during

early conceptual design.

Many relatively small medical device companies cannot easily afford the high cost of providing

the people and infrastructure needed to support high-end design and analysis tools. Yet these

companies still need to expand their industrial design and analysis capabilities in order to compete

successfully against the increasing number of medical products sold directly to consumers.

The SOLIDWORKS Product Portfolio can help you meet these challenges by delivering a complete,

easy-to-use and simple-to-administer solution. Powerful part definition and flexible industrial

design tools foster product innovation while integrated software prototyping, validation, and

simulation tools help create better products the first time. Comprehensive data and design

management capabilities support regulatory compliance while providing collaborative team tools,

better communication, and version control. With SOLIDWORKS Inspection, MBD, and Composer

you can communicate your designs for medical devices and components more efficiently to

manufacturing, allowing you to get your products to market faster than ever.

SOLIDWORKS provides the necessary core product definition, collaboration, manufacturing,

and documentation tools to beat competitors to market. In addition, a wide range of powerful,

integrated analysis capabilities allow you to evaluate the performance of your design concepts

as you create them. Whether you need to evaluate fluid flow, sustainability, frequency analysis,

buckling, drop tests, mechanical stresses, or the effects of temperature, the SOLIDWORKS

Product Portfolio enables you to analyze designs quickly without ever leaving your familiar

modeling environment.

By utilizing the assembly and component configuration management capabilities in SOLIDWORKS

Premium, you can develop and manage families of assemblies and parts with different

dimensions, materials, capacities, and other properties. SOLIDWORKS software makes it easy to

manage the decision-making process. You can store and track each version of a design, along with

the analysis results and other details, which document the engineering decision-making process.

With SOLIDWORKS software, you also have the necessary surfacing capabilities for developing a

modern, stylized design that is as visually appealing as it is functional.

To access the rest of the white paper, please click here: https://www.solidworks.com/media/bringing-innovati...


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