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.
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