Helena Laboratories Medical Device Design and RenderingCompetition, regulation, rising costs, and organizational complexity are among the most challenging demands in the medical device manufacturing industry. Manufactures must find the way to stay in control and address these evolving complexities. Companies are turning to Product Lifecycle Management (PLM) software to do just that. PLM solutions help companies like yours run at its highest efficiencies and encourage collaboration and decision-making centered around managing complex data.

Data gathering and management is crucial with the complex medical products on today’s market. Having the ability to integrate all cross domain knowledge together in a single, logical location and making it available to persons throughout the company allows for decisions to be made anywhere in the process. This data management allows for collaboration to manage the increasingly complex processes.

Regulatory Requirements

Traceability, quality standards, and materials compliance are among the list of regulations present in the medical device industry. To stay in compliance with these regulations, companies must stay in control of their product development and all documents created in R&D, manufacturing, and throughout the supply chain.

Systems Engineering and Risk Management

As products become increasingly more complex, companies must learn to simultaneously manage their risks involved in many different processes. Medical device manufacturers also face challenges centered on globalization and meeting the needs of their consumers from emerging markets to include different features and price points. To stay competitive, companies like yours need to leverage your development and manufacturing resources to synchronize with the world around them. PLM solutions allow companies to do just this.


Competition is constantly increasing with new products introduced to the market every day. Maintaining your market share in a growing and evolving industry can be difficult. You must utilize your resources to create a sustainable competitive advantage including a strategy for powerful design and data management.

Increasing Costs

All medical device manufacturers are constantly affected by rising costs including new taxes, scarce recourses, and the increasing cost of healthcare. These expenses require manufacturers to look elsewhere to reduce costs. The software and PLM solutions we offer help companies, including medical device manufacturers, run a more efficient design through manufacturing processes which in turn reduces the costs involved in product development and manufacturing.


Data Management