Malinda Elien

Malinda is a Principal Technical Program Manager at Fresh Consulting who brings a systems engineering viewpoint to projects. With a deep background in medical device development, she has served in various product development roles, including Director of Engineering and Program Management, for over 25 years.

She has worked at a variety of companies from Fortune 500 to startups, but prefers product development consulting firms where she can leverage her experience from all aspects of medical device development to benefit her clients and help them efficiently make products that will have a positive impact on lives.

Malinda earned a bachelor’s and master’s degree in aerospace engineering from MIT and is a certified PMP (Project Management Professional).

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6 Requirements for Successful Medical Device Development
Product Development

6 Requirements for Successful Medical Device Development

Outsourcing development is a strategic approach that can accelerate product development and expedite time to market. However, it requires careful planning and management to ensure project success, especially for those new to product development. The six themes below are critical as you consider engaging with a company to help you get to market. Requirement #1:
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Medical Software Development: Tips for Choosing a Partner
Product Development, Robotic Software Development, Software

Medical Software Development: Tips for Choosing a Partner

Special care is needed to avoid a tumultuous project with disappointing results when outsourcing a medical software development project. When a company is not experienced in software development, an additional understanding of the unwritten expectations that a software development partner will bring to the table becomes critical for success.  Outsourcing software development can be a
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Medical Device Development: The “It’s Just Software” Myth, Debunked
Product Development, Software, Uncategorized

Medical Device Development: The “It’s Just Software” Myth, Debunked

Medical device development, optimized Medical device designers understand why the phase gates in the hardware design process are necessary to keep medical device development and system integration efforts on track and moving forward. But with the introduction of complex software into the product development equation, staying true to the gated development process can be difficult. 
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Medical Device Software: Strategies for Seamless Development
AI/Machine Learning, Hardware, Product Development, Software, Technology Architecture, Web App Development

Medical Device Software: Strategies for Seamless Development

This article is part of an ongoing series on successfully outsourcing medical device software development and software development for other healthcare technology products. Outsourcing medical device software development has the potential to accelerate product development and expedite time to market, but remember that the process of developing software is different from developing hardware.  The first
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