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Updated: May 23, 2026

Rapid and Low-cost Prototyping of Medical Devices Using 3D Printed Molds for Liquid Injection Molding
Published on: June 27, 2014
Lower cost and faster product approval through proper software design controls
Kevin Stevens1, Anthony Johnson
1Kevin Stevens is president and chief software engineer at Blue Mars Software, Buffalo, N.Y. He also is a strategic partner of Buffalo Biosciencies.Anthony Johnson is partner at Buffalo Biosciences, and president and CEO of Empire Genomics, also in Buffalo.
Software programming is critical for medical device market success. Neglecting software development can result in expensive recalls and legal liabilities.
Area of Science:
- Medical device engineering
- Software development for healthcare
Background:
- Market success of medical devices is increasingly tied to sophisticated software.
- Historically, software has sometimes been treated as a secondary consideration in device development.
Purpose of the Study:
- To highlight the integral role of software in medical device functionality and market viability.
- To emphasize the risks associated with inadequate software development focus.
Main Methods:
- Analysis of industry trends in medical device development.
- Review of case studies involving device recalls and liability issues related to software.
Main Results:
- Software is a primary driver of medical device performance and user experience.
- Insufficient attention to software programming directly correlates with increased risk of market failure.
Conclusions:
- Prioritizing robust software development from the outset is essential for medical device success.
- Addressing software as a core component mitigates risks of recalls and legal challenges.
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