--- title: Innovation Vault - Blog | Gregory Montalbano description: Gregory Montalbano is the Co-Founder and CEO of MIDI Medical Device Development in Smithtown, New York. --- [CALL: 631-467-8686](tel:631-467-8686) [CALL ![](https://blog.midipd.com/hubfs/MIDI_April_2020_Theme/Images/call.png)](tel:631-467-8686) [EMAIL ![](https://blog.midipd.com/hubfs/MIDI_April_2020_Theme/Images/email.png)](mailto:innovation@midipd.com) [![MIDI](https://blog.midipd.com/hs-fs/hubfs/raw_assets/public/MIDI_April_2020_Theme/images/logo.png?width=200&height=2048&name=logo.png "MIDI")](https://www.midipd.com/) - [About MIDI](https://www.midipd.com/about.php) - [Our Process](https://www.midipd.com/process.php) - [Services](https://www.midipd.com/process.php) - [Case Studies](https://www.midipd.com/gallery.php) - [Healthcare Strategy](https://www.midipd.com/healthcare.php) - [Innovation Vault](https://info.midipd.com/podcast) - [News](https://www.midipd.com/news/) - [Contact](https://www.midipd.com/contact.php) - [About MIDI](https://www.midipd.com/about.php) - [About MIDI](https://www.midipd.com/about.php) - [Product Experience](https://www.midipd.com/about_product.php) - [Interaction/Environment](https://www.midipd.com/about_interactive.php) - [Development Inputs](https://www.midipd.com/about_development.php) - [Value-Added MFG and Industry Partner Network](https://www.midipd.com/go-china.php) - [Our Process](https://www.midipd.com/process.php) - [Process Overview](https://www.midipd.com/process.php) - [DevelopmentDNA Steps](https://www.midipd.com/process_development.php) - [Regulatory Compliance](https://www.midipd.com/process_regulatory.php) - [Services](https://www.midipd.com/process.php) - [Research (Discover/Uncover)](https://www.midipd.com/services.php) - [Strategic Product Planning](https://www.midipd.com/services_strategic.php) - [Technology & IP Development](https://www.midipd.com/services_technology.php) - [Regulatory & Certifications](https://www.midipd.com/services_regulatory.php) - [Industrial Design/Innovation](https://www.midipd.com/services_industrial.php) - [Usability & Ergonomics](https://www.midipd.com/services_usability.php) - [Mechanical/MFG Engineering](https://www.midipd.com/services_mechanical.php) - [Engineering Analysis](https://www.midipd.com/services_engineering.php) - [Computer Aided Design](https://www.midipd.com/services_computer.php) - [Electrical Engineering](https://www.midipd.com/services_electrical.php) - [Interaction Design/GUI](https://www.midipd.com/services_interaction.php) - [Software Development](https://www.midipd.com/services_software.php) - [Rapid Prototyping](https://www.midipd.com/services_rapid.php) - [Manufacturing Liaison](https://www.midipd.com/services_manufacturing.php) - [Case Studies](https://www.midipd.com/gallery.php) - [Healthcare Strategy](https://www.midipd.com/healthcare.php) - [The Deep Dive: DevelopmentDNA](https://www.midipd.com/healthcare.php) - [Regulatory & Certification](https://www.midipd.com/healthcare_regulatory.php) - [Meaningful Relationships](https://www.midipd.com/healthcare_meaningful.php) - [Designing Globally](https://www.midipd.com/healthcare_designing.php) - [Environmental Field Context](https://www.midipd.com/healthcare_environmental.php) - [Surgeon to Patient](https://www.midipd.com/healthcare_surgeon.php) - [Optimize: Time, Money, Reliability](https://www.midipd.com/healthcare_optimize.php) - [Innovation Vault](https://info.midipd.com/podcast) - [Podcast](https://info.midipd.com/podcast) - [Blog](https://blog.midipd.com/blog) - [White Papers](https://info.midipd.com/white-papers) - [News](http://midipd.com/news/) - [News](http://midipd.com/news/) - [Awards](https://www.midipd.com/contact_awards.php) - [Contact](https://www.midipd.com/contact.php) - [Contact Us](https://www.midipd.com/contact.php) - [Client Zone](https://www.midipd.com/contact_client.php) # Gregory Montalbano #### Gregory Montalbano is the Co-Founder and CEO of MIDI Medical Device Development in Smithtown, New York. - [Podcast](https://info.midipd.com/podcast) - [Blog](https://blog.midipd.com/blog) - [White Papers](https://info.midipd.com/white-papers) [Human Factors Usability Research: How and Where to Apply HE75 in Development](https://blog.midipd.com/blog/human-factors-usability-research-how-and-where-to-apply-he75-in-development) *June 10th, 2024* [![Human Factors Usability Research: How and Where to Apply HE75 in Development](https://blog.midipd.com/hs-fs/hubfs/MIDI_Series%2011_Ep.%204_Soundcloud%20(1).png?width=767&name=MIDI_Series%2011_Ep.%204_Soundcloud%20(1).png)](https://blog.midipd.com/blog/human-factors-usability-research-how-and-where-to-apply-he75-in-development) For well over a decade, the FDA has placed intense focus on how use errors contribute to the majority of adverse medical events. This focus has driven the generation and implementation of... Click Image to Read More [The Overtures of Human Factors Guidance for U.S. Submission, Part 2: Overview of U.S. & International Standards, General & Device Specific](https://blog.midipd.com/blog/the-overtures-of-human-factors-guidance-for-u.s.-submission-part2-overview-of-u.s.-international-standards-general-device-specific) *May 13th, 2024* [![The Overtures of Human Factors Guidance for U.S. Submission, Part 2: Overview of U.S. & International Standards, General & Device Specific](https://blog.midipd.com/hs-fs/hubfs/MIDI_Series%2011_Ep.%203_Soundcloud-1.png?width=767&name=MIDI_Series%2011_Ep.%203_Soundcloud-1.png)](https://blog.midipd.com/blog/the-overtures-of-human-factors-guidance-for-u.s.-submission-part2-overview-of-u.s.-international-standards-general-device-specific) With its numerous steps and intricacies, the process of receiving FDA approval can easily be seen by those working with medical devices as the proverbial brick wall waiting at the end of the... Click Image to Read More [The Overtures of Human Factors Guidance for U.S. Submission, Part 1: Origins & History](https://blog.midipd.com/blog/the-overtures-of-human-factors-guidance-for-u.s.-submission-part-1-origins-history) *April 29th, 2024* [![The Overtures of Human Factors Guidance for U.S. Submission, Part 1: Origins & History](https://blog.midipd.com/hs-fs/hubfs/MIDI_Series%2011_Ep.%203_Soundcloud.png?width=767&name=MIDI_Series%2011_Ep.%203_Soundcloud.png)](https://blog.midipd.com/blog/the-overtures-of-human-factors-guidance-for-u.s.-submission-part-1-origins-history) Meeting regulatory standards and acquiring FDA approval is the last major hurdle to overcome before a new medical device can enter the market, serve its intended purpose, and benefit its intended... Click Image to Read More [The Importance of Human Consideration: Understanding FDA Perspectives on Usability Research & Human Factors Engineering](https://blog.midipd.com/blog/the-importance-of-human-consideration-understanding-fda-perspectives-on-usability-research-and-hfe) *April 15th, 2024* [![The Importance of Human Consideration: Understanding FDA Perspectives on Usability Research & Human Factors Engineering](https://blog.midipd.com/hs-fs/hubfs/MIDI_Series%2011_Ep.%202_Soundcloud.png?width=767&name=MIDI_Series%2011_Ep.%202_Soundcloud.png)](https://blog.midipd.com/blog/the-importance-of-human-consideration-understanding-fda-perspectives-on-usability-research-and-hfe) Medical devices entering the market today have many barriers to overcome before being put into use, and for a good reason. The FDA and other governing bodies, as well as the guidance they set forth,... Click Image to Read More [Introduction to Human Factors Engineering and Its Role in Medical Device Design](https://blog.midipd.com/blog/introduction-human-factors-engineering-and-its-role-in-medical-device-design) *April 1st, 2024* [![Introduction to Human Factors Engineering and Its Role in Medical Device Design](https://blog.midipd.com/hs-fs/hubfs/MIDI_Series%2011_Ep.%201_Soundcloud%20(3).png?width=767&name=MIDI_Series%2011_Ep.%201_Soundcloud%20(3).png)](https://blog.midipd.com/blog/introduction-human-factors-engineering-and-its-role-in-medical-device-design) All products designed for human use must account for the specifics of its users. Everything from physicality to emotional state can influence the success of a product or its failure. This is... 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