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Case Study Spotlight

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Navigation System for Spinal Surgery
with Bolt
From 2020 to 2021, LHF provided complete human factors support to a start up device company called Bolt® Navigation (Bolt). From HF strategy and risk documentation to IFU design and usability testing, our team provided it all for Bolt’s one-of-a-kind spinal navigation system for the placement of pedicle screws. With our help, Bolt was able to develop a safe and usable system that improves accuracy and efficiency for surgeons and the surgical staff. The Bolt Navigation System received FDA market approval in December 2023.

Additional Case Studies

Due to NDAs and MSAs, LHF is not able to provide full case studies for every project we've completed. The following case studies may have generalized device or company information, stock pictures, and/or media of prior generation products to avoid revealing proprietary details.
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Medication Management System
with Medical Company

Services:

  • Wireframe and icon design 

  • IFU and QRG design 

  • Expert review 

  • Formative and summative studies

  • Online survey

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Chest Drains
with Medical Device Company

Services: ​

  • HF strategy  

  • HF-UE plan 

  • URRA development and refinement 

  • Aseptic presentation study 

  • Design recommendations 

  • Formative and summative studies 

Past Projects

Due to NDAs and MSAs, LHF is not able to provide full case studies for every project we've completed. However, you can find details about some of our projects that can be partially revealed below. 
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Ventilator

Services:

  • UE plan

  • Use specification

  • Task analysis

  • URRA

  • Formative comparative study 

  • Pre-summative study

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Drug Delivery System

Services:

  • Use specification

  • Task analysis

  • Concept and storyboard generation 

  • Remote exploratory study with card sorting, VOC pain point identification, and concept selection 

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Oxygen Concentrator

Services:

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RFID Localization System

Services:

  • 2 summative studies

  • Stakeholder interviews

  • EU MDR gap analysis

  • Regulatory advice

More to come!

"I have heard a lot of great things about LHF, and that means a lot because our team is very passionate and expects a lot from their partners. I usually hear some good things, but literally hearing all good things from multiple team members is very uncommon. So we know we are working with the best."

~ Anand Krishnamurthy, Becton Dickinson

CONNECT WITH US

 

beth@loring-hf.com

(978) 799-9359

Loring Human Factors, Inc.

9 Cornerstone Square

B400 #122

Westford, MA 01886

© 2024 Loring Human Factors, Inc.

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