A flow chart was utilized to visualize the iterative design process for this project.

 

The itemization below shows a summary of our process.

• Medical Problem:
  • Pocket hematoma formation at cardiac implantable electronic device (CIED) sites.

• Proposed Solution:
  • Design of a compression vest at the CIED site
  • Design criteria include:
    • High motility
    • Cost-effectiveness
    • Appropriate pressure 
• Design Features:
  • Torso straps for mobility and fit.
  • Durable, breathable elastic fabric over the cardiac device site.
  • Integrated PVC airbag for customizable compression controlled by an air pump-button.
• Design Process:
  • Preliminary 2D sketches showing the shape and fit of the device.
  • Development of a 3D computer-assisted design (CAD).
  • 3D printing of the CAD design for visualization.
• Prototype Development:
  • Build a prototype using materials outlined in the design criteria.
  • Test effectiveness through clinical trials with a target population of 60+ year old male and female patients.
• Clinical Trial Evaluation:
  • Assess the need for design changes based on trial outcomes.
  • Review results with patients and clinicians to identify potential sources of error (e.g., mechanical, design-related, manufacturing, ethical).
  • Make revisions and develop a new design if necessary.
  • Retest the revised design in clinical trials.
• Finalization Process:
  • If no further changes are required, finalize the design.
  • Add customizable options and features for users.
• Regulatory and Production Steps:
  • Apply for a patent and Class II medical device classification.
  • Obtain necessary certifications and comply with guidelines before mass production and marketing.
• Post-Market Monitoring:
  • Monitor patient satisfaction.
  • Ensure continued compliance with safety certifications.