Medical Device Design 

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Role: Design Researcher + Physical Product Designer


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Problem 

Arterial blood provides clinicians with critical information but drawing the blood can be challenging. The radial artery is deeper than surrounding veins, making it difficult to locate. This often results in the physician having to "stick" the patient more than once to complete a successful draw. This causes frustration for the physician and pain and anxiety for the patient. 

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Solution

We created a single-use, disposable wristband that helps clinicians locate the radial artery to enable quicker and more accurate arterial blood draws. An indication light tells the user where the artery is located and guides their needle placement. It is designed to work with existing vital monitors and is adjustable to fit a range of adult patients.  

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Value Proposition

By making arterial blood draws easier, any clinician would be able to perform them efficiently regardless of experience - minimizing error, saving time, and improving the patient's experience. Patient satisfaction increases and physicians have more time to focus on more important, demanding procedures. 


Teammates:

Rahul Chandrawanshi (Engineering/Design)

Spencer Workman (Clinical)

Chris Nash (Clinical)

Filipe Mesquita (Business/Marketing)

Daniel Drabarz (Law)

Personal Contribution:

  • Product Management - evaluation of user, market, & regulatory needs and development of product requirements
  • Evaluation of concepts based on desirability, feasibility, and viability 
  • Primary and secondary research
  • Stakeholder needs analysis
  • Development of design imperatives
  • Prototyping and testing
  • Patent preparation
  • Final product sketch, product name and logo design
  • Presentation to medical device executives

Getting ready to shadow in the Interventional Radiology Surgical Suite

Needs Finding and User Research

Goal of research was to identify an unmet medical need by conducting contextual observations and interviewing medical professionals in a variety of specialties and clinical environments.  

  • Conducted secondary research to prepare for shadowing by reading journal articles and analyzing industry trends
  • Shadowed nurses and physicians, observed procedures, and interviewed clinicians in ER, ICU, and interventional radiology
  • Interviewed Director of Operations and Supply Chain and other purchasing stakeholders to understand how a new medical device is adopted
  • Identified over 50 potential design opportunities. 

Opportunity Identification

Stakeholder analysis - identified physicians and nurses as our primary stakeholders 

As a team, we evaluated the desirability, feasibility, and viability of the different opportunities we had identified during our research. We decided to tackle improving arterial blood draws based on the positive feedback we received from clinicians and purchasing managers.   

Key Observations: 

  • Found that physicians sometimes had to  “stick” patients several times because of the difficulty in locating the radial artery 
  • First attempt success rate of stick depended on clinicians experience level
  • Ultrasounds can be used to locate the artery but are expensive, not readily available, and require training to use
  • Who performs the procedure (nurse or physician) varies between hospitals 

Design Imperatives and Prototyping

From our user research we developed high-level design imperatives that we used to guide our design concepts. Over the course of several weeks, we tested several different sensor technologies and iterated on the physical form the device would take. We took inspiration from existing pulse oximeters and hospital identification wristbands. 

    High-Level Design Imperatives

    1. Device must be able to locate the radial artery and 1. signify to the user where the artery is located and 2. where to stick the needle
    2. Require little training - can be used by nurses or physicians
    3. Fit into current hospital workflow
    4. Must be packaged with or stored near rest of arterial blood draw equipment (needle, iodine swab, etc.) 
    5. Must be able to fit most adult patients
    6. Must be able to be used by one person (i.e. must not complicate the existing arterial blood draw process)

    Prototype Testing

    Video of my teammate Rahul and I testing our prototype. You can see on the oscilloscope distinct peaks and valleys in the voltage reading, those peaks and valleys are a visual representation of the arterial pulse. The radial artery is distinct from the surrounding tissue in that it is pulsatile, i.e. the volume of blood changes through the artery based on the heartbeat. We are able to see the pulse, because as the volume of blood changes (pulses) through the artery, the amount of light absorbed by the passing blood also changes. We can detect that change in absorption with our sensor and therefore differentiate the radial artery from the surrounding tissue that has constant absorption. This can be seen as Rahul moves the sensor off his radial artery, the waveform disappears and then reappears as he moves it back over his artery. 


    Final Deliverable & Impact

    My team and I delivered a minimally viable prototype that was able to locate the radial artery by detecting the radial pulse and using that to differentiate it from the surrounding, non-pulsating tissue. Our product concept was pitched to high level medical device executives and received high praise from both clinical and business stakeholders. A provisional patent for the technology has been filed. 

    Sketch of the future embodiment of the product concept

    With my team at the design expo demoing our final prototype