Defibrillator

Andrews-Cooper has worked extensively across the design and engineering of this Class III medical device. Although we are not seeking work with any competitor to our key client in this area, we offer this information solely to demonstrate the range of capability we bring to any medical device firm and development project we work with.

New Device

The Philips HeartStart XL+ is a durable crash cart defibrillator and cardiac monitor.  Philips had already established an overall strategy for the look, feel and construction of the device.  Andrews-Cooper led the mechanical engineering of the device including a focus on several areas of the design that needed refinement.  This included a number of A-C personnel integrating their efforts with internal client efforts over a multi-year development effort.  The approach included:

  • Prototype: Several rounds of prototypes were built in order to make sure that the concepts met all the requirements with no surprises during detailed design.
  • Detailed Design: Detailed part design was completed for each component, making sure that the components that Andrews-Cooper was responsible for would work seamlessly with those designed by the clients internal engineers.
  • Review: Rigorous review sessions were held with the client’s engineering team as well as a multi-function team including suppliers, manufacturing and support personnel.  Designs were adjusted based on those reviews and then released for a prototype build using rapid-prototyped components. After the designs were proven by prototyping and testing, final design adjustments were made for part manufacturing.  Several large, complex injection molded parts were designed by Andrews-Cooper for this project.
  • Testing: The testing process was shared by our company’s resources and the client’s internal resources. Test plans and procedures were written, reviewed, and approved. Tests were assigned to team members to complete, and the overall test effort was managed by our lead engineers.
  • Design for Production/Manufacture: Andrews-Cooper worked with a 3rd party to create purchasing specifications and sourced the supplier for the molding.

Results:  Drawing on over 75 years of principle-level engineering experience in defibrillator development, Andrews-Cooper became a seamless extension of the customer’s engineering team on what would become a flagship product


Sustaining Engineering

The Philips HeartStart MRx defibrillator is a durable cardiac monitor made for real-time communication between an ambulance and a hospital to allow hospital staff to have patient data prior to their arrival. It features patient data transmission through wireless network and cellular transmission capabilities. This class III medical product is currently targeted for the EMT environment.  The Philips staff was preoccupied with other tasks but wanted to release an additive feature to this product.  A-C worked with a third-party vendor to deliver the upgrade. Independently, we did the mechanical design for the enclosure and supplier oversight.  The client was most concerned with minimizing time-to-market. The competition already had a product in the market, so project delivery was critical. Andrews-Cooper takes project urgency seriously and delivers results with adequate speed while also ensuring functionality.


Paddle Design

Andrews-Cooper has been significantly involved in multiple paddle design projects.  These efforts have included durable and disposable designs.  The most recent project approach included:

  • Industrial Design: With a new generation of defibrillator paddles, the user interaction was critical.  This necessitated that industrial design play a major role in the concept phase of the project.  Andrews-Cooper rose to the challenge by providing the effort – several concept sketches were generated and the two favorites converted to foam core models.  Further refinements were made based on user-group studies and a final concept was selected.  Concepts for meeting each mechanical and electrical requirement were defined and integrated in to a single implementation strategy.
  • Prototype: The refined concept was prototyped and subjected to additional client and user-group review.  A careful review process, required by the client, allowed close interaction with the physical geometries and validated overall product shape and styling.
  • Mechanical Design: We began with mechanical engineers finalizing the part break up (deciding how to split the product into pieces that could be injection molded). This process required careful attention to ensure all design requirement strategies (water seal, manufacturability, ruggedness, etc.) were maintained. All parts were carefully evaluated and optimized for function; where possible parts were combined to reduce part count.  Each part was scrutinized to ensure maximum functionality.  The detailed design phase culminated with a completely detailed 3d representation of each part.
  • Electrical Design: We provided the circuit design and selected flex circuits as most economical platform implementation. With button locations in multiple planes, LEDs mounted on an arc, and both High and logic voltage requirements; flex circuits were a practical, cost-effective solution. RoHS parts and processes were mandated.
  • Analysis: A rigorous analysis phase ensued where analytical tools such as finite element, draft analysis, mold flow and geometric tolerancing were employed where appropriate. Reviews with injection mold tool makers, material suppliers and regulatory representatives provided additional refinements to each part.

Software Localization

Andrews-Cooper engaged to provide a senior resource to this leading medical device firm.  The resource led a software localization project coordinating internal and external resources to complete software translation/verification into 19 languages for distribution to 69 countries.


Benefits

  • Faster time to market
  • Cost efficiency – variable staffing model
  • Virtual bench – access to a wider range of technical expertise
  • Risk reduction – ability to phase a trusted partner onto a development effort without added risk
  • Synergy – the benefits of working time after time with a strong 3rd party engineering team

A-C Responsibilities

  • Initial Study
  • Industrial Design
  • Prototype
  • Engineering
    • Mechanical
    • Electrical
    • Software
    • Manufacturing
  • Manufacturing
    • Transfer to Production
    • Production Support
  • Sustaining Engineering

Medical Product Case Studies