Case study

Wearable cardioverter defibrillator vest

  • FDA approved wearable cardioverter defibrillator (WCD) vest, for patients who are at risk of Sudden Cardiac Death (SCD).
  • Customer was looking for a overmoldable, fully encapsulated, medium powered vibration motor.
  • In partnership, we designed an encapsulated motor, completely sealed, and validated it for low pressure overmolding.
Home » Case Studies » Wearable Cardioverter Defibrillator Vest

Challenge

  • Our client required a fully encapsulated, high reliability, medium powered vibration motor, for tactile vibration alerting.
  • The vest had to be washable and therefore it was important to prevent ingress of water into the motor. The eccentric rotating mass was free to rotate by virtue of the hard-case encapsulation. When worn the vibration had to be strong enough to penetrate any fabric and clothing worn.
  • Pricing was flexible but reliability was an area of concern for our client.

Solution

  • We worked closely with the customers team to develop two possible motor solutions.
  • After testing both solutions, we manufactured an encapsulated vibration motor, which was then further sealed, for complete IP68 protection against water ingression.
  • We worked with the customer to validate the end solution fully, before preparing manufacturing jigs and processes to go into mass production.

Results

  • A custom vibration motor was developed that addressed the unique design problems, faced by the customer.
  • The device received FDA Certification and has has been successfully launched into the trial market with secondary market with their launch dates brought forward.
  • We have an ongoing relationship with the customer to support their future projects.

Project scope

Tactile vibration alerting with a high realiability

Our customer approached us as they were designing a FDA approved wearable cardioverter defibrillator (WCD) vest, for patients who are at risk of Sudden Cardiac Death (SCD).

These patients could not have a surgically cardioverter defibrillator (ICD) fitted, and therefore the defibrillator has to be worn externally. The device monitors the heartrate patterns of the wearer and, and in the case that defibrillation event is needed, the unit sends an audible and tactile warning to the user. This is so that user can pull over, if for example, they’re driving.

As such, it’s very important that the vibration motor is reliable, particularly after the vest has been washed, and that’s where the need for full IP68 encapsulation was needed. The motor was to be further overmoulded as part of the application, so it also had to withstand the heat generated by the overmoulding process.

We worked with the customer to develop a bespoke solution, and after extensive validation we brought the module into ongoing mass production.

Our customer approached us as they were designing a FDA approved wearable cardioverter defibrillator (WCD) vest, for patients who are at risk of Sudden Cardiac Death (SCD).
FDA approved wearable cardioverter defibrillator (WCD) vest
These patients could not have a surgically cardioverter defibrillator (ICD) fitted. The device needed to be able to monitor the wearer’s heart and send a warning alert to the wearer ahead of delivering a treatment shock to restore a normal heart rhythm.
Tactile vibrating alert sends a warning to the wearer

STAGE 1

Working together

  • Our client required a fully encapsulated medium powered and highly reliable vibration motor.
  • It was important to reduce the risk of the motor coming into contact with any moisture and material as part of the overmould process.
  • The customer was flexible on price but had high quality expectations. Their primary concern was the solution meeting the reliability needs of the application.
  • Working with their design team, our engineers built a specification based on shared input and ideas to create a collaborative partnership.

STAGE 2

Motor design and testing

  • Their team were open to the changes in design we suggested to overcome production challenges.
  • After testing, our solution was an encapsulated motor, fully sealed, creating an IP68 unit which could then be overmolded by the customer, in their application. 
  • We developed and manufactured a completely sealed vibration motor with circuitry encapsulated, totally removing the risk that material would ingress, and offering a further line of defence against water, when the vest was washed.

STAGE 3

Results and relationship

  • The device received FDA certification, and the product has been successfully launched into the trial market. The launch date for a secondary market has been brought forward.
  • Our customer was pleased with our collaborative approach, and we were able to develop a solution that met their exact needs and specification.
  • We also felt that there would be a need for this type of fully encapsulated motor in other market sectors, so we have added an adapted version to our catalogue as a standard part, enabling us to offer it as a solution to other customers.

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