Diaphragm Therapy System

Lungpacer Medical

AeroPace® Neurostimulation Console

Background

Lungpacer Medical asked Shore to help them bring their innovative AeroPace® System to life – a minimally invasive device that strengthens the diaphragm and supports critically ill patients in weaning off mechanical ventilation.


This ground-breaking therapeutic solution addresses the widespread issue of ventilator-induced diaphragm weakness, promoting natural breathing and reducing Intensive Care Unit (ICU) stays. Recognising our expertise of transforming core technologies into successful products, Lungpacer approached us to develop the Neurostimulation Console used to place, map, customise and control the catheter electrodes attached to the phrenic nerve in a fully realised device.


Firstly, we conducted in-depth ethnographic research across respiratory wards in Europe and the USA, observing and interviewing key hospital stakeholders to gain a comprehensive understanding of the needs of nurses and maintenance staff. These valuable insights guided us in defining the intended use and environment for the product, directly shaping its specifications.


Our experts in industrial design, user experience, user interface and engineering all worked in parallel on developing the system, while adhering to regulatory standards for medical electrical equipment and human factors engineering guidelines.


Now, the AeroPace® System has achieved a significant milestone: FDA premarket approval (PMA), making it the first device of its kind to earn this distinction.


Visit Lungpacer’s website to read more about the AeroPace®.

Value Delivered

  • Complete development including core device, hand controller and cart.
  • Compact design, fully compliant with IEC 60601-1-11:2015.
  • Legibility, functionality, and ergonomics fit for the ICU environment.
  • Transferable, flexible supply chain to support trials and initial production.

Project Scope

Research & Planning, Human Factors, Industrial Design, User Interface (UI) Design, User Experience (UX) Design, Prototyping & Testing, Engineering, Mechanical Engineering

Project Scope

Research & Planning

Human Factors

Industrial Design

User Interface (UI) Design

User Experience (UX) Design

Prototyping & Testing

Engineering

Mechanical Engineering

Sector

Therapeutics

The AeroPace® System received FDA premarket approval in December 2024. 

It’s the first device of this kind to be approved.

“We’re thrilled for the Lungpacer Medical team. The AeroPace®’s PMA marks a major milestone in the advancement of this ground-breaking technology. Collaborating on every aspect of the system’s development has been a privilege, and we’re very proud of our partnership”

James McLusky, Director and Project Lead, Shore

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