Improving quality of life and quality of care
Wearable medical device development
Health innovations and wearable technology
We’ve developed a wide range of health and medical wearable devices, both independently and together with partners. These wearables take advantage of the latest advances in electronic textiles and medical science to:
- Improve the daily lives of people with medical conditions, such as balance disorders.
- Help medical practitioners such as neurosurgeons perform their work more safely and efficiently.
- Facilitate research into new and innovative ways to address disabilities or other medical conditions.
To discuss your own ideas for wearable medical devices, please get in touch with us.
Contact us
Interested in learning more about the possibilities? Make sure you check out our free webinar on realising the potential of haptic technology for medical wearable devices!
Our expertise in medical wearable design and development
Elitac Wearables is not like any other product design agency. Our multi-disciplinary team of hardware and software developers, product and textile designers, bio-medical engineers and researchers, all have a rich experience in the development of wearable medical devices and a thorough understanding of bio-medical principles.
Medical soft goods development
These days, quite some corporates and agencies have the ability to develop medical devices. But as soon as the device has a textile or softgoods component to it, becoming a medical wearable device, most companies start to struggle.
First of all, they don’t know how to design for textile components. Textile, with its’ flexibility, elasticity and specific way of handling and production, is always hard for conventional engineers, who are used to rigid plastics and metals.
Next to that, textiles for wearable medical devices need special certification; like for bio-compatibility. At Elitac Wearables, we know material to use when, and where to source it.
When going to production or assembly with your development, it is important to have the right partners. Elitac Wearables has a vast network of companies able and willing to work with both electronics and textiles. This is rare, considering that the production of electronics and the production of textiles are two completely different worlds with their own requirements. It becomes especially rare when producing medical wearable devices, as the certification and legislation becomes more prevalent.
Read more about Medical Softgoods Development.
A selection of our health and medical wearables
BalanceBelt
The BalanceBelt is a medical class 1 wearable device, helping people suffering from severe balance disorders. It was developed in-house in line with medical documentation for medical wearable device development. It is being produced by a certified manufacturing partner in the Netherlands.
The BalanceBelt is a collaboration between Elitac Wearables, Prof. Dr Kingma, and the MUMC+.
Read more about the BalanceBelt.
FSS - Flight Sense System
The Flight Sense System enables real-time medical grade physiological monitoring and post-flight feedback for fighter pilots. It features ECG, respiration, movement tracking, and more within a single textile wearable garment.
This innovation aims to enhance the safety and well-being of fighter pilots during future flights. Although the FSS is not yet medically certified, the components used are developed with medical wearable device certification in mind. Some subcomponents are already received medical certification in other use cases. We plan to medically certify this product at a later stage in development, when the design and development is finished and the product will be officially launched.
The project is a collaboration between Elitac Wearables, 2M Engineering, TNO and the Ministry of Dutch Defence.
Read more about the Flight Sense System.
NeuroShirt
The NeuroShirt is a haptic feedback enabled shirt that helps guide neurosurgeons during skull base surgery to prevent damage to critical structures such as veins and nerves. It reduces workload and risk during surgery. It is also considered a medical wearable device, as it is a tool for a surgeon.
One could compare it to a ‘car-parking-sensor’, giving information about the object (in this case the drill-bit) in relation to other objects.
Distance and direction to critical object can be depicted to an accuracy of 0.3 mm!
It is a collaboration between Elitac Wearables and the UMC Utrecht (NL), with financial support from Kansen4West(G4P4) and the European Regional Development Fund.
Read more about the NeuroShirt.
Frequently asked questions about developing medical wearable devices
What types of medical wearables can you develop?
First of all, orthoses (like supportive or compression wraps) and prostheses are a logical ‘wearable’ development, combining electronics and textiles.
Next to that, active therapy devices such as muscle stimulation (EMS) braces, direct haptic feedback devices, helping people with correct movement.
And last but not least; ECG and other continuous medical parameter monitoring. There is a big trend and demand for more comfortable, high accuracy (medical grade), out-of-hospital devices.
How do you ensure compliance with regulatory standards (e.g., FDA, CE) in medical wearable development?
At Elitac Wearables, we take pride in documenting our requirements, design decisions and sticking to a set process, which continuously validates the design to the set requirements.
We work with experienced and trusted partners, who are certified or provide certified materials and components.
What is your process for developing a custom medical wearable device from concept to production?
In short:
- We set up technical documentation, requirements, risks and evaluation methhods for the medical wearable device.
- We define the Intended Use (and use case), on which the medical classification can be based.
- We develop in an iterative manner, documenting our design choices, and validating them.
- We select certified partners, like suppliers and medical institutes.
Find more information about our development process.
Can you integrate your medical wearable devices with other healthcare systems or platforms?
Yes we can! We need an API (An application programming interface) or provide other parties with our SDK (software development kit) so that we ensure the systems can communicate correctly.
We don't like to brag, but our medical wearable devices make a difference
”Thanks to Elitac Wearables' experience with haptic feedback, usability and the scaled production of wearable electronics, we were able to develop a lightweight, comfortable and cost-effective version of the BalanceBelt.
Prof. Dr Kingma, Maastricht UniversityBalanceBelt development partner
”Thanks to the BalanceBelt, I am still able to live an active life, which wouldn’t otherwise be possible.
Mr van TijenBalanceBelt user
”The NeuroShirt […] helps us to know where we are and where the dangerous structures are, which we are trying to avoid.
Prof Dr. J.W. Berkelbach vd Sprenkel, UMC UtrechtNeuroShirt development partner
Contact us
Interested in developing a medical wearable device with us? We’d love to hear your ideas! Leave your details in the form and we’ll get back to you as soon as possible.
