Philips Healthcare turned to Mectalent to find a solution for certain use cases of a magnetic resonance-controlled ultrasound device. The device, which is sold worldwide, is for example, used to treat cancerous outbreaks that are difficult to treat surgically.
The challenge arises when treating patients with scar tissue on the skin with the Sonalleve MR-HFU.
During treatment, an ultrasound pulse heats the tissue, which can cause a burn to the scar. For the method of treatment to be used safely with all patients, our customer wanted to find a way to shape the ultrasound beam on the skin, so that the scar tissue would not heat up. Thus, a medical device was needed to protect the skin.
Developing and manufacturing medical devices under one roof
All our customers benefit from the fact that at Mectalent, products are developed and manufactured under the same roof. Our designers develop products specifically with our own, familiar manufacturing methods in mind. This speeds up the process and improves quality.
The development of the device ordered by Philips Healthcare started from a clean slate. First, the designer had to find out how the different requirements are met so that there are no risks for the end user, and at the same time take into account e.g.
How the device is assembled
How the device is cleaned
How to pack the device
How the device works clinically
What kind of risks there may be to the patients
We use mechanical simulations and thermal design to help with product design. With the help of simulations, the devices can be tested virtually and the customer's requirements for the product can be met even before the prototype is built. This speeds up the design process and is reflected in the total cost of the device.
Certified ISO 13485 quality system
The device we made for Philips Healthcare, Quick Cover, was an all-inclusive solution to the customer. In practice, in addition to design and manufacture, it meant multi-stage analysis and clinical testing of the product. We took care of technical documentation and operating instructions.
We also handled matters related to product regulatory approval. The CE mark indicates that the product meets the requirements of the relevant EU directives.
At Mectalent, the design and production of medical devices is based on a certified ISO 13485 quality system. It ensures compliance with legal safety requirements and risk management at different stages of the product life cycle.
> Contact our sales if you want to learn more about the development and manufacturing services we offer.