Quick cover – protecting scar tissue
”Mectalent made a completely finished product, which means that we not only planned and manufactured it but also performed multiphase analyses and clinical testing on it.”
Juha-Pekka Nuutinen, Mectalent
Quick Cover is a solution for a product already on the market that requires certain patients to be especially careful. Philips asked for such a solution, and Mectalent delivered.
The solution in question was for Philips Healthcare’s magnetic resonance-controlled ultrasonic method Sonalleve MR-HIFU. The device is sold all over Europe and used, for example, for treating cancerous focuses that would be difficult to treat surgically.
From challenge to solution
The challenge was faced when treating patients with scar tissue on their skin, for example, from a Caesarean section.
The ultrasonic pulse heats the tissue, which can result in a burn on the scar. To be able to use the method for patients with scar tissue, a medical device is needed to protect the skin.
“You have to be able to shape the ultrasonic beam on the skin so that scar tissue doesn’t accumulate heat,” says Juha-Pekka Nuutinen of Mectalent. “We started from a clean slate: from planning the Quick Cover, a device to protect scar tissue. Mectalent made a completely finished product, which means that we not only designed and manufactured it but also performed multiphase analyses and clinical testing.”
The end product after many stages
“What do we make it from and how; how do we clean and pack it; how does it work clinically; what are the potential risks for patients; manuals; translations; and how will we fulfil the various requirements so that there is no risk for the end user,” Nuutinen gives examples of the work stages.
Mectalent also took care of acquiring the approvals demanded by the authorities. The CE-marking is a guarantee that the product fulfils the requirements of the pertaining EU directives.