pSiMedica - Brachysil™
The Challenge
pSiMedica have developed an exciting and effective device BrachySil™, for the treatment of inoperable primary liver cancer - one of the most common cancers worldwide. The outcome following diagnosis is normally poor. And because the disease tends to present at a late stage, only a small minority of patients benefit from surgical resection.
Brachytherapy is a technique involving the implantation of radioactive ‘seeds’ at the site of the cancer and is a common method of treatment for prostate cancer.
pSiMedica’s BrachySil™ is comprised of highly pure biodegradable silicon particles which have been rendered radioactive. The silicon particles have been developed for direct intratumoural implantation into solid tumours (brachytherapy). The particles remain localised within the implanted liver tumour and deliver a retained and targeted dose of beta radiation.
After developing the concept of BrachySil™, pSiMedica then faced the task of designing and developing a novel implantation device to deliver MULTIPLE implants of silicon particles into the tumour through a SINGLE injection system. Together with Europlaz they developed the SIMPLTM (Single Injection Multiple Implantation) Needle, which allows the placement of multiple aliquots of BrachySil™ at various locations within the tumour.
Europlaz carefully selected materials, outsourced components and designed tools to injection mould the various components of the device. They also developed assembly jigs to assist in the manufacture of individual devices before packaging into specially designed pouches, as well as managing sterility validation trials of the device.
Europlaz currently injection moulds the components and assembles them into devices within a class 10,000 assembly cleanroom (accredited to ISO 14644-1 Class 7). Europlaz then performs a number of quality control tests on the devices before packaging them.
The Solution
pSiMedica were seeking a device contract manufacturer to assist them by managing the device development process from concept design to clinical batch manufacture.
pSiMedica visited Europlaz’s stand at the Medical Device Technology Exhibition held at the NEC in Birmingham and were convinced that Europlaz were the medical contract manufacturers capable of taking the project on.
The Verdict
Europlaz have been involved from initial design all the way through to manufacture of the SIMPLTM device for clinical trials. pSiMedica have been extremely impressed by the level of commitment and professionalism shown by Europlaz
Drew Ferguson, pSiMedica