New Current, Matt Higginson, Peterborough, ON
Matt Higginson is a talented research and development engineer who has improved our device to a highly reliable functional level. Matt has designed the device for easy transfer of 3D technology to high speed mould technology.
Joe Kerr Designs, London, ON
Joe Kerr is an innovative medical device design company and who has completed the market version device (Generation V) and the required regulatory documentation.
Avit Manufacturing, Peterborough, ON
Avit has been working with PKA SoftTouch Corp. for a number of years. Projects include the bubble design and filling station equipment which involved the purchase and modification of a Laminar Flow Hood to achieve ISO 5 sterile standards.
Merit Precision Moulding, Peterborough, ON
Merit worked on device design and production for early prototypes. Once the market version device has been completed, Merit will design the production moulds and manufacture the device parts.
Westmount Pharmacy, Peterborough, ON
The ISO 7 Sterile Suite located at Westmount serves as PKA’s pilot plant production facility. Westmount has the capability of filling and assembling devices for proof of concept clinical trials, and production runs. For clinical trials and for small markets, upgrading of this facility will be required for compliance with Health Canada and U.S. FDA regulations for U.S. human trials and production purposes.
Steris Isomedix, Whitby, ON
The ability to ensure that the PKA Micro-needle is safe for use on humans is critical to our success. The device must undergo thorough sterilization: the appropriate sterilization method for the device is Gamma Irradiation. Steris has extensive experience with sterilization of single-use medical devices, pharmaceutical products, tissue/ biological products, and other related consumer products. Gamma irradiation ensures 100% sterile device parts.
Nordion, Laval QE
Nordion, located in Laval, Quebec, also has extensive experience with sterilization of single use medical devices. Additionally, their sister company offers sterility testing to ensure our device is 100% sterile and ready for consumer use.