Protean was developed from initial concept through to verification and production, including the development of a patented assembly method.
Leading manufacturer, Shaily Engineering Plastics, had been in discussion with IDC for some time to develop a generic drug injection pen platform, which was fast tracked once a pharmaceutical client seeking a three dose injector pen came onboard. Such platforms tend to be highly patent protected, making the development of new device very challenging. The team was aware that several patents were expiring for mechanisms within an existing device, which opened the door to developing a new platform with the ability to develop our own IP.
Partnering with Shaily and their manufacturing expertise, we were briefed to develop a high quality disposable injection pen platform capable for use as a single dose, three dose and a 60 unit insulin variant (disposable and reusable variant), for delivery of drugs such as Abaloparatide, Liraglutide or Insulin Glargine, all utilising the same internal core mechanism. The device was to be manufactured at Shaily’s world class facility, with sub-assemblies going on to the pharmaceutical company for final assembly with a prefilled cartridge.
IDC has wide experience of designing drug delivery injection pens. The team’s existing knowledge was invaluable in this respect, since it provided a broader understanding and clarity in what would otherwise have been a long learning process. With several patents still in place on the existing injector platform, our engineers worked to devise new internal features that avoided infringement - right down to how the components connected within the device from the outer button. Safety and accuracy were of the highest priority and our engineers developed a unique ‘last dose lockout’ mechanism to ensure that if any drug was left after the final dose was delivered, the user couldn’t access any further medication along with a patented assembly method.
Protean was designed to be all plastic and built using high performance bio-compatible plastics from DuPont, Celanese and Borealis. The plastics were carefully trialled and selected to provide excellent dimensional stability to work with the tight tolerances of the device. We also worked closely with the pharmaceutical company to develop the cartridge requirements for the devices, advising on materials, design and assembly processes.
We have chosen to partner with IDC on multiple drug delivery device projects now, and each time they have exceeded our expectations delivering great design and engineering work in response to technically complex problems in a short time frame. We really value their ability to develop new IP for our business in what is a challenging market. I highly recommend partnering with IDC for any medical device development projects.]
Injection moulded parts were used for prototyping and testing to give realistic material forces and accuracy of movement to ensure dose accuracy performance. Rapidly developed SLAs were also used early in the development to help visualise form and general function. Our project manager oversaw the mould manufacturing process in Taiwan and worked closely with both Shaily and the pharmaceutical company to support taking the design through to manufacture.
With a plan to launch in the US initially, the team provided documentation for the entire development, ready for FDA approval and the certification process, whilst liaising directly with an accredited test house to oversee the 11608 design verification testing. Maintaining excellent communication throughout the project meant we were able to deliver an outstanding design while meeting the client’s timescale. The single dose and 60-unit device are currently also going into production along with the reusable insulin variant.
If you are interested in utilising the Protean Injection Pen platform as part of your product range, please view the Datasheet below to learn more and feel free to get in touch with us at firstname.lastname@example.org to discuss how we could meet your drug delivery product needs.