HD provided the full characterisation and reverse engineering of a range of multi-dose syringes for an undisclosed client. Thorough reverse engineering, prototype supply and a manufacturing data pack was delivered, together with additional design improvements to enhance the products performance.
HD provided easily accessible, flexible design and development resource through a simple, cost-effective project workflow with clear outputs, allowing our client to easily understand the work and activities required. It enabled effective planning and afforded reduced project timelines so our client could focus on other core activities. In addition to full ownership of the manufacturing data pack, and giving the client ability to select suppliers of choice, the outcomes of HD’s work provided thorough design verification, improved DFM and design for high volume output.
The weekly meetings were very good and kept us in contact with what was going on. This helped the project maintain its progress and deliver on schedule – it felt like we were the same company! – Lead Device Design Engineer at a Leading UK Pharmaceutical Company
Although components had previously been digitally scanned and the 3D data provided, the outputs were of a low resolution meaning that data was inaccurate or insufficient to control the design and engineering required. HD received physical samples of the existing devices, which were disassembled, investigated, and measured by hand to build up an accurate understanding of the design. Physical samples were also inspected to determine plastic injection moulding split lines, ejector pin and gate locations to ensure the previous component moulding schemes were replicated in the new components prior to 3D modelling them in SolidWorks. The models created were well controlled and features labelled to include manufacturing considerations such as draft and gate positions.
An Essential Functions document was created to map-out critical functions of the device both during assembly and, in normal use. Furthermore, a rationale was given to the interactions and component features to determine whether they were function, safety, or assembly critical, and if the interactions needed to be further analysed using our Tolerance Analysis document.
HD created a manufacturing data pack consisting of: Geometrically toleranced drawings, specification of materials, surface finishes, split lines and gate feed points. Having created a manufacturing data pack, the next phase was to enhance the products performance.
Full tolerance analysis was undertaken throughout iteration and design development, allowing the design to be fine-tuned and aligned with the estimated best and worst tolerance fits. Tolerance analysis documents were created to communicate a range of information such as fits and stacks based upon new syringe tolerances. HD were able to provide fast access to polymer testing and engineering expertise to supplement this. CAD models were adjusted as per results of the tolerance and draft thickness analysis and prototypes of all sizes in the range manufactured, tested and evaluated throughout.
The project was successfully completed to meet required timelines and full ownership of the device design data and manufacturing data pack provided to the client. In addition, HD identified, assessed and presented potential manufacturing partners for capability and cost effectiveness.
The client benefited from the outset of this project by HD’s simple, cost-effective project workflow with a clear output. HD provided an easily accessible, flexible design and development resource which allowed for easy adjustment to suit and reduce project timelines. In addition to full ownership of the manufacturing data pack and giving the client ability to select their supplier of choice, the outcomes of HD’s work provided thorough design verification, improved design & manufacturability, as well as design for high volume output.
If you would like to learn more about this project or discuss how we can help with your product or medical device development, please get in touch.
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