Within the medical device industry, many companies get their start by developing a single device or product line, and as this device becomes more and more mainstream, larger companies become interested in adding that device to their portfolio. A medical device company that Forum Plastics produced a family of Access Cannulas with corresponding Trocars and a Smoke Filter system was purchased by one of our larger customers. Due to the acquisition, the engineering departments were consolidated, and the staff responsible for this product was no longer with the company.
When volumes were increasing beyond the capacity of the original single cavity tools, it became time to purchase new tooling for a product line expansion. However, it was discovered that the documentation was not kept up to date, and the CAD models and drawings of the components did not match the molded parts. Since the original design team was no longer available to update the models, Forum offered to provide dimensional analysis of the current parts.
The urgency to get new tools online was high – the original, low-cavitation tools were running at their capacity limit and demand for the product was exceeding capacity. There was a mutual interest in building new capacity as quickly as possible, and updating the drawings and models was a top priority. The medical device company engaged with Forum to provide accurate and timely CT-scanned data to quickly update their drawings and models to the current level so that the new tool builds could begin.
One component of the Access Cannulas, the housing for the Smoke Filter, has an overly complex geometry and a critical feature that runs around the perimeter of the part. Any deviation to this feature would cause a failure – a leak – upon assembly with mating components. Being an extremely critical feature that was too fine to be measured optically and too complex to be measured with a touch probe, Forum leveraged its RX Solutions Desk Tom CT Scanner. The scanner is capable of collecting the profile data of the feature, exactly comparing it to the solid model, and identifying any areas that are not matched. By providing this data to the customer, Forum can perfectly match their 3D-model and drawings to the molded part that is currently being produced.
Forum's CT Scanner Fact Box
RX Solutions Desk Tom CT Scanner
CT Scanner captures measurements with 10 μm accuracy and 4 μm resolution.
CT Scanner Analysis
The CT scanner has the ability to provide data outside of normal FAI and Capability studies such as:
Nominal/Actual comparison – A color deviation plot which maps the entire part surface to determine how much (+/-) the actual part is deviating from the CAD model.
Porosity Analysis – This analysis looks “inside” the part to see if there are voids or inclusions. This analysis does not require the part to be sectioned or destroyed to examine for any defects.
Assembly Analysis – Assemblies can be analyzed to see how mating components fit together or if there are any interferences which can’t be seen inside the completed assembly.
Reverse Engineering – A physical part can be scanned in the system, and from that scan, a CAD model can be created. This CAD model can then be used to create a master model and drawing for production use.
Forum Plastics scanned the current molded part to accurately collect all of the part geometry, including the critical features. We then compared the scan of the part to the current 3D-model and showed all of the areas that were discrepant. This is shown as a color gradient with a corresponding dimensional scale as seen in Figure 1. Through our scanned data and corresponding measurements provided in a full 3-pcs dimensional report of the molded part, the medical device company was able to revise their CAD model and drawing to the correct geometry. The final model and CT-scanned part matched perfectly.
With the updated CAD, Forum was able to produce new tools for their product line expansion and meet their supply chain requirements. Continuing to use the CT scanner, Forum compared the molded parts from the new tooling to those of the original tooling showing full capability between the parts.