Quality, time and cost were critical as Insulet Corp. prepared a dramatic innovation in diabetes treatment for market entry.
Insulet’s breakthrough OmniPod Insulin Management System consisted of two, fully integrated wireless components:
The OmniPod – a small, lightweight, self-adhesive pod that delivers insulin according to pre-programmed instructions. One of the features of the pod is automated cannula insertion, replacing tubing used in insulin pumps.
The Personal Diabetes Manager (PDM) – a hand-held device that programs the OmniPod with customized insulin delivery instructions, monitors the OmniPod’s operation, contains a fully integrated blood glucose meter, and stores data. The PDM sends a message to the OmniPod which inserts the cannula beneath a patient’s skin, delivering insulin.
The new system was designed to compete with insulin pumps, which gained very little traction with diabetics because they can be complicated to operate and are visible to other people. The Insulet system is also priced differently from pumps, making them attractive economically as well.
Founded in 2000 with venture capital funding, Insulet received 510(k) clearance from the Food & Drug Administration on Jan. 3, 2005 and was anxious to move the product to market quickly.Insulet chose Phillips Plastics of Hudson, WI to do rapid models, rapid prototyping, prototyping, and production of the components.
“I had prior experience with Philips and they are a first class supplier,” commented Kevin Schmid, vice president of manufacturing at Insulet, Bedford, MA. “Phillips was engaged early in the product design process. This ensured that we achieved the most effective component and system design with respect to design for manufacturability and assembly (DFM/DFA), process control, and component cost. Phillips is a one-stop shop and the Company’s diversified capabilities were a huge benefit to us.”
The manufacturing challenges for the system were significant and demonstrated the advantages of dealing with a partner with integrated art-to-part capabilities and mindset.
“We have been able to utilize a variety of our capabilities on this program,” comments Phillips program manager. “The term one-stop-shopping really is emphasized for this program. We offered everything from a variety of prototyping options; to our focused factories including medical molding, clean room, micro molding, painting, window decoration and assembly, multi-shot; and many secondary operations. Rather than Insulet having to go to a handful of molders to complete all of these requirements, they came here and we did it all for them.”
The OmniPod consists of 14 molded pieces and the PDM has five. The finished manufactured product encompasses several manufacturing technologies within Phillips: micro molding, multi-shot molding, lens molding, decorating and medical molding. In addition several technologies were used in the prototype stage, including Phillips Plastics’ proprietary RPTech Process, stereolithography and aluminum tools.Those techniques gave Insulet engineers the ability to get a touch and feel for components and do some testing.
Serious functional testing requires use of parts made in an actual production tool. Phillips’ engineers recommended development of a one-cavity tool that could produce parts for functional testing yet minimizing tooling costs if revisions were required.
“The one-cavity pull ahead approach allowed for an improved time-to-market solution as well as minimizing revision costs since only one cavity was initially
built,” comments a Phillips’ engineer. “This helped Insulet with their evaluation
of the initial design, making sure the design was right in the first cavity before the second cavity even began.”
Phillips Plastics also used its tooling know-how to solve other daunting problems in the OmniPod system design.
Case in point: the most critical structural element in the system is the chassis for the OmniPod, which includes a circuit board and a plateable electrical pathway. The solution was a multi-shot part, with a first shot of polycarbonate and a second shot of a plateable alloy of polycarbonate and ABS.“We realized right away that the geometry was complicated as we knew we had to create 12 separate areas of plateable material to provide 12 separate electrical pathways for the circuit board,” said the project engineer for Phillips. “The challenge was figuring out how to gate and fill the part because, normally, everything would be connected and fill at one time.”
The Phillips engineers designed a process based on a three-plate mold and extensive MoldFlow analysis. “We mold the first shot. Then for the second shot we use a three-plate mold where we drop into a runner and it splits off and has 15 drops come down and hit the 12 areas on the part to fill,” says the Phillips program manager. The MoldFlow analysis was important in balancing the runner system because each area has a different volume and some drops were done with two gates. Critical shutoffs were also critical to avoid flash that could interfere with the electrical current. Bondability to the first shot was also a concern due to the small size of the 12 areas.
Other manufacturing technologies used in the project were insert molding and micro molding. “We have a component in the device where we insert a steel lead screw with a plastic tip and we weren’t sure what direction to go to make it work,” says David Clare, Insulet’s program manager. “Phillips steered us in the right direction with insert molding and ever since, it has worked out very well for us.”
The result was a product that met its design and cost targets and made a rapid and successful market entry.