Kevin Deane, vice-president, innovation, Phillips-Medisize and David Wolgemuth, molding and manufacturing technology specialist, Phillips-Medisize discuss smart manufacturing in the medical plastics industry.
1.There is a huge emphasis on bringing a device to market as quickly as possible. In order to achieve this, what changes do you think should be implemented in to the manufacturing process?
We have focused on developing an integrated core platform that combines plastic components, electronic components, sensor technologies and associated software at Phillips-Medisize. Basing development of connected medical devices on these platform technologies provides the opportunity to use proven designs and established, repeatable manufacturing processes. This often enables manufacturers to utilize existing infrastructure and facilities to continuously produce the core product across multiple customers. At the same time, it provides an opportunity to customize design features as needed to meet unique customer applications.
2. How do you believe production timelines can be optimized?
The key to production timeline optimization is allowing sufficient time upfront to review and revise designs before beginning any production line preparation. Otherwise, process qualification for parts, assemblies and automation may delay production launch. Therefore, working with a knowledgeable and responsible manufacturing design partner is critical. It is also vital to involve the supplier early in the design process and to implement the feedback provided, since it may require re-design or re-testing of the verified design.
3. What are the most efficient ways to tackle the initial design and concepting phase between manufacturers and partners?
Our goal is to pull together a combination of stakeholders, including design, marketing, finance, procurement and manufacturing, in the earliest stages of connected medical device development. This approach allows us not only to work with front-end innovators to define the concepts that deliver the best features and usability for patients, caregivers and healthcare professionals, but also to identify the manufacturing and commercial realities that will contribute to the product’s success in the marketplace.
The device manufacturers’ needs are built more around business requirements, so it’s vital to strike a balance between design features and the cost of goods, length of use, production time and manufacturing complexity. Ultimately, the product must be developed at a cost point, scale and level of reliability that will generate return on investment.
4. What are the main challenges associated with the smart manufacturing of plastics?
The challenge is that most parts are designed first for the mechanical application, and the molding design is added afterwards. Although this is understandable, it is important to integrate molding requirements early in the process in order to address shrink, sink and a host of other factors caused by heating, forming and cooling thermoplastics. These changes may affect the mechanical design, requiring adjusting the overall device design to avoid molding parts with unmanageable tolerances and quality issues.
5. How can these challenges be overcome?
Design is crucial to the smart manufacturing of thermoplastic parts. The first priority is geometry that provides part gating, filling, ejection and removal from the mold with ease. Suppliers understand the injection molding process and most thermoplastic materials extremely well, and while many new injection molding machines offer added features and control aspects, even older machines are typically consistent and repeatable.
The value of involving the manufacturer upfront in the design process, even as early as conceptual drawings, cannot be emphasized enough. Designing mechanical assembly, electronic integration and full device function while including all relevant molding, assembly and automation production requirements is not a sales pitch to lock in a supplier early. It is a smart strategy that can accelerate the production timeline, support compliance and even provide unexpected solutions that deliver a competitive edge.
6. Do you think that connected health plays an important role during plastics manufacturing?
Embedded electronics and connectivity are emerging trends in medical devices. Therefore, it’s important for companies to understand how to merge the somewhat disparate industries of high-volume, low-cost plastics manufacturing with high-volume electronics manufacturing in order to design and produce integrated systems that work for patients and healthcare professionals.
To meet this need, Phillips-Medisize has been instituting a set of strategic initiatives which includes hiring electronics experts, acquiring Medicom Innovation Partner for its expertise in integrated and vertical medical devices, and being acquired by Molex to provide electronic components and innovative electronic development on a global scale.
7. How do you believe connected health could enable manufacturers to accelerate the production process of plastic components?
Adding connectivity to medical devices often makes them viable as reusable devices and moving away from the disposable market into the reusable one offers advantages for plastics manufacturers. Reusable devices reduce the overall volume of parts that need to be produced, in turn reducing the complexity of the plastic molding manufacturing operation and accelerating time to market.
8. What can be done to ensure tighter compliance with FDA regulations during the manufacturing of plastics?
Meeting established plastics design standards, tolerance expectations and tooling design increases the overall device design effectiveness, which reduces variability and tightens compliance. Device function and electronics integration must be built on properly designed mechanical features, which are shaped during the plastic molding process. The filling, cooling and any associated warp from the molding process affect the final geometry and dimensions of these critical function features.
To ensure consistent molded plastic results, Phillips-Medisize emphasizes proper design review, processing knowledge and preparation. The right initial design is essential to accurately and efficiently completing all downstream activities that qualify or validate the process.