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Plastic Injection for Medical Grade Devices – Case study
Starting with Alcami - Strategic Shifts
Talking with Esther she shares the following:” When we started our product development process our initial thinking was that it would be easiest if the components of our product were developed and manufactured in China. This strategic choice provided us with a solid foundation to start with, but challenges brought about by the pandemic necessitated a shift. It became imperative to diversify the company’s sourcing network, and focusing on Southeast Asia was the logical next-step.”
Esther continues:” Our goal was not only to enhance our manufacturing capabilities but also to optimize the supply chain for the enclosures of our devices. Moreover, this shift aimed at facilitating the final assembly process of our product within the region, thereby streamlining operations, ensuring efficiency, and avoiding geo-political risks. The quest for a reliable manufacturing partner led us to Alcami Global.”
The turning point in Esther’s search for a manufacturing partner occurred in an unlikely place, a Muay-Thai gym, where Esther chanced upon an introduction to Mr. Kris Withouck, the founder of Alcami Global. This chance meeting paved the way for a strategic partnership that would leverage Alcami Global’s expertise in manufacturing and logistics to bring Esther’s product vision to life.
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Why Medical Grade Plastic Casings?
In developing Esther’s wearable sensors, a critical component has been the selection of materials that ensure durability, reliability, and user safety. Specifically, the use of medical grade plastic casings stands out as a key decision in the manufacturing process. These materials meet stringent standards for:
- Enhanced safety and biocompatibility
- Resistance to chemicals, and physical stability
- Compliance with rigorous health and safety regulations
Qualities that make them ideal for a wide range of applications. When developing a product that necessitates such specifications, it’s crucial to incorporate medical-grade plastics early in the design process.This choice reflects the brand’s commitment to providing products that not only meet but exceed industry standards for quality and safety.
Esther shifted her base of operations to Thailand to better align her collaboration with Alcami’s team. Alcami Global is known for its focus on innovation: They are adept at overcoming manufacturing challenges through customized solutions. They’ve a proven proficiency in plastic injection for electronic and medical device casings, so over three months Kris and the Alcami team transformed Esther’s initial 3D conceptual models into production-ready prototypes.
Why Plastic Injection?
Plastic injection molding is a key process for efficiently manufacturing high-quality plastic parts. It offers unparalleled precision, scalability, and cost-effectiveness, especially when producing components with complex geometries. For hardware entrepreneurs, understanding the intricacies of plastic injection molding can unlock significant advantages:
Precision Manufacturing
Utilizing advanced plastic injection techniques, it’s possible to achieve high precision in the manufacturing process, ensuring each component fits seamlessly and functions flawlessly.
Cost-Effectiveness
Reduce material waste and streamline production processes for better overall economics.
Material Versatility
Utilize a wide range of plastics, including medical-grade options, to meet specific product requirements.
Durability and Reliability
Medical grade plastics offer unparalleled durability and reliability, essential for wearable technology that may be exposed to various physical stresses.
Safety and Comfort
Ensuring the safety and comfort of the end-users, especially given the direct skin contact involved with wearable devices.
Premium Device Casing is About Quality
The commitment to utilizing medical grade plastic casings and precision plastic injection techniques testifies to the dedication to quality and innovation held by this team. This approach not only enhances products’ durability and safety, but also aligns with the brand’s goal to provide cutting-edge solutions.
Engineering Excellence in Medical Grade Plastic Casing
Esther shares her experiences, highlighting the collaborative journey with the Alcami team: “They were instrumental in devising the most effective engineering strategies to address the main obstacles we faced with our product designs,” Esther remarks. She then delves into the specifics of the engineering.
Durability and Water Resistance
The team was tasked with a complex challenge. The product, a sensor designed for use during physical activities, required a robust and water-resistant design. Achieving this was particularly demanding given the compact size of the device. Moreover, the necessity for exposed metal conductive elements, which are crucial for the device’s charging capability, added an extra layer of complexity.
Optimized Plastic Injection Molding Solutions
To navigate these challenges, the Alcami Global team suggested an innovative approach—over-molding the metal insert pin for charger connectivity. This technique ingeniously encased the metal conductive element, ensuring the device remained waterproof. At the same time, it kept the charging pin accessible, maintaining its functionality.
Innovative Sealing Solutions for Irregular Shapes
Esther illuminated another significant hurdle—achieving a watertight seal for the device’s uniquely shaped casing, which is a pivotal aspect of their brand identity. The irregular form factor rendered standard sealing solutions, like o-rings, ineffective. “This was a major concern, as it directly impacted the feasibility of mass production,” Esther explained. The Alcami team engineered a solution: an over-molded TPE (thermoplastic elastomer) seal integrated directly onto the sensor casing components. This method not only circumvented the need for conventional o-rings but also enhanced the device’s design integrity and water resistance.
Alcami's Support to Engineering and Manufacturing
According to Esther, beyond manufacturing plastic casings, Alcami Global supports hardware startups with a suite of additional services that can include:
- Quality assurance
- Product assembly
- Packaging
- Supply chain management
By consolidating these services under one provider, startups can streamline their operations, reduce overheads, and focus on core product development and market entry strategies. Alcami’s support to Esther and her team also included auxiliary and ancillary service components such as those listed below.
In-House Testing and Quality Assurance Practices
According to Esther, Alcami played a pivotal role in her project’s success by providing innovative manufacturing solutions and robust support. One key aspect was the access Alcami afforded Esther to their clean rooms and heat chambers, which were both essential for testing the sensor-based electronics in the products under varying environmental conditions..
Rapid Prototyping and In-House Tooling Capabilities
The necessity for rapid iteration in product development is a challenge that many technology companies face. Alcami Global addresses this issue with its own in-house rapid prototyping capabilities, including 3D printing and CNC milling. This allows for quicker feedback cycles and adjustments in product design, significantly reducing the time and cost associated with external sample production and validation.
The Importance of Trust and Ethical Practices
The importance of trust and integrity in manufacturing cannot be overstated, especially when it comes to protecting intellectual property and ensuring scalable production capacities. Esther notes the positive impact of Mr. Withouck’s leadership on Alcami Global’s culture, and how that gave her the necessary confidence to trust the company with her project. This aspect of trustworthiness and ethical conduct is essential for long-term partnerships and successful project outcomes.
Embracing Change in Plastic Casing Development
For hardware entrepreneurs the journey from concept to market-ready product is fraught with challenges and learning opportunities. Esther’s advice to newcomers is to value the importance of starting with manageable, scalable tools. This approach not only conserves resources but also allows for greater flexibility as you refine your product based on real-world feedback and insights.
The Significance of Choosing the Right Production Partner
When asked about her final piece of advice for those embarking on the path of hardware development, Esther stresses the importance of selecting the right production partner. She mentions that Alcami Global’s quality and comprehensive support are invaluable as enablers for her journey: ”The choice of a production partner can significantly influence the trajectory of your product development process, impacting everything from the pace of iteration to the final product quality.”
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