Timely Prototype Manufacturing for Medical Covers
iThera Medical: How the medical technology company was able to reduce costs and meet accelerated deadlines successfully with the formary supplier network.
Development of Non-Invasive Imaging Technologies
iThera Medical is a leading medical technology company specializing in high-resolution photoacoustic, non-invasive imaging technologies. With its innovative multispectral optoacoustic tomography (MSOT), iThera Medical enables real-time visualization and quantification of biomarkers such as hemoglobin in blood or collagen in muscle, which vary in certain medical conditions. This technology significantly contributes to improving patient care in the field of medical research.
Watch the case study video and find out how iThera Medical was able to benefit from the B2B platform formary.
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💡The deep-drawing project with iThera illustrates how formary takes on projects with demanding requirements, including tight schedules, small-volume material procurement, and complex post-processing steps. The result: The client can relax knowing that formary handles all requirements, ensuring that all specifications are met through its powerful supplier network.
New Generation of Medical Devices with Complex Requirements Complex Requirements for Medical Enclosures
iThera set out to achieve a 50% reduction in both the cost and volume of the MSOT Frontier platform for the new generation of devices. At the same time, Torsten Parth, Mechanical Engineer Lead at iThera, faced significant challenges in maintaining quality and design standards for the device's plastic casing.
The requirements for plastic enclosures in the medical field are demanding. Material specifications include fire resistance, scratch-resistant surfaces, resistance to cleaning agents, protection against electromagnetic radiation, UV protection, and reliable ventilation for electronic components. Additionally, a clean, flawless, and exceptional appearance is crucial for medical parts used in practices and hospitals. The gap-free assembly of the device and ventilation compensation involves complex milling processes in the manufacturing phase.
“When we approached formary, the initial focus was on prototype manufacturing, which was to be transferred into series production after various approval processes,” says Torsten Parth. “Since the process wasn't finalized, we first submitted several designs for feasibility testing in thermoforming with formary.”
Challenge
Enclosure part for medical device with complex requirements and a goal of 50% cost reduction. Very tight deadlines due to accelerated external verification tests. Scarcity of special material availability.
Solution
Achieving the goal through the design of cost-benefit optimized enclosures while meeting all medical requirements. Timely production with thermoforming and post-processing carried out by multiple suppliers, ensuring the right allocation of available materials at the correct locations within the network.
Optimal Design with Achievement of Cost Reduction Goals
Based on the initial design drafts, formary developed a series of further proposals aimed at a more efficient and cost-effective implementation of the prototype enclosure parts. All key aspects of a cost-benefit evaluation were considered:
- Material selection and procurement costs
- Design of the thermoformed parts with regard to necessary milling, trimming, and assembly elements
- Tooling design using aluminum or an alternative material
- Material thicknesses considered from a tooling perspective
- Impact of these factors on the delivery schedule and its manageability
The consulting process provided detailed recommendations regarding the optimal material selection, including specific material thicknesses, chosen with consideration of mechanical requirements and cost. The result was the design of three optimized, aesthetically high-quality enclosure parts that provided EMC shielding through coating, ensured UV protection and flame resistance (UL94 V0), and allowed for ventilation of electronic components and the CPU—achieved with a small batch and sample production.
“For us, it was crucial to receive the fully manufactured parts on time and be able to integrate them directly into the prototypes. In the end, thanks to the sophisticated quality management, we received flawless enclosure parts with precise tolerances and excellent optics.”
— Torsten Parth
Critical Hurdle: Accelerated External Testing
However, an unexpected challenge arose during the project. "Due to an accelerated external verification test – specifically an EMC (Electromagnetic Compatibility) test – we urgently needed approval-ready enclosure components," says Torsten Parth.
Due to the tight schedule, the specialized manufacturer initially selected by formary could not procure the required specialty material in time. The delivery of the fully produced and post-processed parts, including milling and external coating, seemed impossible.
Flexible Supplier Network Ensures Timely Completion
In this critical situation, formary leveraged its extensive supplier network. Thanks to its deeply integrated network and thorough knowledge of supplier capacities and capabilities, formary quickly identified an alternative operation that had the required specialty material in stock.
This facility not only provided the material on short notice but was also able to thermoform one of the three parts, which was less complex. However, complex post-processing could not be done at this facility, so the parts were sent to the originally specialized manufacturer, along with the necessary materials to complete the remaining enclosures.
The manufacturer took over the remaining production, focusing on the more complex parts that required specific manufacturing techniques and post-processing. To speed up the completion of the components and ensure the quality of the surface finishing, formary also organized the transport of the parts to a third-party post-processing service provider from the network.
This provider handled the final coating of the parts. Through this coordinated collaboration of various specialists, the project was successfully and timely completed despite the initial material procurement issues.
Successful Completion of EMC Test
After quality checks, the three finished enclosure parts were sent to iThera Medical. Thanks to the continuous search for new solutions to meet the schedule, the medical company could focus on the many other challenges of product development.
iThera Medical received regular status updates and was always informed about the progress of the project while formary handled the coordination and management. "For us, it was crucial to receive the fully manufactured parts on time and be able to integrate them directly into the prototypes. In the end, thanks to the sophisticated quality management, we received flawless enclosure parts with precise tolerances and excellent optics." (Torsten Parth)
The first internal and external tests, as well as the general introduction of the prototype at iThera Medical, were successful.
