What Are the Major Steps Involved in the Manufacturing of a Medical Device? Part 2
What Are the Major Steps Involved in the Manufacturing of a Medical Device? An idea for a medical device might seem revolutionary in theory but, when put to the real test in terms of an end product without adequate input and research, it might not live up to previous billing or, most notably, the expectations of the end user — the customer. Roberson Machine Company strives to provide our customers with the best components and products, from the initial development phase to prototyping to full production runs.
Medical device manufacturing requires a multidimensional approach, the spot where we thrive. Our single-source manufacturing experience, along with our innovative design techniques and customized CNC machining services, make Roberson Machine Company the premier choice among medical device manufacturers.
We follow our 7-step approach to medical device manufacturing:
The primary stage of conceptualization involves evaluating the idea on multiple levels, and with a multitude of opinions locally, to understand its worth and market position. In addition to geography-specific regulations to keep in mind as conceptualization progresses, this process involves:
Now that the concept is finalized, we are ready to pen down the strategy for raw material requirements, potential vendors and overall production costs. We have an extensive manufacturing portfolio, highlighting our ability to cut costs by keeping everything in-house. Also, this step is the prime time to pre-plan for supply chain and logistics to avoid delay in time to market.
3. Design & Development
The primary motive of the design phase is to give practical shape to the initial rough idea. The design phase covers:
- Industrial design — testing the feasibility of the medical device for the intended use.
- Mechanical design — testing the aesthetics and handling aspects of the device.
- Software design — incorporating the intuitive UI/UX for easy operation.
- PCB/Electrical design — involves making the functionality efficient.
This stage involves multiple iterations of the design to account for the feasibility, scalability, and effectiveness of the design created. Our CNC machining experts can test the product’s proficiency over and over again, at high speeds with unrivaled precision, based on our cost-cutting efficiency.
In addition to the aforementioned stringent FDA approval process, Roberson Machine Company performs a validation phase of its own using a third-party clinical evaluation. This process involves checking the device for its intended use and impact under multiple parameters. Any risks associated with the device are checked, minimized, and reduced to transfer the best iteration of the product for manufacturing.
6. Technology Transfer & National Provider Identifier (NPI)
The technology transfer refers to the stage when all the knowledge about the conceptualized design is transferred to the manufacturing stage. This is simplified and sped up by our CNC services. Before transferring the data and the design, each of the device-specific processes is validated, cross referenced, and verified. The NPI is a directory of all active records regarding a healthcare provider and/or device. Providers and manufacturers acquire their unique, 10-digit NPIs to identify themselves in a standard way throughout their industry. The identification is also used by the FDA in its postmarket guidelines and follow ups. The FDA continues to monitor both the performance and side effects of the device, primarily by receiving reports of device malfunction in accordance with the NPI identifiers. Manufacturers also have postmarket surveillance requirements specific to different device types.
Once everything is in place, all the i’s have been dotted, and the t’s crossed, the approved prototype is transferred for mass manufacturing. This is where our single-source manufacturing comes in handy. Many companies are outsourcing the manufacturing of their medical devices. Not Roberson Machine Company. We do everything here. And we look forward to doing the same for you.
What Are the Major Steps Involved in the Manufacturing of a Medical Device? | Roberson Machine Company
Roberson Machine Company is your home for medical device manufacturing. Whether you want to source CNC machining services for your medical device manufacturing needs, create prototypes, or simply cut costs without sacrificing product quality, call us today at 573-646-3996 or contact us.