Launching a new or updated medical device means you face time to market constraints, but with the right medical device manufacturing steps, you can streamline your medical device’s time to market date.
Let’s take a deep dive into the medical device manufacturing process from start to finish.
Medical Device Manufacturing Steps
The medical device manufacturing process starts with an idea for a new product or updating an existing one, but after that, it’s a journey lined with multiple steps to reach the medical device’s time to market date.
Below is a breakdown that explains medical device manufacturing steps in detail:
Step 1: Quoting and Rapid Prototyping
The first step in manufacturing a medical device is quoting the product, receiving proof of concept, and producing a prototype. As a part of the medical device design process, most manufacturers use 3D printing to develop parts quickly at an affordable price using a CAD file. It’s common for manufacturers to create multiple part configurations simultaneously, allowing them to rapidly evaluate different device design options. Once the product is quoted, and a proof of concept is approved, manufacturers use rapid prototyping to create a model of the device. Rapid prototyping allows you to hold your device physically before production, ensuring accurate form, fit, function, and appearance before moving on to the next medical device manufacturing step.
Step 2: Continued Prototyping and Validation Testing
After the device prototype is approved, continued prototyping and validation testing can begin, bringing you one step closer to your medical device’s time to market date. This step involves improving your prototype using high-precision equipment like CNC machining and high-performance materials to create a prototype with a better look and feel of your finished medical device, giving you the perfect balance between rapid production and precise engineering. Once continued prototyping is complete, consider validation testing with stakeholders to ensure that the design meets their final product requirements.
Step 3: Engineering Build One
Once the prototype is verified as functional, it’s time for the first engineering build. This medical device manufacturing step includes developing the device further so it’s as close to the end-product as possible before releasing the design to the engineering floor for final manufacturing.
Step 4: Final Manufacturing
In the medical device time to market process, step four is where final manufacturing takes place and includes processes like assembly, soldering, ultrasonic welding, laser marking, and pad printing. Final manufacturing may also involve plastic injection molding, a process developed for producing medical device parts in large, repeatable volumes. When you reach this step in the medical device time to market process, your product should already be submitted to the FDA and waiting for 510(k) clearance.
Step 5: Steel Tooling to Launch
Once the 510(k) submission is cleared by the FDA, it’s time to ramp up your device’s production with steel tooling. Your medical device is ready to launch after the injection-molding processes are qualified using the steel tooling. Qualified processes are capable of consistently and reliably producing parts that meet specifications, resulting in safe and effective medical devices.
The Medical Device Development Timeline
Many factors affect how long it takes for a new medical device to reach the market, but if the process goes smoothly without major roadblocks, your medical device’s time to market may only take as little as 22 weeks.
Here is a general medical device development timeline to use as a rule of thumb:
- Rapid prototyping with 3D printing and CNC milling: 4-6 weeks
- Continued prototyping and validation: 4-6 weeks
- Engineering build one: 4-6 weeks
- Engineering build two: 2-3 weeks
- 510(k) submission: 4 weeks
- Steel tooling to launch: 4 weeks
A Single-Source for Medical Device Design Innovation, From Concept to Market Launch
At Remington Medical, we’re a single-source medical device manufacturer that offers everything you need to launch a new medical device or update an existing one. When you partner with us, we fulfill your needs from concept to delivery, ensuring that your medical device’s time to market is on time and successful.
We have a proven process that results in successful medical device design innovation, from concept to market launch. Our team completes most of your manufacturing processes in-house, starting with prototyping and ending with sterilization and packaging. Remington also manufactures a wide range of disposable medical devices, so we know how to guide you through the process from start to finish. Contact us today to learn more about how we can help streamline your medical device’s time to market process.
