When designing and planning for a new medical device, sometimes the individuals developing them get lost in the creation process, and don’t consider all the assembly options beforehand. Therefore, finding the right partner, with experience in moving a device or component from design through development to manufacturing, is so important.
We must consider the assembly portion of the process from the start. In fact, it can be discussed and determined in the earliest stages. There are also two different types of assembly: fully automated and semi-automated. When is the fully automated assembly the right one to use?
Flexan has years of experience in helping medical device companies go from those early stages to development and into delivering new products to the market. Our approach looks at each key development step across the entire process validation plan, including assembly. Find out what we can do and contact us for more information.
Why is determining the right device assembly method is so important from the start?
This part of the entire process is often the most time-consuming. Why? Because there are a lot of factors that come into play. For example, the assembly process is often the most expensive part of bringing a device to market. There are options which can mitigate this, and the right partner can help with the costs, too. How?
Thinking about assembly right from the start can reduce those expenses in the long run, even when a more costly option is used. Many times, using a fully automated assembly seems like a tremendous expense, but having it planned out early and determining the right form mitigates risks, while not planning, can lead to difficulties that may cause costly delays.
During the assembly process, especially when fully automated assembly is chosen, it usually requires elements such as custom tooling, machinery, and fixtures, to make the device. This is because there isn’t a good one-size fits-all approach to automated assembly machines that ensures consistent assembly and product. It’s another reason the determination of the assembly process can take a long time to development and validate, which may add to the expense.
There are costs, timeliness, and other issues that come into play if we do not plan this process early on.
Here’s when fully automated assembly makes sense
Going to a fully automated assembly process may not be the right fit for every case. However, there are certain factors where it makes the most sense. This is not a comprehensive list, but some of these factors include:
- When productivity and timeliness are an issue
When the assembly process is fully automated, the speed of assembly is increased. The timing of volume scale-up determines the plan to fully automate. The key is to parallel plan and should also include sequencing the steps and removing non-value steps. This streamlines the assembly process, making it faster, more productive, and more efficient.
This early planning can also spot potential resource flow issues and other areas where efficiency can be improved. So, if timing is a concern, and producing significant amounts of the device is crucial to the ultimate goal, a fully automated assembly process is most likely the right way to go.
- Accuracy improvement
For accuracy, there is a lot that should be considered at the start to improve this metric. The machines must be calibrated, custom tooling might be necessary and building the machines that will build the device can take time. However, once the fully automated system has undergone this, the machines will make fewer mistakes than if there is human involvement and greatly reduce the margin of error. This also increased the speed, productivity and eventually reduces costs by eliminating the need for rework.
- Employee and patient safety
When we talk about safety, we’re talking about the safety of patients when they receive the medical device, but also the safety of the employees who work on the assembly line. When the system is fully automated, of course humans are still needed, but a fully automated system requires less interaction with the moving parts of the machine, reducing the chances of injury.
- Quality improvement
Full automation can focus on the complexity of assembly and ensure top quality output from the automation repeatedly. Manufacturers must incorporate quality standards into the assembly process from the start with 100% of the process for assembling a medical device stringently validated.
The determination about quality must start early because instructions for assembly workers must be started early, too. Improper instructions can send the entire assembly process off the rails. In addition to the assembly steps, proper training for workers is important and planning this takes time and needs to happen sooner than later. Skipping this consideration just to move on to manufacturing can lead to problems down the road, rework and even possible recalls.
- Repeatability
Once the assembly steps begin, a manufacturer is going to want a process that is repeatable and continues to produce top quality products. Automation, once the process validation portion is over, accomplishes this. Machines will do the same steps, the same way, repeatedly until reprogrammed to do them differently.
- Cost savings
Medical device companies are always looking for a way to save money, but still produce quality devices. When you first look at the set-up for an automated assembly process, it might not seem like there’s a cost-savings involved. It’s true, sometimes setting up the automated assembly part can be expensive, but less rework, less lost materials because of poorly made products, and improved speed can create efficiency that generates a favorable ROI. Plus, often the biggest expense is labor. Additionally, automated assembly allows for the flexibility for domestic manufacturing rather than locations far away. Early planning for assembly can determine which assembly process is the right one so that labor costs can be mitigated. Of course, even fully automated processes still have a human factor involved, but it can greatly reduce a labor force when full automation is implemented. Basically, reducing movement, whether man or machine, improves efficiency and can significantly reduce costs.
There’s a lot that goes into cost and a lot can also depend on the intended volume for the end product. Even fully automation systems can have larger upfront costs for materials if significant volumes are planned.
Flexan’s process can help determine if automated assembly is right for you
With our years of experience in the medical device field, we at Flexan have created what we call our Flexacution Operating Model to produce medical devices and components. We start at the earliest stages, becoming a partner with clients who may only have a prototype in hand, to help them bring that device to market.
Our methods analyze the process from concept to manufacturing. This allows us to spot potential problems early to correct them before they become serious. Overall, this allows us to be more effective and efficient, leading to lower costs, better quality, and more efficient processes. Early on we can determine whether fully automated solutions are the best solutions and recommend the process, then implement it.
Understanding whether fully automated assembly is correct takes experience
To mitigate costs, timeliness, and other factors, in order to produce a safe, effective, innovate medical device means assembly has to be part of the concept phase, to determine if full automation is the solution. Here at Flexan, we can help you make that determination and provide the best solution for your device or component.