Manufacturing is where your medical device becomes reality and when potential snags between design and full-scale production reveal themselves. Therefore, honing the manufacturing process needs to be your top priority from the start. While there’s a lot to consider, preemptively think about manufacturing – particularly compatibility between the processes and device materials – and develop a plan that addresses the multitude of potential challenges that could crop up so you can meet deadlines, stay within budget, and make a higher-quality device.
Laboratory to production
No matter how painstaking your testing in the lab or in small-scale production, unpredictable factors can arise when advancing to full-scale manufacturing. From the type of machinery used to the rate of production, it can be challenging to replicate the conditions that materials and overall designs typically face, which can cause unanticipated occurrences when it’s time to scale.
A successful transition comes down to how the materials and processes interplay, which will determine the scale-up outcome. Keep the following examples in mind as you move forward in your next project.
Device material compatibility – It can be difficult to fully evaluate your device’s material compatibility before full-scale production. Unforeseen adverse effects could impact device performance or lead to unexpected failures. For example, device adhesive needs can change with alterations in production equipment. If this compromises the stick-to-skin component, other design effects can be detrimental.
Regulation of material effects – Following material compatibility optimization, it’s important to determine whether your raw materials are compatible with your manufacturing process. To be certain your device can withstand the manufacturing process, test the final version of the product. Testing a prototype can be helpful, but there’s no substitute for verifying your finished device against the production process.
Material characteristics after sterilization – Sterilization can alter material properties. Consider all of your device’s components, in addition to the sterilization method’s temperature, duration, and whether the device will be sterilized in its packaging.
Forecasting environmental conditions – Be aware of how your device might function in different climate conditions. For example, manufacturing plants in many regions can be extremely hot and humid during summer and dry and cold during winter – and everything in between. Talk to your manufacturing partner about climate control for your manufacturing process.
Control process effects – Be aware of the way heat, pressure, and other factors can alter your manufacturing processes. Also consider how any of these factors can affect the adhesive liner, particularly with friction.
To navigate through issues of material conditions during manufacturing, it can be helpful to take a step back, and perhaps take a deep breath.
The concerns and potential trouble spots listed above can take time to parse, but glossing over the possibility that your design may be incompatible with the ideal materials and processes until it’s too late doesn’t do any favors. Slowing down to examine – and even challenge – your own development process can flag concerns before they escalate.
Some other factors to consider include:
Establishing a consistent communication cadence with your material supplier – Changes to materials are expected, but they can be inconvenient if they happen unexpectedly during a project. Establishing a regular cadence with your material supplier ensures potential changes are communicated proactively. It might also be helpful not to overload yourself with too many external partners. Adequate planning will confirm that your process is streamlined and nimble if you have to change a material mid-process.
Keeping an eye on adverse effects – If contending with heat, pressure, or friction, scheduling preventive equipment maintenance can mitigate issues. Some materials are more sensitive to wear and tear than others. A regular equipment cleaning plan, using the proper cleaners, can also prevent problems such as adhesive gumming up equipment.
Environmental factors can also play a part in device performance, even during transportation or storage. Don’t wait for any surprise temperature or humidity changes – if you have any questions, connect with your logistics partner.
Sterilization’s huge impact – Mindfulness about sterilization methods allows you to be proactive. Some medical devices require specific sterilization methods, so think of those methods when determining the best materials for the application. If a specific method is not required, it will be important to determine the method alongside the material so they are compatible with one another.
Planning a redesign – If planning future device iterations, think ahead with the manufacturing process. If you bought equipment and tuned or built it to a specific process for the device, it may be possible to reuse it with the proper forethought. Maximizing your investments depends on the timeline and turnaround you might be planning with any next- generation device.
Not everything during your manufacturing process is going to be straightforward, so it can be beneficial to think of balancing your design with manufacturing as another iterative challenge to solve. Your experience with the manufacturing process can also directly impact futureimprovements. As you learn and gain resiliency, you will improve yourself and those on your team so you can support each other during a challenging, yet rewarding, process. This can build the foundation for success for future projects.