In the following article we cover some of the common mistakes that are made when transferring medical device manufacturing to high volume. The ability to identify these areas at an early stage together with proper management, can be critical to a medical device’s lifecycle. These common pitfalls that result in costly corrective actions can be avoided altogether.
A common mistake is assuming that product development team & engineers have manufacturing in mind during the medical device development phase. During the development phase, engineers will be thinking more about design outputs meeting the design inputs, rather than long term product manufacturing. Design inputs can be vaguely or improperly defined, especially at early stages. The design teams can easily be led to allocating more effort towards meeting design goals and only little effort to incorporate manufacturability into the design.
Many costly mistakes and drawbacks commonly occur during the transfer of a medical device from prototype to high volume. This is due to improper implementation of Design for Manufacturing (DFM) and pre-Process Failure Mode Effect Analysis (pre-PFMEA).
With insufficient DFM, the product, components, and assembly processes will not fit the capabilities and parameters of the mass production facility. Therefore hindering effective and smooth transition from the prototype to production phase. Similarly, without proper pre-PFMEA the potential points of failure for high volume production will not have been identified and evaluated from early on in the medical device product development lifecycle.
This results in having to take corrective measures after problems arise when reaching the production stage, instead of implementing a preventive approach that addresses issues from the design phase.
Even though you may have employed the proactive practices mentioned above, some amount of changes can occur when transitioning to high volume production. Even for things that are seemingly simple such as cosmetic finishes, branding, or label revisions.
For example, cosmetic revisions can occur because the development phase is too early to commit to manufacturing injection molded parts. As a result, low volume prototyping methods are utilized. However, these don’t produce the initially desired cosmetic finish, making some revisions necessary when transitioning to mold manufacturing.
In many cases there is a tendency to overestimate the significance of completing the design, prototype, and testing phases of a medical device, thinking that the hard part is done. This can’t be further from the truth however, as making a few test prototype units and mass manufacturing many identical units are two entirely different sets of problems.
For every part used in high volume manufacturing there is an acceptable range for each value of its specified features. This range is referred to as tolerance. After making just a few prototypes, not enough tolerance variations may have surfaced yet.
Once a medical device transitions to mass manufacturing, some components tolerances can add up, leading to assembly problems or even device failure. This can occur in devices designed with narrow sensitivities where tolerance specifications were not properly defined. Another common occurrence is miscommunication between the engineering and purchasing departments. Such issues can lead to re-ordering already purchased parts with newly defined tolerances, or even rework of production tooling to accommodate component or process changes.
Medical device assembly processes are not only tied with the device itself but can take different forms depending on the device specifications and volume of production. Some devices may need delicate manual work, requiring highly trained and skilled operators. Other devices may require assembly under specialized cleanrooms with a certain ISO classification. Finally, in some cases the high required production volumes can make the use of automation absolutely necessary. Resulting in the need to invest in equipment such as fixtures and jigs.
It is often jokingly said that a project manager is a person who thinks “if one woman can give birth to a baby in 9 months, then 9 women can give birth to a baby in one month”. However, behind the wit, this phrase holds a certain truth for medical device developers as well, since it is a common trap to estimate unrealistic times when trying to project into the future.
An example would be when a developer is inserting a component manufacturer’s lead times directly into a plan, without accounting the extra time required for transporting, customs clearance, or other issues that may arise. Another example is when medical device manufacturers overestimate how quickly the product will need to be mass produced. Or, underestimate the effort that will be required to achieve the medical device market launch.
An effective way to avoid common mistakes is choosing an experienced partner for both medical device development and mass manufacturing. Quasar has over 30 years experience of taking medical devices from concept to mass produced products. We proactively take into account all factors from the early design stages and leverage our network of suppliers and world class manufacturing facilities, bringing your medical device to market on time and within budget.
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