Common Mistakes When Transferring The Manufacture of Medical Devices to a Large Volume

In the following blog, we cover some of the common mistakes that are committed when transferring the manufacture of medical devices to a large volume. The ability to identify these areas at an early stage along with proper administration can be critical to the life cycle of a medical device. These common pitfalls that result in costly corrective actions can be completely avoided. 

Assuming that the development team is proactively thinking about manufacturing

A common mistake is to assume that the product development team and engineers have manufacturing in mind during the development phase of medical devices. During the development phase, engineers will think more about design outputs that comply with design inputs, rather than long-term product manufacturing. Design entries can be defined vaguely or inadequately, especially in the initial stages. You can easily direct design teams to allocate more effort to meet design goals and only a small effort to incorporate manufacturing capacity into the design.

Insufficient design for manufacturing (DFM)

Many errors and costly disadvantages usually occur during the transfer of a medical device from a prototype to a large volume. This is due to the incorrect implementation of the Design for Manufacturing (DFM) and the Pre-Process Failure Mode Effect Analysis (pre-PFMEA).

With an insufficient DFM, the product, components and assembly processes will not conform to the capabilities and parameters of the mass production facility. Therefore, hampering the smooth and effective transition from the prototype to the production phase. Similarly, without an adequate pre-PFMEA, the potential points of failure for high volume production will not have been identified and evaluated from the beginning of the life cycle of medical device product development.

This translates into the need to take corrective measures after problems arise when reaching the production stage, instead of implementing a preventive approach that addresses the problems of the design phase.

Do not post revisions

Although you may have used the proactive practices mentioned above, some changes may occur when making the transition to a high volume of production. Even for things that are seemingly simple, such as cosmetic finishes, brands or label reviews.

For example, cosmetic revisions may occur because the development phase is too early to commit to manufacturing injection molded parts. As a result, low-volume prototyping methods are used. However, these do not produce the cosmetic finish initially desired, so it is necessary to make some revisions when going to the manufacture of molds.

Underestimating the challenges of mass manufacturing

In many cases, there is a tendency to overestimate the importance of completing the design, prototype and testing phases of a medical device, thinking that the difficult part is over. However, this can not be further from the truth, since by making a few test prototype units and mass manufacturing, many identical units are two completely different sets of problems.

Tolerances

For each part used in the manufacture of large volumes, there is an acceptable range for each value of its specific characteristics. This range is known as tolerance. After making only a few prototypes, not enough tolerance variations have yet emerged.

Once a medical device goes into mass production, some tolerances of the components can add up, which can cause assembly problems or even device failure. This can occur in devices designed with narrow sensitivities where the tolerance specifications were not defined correctly. Another common occurrence is the lack of communication between the engineering and purchasing departments. These problems can lead to reordering already purchased parts with recently defined tolerances, or even reworking production tools to adapt to changes in components or processes.

Challenges of the Assembly

The processes of assembling medical devices are not only linked to the device itself, but can take different forms according to the device's specifications and production volume. Some devices may require delicate manual work, which requires highly trained and trained operators. Other devices may require mounting in specialized white rooms with a certain ISO classification. Finally, in some cases, the high production volumes required can make the use of automation absolutely necessary. Resulting in the need to invest in equipment such as accessories and templates.

Unrealistic and pressured deadlines

It is often jokingly said that a project manager is a person who thinks "if a woman can give birth to a baby in 9 months, then 9 women can give birth to a baby in a month". However, behind the ingenuity, this phrase is also true for the developers of medical devices, since it is a common trap to estimate unrealistic times when trying to project into the future.

An example would be when a developer inserts the delivery times of a component manufacturer directly into a plan, without taking into account the additional time required for transportation, customs clearance or other problems that may arise. Another example is when the manufacturers of medical devices overestimate the speed with which the product should be mass-produced. Or, underestimate the effort that will be required to achieve the market launch of medical devices.

Technosoft Innovation: your reliable partner

Technosoft Innovations is a medical device new product development & prototyping house.  Technosoft Innovation has more than 10 years of experience in taking medical devices from concept to mass-produced products. We take all factors into account proactively from the early stages of design and take advantage of our network of suppliers and our world-class manufacturing facilities, bringing your medical device to market on time and within budget.