Applying Critical Dimensions to Medical Device Design and Development

Posted in Design Services by bmichaels on November 10, 2014

By following a set of strategies for identifying critical dimensions early in the development process, designers can help manufacturers streamline the production process.

Bert Uschold

When developing medical device products and the parts that comprise them, engineers must usually decide what elements of the design are critical to function and, therefore, what dimensions require closer attention during manufacturing. There are many
names for such dimensions, including critical dimensions, critical-to-function dimensions, and inspection dimensions.

Regardless of what you call them, it is prudent to have a strategy in place to determine what dimensions are critical and communicate to the manufacturer exactly what critical means. If the engineer identifies too many dimensions, the part will require
additional inspections, increasing costs unnecessarily. If the engineer identifies too few, quality could be compromised. This article reviews a set of strategies for identifying critical dimensions early in the development process and for communicating their
meaning and importance to the manufacturer.

Defining Critical Dimensions

Before describing how to communicate critical dimensions to the manufacturer, medical device engineers should understand how they are defined. Critical dimensions are those that must meet the print requirement to avoid compromising one or more of
the products critical functions. The critical function could be proper assembly, or it could be used to identify dimensions that are important to the interchangeability of parts or assemblies. Legos are a good example of interchangeability. A critical
dimension can also be defined as a dimension that must comply with
regulatory or industry requirements, such as the size of a USB connector.

In order to indicate how critical the dimension is and how it will be inspected,
a critical dimension can be divided into subtypes. The first subtype is called a
statistical process control (SPC) dimension. The most important dimension in
the design of a product, the SPC dimension is part of an in-process
inspection plan throughout the production process. A noncompliant critical
dimension will likely cause an important feature to be defective.

Another type of critical dimension is the validation dimension. While the

validation dimension is critical to the function of the product, it has also been
shown to or is expected to correlate well with another dimension inspected
during the process. Therefore, it needs to be inspected only during a process
capability study and in the first production article.

A target dimension is another type of critical dimension. While a target

dimension is critical to product function or assembly, it is not as critical as an
SPC or validation dimension. Thus, it is only inspected in the first production
article, whereby it must be within 66% of the drawing tolerance. Why not just
make the drawing tolerance tighter? Because a thorough tolerance analysis
does not require it. The 66% requirement ensures a high confidence level
throughout the production process that the dimension will be in spec. If a first
article is measured just within the specified limits, it is probable that it will
frequently be out of spec during production. A tighter first-article requirement
is like a minivalidation or process capability study.

A process-sensitive dimension (PSD) is a special type of critical dimension.

While it might not be important to the function of a part, it is easy to measure
and is a good indicator of whether other dimensions are in spec or not. For
example, a validation study may show that three part dimensions vary
similarly above and below spec. If one of these dimensions is easy to
measure but not critical to function, it could be a proxy for the other two if
they are important to the function of the part and are difficult to measure.
Overall length is a typical PSD. A tolerance analysis drawing before subtypes have been specified.

Applying Critical Dimensions in Practice

How should engineers apply critical dimensions in a typical medical device manufacturing program? In the early stages of a development project, the first manufactured parts are usually machined breadboards or those made using a variety of addit ive
manufacturing processes. Often, such parts can be made without drawings. The critical dimensions, if any, are those that the engineer measures when the parts arrive and are probably not identified in any formal manner. In some cases, it is appropriate to
sketch a development drawing delineating a few dimensions in order to communicate some design intent to the personnel respons ible for making the part. Designating the handful of dimensions on a development print as critical is probably superfluous
because most such dimensions are critical.

The next stage in the development process is the creation of prototype parts. While a wide range of manufacturing and design intent options can be used to produce prototypes, they are not final production parts. Prototyping is a production-like process
that creates parts that closely resemble final designs. While an accompanying drawing is not necessarily production-ready, it must be more than a glorified hand sketch suitable for an initial evaluation piece. A drawing suitable for creating a prototyped part
should show most of the dimensions and tolerances that will appear on the final production print.

At this point, the engineer should seriously consider the critical dimensions of the production part. Because all critical dimensions are treated as target dimensions at this stage, it is not necessary to specify other subtypesa step that will be performed
later. The critical dimensions need to be specified in the drawing, and ovals are commonly used to designate them.

Now, the engineer has developed a moderately mature but not final design, has decided on a production-like manufacturing process, and has created a drawing that identifies critical dimensions without specifying their subtypes. If an injection mold is
required, it is probably necessary to instruct the molder to measure the critical dimensions and perhaps a few other dimensions as well. While a complete first article is not usually produced at this stage, it could be produced if necessary.

Honing Critical Dimensions

When the part is ready to be fabricated using a final production method, the critical dimensionsincluding their subtypesshould be defined. Since a production process is being used, it is appropriate to identify the PSDs. While there is usually just one
process-sensitive dimension, circumstances could demand more.
Next, the medical device engineer should decide which target dimensions
should be upgraded to validation dimensions for measuring in a process
validation study. To accomplish this task, the engineer should consider how
critical the dimension is to the design and determine whether it is a tight
tolerance or a highly variable dimension. For example, if a dimension in an
injection-molded part is susceptible to warp, it should probably be validated.

When two target dimensions are close to each other and the engineer is
confident that they will vary with each other, one of them can be validated
while the other remains a target dimension. While identifying critical
dimensions as SPC dimensions at this stage is optional, the engineer may
decide to do so if the dimension in question is crucial to functionality, impacts
a regulatory requirement, or is known to have been an SPC dimension in the
past.

In order to proceed confidently with a process capability study, engineers

should determine that all dimensions slated for such a study fall within 66% of
the drawing tolerance at first-article inspection. However, the 66% standard is
not a hard and fast value. If the tolerance is on the large side or the process is
known to be tight, a higher value might be acceptable. On the other hand, the
engineer may have reasons to set it at a lower value. Clearly, if a critical
dimension were measured at the limit of the drawing tolerance, few engineers
would proceed with a process capability study because the chance of passing
would be low.

Finalizing Critical
Dimension
Studies

After the process

validation study
has been A tolerance analysis drawing with all subtypes specified.
completed, the
engineer knows
which dimensions
easily meet the
process capability
(Cpk) requirement
and which do not.
Validation
dimensions that
barely pass or that
do not correlate
well with a process-
sensitive dimension
are good
candidates for
ongoing evaluation
and for being
Example of a typical tolerance analysis.
identified as SPC
dimensions. In
such cases, ongoing inspection is required because the PSD is not a good proxy for the validation dimension. Alternatively, the engineer could identify a different process control dimensi on as a better indicator. However, especially if a PSD is present, it is
not necessary to define any dimensions as statistical process control dimensions. Since fewer inspections result in lower costs, engineers should decide which validation dimension is harder to measure and choose the easier one.

What if a dimension is both an SPC and a PSD? In such cases, the dimension should be designated as both on the drawing. If the SPC designation is left off, the manufacturer could inappropriately decide to change it. If the PSD designation is left off, the
drawing will appear to be missing information, especially if other parts made by the manufacturer call out a PSD. Thus, the PSD designation is not critical and can be left off a drawing for the sake of simplicity, while the SPC designation should always
appear because it is important to the designer.

Conclusion

The system described in this article is not perfect. For example, what happens if a vendor is unaware that part dimensions must be inspected in process and a post-validation drawing subsequently shows the existence of one or more SPC dimensions? In
such cases, tensions between the designer and the manufacturer can arise over the parts manufacturing scope, cost, or even delivery time.

The solution to this dilemma is early communication, allowing the parties to estimate a final inspection plan and the costs i nvolved. However, depending on a programs schedule and the time required to create inspection fixtures and gauges, SPC
dimensions may need to be identified before the process validation study is performed. Thus, while designers and manufacturers try to create simple procedures, they must follow them with an eye toward accommodating necessary exceptions