Biomedical & Medical DeviceCommercial ProductionOliver Design

Production Representative Samples: Worth It!

April 5, 2022 | Mark Foster

Production Representative Samples

In our experience at Oliver Design, production representative packaging samples offer advantages in many instances. Samples are an opportunity for early identification of defects, risks or unexpected usability findings or human factors (HF) that must be addressed. Samples also provide a barometer for validating the actual production process and calculating costs-to-produce, based on the findings of test runs. Using generic, basic or rough prototypes dilutes the accuracy and predictive value of findings. That said, how sophisticated do they have to be?

The pushback is that samples can be difficult to procure in a timely fashion. They also add cost and calculating sample sizing and processes can be murky territory. Yet, with the remedial requests for help we’ve seen and the HF direction unfolding globally, we believe that using production-ready samples wherever possible is a prudent approach.

Benefits of Production Representative Samples

It is very common to see packaging prototypes created from a preliminary or high-level design concept, with that built out as a prototype. Certainly, in some instances, this can seem like a reasonable route to take. It may suffice early on, yet major challenges often rear up down the road.

True, there are some designs and production processes that will be different—in some way—than a sample set. Samples are intended to match or come close to what the packaged product looks like, feels like, and works like. Depending on the packaging platform and/or specific design, there can be greater degrees of variability between samples and production run parts within those perspectives.

Oliver Design set out to create a versatile solution that would enable drug and device firms to procure fully engineered, production representative samples appropriate for many scenarios. We knew our approach must be cost-effective and readily responsive.

To ensure our capabilities aligned with industry needs, we assembled the in-house technical, engineering and mechanical capabilities to produce precision, fully engineered samples. We can refine a concept into a fully engineered CAD model. Our tooling team then takes the CAD prototype and programs the specs into our CNC machine. We work with your team throughout and the samples you receive are fully engineered and production ready. Additionally, because of both our equipment and the collaborative design process, we can be extremely responsive in terms of quantity and lead times. We are thrilled to be able to fill this gap for clients.

Samples for Usability and Human Factors

Patient and caregiver focus groups and clinical end-user feedback are important resources as pharma and medical device firms integrate HF and usability data into development and production processes. What we see on a regular basis has given us a strong sense of when is an ideal point to test and collaborate on representative samples for HF studies and CR/SF testing. Having the voice of experience involved at this phase can be invaluable for implementing the quick design iterations that are often needed for these types of assessments.

Once you’ve engaged with a usability consultant, the finish level of your samples takes on deeper significance. Let’s say you have a combination product—a kit, and it is intended to treat a mental health condition. The usability/HF consultant would assemble a focus group that will include individuals who have a diagnosis of that condition, as well as other surrogate participants to present a variety of data. Giving the subjects samples that are not representative of the finished packaging and product set the stage for poor data quality. Additionally, risks and potential red flags can go undetected.

Child resistant or senior-friendly packaging are other good examples of targeted packaging categories that call for production ready samples. You’ll have a panel of children under age 5 or seniors 65 and up interacting with your samples. It doesn’t take a lot of thought to envision the pitfalls of having these populations interact with less-than-representative samples.

Production ready samples are also ideal to use for FDA submissions, engineering studies, and market evaluations.

Samples for Validation Testing

As we all know in the industry, there is no such thing as “cookie cutter” anything. So, can production ready samples be used for validation testing such as stability, transit, and sterilization studies? That’s when we must answer, “it depends.” When applicable, production representative sample sets are an appropriate choice to complete initial feasibility testing for stability assessments. It is always better to fail early or to complete a feasibility study using two alternative materials for comparative assessments before launching a months’ long study only to find issues later that an initial study would have identified.

In closing, there is much conversation to be had around sample sets. Right now, there is a gift of time to establish your company’s plan, based on the current draft status of regulatory guidance regarding usability and human factors. If you are already talking about it, would like to start talking about it, or have questions, please contact us. We’ve worked hard to bring together everything needed to produce fully engineered production ready sample sets, quickly, efficiently and collaboratively.

Mark Foster
General Manager
Oliver Design

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