It's no secret that complying with many packaging regulations burdens medical-device manufacturers. Packing is more than a wrapper. In a nutshell, the package's structural integrity must contain and preserve the product until use, and accurately describe its benefits and warnings. Regulations also require companies adhere to a defined process. But here's a puzzle: Why does it seem that every department in a medical manufacturer is well automated except for packaging design? This lack of routine process is a breeding ground for regulatory non-compliance.

The good news is that package design and development is far more repetitive than complex because it has many steps and collaborators including designers, regulatory-compliance officers, brand marketers, and manufacturers. Packaging design begs for systemization. The pioneer of modern quality and innovation, W. Edwards Deming, observed that more than 90% of all errors are systemic in nature — the result of faulty processes. Less than 10% are actually the result of human error.

The FDA recently stated that in a six-month period, 51% of its recalls were the result of mislabeling, and another 13% came from faulty packaging. More than 66% of the recalls are attributed to poor packaging. And most of these flaws can be tracked back to the process.

The bad news is that as more medical devices become available over the counter, expect the situation to worsen. Patients, not doctors, will administer devices for the own personal care. That means packaging will play a greater role because consumers will be unfamiliar with a device's workings. Packaging will carry the instructions.

Fortunately, regulations and guidelines are in place to define “good labeling and packaging.” For example, 21 CFR Part 11 allows using electronic records and electronic signatures in place of, or in addition to paper records and handwritten signatures. To comply with the regulation, medical-device manufacturers must consider the following provisions and find technologies to support them.

Electronic records should:

• Give only authorized individuals access to records and systems that maintain them.

• Create and maintain audit trails. Valid audit trails must record all operations with a secure, computer generated date and time stamp.

• Establish and adhere to standard operating procedures and those for revision and change control.

A few requirements for electronic signatures include:

• Manifestations that include the printed name of the signer, date and time of the signature, and the meaning of the signature (authorship, review, approval, or authorization).

• Each signature must be unique.

• Electronic signatures not based on biometrics must include at least two identification and verification components, such as an identification code and password.

Lastly, computer systems validations:

• Should be fully documented from project initiation through system retirement.

• The medical-device company must confirm the system meets documented requirements for its intended use.

Appropriate and validated computer systems along with a systematic process are the best ways to ensure packaging is clear, error-proof, and complies with FDA regulations.