For Medical Device Manufacturers (MDM), collaborating with a contract packager serves as a cost-efficient alternative to hiring packagers. Maintaining an in-house packaging line could rack up to hundreds of thousands. Instead, startup MDMs could use this money to expand their business and bolster their product development.

Of course, cost-efficiency plays a crucial role in choosing contract packagers. However, you can’t blindly jump at the first brand that offers you the cheapest packaging solution. Otherwise, you’ll compromise product quality. The medical industry leaves no room for error. Poor packaging could make or break your brand, especially as a startup.

Don’t worry if your company doesn’t have a packaging system yet. To ensure that you enlist the best contract packager, make sure you consider the following key points:

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1. ISO-Compliant Packaging

Before anything else, you need to ensure that your contract packager provides solutions compliant with the International Organization for Standardization (ISO) guidelines. The ISO has several guidelines for medical devices and drugs. However, to give you a brief overview, most of their sections require packaging materials to be:

  • Non-Toxic: You can’t add toxic preservatives and extenders to your product packaging, even if they improve durability.
  • Traceable: The ISO requires MDMs to use traceable, known materials for their packaging. Incorporating unknown minerals or chemicals into your packaging could negatively affect the makeup and consistency of your product.
  • Damage-Free: All products shipped need to undergo quality control to ensure all packaging has no dents, creases, holes, or punctures, among other physical defects.
  • Medically Intended: Ensure that your contract packager uses packaging materials intended specifically for containing medical devices, paraphernalia, and medication.
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2. Industry Experience

Any brand can draft a convincing landing page. However, if you want to get the best packaging solutions for your MDM company, we encourage you to go beyond sales newsletters and look into the company’s experience. Assess how long they’ve been in the industry.

As a general rule, avoid working with contract packagers backed by less than 10 years of experience. Yes, they might have a competent team. However, packaging companies that have undergone several ISO guidelines changes throughout the years can provide safer, compliant solutions.

Also, look into the company’s client base if possible. Prioritize working with experienced, tenure packaging companies that serve widely known MDMs in the same industry.

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3. Medical Technology Knowledge

You’ll come across hundreds of packaging service providers specializing in different industries, from fast-paced consumer goods to perishable products. You might notice that some packagers offer much lower rates or more unique designs.

However, don’t consider pricing yet. Instead, narrow down your choices to packagers specializing in medical devices, paraphernalia, and medication first. Again, medical packaging solutions follow stringent guidelines. Blatantly overlooking these restrictions to cut costs and work with non-medical contract packagers has grave legal consequences.

When in doubt, ask for their client history and packaging portfolio. Go through the types of packaging they offer, review their packaging materials, and browse their typical clients before assessing whether they can address your MDM company’s packaging needs.

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4. Packaging Design Customizations

Yes, secure, cost-efficient packaging is crucial, but you don’t have to neglect design customization altogether. Choose a packager that customizes packaging designs.

Trust us — a well-made, eye-catching design sets your brand apart from competitors. Give your brand an identifying pattern that customers will automatically notice when visiting pharmacies and drug stores.

Also, use colors wisely. Consumers typically associate colors with different meanings. Familiarize yourself with them so that you have total control over the emotions your products evoke.

For instance, white and gray signify neutrality. You can use them as the base colors of your product packaging to convey a sense of cleanliness and security. Meanwhile, loud, vibrant colors work best for warnings. Most devices use red, orange, or blue to label legal disclaimers and medical instructions.

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5. Effective Package and Process Validation

Your contract packager will handle your medication’s product packaging needs. However, you are still legally responsible for validating your MDM company’s packaging system. You can expect the U.S. Food and Drug Administration (FDA) to inspect your product packaging solutions, regardless if you have an in-house team or outsource workers, and see whether they meet the industry standards. If not, you will face the legal consequences yourself.

Although MDMs follow varying guidelines based on their products, the FDA generally asks for documentation regarding:

  • Installation Qualification (IQ): IQ checks the documents about the packaging system’s setup. The FDA assesses whether your packager has efficient, up-to-date technology that meets modern standards.
  • Performance Qualification (PQ): The FDA will assess your packager’s system for forming, sealing, and installing products. Efficiency is important. However, the inspectors will likely focus more on ISO compliance.
  • Operational Qualification (OQ): OQ involves documentation regarding your packager’s team. Its employees should have the necessary training and education to provide quality, compliant packaging solutions.
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6. Streamlined Packaging System

We strongly encourage MDMs to visit their potential contract packager. Although you’ll learn a lot from reading the company’s client records, licensing documents, and ISO certifications, you can’t forgo in-person checkups.

Tour the factory for at least an hour. Ask the floor manager to introduce the team to you, explain the technologies they use, and provide sample finished products. Do the same checkups with all your potential packagers.

Also, in-person visits don’t end once you sign a deal. Strive to visit your packagers at least every month or two to ensure they’re holding up their end of the deal. Don’t be afraid to terminate contracts if you find anything unusual. Securing new contract packagers might set back your production expectations, but overlooking quality issues will compromise your entire brand.

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7. Transparent System Calibration and Maintenance

Ask your potential contract packager about their calibration and maintenance checkups. Again, the FDA will hold you legally accountable for system malfunctions, even if you outsource your packaging needs to a third-party service provider. For this reason, make sure that your packager guarantees checkups.

Ask for their routine calibration maintenance checkup paperwork for the last few months. Scour the documents for irregularities. Don’t feel afraid to ask your packager about months or quarters when they neglected certain aspects of their routine checkups.

Note: If you don’t know what areas to inspect, please refer to the guidelines listed on the ISO website. You can also reach out to a representative.

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8. Ongoing Training and Education

The ISO and U.S. FDA update their guidelines regularly. The medical industry is a fast-paced sector with ever-changing needs, and you need to stay updated if you want to build a solid, reputable MDM brand.

Of course, the same rule applies to medical contract packagers. Apart from keeping up with the latest guidelines, they also have to apply them throughout their factory. And the only way to do so is through ongoing education.

Ask your contract packager about the training programs they provide their workers. See if they cover mandatory updates and restrictions. Also, you’d do well to find a packaging company that goes above and beyond to train its workers on how to utilize new technologies.

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9. Change Control Updates

Look for contract packagers that are transparent with their change controls. Ideally, your packager should inform you right away if they decide to update anything with their operational workflow, manpower, or production system. Overall, they should keep you in the loop with anything that might affect your packaging solutions.

10. Upfront Pricing and Rates

Don’t automatically agree to the first contract packager with the lowest base rates. Note that most contracts come with extra costs. So, while a packaging company might have industry-low production costs, it could still spike its rates with hidden fees and miscellaneous expenses.

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Avoid these types of packagers. Overall, look for honest, trustworthy partners who are 100% upfront about their rates right from the get-go. Also, accurate estimates will help you make more realistic profit projections.

11. Multiple Relevant Services Offered

Look into the other services that your contract packager offers. Creating in-house teams costs significant resources, which MDM startups could allocate for other expenses. You’ll significantly minimize your overhead by outsourcing first.

For instance, let’s say your brand sells medical devices. Once your incoming orders exceed your current production system’s threshold, you can either invest in new manufacturing equipment or outsource to another manufacturer.

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Of course, an in-house manufacturing system yields better long-term results. However, for startup feasibility, you’ll effectively lower your initial operational costs and hasten production by collaborating with an experienced contract manufacturer.

Bottom Line

Your contract packager will play a crucial role in the success of your MDM brand. You need an experienced, reliable company that can help you retain the quality of your products throughout the manufacturing, shipment, and storage process. Otherwise, you’ll compromise your brand’s reputation.

Are you still lost on where to find contract packagers? For a solid starting point, reach out to Pro-Tech Design & Manufacturing. Apart from packaging, the company also provides assembly, medical device outsourcing, sterilization, and laboratory services.

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Do you currently work with a medical device contract packager? Share in the comments section below what factors you considered before deciding to let them handle your brand’s packaging needs!