5 Strategic Success Factors for Secondary Packaging and Device Assembly

August 5, 2020

Starting early to discuss the secondary packaging strategy can save you time and money. From our experience as a globally leading CDMO we would like give you some food for thought.

“Start with the end in mind.”

In his book The 7 Habits of Highly Effective People, Dr. Steven R. Covey provides some valuable guidance for anyone who wants to succeed at a new endeavor. His simple, powerful advice: Start every day or task with a clear goal you want to achieve. Then work toward it.

Dr. Covey’s words are wise ones for any biopharmaceutical company launching a new product—especially when it comes to secondary packaging and device assembly. All too often, sponsors pursue new launches with no clear “end in mind” for these vital product features. Many commercially minded teams give their secondary packaging strategy far too little attention, far too late—with serious downstream implications for product processability, presentation, cost, and time-to-market.

Our Vetter team has helped numerous customers navigate this challenge. As one of the world’s leading Contract Development Manufacturing Organizations (CDMOs), we know how important it is to set a strong, clear secondary packaging strategy early in the product development process. These 5 success factors are vital to that effort.

1. Start with primary packaging

What is the best time to start developing your secondary packaging strategy? When you’re deciding on primary packaging.

Upstream decisions about your primary packaging will have a big impact on downstream requirements for your secondary packaging. For example, if your product will be packaged in a syringe with an autoinjector:

The syringe and its barrel flange must be formatted to fit the requirements of the whole injection system.

The syringe will need to be designed to resist higher mechanical forces during manufacturing.

The injection system will typically be produced on an existing manufacturing platform customized for your product. This customization will require usability studies.

The assembly machines for your product’s delivery system will need to be optimized to process the combined format of all the product components.

This kind of adaptation and customization is critical for successful secondary packaging development. It also takes time and proactive planning. Factor both into your launch strategy as early as possible to ensure accurate and realistic go-to-market timelines.

2. Focus on key users and use cases

Who will use your product? How will they use it? How and where will it be administered? Use case questions like these can have a big impact on your secondary packaging strategy. Asking them early can help set you up for downstream success.

Take syringes, for example. They can be optimized for many different use cases. Ophthalmologists need syringes designed for the fine motor skills required for intraocular injections. Patients taking at-home therapy for arthritis will have very different needs in a syringe. Your users’ age, education, and physical capabilities are all important strategic considerations as well.

Geography can be a critical factor too, especially if you’re planning to commercialize a product in multiple countries and markets. You may need multi-country/market labels and booklets that take time to produce and vet internally. You may also need to adapt your strategy to different reimbursement landscapes. For instance, health insurance companies may prefer cost-saving autoinjectors that patients can administer at home, while physicians may prefer vial kits that require more costly in-clinic administration but allow for closer patient monitoring.

Plan for user- and market-level packaging needs like these in advance. It can help you manage their impact on your secondary packaging strategy, development costs, and timelines.

3. Prepare for market-specific regulations

Many regional markets now require additional validation and documentation for more complex secondary packaging configurations like autoinjectors.

For example, regional market requirements often include additional labeling and mandatory variable data. These extra secondary packaging requirements don’t just take up extra labeling space. They often require country-specific packaging variations too. Customized regional packaging variants can then melt large production runs into smaller country-by-country production orders—with significant implications for your supply chain.

Proactively scouting and planning for market-level needs like these can help you stay ahead of potentially major delays and cost drivers.

4. Take advantage of an opportunity for product differentiation

Secondary packaging can sharpen your product’s competitive edge. Approached in a strategic, user-centric way, it can be a valuable product feature that helps address many of your users’ most important needs.

For instance, ophthalmic syringes can be optimized for precision control by retinal vitreoretinal specialists. Autoinjectors can feature easy-open packaging for patients with reduced dexterity. Secondary packaging that’s convenient, functional, user-optimized can help enhance safety, reduce dosing errors, and support compliance.

It can also be a goal you pursue in stages. After all, few product teams have the time they need to develop a product to its full commercial potential at launch. You can always build further development into a lifecycle strategy that continually enhances your product’s value over time.

5. Have a commercial-ready manufacturing partner

Your secondary packaging needs and production runs will scale up rapidly the closer you get to commercialization. Having the right strategic manufacturing partner is critical during this period, whether you rely on an in-house production unit or a CDMO.

Wondering what you need in that partner? Here are a few critical skills and resources to look for:

  • A scalable production setup with high-grade automation that can manage significant demand changes without sacrificing quality
  • A supply chain capable of reliably delivering consistent quality materials at any quantity
  • In-house engineering and tooling skills to manage equipment changes and mitigate errors when needed
  • Proven success in process development and qualification

Look for these qualities in your manufacturing team as early as possible to ensure smooth scale-up and a secure supply of your product.

Industry trends to keep in mind

As you plan your secondary packaging strategy, consider these ongoing global shifts in the pharmaceutical and biotech markets:

  1. Health authorities’ rapidly increasing demand for commercial products
  2. Continuing FDA emphasis on real-world evidence of product efficacy
  3. Increasing EMA demands for post-market surveillance to monitor product safety
  4. In reimbursement markets, payers and pharmacy benefit managers are demanding verification of intended product benefits and patient compliance.
  5. Growing popularity of pay-for-performance models in certain markets, especially for expensive treatments

Many medical professionals, biopharma companies, and payers are adapting to these trends by leveraging new digital solutions—like smart labels and connected devices—that help deepen the industry’s understanding of disease and patient behavior.

The global megatrend of sustainability is also gaining traction in the biopharmaceutical industry, especially with larger companies pursuing Corporate Social Responsibility (CSR) strategies. Novartis has already pledged to be “completely plastic neutral, with all new products meeting sustainable design principles*” by 2030.

Summary: Set your goals before you start

Keep Dr. Covey’s smart advice in mind when you’re developing your secondary packaging strategy. The sooner you establish goals for this vital component of your product profile, the sooner you can begin proactively working to attain them—with even greater confidence in your budgets and timing.

Start the secondary packaging discussion early, and you can get a jump on optimizing product manufacturing, maximizing flexibility, enhancing user-centricity, and ensuring the best possible coordination of your product’s primary packaging, secondary packaging, and manufacturing needs. With the support of the right strategic partner, you can ensure that you have the end in mind from the very beginning—and that every step you take will move you and your product toward that valuable goal.

*https://www.novartis.com/our-company/corporate-responsibility/environmental-sustainability/waste, Visit 04.09.2019