The Rise of Patient-Centric Packaging in Pharmaceuticals

This week in the Guardrail... we examine the fundamental shift occurring in pharmaceutical outsourcing as companies recognize that packaging is no longer just a container but a critical tool for improving patient adherence and safety.

By Michael Brofman, for Metis Consulting Services

Monday November 24, 2025

In recent years, the pharmaceutical industry has begun to rethink its approach to drug packaging. No longer is packaging only a protective shell for medicines. Today, it is evolving into something much more meaningful: a bridge between drug makers and patients. This shift is called patient-centric packaging. In this post, we will explore what patient-centric packaging is, why it matters, and how it is transforming the way medicines are delivered and used.

What Is Patient-Centric Packaging?

Patient-centric packaging means designing medicine packaging around the needs, abilities, and experiences of the people who will use it. According to Esko, a leader in packaging design, this kind of packaging considers three key elements: patient adherence, patient outcomes, and patient experience.

Traditionally, pharmaceutical packaging focused on safety, regulatory compliance, and product protection. But patient-centric design adds a new layer. It makes packaging more accessible, more intuitive, and more supportive of patients as they take their treatments.

Why Is This Shift Happening Now?

There are several reasons why pharmaceutical companies are embracing patient-centric packaging. Here are the main drivers:

1. Medication Adherence Problems
   
   Many patients do not take their drugs exactly as prescribed. Poor adherence can lead to worse health outcomes and higher costs for the healthcare system.
   

2. Aging Population
   
   As more people grow older, there is a bigger need for packaging that is easy to open, read, and use. Many older patients have physical challenges, such as arthritis or reduced vision.
   

3. Rise of Home Therapies
   
   Treatments that were once administered in hospitals are now used at home, which includes biologics and injectables. For patients to self-manage safely, the packaging must help guide them.
   

4. Trust and Safety Concerns
   
   Patients need to know their medicines are authentic, safe, and appropriately stored. Innovative packaging helps build this trust.
   

5. Digital Innovation
   
   Technologies such as QR codes, NFC chips, RFID tags, and “smart labels” enable packaging to interact with the patient, provide information, and monitor use.
   

6. Regulatory and Industry Pressure
   
   Regulatory bodies and patient advocacy groups encourage more patient involvement in drug design, including packaging.
   

7. Contract Packaging Growth
   
   Pharmaceutical companies are outsourcing more packaging to experts who focus on patient-centric design. 

What Does Patient-Centric Packaging Look Like?

Patient-centric packaging can take many forms. Here are some standard design features:

• Blister Packs with Calendars
  
  These are packs arranged by day and time so patients can clearly see when to take their medicine. For example, a 3 × 7 blister layout displays a three-week course in a single view.
  

• Multi-Compartment Containers / Pill Boxes
  
  These let patients sort their medicine by dose. A meta-analysis shows that using these types of packaging improves adherence.
  

• Braille or Large-Print Labels
  
  Some packaging provides accessibility for those with low vision or other challenges.
  

• Ergonomic Closures
  
  Packaging that is easy to open, even for people with limited hand strength, is growing in demand.
  

• Smart Packaging
  
  Innovative Packaging includes connected features: QR codes or NFC can link patients to digital leaflets, video instructions, or reminders.
  

• Serialization & Anti-Counterfeiting
  
  Packaging can include RFID tags, tamper-evident seals, and other security features to assure patients that their drug is genuine.
  

• Sensor-Enabled Packaging
  
  For temperature-sensitive medicines (such as biologics), packaging can include sensors that monitor storage conditions. 
  

Real-World Examples

One well-known example of patient-centric packaging is ClearRx, a redesign of the standard medicine bottle created by designer Deborah Adler. The ClearRx bottle stands on its cap so the label folds over the top, which makes the drug name easy to see. The label also uses a large font, and there is a place for a color ring so different people in a household can tell their medicines apart. 

Big pharmaceutical companies are also doing more. In several studies, companies have reported that patient-centered packaging makes medicine use more intuitive and self-explanatory. 

Benefits of Patient-Centric Packaging

Why does patient-centric packaging matter? Here are some significant advantages:

1. Improves Adherence
   
   By helping patients remember when and how to take their medication, patient-centric packaging supports better adherence.
   

2. Reduces Errors
   
   Clear instructions, intuitive layouts, and better labeling reduce the risk of misuse.
   

3. Builds Trust
   
   Innovative packaging features help patients verify authenticity and track storage conditions, building confidence in their treatment.
   

4. Supports Accessibility
   
   Packaging designs that consider older adults or people with disabilities make medications more straightforward to use.
   

5. Enables Better Communication
   
   Digital packaging can connect patients directly to educational content, helplines, or telehealth services.
   

6. Helps Sustainability
   
   More innovative packaging can reduce waste and support environmental goals, especially as the industry moves toward more sustainable materials.
   

7. Regulatory Alignment
   
   Innovative packaging helps companies meet regulatory requirements for serialization, traceability, and other requirements.

Challenges and Risks

While patient-centric packaging offers many benefits, it also comes with real challenges:

• Cost
  
  Designing and manufacturing new packaging solutions costs more than simply using traditional containers.
  

• Regulatory Burden
  
  Changes to packaging must comply with strict regulations. Any redesign may require new approvals.
  

• Technology Adoption
  
  Not all patients will use or trust digital features like QR codes or smart sensors. Some may lack smartphones or digital literacy.
  

• Supply Chain Complexity
  
  Connected packaging and smart labels may require new logistics, serialization, and supply chain management.
  

• Privacy and Data Security
  
  If packaging tracks use or transmits data, companies must protect patient privacy and secure their systems.
  

• Sustainability Trade-offs
  
  While some innovative packaging is eco-friendly, others may require more materials or electronic components, which create waste.

What Is the Industry Doing to Overcome These Challenges?

Pharma companies, packaging firms, and contract manufacturers are working on solutions:

1. Outsourcing to Packaging Experts
   
   Many drug makers are hiring contract packaging organizations that specialize in patient-focused designs.
   

2. Engaging Patients Early
   
   In some projects, companies talk to patients during development to learn what works best for them.
   

3. Using Human-Factor Engineering
   
   Designers apply what is known as “human factors” to make packaging more straightforward to use (for example, easier caps, larger print).
   

4. Implementing Smart Technologies
   
   Packaging developers are embedding NFC chips, QR codes, sensors, and serialization to bring packaging into the digital age.
   

5. Developing Digital Information Services
   
   Instead of relying solely on paper leaflets, companies are offering electronic patient information leaflets (ePIL) that users can access via smartphones.
   

6. Improving Multi-Compartment Packaging
   
   By building better blister packs, MDDS (multi-dose dispensing systems), and pill boxes, pharma companies are making it easier for patients to manage their regimen.
   

7. Balancing Innovation and Sustainability
   
   Firms are exploring sustainable materials while still adding innovative features.

What Does the Future Hold?

Looking ahead, patient-centric packaging is likely to become even more common. According to recent market forecasts, connected and intelligent packaging will continue to grow as key areas of innovation. 

We can expect to see:

• More personalized packaging tailored to individual patients (for example, dose-specific packets for personalized medicine).
  

• Smart sensors that monitor conditions like temperature and communicate with patient apps or providers.
  

• Multimedia support (video, audio) built into packaging to help patients understand how to take their medicines safely.
  

• Greater regulatory support for patient-centered designs, especially as patient engagement becomes a priority in health care.
  

• Sustainability integration, where eco-friendly materials align with patient safety and usability.

Why This Matters for Patients and Pharma

For patients, the rise of patient-centric packaging means better experiences, fewer mistakes, and more substantial confidence in their treatment. It may help people take their medicine correctly, avoid serious health risks, and live with more independence.

For pharmaceutical companies, focusing on patient-centric design is not only the right thing to do,  it also makes good business sense. Better adherence means more effective therapies. Innovative packaging can reduce recalls, improve brand trust, and even open new opportunities for patient engagement.

Final Thoughts

The rise of patient-centric packaging marks a fundamental shift in how the pharmaceutical industry sees its role. Packaging is no longer just a box or a bottle. It is a key part of the patient journey. By designing packaging that is thoughtful, accessible, and smart, companies are placing patients at the center of their innovation.

This change is more than a trend; it is a movement toward safer, more effective, and more human care. As technology advances and patient voices grow stronger, we can expect packaging to become even more deeply rooted in meeting real-world patient needs.

The era of patient-centric packaging is here, demanding innovation, regulatory compliance, and a revamped supply chain. Don't let these complex challenges become a risk; contact Metis Consulting Services today at Hello@Metisconsultingservices  to guide your team’s strategy, aligning your packaging design with human-factor engineering and digital technologies to capture value and ensure patient trust.

References

1. Esko. “Patient-Centered Packaging – Changing the Pharma Focus.” Esko.

   Pharma Manufacturing. “Building stronger patient trust through packaging design.”

2. MDPI. “Patient Centric Pharmaceutical Drug Product Design: The Impact on Medication Adherence.”

3. Carli Lorenzini G, Olsson A. Exploring How and Why to Develop Patient-Centered Packaging: A Multiple-Case Study with Pharmaceutical Companies. Ther Innov Regul Sci. 2022 Jan;56(1):117-129. doi: 10.1007/s43441-021-00338-0. Epub 2021 Sep 28. PMID: 34581997; PMCID: PMC8688390.Röchling Medical. “Patient-Centric Pharmaceutical Packaging Design.”

4. CPHI Online. “2025 Pharmaceutical Packaging Market Prospects.”PubMed. “Exploring How and Why to Develop Patient-Centered Packaging: A Multiple-Case Study with Pharmaceutical Companies.” Lund University Publications.

5. GreyB. “Pharma Packaging: Top Challenges and Solutions in 2025.”

6. Exploring how and why to develop patient-centered packaging: A multiple-case study with pharmaceutical companies | Lund University Publications. https://lup.lub.lu.se/search/publication/3f185851-48e5-4929-9886-2b7ae69671f5
   
   

The Advantages of Bringing Pharmaceutical CMOs Back to the United States

For Metis Consulting Services, Inc. 

By Michael Bronfman

August 11, 2025

This week in the "Guard Rail," we at Metis are exploring "Reshoring" of CMOs. We can't afford to settle for anything less than a fortified, domestic, and regional pharmaceutical industry. For decades, the lure of international manufacturing offered a path of lower costs, but this road has proven to be full of potholes.

The Benefits of Bringing Pharmaceutical CMOs Back to the United States (Reshoring)

The pharmaceutical industry plays a central and critical role in public health. Every stage in the drug development and manufacturing process impacts the final quality and safety of medicines. Contract Manufacturing Organizations, known as CMOs, are third-party organizations that manufacture drugs for pharmaceutical firms. These organizations handle activities ranging from producing active pharmaceutical ingredients (API) to packaging and labeling.

Over the past several decades, a large number of pharmaceutical manufacturers have moved overseas. Let's talk about why this is happening: cost savings, reduced labor expenses, and relaxed regulatory environments often tempt companies to China and India.

There have been growing discussions lately about the benefits of bringing pharmaceutical CMOs back to the United States. The term for this movement is "reshoring." The trend to shift overseas has come with a set of challenges and risks that directly impact quality, safety, and national security. Although reshoring requires investment of all kinds, including time and workforce development, among others, it also brings a wide range of returns on those investments. These advantages include improved supply chain resilience, increased product quality, strengthened national security, job creation, and a reduction in reliance on foreign manufacturing. And isn't that what we all want?

Here, we will take a bigger look at how reshoring CMOs to the United States offers long-term benefits to both the pharmaceutical industry and the public.

Improved Supply Chain Reliability

Pharmaceutical manufacturing operates most effectively with a stable supply chain. Delays, shortages, and disruptions have serious consequences for patients' access to the drugs they need. The complexity of global supply chains is in itself a challenge that creates multiple points of vulnerability. Drugs may pass through several countries before reaching their final destination. Disruption along this path, at any point, can lead to delays or stockouts. The long, complex chain is vulnerable to myriad forms of delay, including political tensions, natural disasters, or transportation failures.

By relocating CMOs to the United States, pharmaceutical companies can reduce the number of steps involved in the supply chains. As a result, we would expect faster delivery of finished products and improved response times during public health emergencies. A domestic manufacturing base allows for greater control over production scheduling and inventory management.

During the COVID-19 pandemic, global supply chain disruptions exposed the risks of overdependence on foreign manufacturing. Not just for us here in the US, but globally. Shortages of essential medications and active pharmaceutical ingredients were rampant. A more localized supply chain could help prevent similar problems in the future.

Enhanced Quality Control and Regulatory Oversight

The United States Food and Drug Administration enforces strict regulatory standards. The manufacturers must follow detailed guidelines to ensure safety, consistency, and efficacy. When pharmaceutical companies outsource production to overseas CMOs, consistent quality and quality oversight are more challenging. Regulatory agencies often lack the same reach and oversight capabilities in other countries.

If their CMOs are located back here in the United States, companies gain better access to real-time oversight, audits, inspections, and monitoring. Regulatory compliance is easier to enforce, and deviations from quality standards can be addressed more quickly. This results in fewer product recalls, improved batch consistency, and greater confidence in the quality of the medication supply.

Patients should always be the guiding light in pharmaceutical manufacturing. They deserve safe and effective treatments. A return to domestic production would enhance quality assurance. Improving it every step of the way, from raw material sourcing to final packaging.

Stronger National Security

Pharmaceutical products are a cornerstone of national health and security. When production is concentrated overseas, vulnerabilities become more apparent. Whether it is interruptions to supply or trade restrictions, or foreign political instability, we have more challenges to the health and security. In times of crisis, foreign governments may prioritize domestic needs and restrict exports of critical medications.

Now let's look at that risk when considering essential medications such as antibiotics, vaccines, and insulin. The lack of domestic manufacturing capacity limits the nation's ability to respond to emergencies. If there is another pandemic, or there are bioterrorism threats, or a natural disaster, reshoring pharmaceutical CMOs will strengthen national security by reducing dependence on international suppliers. This will allow for faster production of essential drugs in response to urgent needs. We need to mitigate the vulnerability before any of these disasters strike. With a domestic manufacturing infrastructure in place, as a result, the United States, or even the Americas, will be able to better protect its citizens during emergencies and avoid the harmful effects of drug shortages.

Economic Growth and Job Creation

Potential for economic development is another major advantage of bringing CMOs back to the United States. The pharmaceutical industry is a sector that is growing and expanding. This vital industry can provide high-paying jobs in science, engineering, quality control, and logistics.

Local communities are economically stimulated in related industries, including transportation, utilities, and construction. Building new manufacturing facilities or expanding existing ones could create employment opportunities for both skilled and entry-level workers. As more companies invest in domestic production, entire ecosystems develop around pharmaceutical hubs. These ecosystems create long-term economic benefits that go beyond the companies themselves.

In regions facing economic decline, pharmaceutical manufacturing plants have the potential to provide a much-needed economic boost. The jobs that are created tend to have better wages and benefits than many other industries, contributing to a higher standard of living. This, in turn, creates community stability.

Increased Transparency and Accountability

Patients, providers, and regulators must know where medications are produced and under what conditions. Transparency is essential. When production is moved overseas, transparency often decreases.

Domestic manufacturing encourages greater openness. Regulatory agencies have greater ease of access to inspect facilities and review records. Companies can communicate more clearly with the public about sourcing, safety, and compliance. This builds trust between the pharmaceutical industry and the patients it serves.

Consumers are showing interest in where their medications are made. Just as people care about the origin of their food, many want to know whether their medicines are produced safely and ethically. Reshoring supports this desire for greater accountability and corporate responsibility.

Technological Advancements and Innovation

When pharmaceutical manufacturing is brought back to the United States, there is a greater opportunity for innovation. Continuous manufacturing, advanced automation, and improved quality control systems are all more likely with a chain of domestic facilities. They are more likely to adopt cutting-edge technologies. These technologies increase efficiency, reduce costs over time, and enhance product consistency.

In contrast, many overseas facilities are slower to modernize due to limited capital investment or regulatory restrictions. Reshoring CMOs allows American firms to lead in pharmaceutical technology and manufacturing science.

Collaboration is strengthened: manufacturers, research institutions, and universities work together more naturally. The exchange of knowledge and technology accelerates innovation and shortens the time needed to bring new treatments to market.

Resilience in Times of Crisis

We have seen how vulnerable the global pharmaceutical supply chain can be. Recent events have led to delays, shortages, and rising prices. When companies rely too heavily on foreign suppliers, they lose the ability to adapt quickly to changing circumstances.

Creating a network of CMOs domestically increases resilience. Manufacturers will be able to launch emergency initiatives in a timely manner. They can adjust production levels or shift resources without waiting for overseas partners. This flexibility is essential during times of national crisis.

By investing in domestic capacity now, pharmaceutical companies can ensure they are prepared for the challenges of tomorrow. Reshoring is a long-term strategy that increases preparedness and stability.

Ethical and Environmental Considerations

Ethical labor practices and environmental standards can vary widely across different countries. CMOs may or may not operate under conditions that do not align with US values. There might be extremely low wages, unsafe working conditions, or limited environmental protections.

Bringing pharmaceutical manufacturing back to the US ensures compliance with fair labor laws and environmental regulations. Companies are required to provide safer working conditions and reduce their environmental impact. And consumers, in this case, patients, are increasingly interested in how products are made. These efforts support sustainability goals and improve corporate reputation.

Ethical sourcing and responsible production practices are no longer optional. Reshoring aligns with public expectations and supports the broader goal of corporate social responsibility.

I hope that after reading this, we all can agree that the decision to bring pharmaceutical CMOs back to the United States is both strategic and responsible. Offshore manufacturing has seemed to offer short-term cost savings. At the same time, it has created long-term risks related to quality, supply chain stability, and national security.

By investing in domestic production, the pharmaceutical industry can strengthen its foundation. Advantages include more reliable supply chains, enhanced quality control, stronger national security, economic growth, technological leadership, and ethical transparency.

Reshoring is certainly not without its challenges; it requires capital investment, workforce development, and regulatory planning. The long-term benefits do outweigh the initial costs. We can deliver safer, more reliable treatments to the people who need them most by producing more of our medications closer to home. And our industry will do all of that with a smaller footprint.

As the pharmaceutical industry faces growing complexity and rising public expectations, reshoring CMOs is a powerful step toward a more secure, transparent, and innovative future. The time has come to rebuild U.S. pharmaceutical manufacturing, for both economic reasons and the health and well-being of the nation.

If you are in a position to contract your organization's CMO and would like to discuss how to reshore manufacturing, please contact us at

hello@metisconsultingservices.com

Or for more information, see our website at:

https://www.metisconsultingservices.com/

Or better yet, schedule an appointment:

https://calendly.com/sbradley-metisconsultingservices

Navigating the Current Regulatory Climate

Written by Michael Bronfman

Need help in the current Regulatory Climate? A consultant can help you get to Compliance and Beyond

To address the challenges faced by biotech companies as they enter new markets, a good consultant can leverage its expertise in navigating complex regulatory environments, ensuring compliance, and optimizing quality systems. Here are some ways Metis Consulting Services could help your organization meet the challenges highlighted in a survey * of over 200 regulatory, safety, and quality directors from small to medium-sized biotechs in the EU (Ireland) and North America (U.S.) :

1. Navigating Complex Quality Requirements

Metis Consulting can assist biotech companies in setting up and optimizing quality management systems (QMS) to meet the specific regulatory and licensing requirements of new markets. By providing expert guidance on local regulatory frameworks, Metis can help clients avoid common pitfalls related to misunderstanding market-specific requirements.

2. Pharmacovigilance Expertise

The survey highlighted pharmacovigilance as a critical challenge. Metis could offer tailored pharmacovigilance services to help biotech companies integrate and scale their pharmacovigilance activities early in the development process. This would include creating robust systems for adverse event reporting, risk management, and regulatory submissions to ensure compliance in various markets.

3. Streamlining Regulatory Approval Processes

With regulatory approval times being a significant challenge, Metis can help companies navigate regulatory submission and approval processes more efficiently. This can include regulatory strategy development, gap analysis, preparation of submissions, and liaison with regulatory bodies to expedite approvals and reduce delays.

4. Cost Management and Market Strategy

To mitigate the higher-than-expected costs and avoid market entry withdrawal, Metis could assist in conducting cost-benefit analyses for entering new markets. This would involve identifying the most cost-effective strategies for market entry, regulatory compliance, and operational scaling in challenging markets like China, Brazil, and others.

5. Early Integration of Key Planning Functions

The survey pointed out the need for early integration of pharmacovigilance, regulatory, and quality planning. Metis could offer integrated consulting services that help biotech companies align their regulatory, quality, and safety strategies from the outset. This proactive approach can help reduce the likelihood of unforeseen roadblocks and inefficiencies as companies scale and enter new markets.

6. Adjusting Strategies for the U.K. and EU Markets Post-Brexit

With heightened focus on the U.K. due to Brexit and the evolving regulatory landscape, Metis Consulting can offer specialized services to help biotech companies navigate post-Brexit regulatory challenges in the U.K. and the EU, ensuring that they remain compliant while maintaining smooth operations across both markets.

7. Success Redefined: Compliance and Investor Relations

As compliance and investor payback become more critical success metrics, Metis Consulting can help biotech companies develop robust compliance strategies that align with the increasingly stringent requirements in the U.S. and other markets. Additionally, Metis could assist companies in crafting strategic plans to demonstrate strong compliance performance, which would be crucial for maintaining investor confidence.

8. Strategic Market Entry and Representation

For companies looking to expand into high-priority markets such as the U.S., U.K., Canada, Brazil, and the Middle East, Metis can provide strategic advice on market entry, representation models (direct vs. partnerships), and regulatory considerations specific to those regions. This could include helping biotech companies decide whether to pursue direct representation or rely on local partnerships, depending on the market's dynamics.

9. Tailored Regional Guidance

Metis can also offer tailored insights into specific regions that are becoming increasingly important for biotech market access. For example, the firm could assist in navigating regulatory complexities in Brazil, which has become a key biotech market in Latin America, or help companies looking to expand into the Middle East, where the biotech sector is growing rapidly.

By offering these comprehensive consulting services, Metis Consulting can position itself as a trusted partner that helps biotech companies overcome regulatory, safety, and quality challenges while successfully entering and expanding in new markets."

* https://www.linkedin.com/pulse/top-pharma-biotech-news-1-january-edition-symmetrictraining-ndtgf/