Quality control is important for all industries. But for pharmaceutical and drug delivery products, it’s particularly critical because the drugs are consumed by humans and quality could mean the difference between life and death. As such, process consistency, adherence to stringent specifications and compliance to governmental regulations are vital to product safety. Control over the quality of products also inspires the confidence of patients and health care professionals while bolstering a company’s reputation. It ensures the product performs as designed and protects the public by keeping faulty products out of the market.
The trajectory of medical technology development has led to the introduction of more devices that enable patients to administer medicines themselves. In fact, Medical Design Briefs expects the injectable drug-delivery device market to grow to $37.5 billion in 2025, up from $16.7 billion in 2016, with more sophisticated products offering new user-friendly, smart features. As pen injectors, auto injectors, on-body injectors and other drug-delivery devices grow more complex—along with the medicines being inserted into them during production—quality control efforts can become significantly more complicated. Deep experience and expertise in device development are crucial to ensuring successful execution of the quality process.
The Difference Between Compliance and Continuous Improvement
Two important aspects of quality control are compliance and continuous improvement. Compliance encompasses the efforts of a manufacturer to ensure products meet the breadth of governmental standards and regulations. For instance, agencies investigate whether validation protocols are in place and are followed. Agency inspectors do not, however, take into consideration whether validation processes also optimize production.
Continuous improvement, on the other hand, is a coordinated effort to optimize the manufacturing processes to ensure the most efficient production cycle. Take the example of a drug-delivery device meant to be administered by patients rather than by health care professionals. A continuous improvement program might analyze ways to make production faster in order to provide more devices to a growing market while maintaining the same stringent specifications. Or it might leverage data from production processes to reevaluate a device’s design to make it easier for patients to use, with the goal of improving adherence and disease management.
There is also overlap between compliance and continuous improvement efforts. Government agencies require data for a company to prove compliance. Continuous improvement programs generally collect large amounts of data to inform their efforts, and this information can be used as part of the compliance documentation submitted to government agencies.
Trends in the Pharmaceutical Market Affecting Quality Control
More-Complex Products: In a recent Molex survey of pharmaceutical professionals from companies with a digital drug-delivery strategy, 69% of respondents cited the improvement of patient engagement as one of the factors driving their organizations’ interest in drug-delivery solutions. The development of special features to encourage patient adherence, including devices that transmit data and reusable drug-delivery devices that contain medicine, is among the trends leading to increasingly complex products and, by extension, increasingly complex quality control efforts.
Drug-delivery devices designed to be administered by a patient rather than by a health care professional present a specific type of product sophistication. Because the end user might not be medically trained, the device design should include safety features—like an auto injector with a simple sleeve-triggered activation that uses illuminated icons and sound to provide feedback to users. Also, smart devices that are often connected to an app to help both patients and health care professionals track adherence and disease management contain more electronics than pen injectors and auto injectors of the past. Both of these are examples that would add to design intricacies and complicate the manufacturing process. In turn, quality control procedures necessarily grow more intricate, too. Indeed, quality control becomes even more important because a company’s reputation will be a vital factor in convincing millions of patients to self-administer drugs with cutting-edge connected devices.
Demand for Data: Developments in Industry 4.0 have made it possible to gather and process enormous amounts of data. As a result, forward-looking companies are making decisions for next-generation products and design for manufacturability (DFM) by leveraging the availability of data, which adds additional layers to quality control efforts. Pharmaceutical manufacturers need to validate software and data systems to adhere to regulations and safeguard patient privacy, and this validation applies not just to software in connected devices but also to software and data systems used in the plant during the manufacturing process.
Plant Automation: Robotics and artificial intelligence are reducing the human aspect in manufacturing processes, eliminating the potential for human error and tightening quality control efforts, all of which support and aid compliance. As the manufacture of drug-delivery devices grows more complex—including drug handling, serialization, cold chain storage and final packaging—the benefits of automation on quality control only grow. Automation, however, is also a significant investment and is often cost prohibitive for many pharmaceutical manufacturers.
When Should Pharmaceutical Companies Consider Contract Manufacturers?
The unique situation and need of a given company should inform the decision to consider contract manufacturing. For example, a small pharma company with limited resources and expertise may have a great idea but lack the means to develop the product and bring it to market. But the right contract manufacturer with an experienced engineering team can develop the device from initial concept and leverage vast and diverse expertise to provide guidance on patient-centered designs.
Conversely, a pharmaceutical company with a big R&D department might be able to manage the initial design but lack the manufacturing facilities to produce at scale. Here, a contract manufacturer with the right facilities, equipment and experience fills critical gaps, providing design for manufacturing capability and optimization as well.
Likewise, some pharmaceutical companies look for help with post-production initiatives, such as managing compliance and complaints. Contract manufacturers apply global expertise in data and reporting compliance and can conduct complaint investigations and respond with product adjustments to enable reapplication for compliance as needed.
The Phillips-Medisize Advantage
For years, Phillips-Medisize, a Molex company, has been an industry-leading expert in quality control. Its commitment to quality enables Phillips-Medisize to provide high levels of efficiency and effectiveness at every stage—from design and development to manufacturing and post launch. Phillips-Medisize leverages standardized global quality system processes, tools and software platforms. Further, Phillips-Medisize takes a uniquely proactive approach to risk management, embedding best-in-class quality controls into product designs from the start.
Expert in ensuring regulatory compliance across all sites to comply with applicable legal, industry and country-specific standards, Phillips-Medisize also develops concept design and refinement and optimization of existing designs. Decades of experience in a broad range of electronic component and material optimization initiatives with the support of Molex, along with the company’s drug-handling capabilities, enable Phillips-Medisize to provide cutting-edge solutions and products to its customers.
To learn more about the Phillips-Medisize capabilities and collaborative approach, watch this on-demand webinar outlining how manufacturers are creating the infrastructure to provide multiple facets of drug-device production, including cold chain storage and serialization. Or read a case study about a collaboration between Exact Sciences and Phillips-Medisize to fight colorectal cancer—just one example of how Phillips-Medisize is Bringing Possibilities to Life every day.