Injection Innovation: The Future of Drug and Reagent Handling

In these turbulent times, many across numerous sectors are seeing “the future” is fraught with market challenges — as well as brilliant promise. With so many recent changes in the way people receive their medical care, the drug and reagent handling marketplace is experiencing tremendous pressure to design solutions that answer the need for ease of use and broad access to needed drugs and monitoring while keeping a strong focus on environmental sustainability. The result is an emerging reliance upon companies that can supply both in an integrated end-to-end process that takes place on-site at the device manufacturer.

The potential benefits of such a model are numerous, including reduced cost, optimized vendor management, streamlined logistics, and rapid time-to-market. A major factor driving this movement is economics; ease and comfort in use encourages patient affirmation and thereby stronger demand, while sustainable practices conserve resources. Both are key to addressing the market need with high product availability while keeping costs low. This is especially critical at a time when global healthcare costs are increasing substantially. However, the risks and complexity associated with delivering drugs that have become more complex and require tighter temperature handling controls must also be addressed. These variables must be considered in the plan for not only design and development of these devices, but also manufacturing and production.

Alternatives to the commodity device

Prefilled syringe cartridges are an important example. With drugs delivered in syringes often serving patients with single dose requirements per day, the cartridges have become a commodity. Yet for many applications, a separately designed and manufactured set of components won’t suit the requirement for either patient ease-of-use or overall cost to manufacture.

A clear alternative is turning to one organization to architect an integrated design that incorporates all variables of use, manufacturing, and disposal. Likewise, the organization might design a container specific to the drug or testing device handling needs and then fill and assemble the container within the device packaging, serialization and compliant packaging. 

The business model requires both product development in an advanced Development Center in addition to the ability to leverage innovation, experience and precision expertise in the timely launch of products to commercialization through high-volume manufacturing.

A vision of greater vertical integration

One of the ways new market entrants stand apart from existing players —as well as new disruptors – is through vertical integration. Likewise, applying this strategy allows companies to enter niche markets, rather than limit their capabilities to those players in high-volume markets where bigger players may dominate.

Drug and reagent handling provides a powerful avenue for vertical integration in niche categories, where better alignment with customer process value streams can be achieved. Internal laboratory capabilities for microbial analysis or actual drug analysis can further enable that vertical integration. Such integration enables shorter product and process development cycles, faster time to market, and greater manufacturing efficiency. This, in turn, can help facilitate development of precision medicine — based on the need to prescribe an exact dosage of a drug or combination of drugs based on the patient’s genome.

Simultaneously, the means of delivery are also undergoing a wave of innovation. Instead of being injected, drugs today are also being inhaled via nebulizers and delivered through other emerging and less invasive technologies requiring unique device delivery options.

Optimizing time-to-market

As drug delivery requirements are becoming increasingly challenging and complex, Phillips-Medisize has emerged as a powerful partner in the delivery of diverse drug delivery devices, also bringing a unique set of expertise in production and manufacturing to optimize time-to-market.

A case in point is the growing demand for large-volume injectors to reduce injection frequency. These devices must be easy to use, as well as prefilled to support in-home medication delivery, as a means for potentially moving more treatments out of hospital settings.

The innovation injection

Philips-Medisize provides a unique combination of design and volume build capabilities, as well as drug and reagent handling. Add to this the deep legacy of its parent company, Molex, in providing both electronics expertise and high-speed manufacturing and you have a combination of capabilities that support drug companies from start-up to mass production at speed. And, as drug delivery devices evolve, the knowledge of how to effectively integrate enabling technologies such as flexible circuitry and wireless communication will be paramount. The requirements are not trivial, from effective cold chains to high-quality and extremely compliant processes, to clean room capability that is aligned with product quality needs. And they are seldom found under one roof.

Molex and Phillips-Medisize leverage decades of experience to provide holistic solutions for their customers, both vertically integrated and cutting edge. And the result? High-precision product launches with time-to-market speed and premium quality.

The digital transformation of drug handling

Drug development and reagent handling have recently evolved from mechanical, plastics-driven design to incorporating electronics to ensure the patient receives the correct medication and the recommended dosage levels.

Effective integration of these technologies into these critical medical and pharmaceutical solutions requires a strong background in advanced electronics, connectivity and sensor technologies.

The Aria Smart Autoinjector Platform from Phillips-Medisize serves as a strong example of a successful connectivity and device marriage.

Aria features a reusable electronic drive unit, plus single-use, disposable cassettes to elevate patient care while reducing environmental impact. The thoughtful design results in a compact, easy-to-use device with built-in Bluetooth or optional RFID to enable connectivity with smartphones, tablets and mobile apps.

Also, devices such as wearable biosensors are being used to monitor a wide variety of data points, including vital signs, step counts and body posture — all in a low-cost, easy-to-use and disposable form factors that wouldn’t be possible without integrated sensor electronics.

Meeting the logistics challenge

Although drug delivery devices are designed to be simple yet sustainable, the logistics problems involved in maintaining adequate supply chains can be formidable. Phillips-Medisize has been confronting the direct physical challenges of safely and effectively managing shipment given the toughest requirements over the most diverse terrain.

In addition to managing logistics of drug delivery within very specific temperature controls, we have spent years acquiring knowledge and innovating to ensure continuous tracking and measurement – a core element of successful material supply management.  By tracking where a product is at all times and understanding how conditions are affecting the drug through the entire shipping process, factors such as humidity and temperature can be regularly monitored and reported.

With the once-separate capabilities of diagnostic, therapeutic and monitoring devices now beginning to converge, manufacturers will need to manage increasingly complex and differentiated supply chains while remaining compliant with stringent governmental and industry standards. Through its existing relationships with distributors, suppliers, specialty manufacturers and design specialists, Phillips-Medisize navigates complex global supply chains to offer a wide range of compliant services, components, and assembly options from highly reliable sources.

The combination of critical global footprint and exceptional capabilities in design, volume and precision manufacturing, drug and reagent handling, and supply chain expertise puts Phillips-Medisize in a rare category of Contract Development and Manufacturing Organization (CDMO) leaders serving both pharma giants and disruptive newcomers. And it’s the vertical integration – complete with drug and reagent handling under one roof that is the secret sauce for both.

Principal Engineer, Phillips-Medisize, a Molex company