Next-Gen Drug Delivery Devices Require Connectivity and Sustainability

As the rise of biologics continues to dominate new drug applications, developing drug delivery devices that can accommodate the increased viscosity and unique delivery needs required remains a challenge for this growing class of pharmaceuticals.

Since the advent of single-use autoinjectors in 2006, impactful innovations in drug delivery devices have essentially plateaued. Single-use devices have several disadvantages, including a negative, high-environmental impact. At the same time, device components remain largely incompatible with the needs of biologic delivery, and adding electronics and/or connectivity to devices is difficult at best.

These challenges are amplified because patients are increasingly demanding drug delivery devices that achieve a balance of sustainability and usability with connectivity for the patients and/or physicians to interact with the drug delivery device.

Better Medication Adherence = Better Patient Outcomes
With over half of all adults in the U.S. and U.K. managing chronic health conditions that require continual medication and/or treatment,^1,2 medication adherence is an increasingly important means of maintaining and improving patient outcomes. For conditions including diabetes, respiratory illness, cardiovascular disease, osteoporosis, and HIV/AIDS, the financial cost of non-adherence can be as much as $43,000 per patient stemming from medication non-adherence.³

Clearly, a means of assisting patients and providers in better managing medications for chronic conditions is critical. Not only will this improve patient health, but it will also ensure better adherence to medication regimens. This, in turn, will save both patients and healthcare payers significant money by preventing related ER visits and/or hospitalizations.

Within their daily lives, adults increasingly use smart or connected devices to help manage their routines. Beyond the realm of drug delivery devices, the larger universe of common household items are welcoming and adopting connected technology. It is estimated that half of all homes will be connected by 2022.⁴ Connected devices are often controlled through smartphone apps to manage everything from grocery lists and lighting to personal calendars and thermostats. For example, when it’s time to change a furnace filter, the smart thermostat sends a reminder.

As a result of increased familiarity with the variety of connected devices in their daily lives, people managing chronic conditions are expected to leverage this same technology to assist in managing and improving their health. There are many benefits to be gained for patients, physicians, and payers by incorporating connectivity into medical devices. Smart autoinjectors, which are designed to connect to a healthcare provider and system, are expected to provide a means to improve patient adherence to medication regimens and treatment plans. By providing a way to connect these devices to physicians, patients can receive dosing reminders and interact with adherence trackers, as well as be provided with education regarding their condition and medications taken for management.

With connected medical devices, physicians have better visibility into monitoring patients’ conditions or diseases, providing an opportunity to make earlier treatment decisions that will improve patient outcomes. For healthcare payers, this could result in reduced uncertainty in treatment costs, which may save tens of thousands of dollars per patient in unexpected hospitalizations.⁵

To achieve connectivity in these medical devices requires additional device components to enable sending dosage information, including the time of the medication and amount of the dose, to a companion smartphone app. This information then could be sent to a cloud-based database or directly to the cloud for users without smartphone capability.

The following device components are critical to the design of connected medical devices:

• Sensor(s) to measure dose activation and amount
• A radio to transmit the sensor data
• A battery to power the electronics

Due to the added device components and complexity, connected medical devices may be best leveraged in high-volume applications, including pre-filled insulin pens, albuterol metered-dose inhalers, COPD dry powder inhalers, and high-volume autoinjectors. The development of these platforms requires sophisticated manufacturing capabilities and expertise working with drug-delivery devices. Equally important is in-depth knowledge of the interplay among medical device manufacturing with electronics, software development, and human-factors design.

Human-centered design plays a major role in ensuring the highest levels of device usability through close alignment with product development and manufacturing. A long list of cross-functional teams must come together to identify ideal form and function from a variety of perspectives, including industrial design, mechanical and electrical engineering, material science, supply chain management, and software development. Bringing all those valuable inputs together from the beginning leads to improved usability and greater adoption.

Incorporate Sustainability into Design Requirements
Sustainability is another major criteria that needs to be addressed from the onset. Throughout 2020 and 2021, there has been increased recognition of a changing environment and the need to develop solutions, in every industry, to improve sustainability of products, devices, and business practices. Pharmaceutical delivery devices are no exception.

Single-use devices represent a significant factor in the waste profile of the pharmaceutical industry. Recognizing this, pharmaceutical companies are increasingly looking to device manufacturers to develop and deliver solutions that will decrease the environmental footprint.

The best way to do this is by incorporating sustainability into design requirements while driving innovation similar to efforts regarding size optimization, weight, functionality, and usability. Device manufacturers embracing a sustainability credo also embrace more sustainable production and energy-efficient manufacturing methods.⁶ Beyond design requirements, meeting heightened sustainability goals is increasingly required as a factor for design input by various regulatory bodies.

An efficient means of achieving sustainable device solutions is incorporating tools such as life cycle analysis (LCA) into the development process. This lets scientists and engineers compare designs, material choices, and processes to make more informed choices earlier in the product development cycle. As a result, use of these tools will improve sustainability of the device while also assisting manufacturers in reducing cost of goods sold.

Other worthy sustainability initiatives include:

• Using biodegradable plastics, like polylactic acid
• Developing modular devices that allow injectors to be separated into medical and non-medical waste
• Allowing reuse of non-medical portions of devices⁷
• Identifying means of reuse for inhaler jackets
• Establishing business models that permit refurbishing non-medical portions of any device platform

These approaches can all be evaluated with LCA to provide measurable and meaningful improvements to the sustainability of products and delivery devices.

The Future of Innovative Drug Delivery Devices
As pharmaceutical developers and device manufacturers look to the future of the industry, it is critical to continue developing innovative solutions in the device market. Priority one is devising and providing solutions that can help people around the world live healthier, more productive lives. Focusing on solutions that create opportunities for improved device sustainability and connectivity are cornerstones of achieving these goals, dovetailing with future discussions centered on the role of regulatory compliance in directing sustainability for design input. 

References

1. bit.ly/mpo211121 (accessed June 9, 2020)
2. Department of Health, 2012. Report. “Long Term Conditions Compendium of Information: 3rd edition.”
3. Cutler, et al. BMJ Open. 2018. 8(1), e016982.
4. P. Austin. “What Will Smart Homes Look Like 10 Years From Now?” Time. July, 2019.
5. Bittner, et al. Medical Devices: Evidence and Research. 2019, 12, 101-127.
6. bit.ly/mpo211126 (accessed July 20, 2021)
7. bit.ly/mpo211127 (accessed July 20, 2021)

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Brett Landrum is vice president of Global Innovation & Design at Phillips-Medisize, a Molex company and leader in drug delivery, diagnostic, and medtech devices.