How Merck KGaA Uses Drug Delivery Device Data to Optimize Manufacturing and Supply Chain

What work are you leading at Merck KGaA?

My role is to help Merck develop drug delivery systems used to administer our injectable medicines. We have a variety of devices, including disposable and reusable pens, autoinjectors and prefilled syringes. Our portfolio includes connected devices, such as our electromechanical autoinjector, Easypod®. 

Drug delivery device development includes defining requirements and test strategy, managing vendors, building design history files and contributing to regulatory filing. I am also responsible for innovation, following trends in the drug delivery space by hunting for cutting edge technologies that will help us differentiate. This involves discussions with the technology vendors and making assessments using feasibility studies.

 

How can companies use drug delivery device data to optimize manufacturing and supply chain?

Pharma can use drug delivery device data with predictive analytics to forecast demand more accurately, aligning production schedules and market needs. The data also enhances quality by enabling real time monitoring of device performance, which can lead to process optimizations and reduced waste. Furthermore, insights from device usage can guide patient-centric design, leading to innovations that improve adherence and overall market success.

"The main driver of collecting RWE is to better understand patient behavior and adherence."

How has drug delivery device data impacted Merck’s decision-making?

Our injector pen has a connected add-on and we have a connected version of our electromechanical injector. Those devices have been collecting data over time, so we now have real-life data allowing us to better understand patient behavior. Our offering comes with different cartridge sizes and while we assumed that small cartridges would be used for small dosages, we found out that is not always the case. Knowing the behavior of the patients and which doses and cartridges they use will allow us to forecast and adjust either the specifications of devices and cartridges or the amount of supply needed within our manufacturing networks.

We can also see if patients do a “double injection,” where they empty a cartridge that does not have a full dose remaining and then supplement with a second cartridge. We can see if these kinds of trends are country-specific or global and then optimize how we manufacture cartridges, like by filling them differently, for example.

 

Are there other elements of real-world evidence that you collect?

The main driver of collecting RWE is to better understand patient behavior and adherence. With these technologies, we can log if the patient is struggling to inject or if there is an electromechanical failure or if patients aren’t adhering. We can then either send reminders to patients or use the data to diagnose issues with the injector. 

 

Do you see real differences between how patient groups use your devices?

There are notable differences in how various patient groups utilize our devices. Our electromechanical injector and ecosystem have several parameters that can be set, such as needle depth, injection speed and notifications. These help patients to tailor their treatment administration to what best fits them.

"Connectivity opens avenues for innovation, leading to the development of new features and functionalities that can significantly enhance patient care."

What benefits do you see when integrating connectivity into devices?

Integrating connectivity into devices offers several substantial benefits. First, connected devices enable continuous monitoring of patient data, allowing for timely interventions and better management of health conditions. It facilitates the collection of valuable data on usage patterns, which can inform product improvements and personalized treatment plans. Additionally, connectivity fosters greater patient engagement by providing reminders, educational resources and feedback directly through the device.

Healthcare providers can offer remote support and guidance, which is especially beneficial for patients in rural or underserved areas. Connected devices can help improve medication adherence through alerts and tracking, ensuring patients follow their prescribed regimens. Finally, connectivity opens avenues for innovation, leading to the development of new features and functionalities that can significantly enhance patient care.

 

How do you weigh the cost of these technologies with the value they bring?

The pharmaceutical industry is still working on optimizing connectivity to achieve the best cost-benefit. We are convinced that a higher-end device helps Merck to differentiate by providing better quality of life for the patients and reassuring them, thus attracting new ones. The value added will have to be weighed against the benefit and this will be specific per therapeutics area, treatment and region.

 

What are the challenges of making this a reality?

On top of an already complex regulatory environment for drug delivery devices, you need to develop and maintain the connected ecosystem (app and software). It is quite complex to do this and it is not the core competency of a pharmaceutical company. Some companies may have a team of hardware engineers or at least know how to work with them, but connected devices also require companies to bring in software and electronics engineers. Most companies rely on external vendors, which requires additional vendor management skills, especially for an area where pharma has less expertise. 

"By analyzing this data, companies can identify barriers to adherence and develop targeted interventions, such as personalized reminders or educational resources."

 

Are there specific therapeutics or indications where connected devices show the most promise?

Connected devices for chronic diseases are great because patients can be monitored over time and will keep the devices for a long time. When treatment is short, it is more challenging to justify adding connectivity. But as the adherence is of utmost importance for a short but highly potent treatment used chronically, connectivity will be beneficial, assuming the right technology is considered.

 

Can connectivity be added on later or is it something that needs to be built into devices early?

If you want to de-risk your drug development, you want to limit the cost during the clinical phase, so you wouldn’t develop connected components until you’re pretty sure of your drug. Usually, companies develop it for lifecycle management, but depending on the maturity of the connected technology and reliability of the vendor, it could be foreseen to be launched with it.

 

How do we ensure these connected devices benefit patients?

There are two ways of approaching connectivity. One is to make it seamless for the patient by not adding any additional handling or use steps, and while keeping cost down, and then feeding that data to the healthcare system to benefit them. The other is to integrate connectivity in an effort to reduce the anxiety of the treatment, reassure them and encourage them.

 
How can pharma companies leverage data-driven devices to increase adherence and reduce patient burden?

Pharma companies can leverage data-driven devices to enhance adherence and reduce patient burden by implementing several strategies. These devices can provide real-time feedback to patients, reminding them to take their medications and tracking their adherence patterns. By analyzing this data, companies can identify barriers to adherence and develop targeted interventions, such as personalized reminders or educational resources.

 

How can companies evaluate software development partners?

You need a dedicated function to look into these kinds of partners. You can bring people in from the software world and teach them about what pharma needs and then they can share their expertise in terms of: who are the key players, what are the technologies, the costs and risks, and what kind of timeline is involved in a project. This is what needs to be evaluated during due diligence. Finally, if the stakes are high, specialized third-party companies could also offer support for due diligence and for technology and company assessment.

In This Article