Drug-Device Combination: pros, cons and challenges

Isn’t a drug-device combination the best possible approach to join BioTech and MedTech innovations, despite their differences? They share a common goal: to support medicine in providing the best possible care and opportunity for speedy recovery.

In most cases, a single approach to a disease is sufficient: either drug therapy or the use of medical devices. However, sometimes this is not enough for a complex problem, and a combined effort is required. The task theoretically seems simple, but in practice, it often proves to be more challenging. Nevertheless, this does not defer engineers from making attempts, due to the potential and results that can be achieved with drug-device combinations.

Drug-Device Combination: what do we know so far

Combining pharmaceuticals and medical device technologies primarily aims to improve treatment effectiveness and ensure precise drug delivery. This approach provides greater control over therapy, minimizes errors in substance administration, and enhances patient compliance with therapeutic recommendations. There is a growing presence of drug-device combinations in the market, and some of the most well-known and widely used include:

• Drug delivery systems: inhalers (which deliver drugs in aerosol form directly to the respiratory tract), autoinjectors (which allow self-administration of substances like adrenaline), and infusion pumps (which precisely control the administration of drugs over a specified period).
• Drug-eluting implants:  these implants release drugs at the target site within the body. The most well-known examples include drug-eluting stems, which prevent the re-narrowing of blood vessels after angioplasty, and hormone implants, which release hormones such as insulin.
• Monitoring and diagnostic systems: equipped with sensors to detect the concentration of desired substances, such as drugs or glucose levels (connected with an insulin pump to dose the appropriate amount of this hormone).
• Negative pressure wound therapy systems: these devices are used for treating chronic, hard-to-heal wounds. They work by creating a negative pressure, reducing the risk of infection, and stimulating healing.

Challenges and Issues Occuring in the Development Process

Creating a standalone drug or medical device and bringing it to the market can cause many sleepless nights. Each must meet a series of requirements and undergo appropriate testing to become certified. This process becomes even more complex and time consuming while developing a drug-device combination product, as each component must meet its own set of requirements.

Another challenge faced by product development teams is ensuring the compatibility and functionality of the entire system. These systems must guarantee precise and reliable drug delivery. At the same time, it is crucial to ensure that the substance does not react with the material from which the mechanism is constructed. This requires careful selection of materials and conducting numerous compatibility tests.

An additional factor affecting the cost and timeline of the entire process of creating and bringing a product to market is preclinical and clinical testing. This involves determining the optimal parameters for drug delivery to ensure maximum therapeutic efficacy. Equally important is minimizing the risk of side effects through extended studies. Furthermore, these tests are often necessary to achieve regulatory compliance in various countries.

Devices are primarily meant to serve people and be used by them. Their intuitiveness and ease of use make them appealing even to individuals without specialized knowledge. Simplicity in usage increases the likelihood of regular and correct use. If mechanisms are too complex, users may struggle to use them properly, compromising the success of the treatment.

Drug-device regulations to follow

Integral products fall under the purview of EU pharmaceutical legislation, specifically Directive 2001/83/EC or Regulation (EC) No 726/2004, which mandates that the medicinal product must secure a marketing authorisation. Concerning the device component, Article 117 of the MDR requires the submission of evidence demonstrating compliance with the applicable General Safety and Performance Requirements (GSPRs) as outlined in MDR Annex I. According to this Article, the marketing authorisation application must include a CE certificate for the device. If the device is not CE marked and requires the involvement of a notified body as per the MDR, the applicant must provide an opinion from a notified body regarding the device’s conformity with the GSPRs.

In situations where the device contains a substance that, when used independently, is classified as a medicinal product but whose action is secondary to that of the device, the product must be evaluated according to MDR requirements. Assessing whether the substance’s action is “ancillary” involves considering its availability within the human body and/or the quantity present.

For products that are co-packaged or referenced together, the medicinal component is regulated by Directive 2001/83/EC or Regulation (EC) No 726/2004, while the device component must comply with MDR requirements and be CE marked.

When a device is intended to deliver a medicinal product, it is regulated under the MDR, while the medicinal component remains subject to Directive 2001/83/EC or Regulation (EC) No 726/2004. However, if the device is designed as a single-use, integral product exclusively for use in combination with the medicinal product and is not reusable, it is regulated under Directive 2001/83/EC and Regulation (EC) No 726/2004, with the device component required to demonstrate conformity with the relevant GSPRs

Benefits of Drug-Device Combination

The saying “no pain, no gain” perfectly applies to the process of developing drug-device combinations. Undertaking this complex task requires preparation for the aforementioned challenges and obstacles. However, the final result justifies the effort due to the benefits of using such products.

Increased Treatment Efficiency

One of the main benefits of this solution, which has already been mentioned, is increased treatment efficiency. The combination of drugs and technology allows for precise delivery of medications to specific areas in the body. This reduces undesirable effects on other organs and, consequently, the risk of side effects. Additionally, such solutions can improve patient adherence to therapeutic recommendations, leading to better treatment outcomes.

Dose Control

Proper dosing is as crucial as the precision and accuracy of the medication’s action. Infusion pumps facilitate easy control over the amount and rate of medication administration. Conversely, they also provide safeguards against potential overdosing. This is particularly important for chronic conditions such as diabetes, asthma, or cardiovascular diseases, where long-term and precise management of therapy is required.

Personalized Therapy and Monitoring

Managing therapy involves not only determining the appropriate amount of substance administered to the patient but also monitoring. Technologies such as glucose monitoring systems or smart inhalers enable doctors to tailor treatment to the individual needs of patients by continuously monitoring their health status. Moreover, prompt responses to changes can help prevent complications.

Benefits for Patients and the Healthcare System

Drug-device combinations can significantly enhance patient comfort by reducing the number of necessary visits to hospitals or clinics. This also allows patients to continue their therapy at home, increasing their freedom and independence. It can also lead to cost savings in the healthcare system by reducing the need for hospitalizations and other expensive medical interventions. Such solutions not only improve the quality of life for patients but also alleviate the burden on the healthcare system.

Summary

Multidimensional health problems require technologically advanced solutions, such as drug-device combinations. Developing such a product becomes a complex puzzle that demands careful consideration of compatibility, regulatory requirements, and cost control. Each stage needs precise planning and interdisciplinary collaboration to achieve optimal results. On the other hand, for many patients, it represents the best chance to manage their illness or recover their health. Ultimately, despite the challenges, this approach can lead to a significant improvement in patients’ quality of life and increase the effectiveness of treatment. This is why the development of such technologies is so crucial for the future of medicine.

If you want to explore the possibilities of drug-device combination or have any questions, reach out to us and let’s discuss how we can shape the future of medicine together.