Best of Both: The Rise of the Medical Device Combination Product

3rd May 2016 (Last Updated July 18th, 2018 10:29)

James Wabby, Director, Regulatory Intelligence and Compliance, delves into the growing world of Medical Device Combination Products

Best of Both: The Rise of the Medical Device Combination Product

Clinical Trials Arena: What are the advantages of combination products?

James Wabby: Combination products have the potential to offer unrivalled medical aid for patients. With a Combination product you are essentially getting the best of both worlds; a medical device and a pharmaceutical drug. If you have a good delivery system in the form of a medical device, you can target the cells more specifically. Using the device you can pinpoint exactly where the cells are, which means you have a greater chance of killing off the infected cells. In turn these devices are potentially a great cure for more complex diseases.

CTA: What are the main hurdles found when trying to develop combination products?

JW: The main area for them is the regulatory considerations that must be taken into account before beginning any combination product trial. To test a combination product on a human, you must first have proof that the device is fit for use on humans through a focus on Human factors engineering. This is a key part of combination product development, as to run the full trials you must first prove that the device is safe to use on humans. This must be done before you test the whole combination product with the drug. Once these preliminary studies are done, you can then begin your first in-human study. Understanding the global regulatory landscape up-front is very important when you are developing your product, or you may be missing key factors, and not be able to proceed with your combination product testing.

CTA: How are regulations in the EU affecting combinations product development?

JW: The EU has always had requirements but now the regulations are changing and it is becoming more complex in terms of what you need approved before proceeding with your device trials.

CTA: What do you consider as key factors when developing your combination product?

JW: One of the most important aspects when developing your combination product is ensuring that you have a vendor to develop your combination products. In this case it is key to be able to work effectively with your vendor. A close relationship is needed in order for the trial sponsor to have a good understanding of the complex regulatory side of combination trials. The Regulatory side is very complex, as you have to understand two sets of regulatory aspects (pharma & medical devices), and in turn need a collaborative cross-training of both spaces. Your CRO must be able to handle both the medical device element and the pharmaceutical element.

CTA: How large is the combination product industry at the moment?

JW: The development of combination products is an area that is seeing more and more growth in recent years as many of the larger medical device and pharma companies are looking into developing their products. It is an area that has often remained clouded, as often pharma companies had not realised their candidate actually counted as combination product; they often didn't appreciate the device element of it. And this has happened for both big and small companies. For example, if you were traditionally a big pharma, but you bought a delivery system, they didn't always realise it was a device. This points to the need for better safety profiles being managed. A lot of companies have these products, but they don't realise they have it. So there needs to be more awareness regarding the classification of devices. Aside from a better understanding, the key challenge for a lot of companies is they must establish their development strategy upfront, before embarking on their trials.