In the medical device space, novel technologies are constantly being developed as researchers look to find ways to help cure some of humanty’s biggest diseases.
CTA spoke with Hoda Tawfik, CMO, Magforce AG, who explains how her company uses nanotechnology to treat rare forms of cancer.
Clinical Trials Arena: What are the biggest challenges you face in your line of work?
Dr. Hoda Tawfik: At our company, we have developed what is called NanoTherm Therapy, which involves injecting nanoparticles into a tumour at the start of the patient’s treatment. The particles agglomerate and the resulting depot stays in the target tumour area. Then, the patient is placed into a NanoActivator, a machine that generates a high-frequency alternating magnetic field which activates the Nanoparticles to generate heat from inside the tumour and kill the tumour cells. Handling such a high tech device and technology, is a complex process. Therefore, the training of site personnel has to be more intensive, when compared to a drug clinical trial.
Secondly, the other challenge we face is in managing clinical trials with medical devices. To conduct a clinical trial for a medical device, you have to be aware of several different facets in addition to everything known about the drug development process. As I alluded to previously, you have to train the clinical study sites from a technical point of view, not only from a medical point of view. Additionally, to find a CRO who combines experience in clinical development (for example, in oncology) with experience in medical devices is also a considerable challenge. That is because there are additional regulatory requirements in the development of medical devices.
CTA: From your perspective, explain the clinical development process behind developing a medical device of this kind
HT: In our case, the procedures we follow are similar to that carried out for drug clinical trials. While there are more technical aspects to a medical device clinical trial, how data is reported is more complicated and elaborate. That is because not only do we have to report potential side effects from the treatment, but also any technical faults with the device itself. So there are several factors to the development process that we have to take care of.
CTA: The clinical development stage for medical devices sounds like a long, arduous process. Is that accurate?
HT: Not necessarily. From a regulatory point of view, the process is certainly not as long as the clinical development of drugs. Even the certification of a medical device is faster. Nevertheless, to get the device accepted into the market involves the same requirements. So you have the certification and the market approval for the medical device, but still, you have to go a long way for it to be accepted by the medical community, which with drugs is different because it is easier to prescribe a tablet than to use medical device.
CTA: Lastly, explain the current landscape in the medical device industry
HT: In the last decade, medical devices were mainly diagnostics, but now more and more devices are being used in therapeutic procedures. However, the problem remains getting therapeutic medical devices into the market. Some medical devices by their nature present logistical issues. Often you need to have access to a lot of space (for example, a hospital room), in order for site staff to use it. So for the industry, that is probably second biggest obstacle. The major challenge, at least for us as a company, is finding a CRO that understands the clinical development process for a medical device.