With the Medical Device Regulation (MDR) starting make its presence felt within the industry, device companies, large and small, have been making process adjustments, ensuring they comply with the new laws.

The MDR’s implementation, while steady, has beget a sea of change that could have lasting implications on how device trials are run and approved. CTA’s Jisong Seo sits down with Dorota Johansson, who’s the Clinical Director of Bactiguard.

In this Industry Viewpoint, Johansson discusses the latest challenges affecting the medical device space, and offers insights on how to overcome them.

Jisong Seo: What are the most pressing challenges in the industry at the moment?

Dorota Johansson: There are new EU regulations, the MDR and the In Vitro Diagnostic Regulation (IVDR), to be implemented in the next few years, so there is a lot of attention on medical device and IVD companies. Today, under MDD, we are not required to have a lot of clinical data for our devices, but with the MDR, the requirements are increasing. We are lucky, because we do have clinical data for all our products, but not every device company is in that situation.

The MDR was published a while ago but it was just a text before its interpretation. How it will be implemented is quite different. Notified Bodies and authorities from different countries have diverse ideas on how it should be done. On one hand, it is very important for us to learn what they will require and audit. On the other hand – we cannot wait, because time is running out.

Many companies will need to perform clinical studies to fulfil MDR requirements, but most of the CROs in the market are specialized in drugs which is quite different from devices and you can’t be sure if they can help you with regulatory compliance in a time and cost-efficient way. IVD companies have a little bit more time than for devices, but the change will be much tougher for them.

JS: Would you say working with CROs can be helpful to obtain the right clinical data under evolving regulations?

DJ: A lot of medical device companies, who do not have clinical data from trials, are using full-service CROs. We have done that in the past as well, but now we manage a lot of clinical trial activities in-house, especially for trials in Sweden and other European countries. The reason is that it is more cost-effective, time-efficient and fosters a good relationship with the investigators. Also, our own staff have a better understanding of our products than CROs.

For overseas trials, we normally need full-service CROs. General advice based on my experience is to find CROs who are specialized in medical devices and know your type of device. Then you have a great chance of success. We also prefer smaller CROs – they tend to be more agile and willing to learn.

JS: What is your tip to get best result working with CROs and internal effort for it?

DJ: Even if we have clinical data for all our devices, we still need to continuously evaluate the clinical effect of our products to address any unanswered questions from a safety and efficacy perspective, or to support claims. We perform quite a lot of trials, both in Sweden and other countries. We always cooperate closely with our marketing and sales departments, and often with our distributors before starting a new trial.

Generally, we never let CROs write the study synopsis or choose the clinical sites. We normally work with our distributors and our own marketing staff, who know the hospitals well and often have the first contact with them. Then we meet the site and potential investigators to understand if they are interested in a cooperation and how we can both learn. We also have some Investigator-Initiated Trials, sometimes we support them with for example free products or advise.

Close cooperation with investigators in any type of study is very important to make a study successful. You need to listen to them about what data to collect and how to collect it. But as the manufacturer you sometimes know better what is critical in a trial to make it relevant to your specific device and your needs. Such questions may include what kind of patients to include in the study, which endpoints are the most relevant and the way the site uses your device.

Even if you coordinate your own study, it is always advisable to have support from specialists, for example, to create the study database, to collect data and possibly for monitoring. In such cases, we normally prefer working with small, specialized CROs, for example, in data management and statistics, or monitors working on a freelance basis. However, we always keep strategic decision making in-house.


About Bactiguard

Bactiguard is a Swedish medical device company with a mission to save lives. To achieve this mission, we develop and supply infection prevention solutions which reduce the risk of health care associated infections and the use of antibiotics. This way, we save significant costs for health care and the society at large. The Bactiguard technology prevents bacterial adhesion and biofilm formation on medical devices.

We offer the technology through license agreements and our BIP (Bactiguard Infection Protection) portfolio of products. Bactiguard’s own product portfolio of urinary catheters, endotracheal tubes and central venous catheters prevent some of the most common infections, which appear in the urinary tract, the blood stream and the respiratory tract. Our three product lines are of class IIA, IIB and III. We have clinical data for all of them, they are all certified and we have done clinical trial as PMCF (Post Market Clinical Follow-up) studies. We do have some on-going trials; we have also quite a lot of trials in the pipeline.