Forming a good partnership is one of the most important factors in a successful clinical trial. For medical device companies, this is not always easy to achieve. Within the industry, it’s difficult to secure the services of a CRO that is specialized in medical devices.

CTA Staff Writer Jisong Seo looks to uncover the reasons behind these challenges as she sits down with two industry experts, Charles-Thibault Burcez of Defymed, and Torsten Kayser of Boston Scientific. In this Industry Viewpoint, both share their opinion on how to form solid partnerships. What’s more, both explain how to ensure trials run smoothly and without delay.

Jisong Seo: What are some of the biggest challenges facing the medical device industry?

Torsten Kayser: Following the new regulation MEDDEV 2.7/1, Rev4 which was published in 2017, medical device companies need to collect more detailed data, and they need to include supporting equipment, delivery tools and software versions to prove their safety. Previously, medical device companies used similar product data to get equivalence approval.

However now, with a newly revised regulation, all new devices must be tested, while the study data needs to be reported separately. Therefore, medical device companies must conduct clinical trials more cost-efficiently. But there are some strategies companies can adopt, such as strategic outsourcing, investment in training, project management tools, decreasing number of sites, and electronic data accrual.

JS: Forming partnerships can be a way to optimize your study. What are some of the pros and cons of outsourcing medical device trials?

Charles-Thibault Burcez: A majority of people understand the benefit of using vendors or CROs for their study. However, it is not easy to find reliable CROs. Some don’t pay enough attention to the needs of, say, small start-ups. Although some vendors may not necessarily be specialized in medical devices, your chosen CRO should have a competent staff that can understand your product, its function and intended use. If your CRO isn’t experienced enough to meet the demands of the trial, there can be serious repercussions.

As the process is getting more and more difficult after the regulation changes, especially for class III and implantable class IIb medical devices, it’s advised companies bring on board an expert who understands the requirements established by the ethical committee. Certainly, it’s to the benefit of the study to find a strategic partner that understands the needs of your trial.

JS: How can we optimize the result of clinical trials regarding partnership?

Kayser: In my opinion, balancing your trial work with outsourced and in-house resources is the best strategy. Internal resources have very specific product knowledge and so the knowledge transfer between the sponsor and vendor is absolutely critical. Having good strategic partners can optimize the quality of your study.

As many of them are not experienced in medical devices, they need to be trained and supervised for some time. So I always have patience and invest in training, giving at least three years to my partners to learn our procedures. By giving trust, partner companies become more dedicated too.

On the other hand, if we shift the focus to in-house trials, the biggest benefit is quality. As the management team sits within the company, it’s easy to communicate and the trials are in better control. It is not only reliable as they work towards the same goal, but also safer as there’s no need to transfer the manufacturer’s knowledge to others. Therefore, it is very important to be aware of which trial design fits your study.

JS: How do you manage long-term partnerships with vendors?

Kayser: It’s important to give vendors or CROs enough time to accrue good quality study data. While it’s normal CROs are overloaded with various activities, to improve their dedication, it is good to have them involved in your study from the design stage. Also, giving enough time to your partners can improve their understanding of your study needs.

JS: What other challenges should the industry be prepared for?

Burcez: There is going to be a new database system for medical device companies called EUDAMED. This database is a platform for manufacturers and health care professionals to obtain data of all kinds from any medical device used in Europe. It has always existed, but it is now open to public, so anyone can access the system to see what your product is and what data you have. This database can be very helpful for the industry to get references and to know what’s going on in the market.

Additionally, it can also provide some insight into your competitors. In my opinion, one other major change for high risk medical devices is to be well prepared for clinical investigations by providing strong documentation. All professionals should be aware of the incoming changes.



*Charles-Thibault Burcez is the Product Development Director at Defymed, and Torsten Kayser, is a Senior Clinical Research Fellow at Boston Scientific. Their views are their own and do not reflect that of their respective companies