Dr. Bassil Akra became head of the Clinical Affairs Department at TÜV SÜD Product Service in 2012. Under the leadership of the expert and holder of PhDs in medical and biomedical engineering, the department quickly evolved into the company’s shooting star. The Clinical Focus Team, as the department is now called, is one of the most successful departments of the company. It is in high demand by medical device manufacturers all over the world, who appreciate the completely redesigned clinical pre-services and standard services.
On June 6, 2015, TÜV SÜD presented the 2014 Innovation Award to the Clinical Focus Team in recognition of these services. In the interview Dr. Akra, a dynamic visionary, introduces himself and his approach to successful clinical concept plans.
Dr. Akra, what is the "focus” in the Clinical Focus Team?
Firstly, our focus is on our core business, i.e. the assessment of clinical evaluations and clinical study protocols within the scope of approval of high-risk medical devices. Secondly, we focus on our clients and the regions in which they are located. It has been my strategy right from the outset to position ourselves as service providers rather than merely a testing and certification body. This means focusing on our clients and their objectives – a strategy that has proved successful.
How did you manage the turnaround?
First of all, I decided to set up a distributed team. We followed our clients to their locations and started to establish clinical resources in Europe, the USA and China. If we want to understand our clients’ clinical concept plan, we go and visit those clients, wherever they are located, worldwide. On the client's side, such a meeting may often involve up to 20 employees. This means our clients save a great deal of time and money by no longer needing to send their experts to visit us in Munich. Instead, one or two members of our team go and visit the clients’ organizations.
In addition, we have developed a fast-track service that allows us to respond flexibly to our client’s needs and provide them with maximum certainty for their scheduling. This fast-track service guarantees that all independent assessments are completed within a 5 days by a pre-scheduled timeslot. By way of compensation, less urgent tests are carried out according to the "first in, first out” principle and are available at slightly lower costs.
One of the first steps in the registration of a medical device involves the clinical concept plan and/or the clinical study protocol. The clinical trials and investigations must be designed to establish the efficacy and safety of the medical device to be registered. To protect patients and manufacturers from superfluous or even inadmissible clinical evaluations, our service portfolio now includes the assessment of clinical study protocols at an early stage, long before the implementation of the clinical investigation.
Does this mean you promise guaranteed certification?
Of course not, at that stage we cannot make any statement as to whether the device will be certified or not, since the results of the clinical investigation are not yet available. After all, the clinical investigation might show that the device has no verifiable efficacy or causes unexpected adverse events that may even require a change in study design. We act as an independent partner, ensuring that no registration strategies are misconstrued according to the current state of knowledge. If we are involved right from the start, even before the clinical investigation is performed, we can pinpoint weaknesses in time and inform manufacturers about our findings in their study protocols. If manufacturers do not realize their results are invalid until after completion of the clinical investigation, they waste a lot of time and money. This can mean the end of the road for some innovations.
Realistically, it must be said that virtually every dossier that we had reviewed resulted in one, or even several, nonconformity reports. Given this, the objective must be to clarify the critical issues at an early stage and reduce the number of review cycles, so that in the end, only the results themselves have to be checked. I therefore regard testing and review during design and development as a highly effective instrument for reducing time to market.
Which critical "issues" in study protocols are you referring to?
Well, first of all it is important to assess whether a clinical investigation is necessary or whether a clinical evaluation report based on existing literature may be sufficient. Of course, every manufacturer would prefer to show compliance with the requirements without a costly and time-consuming clinical investigation. However, it is important to stay realistic and avoid incorrect approaches. The new European Medical Devices Regulation (MDR) will make it even more difficult to choose the equivalence route, requiring even more clinical investigations in the future.
The number of patients needed and the study duration are also prone to errors. Both parameters must be justified on the basis of statistics and scientific methods. Lack of consistency between the clinical concept plan and the marketing approach represents a further frequent source of errors, i.e. the defined outcomes of the clinical investigation are not suitable for confirming the claims. Identification of the issues that make the study design unsuitable for verifying the efficacy and safety of the medical device plays a critical role in striving to obtain device Registration. This applies in particular to highly innovative small enterprises and start-ups, which contribute the majority of innovative medical devices. These companies are generally on a limited budget and need to reach the approval stage as quickly as possible. In other words, they only have this one attempt. However, early information is also important for large-scale manufacturers, which will do anything in their power to be the first to launch a certain medical device on the market.
What does the Innovation Award mean for you personally?
The award is a recognition of achievements – not only for me, but for the entire team. And not only by the Board of Management, but also by our clients. They have recognized the added value that this service offers them and their patients, and thus sealed our success as a focus team. After all, achieving success by working together and creating a genuine win-win situation is the most important confirmation of all.