The medical technology service provider seleon is significantly expanding its Consulting, Quality Management and Regulatory Affairs division. Mr. Hartung, you are the head of this division. What strategy are you pursuing?

The rapidly increasing regulatory requirements for medical devices are leading to strong demand for consulting services related to medical technology. For our corporate customers, it’s often just capacity bottlenecks. Here we offer companies fast and efficient support from our consulting team. In contrast, many of our smaller and medium-sized customers are very uncertain about how to cope with the existing financial and personnel resources. In this case, we offer companies tailored, practicable solutions and even take over complete projects, such as the conversion of QM systems and documentation to the requirements of the MDR. We see clinical evaluations and studies as a special growth area in consulting. We have taken this into account by founding our Clinical Research Organization (CRO).

What are the members of your CRO team?

We have a doctor of general medicine with many years of experience in the management of clinical evaluations and studies as well as in the approval of medical devices. In addition, we have qualified biomedical engineers and biochemists with a doctorate who also have many years of experience in the areas of clinical evaluation and consulting. In addition, we have colleagues from product approval who have been working in this field for many years.

You work with very experienced medical technology specialists. What makes working with this team of experts so special for you?

It is incredibly exciting and invigorating work. We constantly have different, new tasks, exchange ideas about them, and together we always find solutions – often unusual ones – based on our diverse wealth of experience. In doing so, we break new ground in all aspects of medical device approval for companies.

CRO projects are subject to special challenges. What outstanding challenge have you recently mastered with your medical technology team? Please tell us, as far as the necessary discretion allows.

This usually involves novel medical products that are often still in the early stages of development, for example the use of nanoparticles in blood washing.

Another very exciting field is that of so-called drug-device combination products – the combination of a drug and a medical device. It always starts with an idea for a new therapy, initial trials have been carried out or experience from similar previous developments is available.

In consulting, we are called upon to work with our clients – startups or corporations – to develop and implement a clinical strategy and regulatory strategy that proves the clinical benefit of the new medical device as comprehensively as possible, while keeping the costs for the company under control.

seleon has a wealth of experience from nearly 20 years of medical device development and regulatory affairs. This also allows us to directly support our clients in product concept and device and safety architecture development. This sets us apart from most CROs in medical technology.

CRO isn’t everything. You also handle other affairs for companies.

Yes. Let’s talk about the Medical Device Regulation MDR – medical device regulation. Basically, all manufacturers must have adapted their quality management system (QMS) to the requirements of the MDR by May 2020. The so-called technical documentation for their medical devices should also (theoretically) have been converted by this date.

In real life, there is a sampling plan of the notified bodies (certifiers) and according to this, the manufacturers and companies convert the technical documentation step by step.

The current state of affairs in medical technology is as follows: The companies have a plan, and usually already have a project for the conversion, and sometimes have already started. Most SMEs, however, look like a rabbit at a snake, complain a lot, get smart, but usually have not started yet.

Obviously, SMEs are reluctant to face the challenge. With this dimension, no wonder. I assume that seleon offers a solution for companies here?

One of seleon’s performance promises is: “We offer you customized solutions for your company and your products – from QM light to QM XXL.” In relation to the MDR problem in medical technology, this means: Narrow solutions for narrow budgets – nevertheless compliant with requirements and approvable. As long as the notified bodies approach company certification and product approval with a sense of proportion, such solutions are possible. Only when the same standards are applied to corporations and SMEs does it become difficult.

Tell us about CSV

CSV = Computer System Validation. This term has largely been used in the pharmaceutical industry – less often in medical technology.

It is about validation (proving that software tools, equipment, processes, etc. do what they are supposed to do and do it correctly and nothing else) of software systems – mostly complex ERP systems or equipment software.

The new EN ISO 13485:2016 (QM standard, like ISO 9001, for medical device manufacturers only) now requires that all software embedded in the QMS be validated. In the case of corporate groups, this can already be a high double-digit number of software systems, such as ERP system, requirements management system, document management system, plant software, testing and evaluation software, etc. Here, an efficient validation process must first be set up and implemented. Then this process has to be applied to all relevant software tools. This can take months to years.

And you and your consulting team are validation experts and love this complexity?

We are experts. And complexity is our daily challenge. But our love is more for nicer things than pure computer system validation.

We love working with people and exciting companies, getting quick feedback on what we do and often being able to effect positive change/improvement. And we love to share and pass on our knowledge and experience around medical technology. What makes us happy in our job are our satisfied customers.