3 Qs with Peter Brehm – Medical Device Company

logo Peter Brehm GmbHThe Peter Brehm GmbH is a global company providing products and services in areas such as hip and knee endoprothetics and spinal surgery. Core competencies are modular hip and knee revision endoprothetics, primary hip and knee endrophrothetics, pedicle screw systems and spacers for spinal surgery as well as patient-specific implants.

Under the control of a stringent quality assurance system, company specialists collaborate with scientists from the medical and technological fields to provide a steady flow of new products that are created in their own labs and manufacturing sites - from the initial idea to the completed implant.

Leslie HammermuellerPeter Brehm’s principles are entrenched in the belief that dynamic change and adjustment is needed in order to be successful. With this in mind, Elsevier caught up with Leslie Hammermueller, Clinical Affairs Manager, to understand how the company has been leading the way in adapting to the new medical device regulation (MDR) through their clinical data management. Coming from a career in the pharmaceutical industry that spanned over a decade, Leslie understands the rigorous processes around clinical data management*.

What was the impact of the new MDR on existing processes at Peter Brehm?

Prior to the new MDR, it was possible to submit an equivalent or similar product based on clinical data from another company. As a result of the issue with the breast implants by a French manufacturer in 2010, regulations are becoming more stringent and companies like PETER BREHM who are manufacturing medical implants are now required to produce their own clinical data for each product submitted.

The new MDR was a key factor in our decision to take the task of data management in-house as we would need to conduct more clinical studies to fulfill requirements. This was something our contract research organisation did not have the capacity to do at that time.

How and why was the decision made to use MACRO for clinical data management?

As this was the first time we were managing our clinical data in-house, there was a need to look for a system that was of high-quality, fully-validated, compliant with the new regulation and intuitive to use for the investigators involved in our trials. MACRO’s ease of use during set up and testing was an asset that we valued. Usability would be particularly important for our customers who are primarily orthopedics.

The other key factor was the cost model that MACRO provided. Being based on an annual license rather than per study fee meant it was easier for us to calculate costs and did not rely on us predicting the number of studies we would conduct in the coming years.

How has the experience been since migrating to MACRO?

MACRO as a clinical database has enabled us to set up and test studies in a short time frame, and it took minimal training to do so. The site’s intuitive navigation as well as the ease of use, has meant even those who do not have programming experience have adapted easily to the new system. We work with a consulting statistician and it was really easy to export and send data to him in a format that he could use – and this was done on the first try!

For more information on MACRO, please contact Momen Hoque, MACRO Business Development Manager on 07801 254479 or m.hoque@elsevier.com.

* MACRO offers all required support services and has a proven track record over the last 18 years, successfully supporting thousands of trials through to completion. MACRO is pharma-approved with a pharma and academic track record.