Manufacturer of brain pressure sensors

From plastics processor to manufacturer of brain pressure sensors

Telemedicine is not only changing the relationship between doctors and patients. It is also leading to radical changes in the medical technology supply industry. The plastics processor RAUMEDIC has become a distributor of brain pressure sensors. Ingo Bartels, head of the Clinical Products division, explains in an interview with DeviceMed how RAUMEDIC is positioning itself on the subject of telemedicine.

Mr. Bartels, RAUMEDIC started out as a developer and manufacturer of polymer components and systems for medical technology applications, but today it is deeply involved in the field of telemedicine.

Correct. With its Neurovent catheter program, RAUMEDIC is providing the baseline knowledge for the development and manufacture of telemetric products as a basic prerequisite for the use of telemedicine. With our telemetric brain pressure sensors, we are even distributing our own products for ICU patients. So we are clearly more than just a contract manufacturer. Our experiences with patients, clinics and insurance companies also benefit our industrial clients in the development and manufacture of their solutions. As a developer and contract manufacturer, we provide the necessary foundations, without being locked in to particular areas of application or types of patients. We have the right system knowledge and know the right partners to help us with the implementation of complex requirements. We learn from our clients every day about how different health concepts are interconnected, and that helps us to understand the requirements of health services providers. From our perspective, telemedicine is ultimately nothing else than the interconnection of health services providers.

That approach calls for new kinds of expertise, from electronics to certification. How do you, as a traditional polymer processing company, acquire that expertise?

RAUMEDIC has been much more than just a plastics processor for a long time now. At our plant in Zwönitz, in the German state of Saxony, we have been developing and manufacturing pressure measurement probes since the 1980s. That knowhow was developed and expanded within the company and provides us with a solid foundation that we continue to build on every day. Our internal Regulatory Affairs department ensures and monitors compliance with regulatory requirements relating to the production, design and sale of medical devices in more than 50 countries around the world.

And that has now led to the development of a high-precision brain pressure sensor. How does it work?

As an alternative to measuring intracranial pressure (ICP) with traditional brain pressure sensors attached to wires, RAUMEDIC has developed a unique and innovative system based on telemetrics. The pressure measurement probe is implanted on the skull, completely underneath the scalp. ICP is measured wirelessly, and measurement in the parenchyma is possible through the use of Neurovent-P-tel. Calculated with microchip technology and based on a telemetric system, the ICP is transmitted to our scanning device (Reader TDT1 read-P) through the closed scalp with RFID technology that is in standard use around the world. The data are collected and stored on the MPR 1 Datalogger. We are eagerly looking forward to the Raumed Home ICP, an exceptionally light and easy-to-use recording device that patients can use outside the clinic in their day-to-day lives.

So what comes next?

The next step is certification of this telemetric catheter for a longer deployment time of up to one year. This would allow for intracranial pressure monitoring in the comfort of the patient’s own home. A special event management function, which aligns the data with the patient’s activities, provides important information for the choice of therapeutic measures. The display of recovery processes of this type are not possible in a hospital. Electronic monitoring of intracranial pressure in the home environment could therefore lead to more effective treatment. So we will continue to increase our efforts with regard to telemetric ICP measurement. Our goal is to ensure greater mobility for patients, while also increasing therapeutic value. And we will also incorporate these experiences more strongly into our OEM business, because we are convinced that this knowledge is also valuable for our industrial clients and their areas of application.

Is RAUMEDIC also looking at producing digital versions of existing single-use analog products?

RAUMEDIC spends a lot of time thinking about transforming analog products into digital ones. The idea is one side of the coin, but the other side is implementation. That requires lots of resources in terms of people and materials. When it comes to the most common widespread diseases, deploying those resources makes a lot of sense. Take lung diseases, for example COPD, or heart failure and – not to forget diabetes. This is where our innovative mid-sized company needs to collaborate closely with the global players that have access to vast resources, as well as with scientists. Then these kinds of ideas can be implemented. As a development partner and system supplier, RAUMEDIC is just waiting in the front line.

Will medical engineering split into a digital world and an analog one?

A split into digital and analog worlds will not work for medical engineering, because patients and their needs always have to be at the center of everything we do. The doctor-patient relationship is of fundamental importance, and it can’t simply be taken away. Telemedicine can support that relationship and open up new possibilities. Monitoring and supporting patients in their homes provides all kinds of opportunities to improve on therapeutic success. If hospitals, practicing physicians, medical specialists and insurance companies establish effective forms of telemedicine, it will yield long-term benefits for everyone involved, and especially for patients.

The interview was conducted by Peter Reinhardt, Editor-in-Chief DeviceMed