With Different Approach
Special working environments require special solutions. For example, magnetic resonance imaging (MRI) creates a very special environment for contrast injection systems – because of the high electromagnetic field strengths.
Our former client, E-Z-EM in New York, already had contrast injection systems for computer tomography in its product portfolio. The company wanted to expand its business into MRI.
Together, we found a way to deal with both the magnetic field and the already existing patents for different products and solutions.
"BYTEC is a competent life-cycle partner for medical devices. It only took two years from concept sketch through product development to market launch. To this day, the EmpowerMR® injector is a reliable platform for MRI imaging. "
Bob Williams
Chief Executive Officer, IVMatters, Inc.
(previously the managing director of E-Z-EM, Bracco & ACIST Companies)
An Ingenious Coup in Five Acts
The challenge
The motors of conventional contrast injection systems have a magnetic field as do all electric motors. And that changes the MR image of the patient. MRI, on the other hand, interferes with the electronics in the contrast injection system due to its strong magnetic field, which can result in an incorrect delivery of the contrast injection system.
To prevent this interference, the competitor shielded their engine and electronics with metal plates. Among other things, he had a patent for this. However, the shielding effect has limits. At MRI field strengths of over 4 tesla, which provide a more precise image, the shielding is ineffective.
The solution
Instead of relying on a conventional motor, we developed a hydraulic drive. It works with oil pressure and does not generate a magnetic field – a first in the field of MRI injectors worldwide.
At the same time, we developed electronics that do not disturb the MRI because the board does not emit any interference signals. Thus, the device was the first to work at high field strengths of up to 9.4 tesla.
The doubts
The client's lawyers had significant doubts as to whether our approach would bypass existing patents. After three days of negotiation it was clear: It would. But now the customer doubted that the device worked at all. After all, one like this had never been built before.
The proof
Within three months we built up a prototype as a proof of concept using commercial resources, which demonstrated its functionality. Of course, this device was still big as a fridge. At this point, our customer admittedly had doubts as to whether we could shrink the device down to the size of a PC, as promised.
We delivered this last proof within 18 months: not only the complete system, but also CE and FDA approval.
The happy end
The EmpowerMR® worked. So much so that the world's largest manufacturer of contrast media, Bracco Injeneering S.A., bought the company to secure the rights to market the device.
Since then, the device has been in use worldwide. A redesign was only recently necessary – after 10 years – since some of its components are no longer available. And until today the device is the only one that works according to the principle described above.
