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10/28/14   The market for neuromodulation devices is divided into three broad segments: internal neurostimulation, which involves implanting an electrical pulse generator; external neurostimulation where the mild electrical impulses are provided from outside the body; and drug delivery devices such as pumps. The former market is subdivided into spinal cord stimulation, deep brain stimulation, sacral nerve stimulation, vagus nerve stimulation, and gastric electrical stimulation. The external stimulation market is subdivided into transcranial magnetic stimulation and transcutaneous electrical nerve stimulation.

The demand for neuromodulation treatments is increasing as the medical industry becomes more and more sophisticated in the ways in which it approaches patient care. Conventional medicine often uses the biomedical model of disease management whereby the underlying cause is searched for and treated to relieve symptoms. But what happens if the underlying cause cannot be treated. Neuromodulation involves directly treating the nervous system itself to rebalance the activity of neural circuits and thereby manage symptoms. This ability is driving more and more medical device OEMs into the field.

But none of this would be possible without the huge advances in micro manufacturing, miniaturization, material advances, and the manufacture of reliable and compact power supplies.

Neuromodulation devices show just how far the medical sector has embraced the potential for micro manufacturing and miniaturization.

Look at deep brain stimulation, for example.

A leader in this field is Medtronic, which has effectively migrated its expertise in heart electrical stimulation to treat conditions involving the nervous system, and indeed many refer to deep brain stimulation devices as “brain pacemakers”. Heart pacemaker technology has been scaled down and scaled down to make it appropriate for neuromodulation applications, which is extremely challenging on many fronts.

To manufacture devices that are not only small enough to be inserted in the brain, but which have the necessary encapsulation to protect against unwanted electrical transmission, which are biocompatible, and which can function in (and not be degraded by) the in-vivo environment, obviously throw up a myriad of potential problems.

As such, many of the leading OEMs in the field work alongside and partner with leading micro manufacturing experts such as Micro Engineering Solutions (MES) which combine an in-depth understanding of the technologies and techniques in the micro engineering field with an innate understanding of the unique regulatory and manufacturing issues that pertain to the medical device sector.

When looking more specifically at the area of targeted drug delivery systems within the neuromodulation sector, again a profound understanding of the micro manufacturing technologies and processes available (as well as un understanding of material advancements) is vital. For neuromodulation drug delivery devices, pain medication is delivered by implantable pumps that are surgically implanted into the area to be treated and deliver the medication directly to the desired target. It enables a lower dosage to be administered, and decreases — if not eliminates — the side effects seen with systemic absorption.

These devices use drug infused pumps and catheters, requiring that manufacturers not only access technologies that allow the manufacture of such small, complex, and feature-rich devices, but also understand the regulatory environment surrounding combination medical products. Again, MES has navigated the manufacturing and regulatory issues surrounding the production of such devices for numerous medical device OEMs, and can provide a cost-effective, timely, and efficient route to market for products under development.

Neuromodulation sees the coming together of a number of important trends in the area of manufacturing and medical intervention. First, the ability to manufacture tiny, powered, biocompatible devices and drug delivery systems, and second the ability to treat chronic diseases with a one-time implanted device that negates the need for monthly, weekly and sometimes daily medicines or injections.

The knock on effect of this in terms of savings in national budgets for healthcare, and also in the enhancement of patient life styles are huge, and will ensure that the area of neuromodulation will grow and grow in the short, medium, and long term.

Call MES today and let’s discuss the ways in which we can realize your objectives in this exciting area quickly and cost-effectively. The rewards in terms of patient outcomes and your bottom line really are extraordinary.

If you are interested in partnering with MES for the development of neuromodulation devices or for other medical applications, please email Donna Bibber at donna@microengineeringsolutions.com.