Aligning Innovation and Unmet Clinical Needs in Neuromodulation

For physicians and care providers treating neurological disorders, the use of neuromodulation devices represents a potential solution for their patients.

As this technology has evolved and advanced, its therapy applications continue to expand. With over 600 diseases of the nervous system, there is enormous opportunity for neuromodulation to play a major role as an effective treatment option to improve patients’ quality of life. This is good news for those dealing with neurological disorders such as Alzheimer’s, Parkinson’s disease, epilepsy, and chronic pain, just to name a few.

There is no question this technology sector represents a significant and growing area. Global Market Insights projects the neurostimulation device market will exceed $16 billion by 2024. Since the beginning of this decade, the segment has experienced consistent year-to-year growth by virtually every metric, whether in reference to a specific region or globally, or by device type/therapy application. Neuromodulation is well-positioned to increase in size with a track record of helping achieve successful outcomes.

A quick assessment of just a few of the conditions provides an overview of the scope of the market and the role neurostimulation devices can play in treatment protocols. In terms of chronic pain (such as back, spine, trunk, or limbs), its estimated prevalence is 100 million people in the United States and 1.5 billion worldwide; epilepsy affects 4.3 million in the United States and 50 million worldwide; and Parkinson’s patients number 1 million in the United States and approximately 7 million to 10 million worldwide.

A growing market is the perfect time for OEMs to accelerate innovation. While the market is large, it is also competitive and clinically demanding. Therefore, these firms must select the right partners with which to establish a streamlined supply chain, enabling them to be agile and deliver clinically effective solutions to the market. They also require a supplier familiar with the major factors shaping, and in many cases, re-shaping this growing neuromodulation market.

Miniaturization Is Here to Stay
It is hard to consider miniaturization as a trend because it is actually a must-have factor that is expected in the medical profession. Therapies like neuromodulation and miniature components and devices go hand in hand. What is important for designers, engineers, and manufacturing teams to remember is that miniaturization is here to stay; devices and components will not become larger.

Neuromodulation miniaturization, specifically, requires a holistic approach. For a device, every successive generation is on a glidepath to be smaller and more sophisticated, without sacrificing performance. In many cases, the expectation will be to also deliver greater functionality. Miniaturization success requires a team approach from all the critical disciplines: materials science, design, technology innovation, and micro manufacturing. Success requires excellence in all four of these areas.

A New Era for Medical Technology Supply Chains
Every change within the overall healthcare system has a ripple effect on the medical device industry. This relationship is complex, but new solutions can be developed. As a result, the industry has placed an even greater emphasis on supply chain management. In this new era of supply chain management, OEM customers are striving to streamline and simplify their supply chains in the drive to become agile in the marketplace and provide greater speed-to-market to their customers.

What does this mean as companies work to “Lean out” their supply chains? Outsourcing is augmented by a more integrated and collaborative approach between the OEM and their supplier partners. The build-to-print model is evolving into a deeper collaboration that integrates valuable supplier innovation into the OEM’s product development cycle. This approach, called supplier-enabled innovation, has been a critical focus at Heraeus and its medical device customers; in every customer relationship, a supplier company should strive to become a natural extension of its OEM customer’s research and development team.

Solving the Cost Versus Performance Challenge
Every aspect of the healthcare industry—from providers to payers to distributors to manufacturers and service providers—faces the pressures of controlling escalating costs every day. From downstream to upstream, the ripple effect faces every company in this ecosystem.

The neuromodulation segment is no different. Even the most promising or proven treatment therapies are not immune from cost pressures. Added to the mix are requests to provide greater functionality and/or improve performance. Competing in this environment requires agility and a 360-degree approach. Is there another material option that can reduce cost without sacrificing performance? Can a manufacturing process be improved? Can a new or modified design allow for additional functionality or improve the overall effectiveness of the therapy? These are the questions that should be asked—and answered—every day.

What Does the Future Hold?
At Heraeus, we have paid close attention to those trends and incorporated them into our strategic and operational DNA. Neuromodulation therapies have a bright future and will play an increasingly important role in treatment areas, particularly:

• Deep Brain Stimulation (DBS)—Essential tremor, Parkinson’s disease, dystonia, epilepsy, Tourette syndrome, chronic pain, obsessive compulsive disorder, among others
• Spinal Cord Stimulation—Chronic pain and neuropathy

Based on past figures and future projections, neuromodulation has higher growth potential and more unmet clinical needs when compared to some other stimulation markets, such as cardiac rhythm management. Of course, in order for the industry to capitalize on this promising market, companies need to deliver the necessary innovation and device performance to enable clinicians to address those unmet needs. Fortunately, promising indicators can be observed—a high number of startups are active in this segment and large OEMs are making substantial investments.

Whether it is an emerging startup or an established OEM, the challenges remain the same—delivering innovations to market quickly and efficiently while being clinically effective. Supplier-enabled innovation can help address both goals. To capture a share of this market, companies cannot go it alone. Supplier innovation can help OEMs avoid many of the typical challenges, roadblocks, and bottlenecks.

The Role of University Partnerships
There are several basic yet essential unmet clinical needs that have been identified and for which solutions are being developed—improving the precision and performance between electrodes and human tissue, and steering a therapy for increased clinical efficacy.

For example, DBS has the potential to be a life-changing procedure for young and old alike; however, delivering effective therapy while minimizing potential harmful side effects remains a challenge. In DBS, the ability to steer the stimulation to the exact target increases the clinical efficacy of the therapy. Perhaps more importantly, this targeted therapy can minimize or eliminate potential negative side effects that can equal the impact of the original disease symptoms. The goal was to find a new way to enable more effective therapy, with more precise targeting of affected areas with fewer side effects.

As part of Heraeus’ efforts specifically, the company established a research partnership with the University of Minnesota. Thus far, the research has indicated that increasing the segmentation of a DBS array to four electrodes per row and possibly in a four-by-four pattern may be the optimal design for DBS. High-density segmented electrode arrays could effectively address the clinical need of steering DBS therapy to a precise target. A four-by-four segmented electrode lead array could provide significant functional and performance advantages over current legacy devices. Potential benefits include:

• Can enable a higher number of channels, connecting supplier-enabled innovations through vertical integration and miniaturization.
• Increases the potential clinical effectiveness by providing up to 16 segmented electrodes to steer the therapy for more targeted and optimal results.
• Has fewer components while also featuring a higher channel count, which inherently increases reliability and potentially decreases cost.
• Is in the same form factor and size as the current market released four- and eight-channel arrays.
• Utilizes materials and processes currently commercially approved for chronic human use in the brain, thereby eliminating any additional regulatory barriers for this innovation beyond the customer specific submission.

Dr. Matthew Johnson, associate professor of biomedical engineering at the University of Minnesota, research partner with Heraeus, noted, “The clinical effectiveness of deep brain stimulation therapy remains strongly dependent on precisely targeting stimulation within the brain. The Heraeus four-by-four directional lead platform is a significant technological advance over existing lead designs. By improving the spatial targeting capabilities of stimulation and enabling higher-resolution electrophysiological recordings of brain activity near the site of stimulation, this new lead technology is poised to have immediate clinical impact.”

Conclusion
Neuromodulation has enormous potential. Like any promising treatment innovation, however, it has to prove to the medical community that it can deliver superior, safe, and cost-effective therapy when compared to current or legacy treatment options. This journey will require a re-examination and re-imagination of the traditional supply chain to a more agile and vertically integrated model. Tightly aligned internal and external collaboration will be essential to meet the shared vision of improving patients’ lives and can be achieved through supplier-enabled innovation. 

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Mark Hjelle is senior product line manager for Heraeus Medical Components.