Neuromodulation, the ability to regulate nervous system activity for therapeutic benefit, has reached a pivotal moment. Advances in neuroscience, materials science, and device miniaturization have unlocked the potential to treat a wide range of conditions, from bladder and bowel disorders to respiratory and cardiovascular dysfunction. Yet despite this promise, many neuromodulation innovations stall in the lab, unable to advance toward regulatory approval and patient impact.

The National Institutes of Health (NIH) and its SPARC (Stimulating Peripheral Activity to Relieve Conditions) program wanted to accelerate the translation of groundbreaking neuromodulation research into therapies that could realistically reach patients. As a complement to traditional grant mechanisms, NIH wanted to surface the most promising, multidisciplinary approaches, guide innovators through complex regulatory pathways, and incentivize clinically relevant milestones. NIH sought a new approach that could derisk innovation, compress development timelines, and push solutions toward real-world impact.

Neuromodulation is a rapidly advancing and inherently multidisciplinary field, spanning biomedical engineering, neuroscience, materials science, and clinical practice. It is also a highly regulated space where success depends not only on scientific novelty, but also on the ability to navigate complex regulatory pathways, demonstrate safety and efficacy through rigorous clinical studies, and strengthen collaboration between industry, research, and government. 

The SPARC program was already supporting fundamental research and open science tools, and NIH had developed a strong internal capacity for using open innovation mechanisms. Building on this strong foundation, NIH saw an opportunity for a prize competition that could bridge the gap between promising research and patient-ready solutions.

Through a contract with the NASA Tournament Lab, Luminary Labs partnered with NIH to design and deliver the Neuromod Prize, a $9.8 million open innovation program that accelerated the development of targeted neuromodulation therapies. The Neuromod Prize was structured as a three-phase challenge spanning more than three years. 

Each phase combined catalytic funding with clear technical benchmarks, rigorous evaluation, and increasing expectations for regulatory and clinical readiness: Phase 1 (2022) was an open call for novel concepts and development plans. Eight semifinalist teams received $100,000 each and an invitation to participate in Phase 2 (2022-2024), where they conducted proof-of-concept studies and completed FDA Investigational Device Exemption (IDE) pre-submissions. Four finalist teams received $1 million each and advanced to Phase 3 (2024-2025), during which they conducted IDE-enabling studies in large animals and/or humans, generating the safety and efficacy data necessary for regulatory approval. First-place and second-place winners were awarded $3 million and $1.6 million respectively, with an additional $400,000 awarded to teams in interim prizes as they successfully completed milestones during Phase 3.

Luminary Labs worked closely with NIH and its cross-agency partners, including the Food and Drug Administration (FDA), to ensure the program balanced ambition with feasibility. By designing for clinical translation and market-readiness, we demonstrated that a prize competition can meaningfully accelerate therapeutic development in a complex, regulated field. 

Strategic design choices and thoughtful program administration helped this bold competition achieve real-world impact. Of note:

• Regulatory milestones embedded in the competition. FDA engagement was not optional or deferred; it was requisite for success. We worked closely with SPARC and collaborators across NIH and FDA to ensure the competition’s milestones aligned with actual regulatory requirements. These iterative regulatory milestones compressed timelines and ensured teams were building toward real clinical use from the start.
• Broad outreach to engage multidisciplinary innovators. In Phase 1, our communications and outreach efforts attracted a multidisciplinary audience of solvers — neuroscientists, biomedical engineers, practicing clinicians, university labs, health tech startups, and medical centers — extending beyond the traditional SPARC community.
• Consistent, expert judging panels. Judges included program officers and directors from six NIH institutes and centers, ensuring that submissions were evaluated by experts with deep knowledge of the specific therapeutic areas being addressed. Judges stayed involved across phases and were able to see how solutions evolved over time.
• Strategic timing and technical assistance. Teams received both the time and the resources needed to tackle technically complex challenges. Luminary Labs facilitated access to federal subject matter experts through the NIH SEED office for commercialization guidance and FDA for regulatory navigation.
• Visibility and network-building to support progress beyond the challenge. For the Phase 3 winner announcement at HLTH 2025, Luminary Labs provided pitch coaching and storytelling guidance to help finalists present their work to an audience of healthcare leaders, investors, and potential clinical partners.

Following the Phase 3 winner announcement, an NIH open innovation leader celebrated the Neuromod Prize as “yet another open innovation success story.” 

By the conclusion of the program, multiple teams had advanced from early concepts to IDE-ready devices — an achievement that often takes far longer through traditional development pathways. The winning teams’ devices can be adjusted for individualized treatment, have limited or no side effects, and are now ready to be considered for approval in clinical use.

• First-place winner University of Pittsburgh Department of Urology created a multichannel implantable device for sacral-pudendal neuromodulation that addresses bladder, bowel, and sexual disorders.
• Second-place winner Juniper Biomedical developed a highly precise, micro-implantable neuromodulation to treat stress urinary incontinence, overactive bladder, and fecal incontinence.

The combination of funding and resources proved transformative: Announcing its win, Juniper Biomedical said, “The Neuromod Prize has been a profound accelerant in the evolution of Juniper’s technology and clinical solution since the beginning.”