Overview

Pathway NPI is an ISO-compliant team of multidisciplinary experts whose mission is to assist innovators in bringing quality med-tech products to market. Pathway NPI performed design and validation services on behalf of Neurgain Technologies. A CA-based company that focuses on the treatment of spinal cord neuropathic pain, Neurgain invented a Class III surgical device with significant promise to help patients with severe neurodegenerative disorders such as ALS. 

The Opportunity

Using “Precision Neurology” — strategies and delivery methods that can deliver therapeutics directly to the targeted location where they are needed — the device will streamline the administration of medication, making treatments safer and more precise.

Neurgain designed its novel delivery technology to bypass the traditional obstacles of spinal cord disease treatment and provide clinicians, for the first time, with the following features:

  • An alternative to intravenous delivery
  • A single therapeutic delivery for pain relief
  • The potential to reduce the need for addictive pain medication

Challenges

Neurgain needed help with biocompatibility testing, cleaning validation, sterilization validation, and defining the best benchmark performance tests for quality assurance to bring their device to market. They also needed to identify the best suppliers for the parts they required and find appropriate third-party testing facilities. Although the device’s inventors are top-tier, cutting-edge scientists informed by collective genius, they didn’t have the experience or know-how to see their product’s journey from inception to market launch.

While Neurgain’s groundbreaking device will undoubtedly fill a great need and be met with broad acclaim in the field of neurosurgery, the revolutionary aspect of their concept introduced a challenge. Because no predicate device had ever successfully been brought to market, and because of the high-risk nature of the device itself, Neurgain would have to seek premarket authorization (PMA) from the FDA rather than taking the easier path to approval offered by 510(k) submission or the De Novo process. 

Neurgain faced a long, arduous journey but wanted to bring their device to market as quickly and smoothly as possible. Pathway NPI successfully shepherded them through the many complex FDA approval processes and assisted with submission of the device for approval in early 2022.

Solution

Neurgain came to Pathway NPI with what was essentially a first-generation prototype of their device that needed very few design improvements. After tweaking the design so that it could be manufactured more efficiently and cost-effectively, the Pathway NPI team built out manufacturable components and identified suitable vendors and parts suppliers. Then, they subjected the device to rigorous in-house validation and verification testing along with required performance testing, including:

  • Needle penetration testing
  • Strength testing
  • Tensile/pole testing on the interface of tube and needle

Pathway NPI used their in-house OPTICAL COORDINATE MEASURING MACHINE (CMM) to characterize the optimal needle sharpness — a critical component of a device that injects materials into humans’ spines — with high precision. 

CHALLENGE/SOLUTION #2

The team encountered another obstacle along the way: Neurgain originally used a high-cost threaded machined metal component to interface their needle to their manipulator device. This was meant to be disposed of after a single use and was the most expensive component in their disposable needle assembly.  

Pathway NPI advised Neurgain to solve this problem by switching to an injection molding component to replace the high-cost machined part, to manufacture the needles. Pathway NPI CEO and co-founder, Arthur Deptala, estimated the cost savings at as high as 10x the cost of machine-built parts and says using injection molding cut production time in half. 

CONCLUSION

Pathway NPI’s mission was to help Neurgain meet its production goals without compromising the quality of its product. With the infrastructure and pedigree to take products from design to scale, Pathway NPI was equipped to perform the actual manufacturing processes at their facilities. They accelerated the many validation steps by using sophisticated technologies to overcome testing and production challenges. In essence, they were the brawn behind Neurgain’s brains, supporting their creative genius with the practical know-how and resources to bring an extraordinary idea to life.

If you have an idea you’d like to bring to market, contact Pathway NPI today!