Regarding my field of interest, bone regeneration, to the best of my knowledge, several medical devices are in high demand including bone graft substitutes, external fixation devices, stem cell therapy devices and bone stimulation devices. Starting a medical device startup can be a complex and challenging process, but I think people can take some steps to get started. They need to do a lot of research and identify a need, Then they have to build a team which can be small in the beginning, develop a prototype once they have a clear understanding of the problem you are trying to solve. Afterwards, they should conduct clinical trials which require a lot of paperwork (ethics) and financial resources and I think the most difficult step is this one. Once all these are done, they need to secure funding to bring the medical device to market and before your medical device can be sold, you will need to obtain regulatory approval from the relevant authorities, such as the US FDA or the European Medicines Agency (EMA). Finally, you can earn some money after launching Your Product!

I currently work in a research lab on NJIT campus where we conduct research on blast induced traumatic brain injuries (bTBI) using rodent animal models. This research can be linked with similar injuries that soldiers face when they are in warfare conflicts. When an explosion occurs, blast waves are emitted from the site of explosion and if they are at a high enough pressure and the soldier is close enough to the blast radius, they could experience severe bTBI injuries which could be fatally chronic if not addressed or treated immediately. I personally would like to see an injectable drug that could help combat the biochemical response that occurs in the brain when this type of injury is induced on a soldier so that it could prevent long term neural damage. I would propose an injectable drug which contains an encapsulated nanoparticle which would be able to cross the blood brain barrier and reduce chronic microglial activation. To see this project to fruition I would first need some preliminary data that I would be able to show investors to get seed money. From there I would begin pre clinical trials and move forth with the FDA process. The end goal for this project would be to see it used by the entire United States Armed Forces which would be able to save our soldiers' lives.

I currently work in a neuroscience lab that deals with the Protecadherin gene in the brain. This gene codes for the “molecular barcode” of each neuron, and this barcode is used to ensure that neurons make proper connections between each other. When this gene is mutated, incorrect connections are formed, and this leads to conditions such as Autism. This makes these genes and the corresponding proteins a good target for translational applications. 

A potential project that I am interested in is a diagnostic or monitoring platform that uses the expression patterns of the protecadherin gene as biomarkers for early detection of neurological risk, even after genetic testing. This would be applicable for developing fetuses or small children. This would allow doctors to find issues in brain development early on and address them. From a project management perspective, the early steps would include defining the clinical need more clearly with specifics from the patient population, since the population we are working with is very niche. Along with this, feasibility studies would be needed. Regulatory strategy would become a major consideration for validation due to the nature of the project as well. A variety of teams, from research to regulatory, would need to work together to make sure that the scientific goals and regulatory constraints are met. The end goal would ultimately be to help patients increase their quality of life before a neurological disorder takes it over. 

I would like to see how others approach turning basic science research into devices. What are the biggest challenges you have seen trying to move a concept from a lab into the industry? Have you seen any other neuroscience ideas similar to mine?

Based on my research, I’d be interested in starting a medical device project focused on a collagen–chitosan hydrogel bandage for treating second-degree burns, since it has strong potential to support healing while offering intrinsic antimicrobial protection. The early steps would include clearly defining the intended use, completing formulation optimization, and conducting bench, biocompatibility, and early performance testing. From a regulatory standpoint, I’d expect this to fall under a Class II pathway, most likely pursuing FDA clearance through a 510(k), with De Novo as a backup if no suitable predicate exists. As the project progresses, design controls, risk management, and usability testing will become key milestones. The end goal would be to bring a safe, effective, and clinically differentiated burn dressing to market that improves patient outcomes and simplifies wound care.

A medical device project that I have interest which is linked to some of the work I have done within NJIT is researching a new wound-healing material that can be used in varying wound healing applications like burn wounds and major acute injuries. The material that I would like to research and innovate would involve a composite of alginate, collagen, and fish skin as the primary materials within the composite. The choice of materials for this material stems from each of their contributory properties to wound healing and cell regeneration that are vital to wound healing processes, where fish skin has often been used as an extracellular matrix to provide cell proliferation. On the other hand, alginate and collagen have strong mechanical properties and regenerative capabilities that bring structural integrity and healing properties to the composite. In order to innovate this project, I believing that conducting extensive research to each of these factoring materials is crucial to understanding how they interact individually with the human body and contribute to wound healing. Furthermore, clinical testing and trials would need to be conducted utilizing the composite material on mice that have inflicted injuries as a control test against more common wound healing solutions already on the market.