A pediatric nurse practitioner needs help coming up with a physical model for an enhanced nebulizer to optimize the delivery of albuterol to toddlers with reactive airways disease.
Part of our unique strategy to device innovation utilizes our coach coordinators to provide an evaluation for all innovators wishing to work with the NCC-PDI. Below is an example of what a coach coordinator might suggest for this scenario:
|Domain Expertise||Questions / Topics|
|Business||Market Attractiveness – How well does the design score with the end user?
Estabilishing a business case – You should establish a basic business case stating the potential market size and how much money you think it will take to get to market.
|Regulatory||Initial regulatory pathway determination Determine whether the device will be exempt, 510 (k) or PMA from a regulatory standpoint.
Potential for reimbursement –
|Clinical||Clinical Impact – What is the need that this device solves?|
|Engineering||Technical feasibility –
Pre-clinical/bench testing –
Relevant standards – What ASTM or ISO standards are applicable to this devices?
|Funding||Sources for funding identified –
In contrast to previous scenario, an expensive x-ray machine, nebulizers are cheap medical supplies, ranging from $2 for disposal ones to $20 for multi-use model. In the due diligence process, we will advise the innovator to evaluate the clinical benefit versus the cost of the new technology. Specifically, we will connect the innovator with design firms and manufacturers to get an estimate of the production cost of such new nebulizer. We will also help the innovator to collect early feedbacks from Pulmonologist, patient’s parents on such new concept to assess their willingness to pay and likelihood of adoption. If the concept turns out to be too costly and lack significant clinical benefit, we might advise the innovator to redesign or improve the concept with the consortium partners.
Another special challenge of this scenario is the usability, form factor, and human factor considerations when designing new products for small children. Given the target population, toddlers not only small in size, they are also non-compliant, and lack the ability to follow instruction. Working with our engineering team and fast prototyping facilities, we could help the innovator to build several non-functional prototypes for usability testing and getting some early feedbacks from nurses and patient family. If special design challenges emerge in the early testing, we will engage design firms (see support letters from Medical Murray, Key Tech, Root3 Labs, and IDEO) to help address those issues.
Mostly likely, this new invention will fall under the 510(k) pathway. If this device is to be marketed as “optimize delivery” of albuterol, a clinical trial might be needed to show its efficacy and support such claim. This will significantly increase the development cost for device with very low margin. Our advice would be look for an industry partner, advocacy group and foundations for funding to support clinical trials.