Scenario 3

A pediatric neurologist wants to know what type of animal testing might be needed for a device used to treat hydrocephalus, but lacks the resources and expertise to proceed to this phase of development.

In this scenario, the pediatric neurologist pursuing this need probably already used some crude works-like prototypes to show that the concept is feasible. This scenario falls into the pre-clinical stage of our process flow chart, which includes bench performance testing and animal performance testing.

The consortium will help guide the inventor to identify the least burdensome pathway to quickly move to the next stage of development.

  • To determine the kind of animal testing needed, the first step is to identify the predicate devices.
  • After identifying the predicated device(s), we will compare the technical characteristics of our invention to those current being marketed, and determine the required data needed to demonstrate substantial equivalence.
  • Out consortium partner, MHRI/CRI has made their animal facilities available to any researcher who needs GLP or non-GLP animal studies on a fee-for-service basis.
  • Our business team will also help develop a funding strategy to identify and obtain financial support the animal trial.
Domain Expertise Questions / Topics
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 –
  • who pays for this?
  • Are similar products reimbursed?
Clinical Clinical Impact- What is the need that this device solves?
Engineering Technical feasibility-
  • Is the design technically feasible?
  • What level of mechanical design expertise is needed to achieve the building of the prototype?
  • Pre-clinical/bench testing –
    1. How do you plan to test the devices
    2. What are metrics you can use to measure the success of the project?
    Relevant standards – What ASTM or ISO standards are applicable to this devices?
    IP Competitive advantage
    1. How is the device unique and / or better than the current standards?
    2. IP landscape – Is there space for this IP?
    Funding Sources for funding identified –
    1. How much will it cost to bench test a protype?
    2. How much will it cost for design for manufacturing?
    3. What types of grants and non-dilutive funding do you plan to apply for?
    4. Potential for industry partnership funding?
    5. Do you plan to seek venture/equity financing?

    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.

    In this scenario, the inventor is at the very beginning of the product development process, namely Discovery/Ideation.
    • Our engineering team will advise the inventor in flushing out his/her idea. Issues relating to complexity of developing potentially capital medical equipment and concerns for radiation exposure will be discussed
    • With a mature concept defined, we can help evaluate the IP landscape and file for patent protection.
    • Once, technical and clinical aspects are vetted, we will bring experts from our clinical, regulatory and IP partners to evaluate the development plan and strategy
    • Meanwhile a business development team will help identify opportunities for industry sponsored research, licensing agreement, or strategic alliances.
    • Exit strategy will be developed early and iterated often during all stages of development .