Challenge
Our client was a small, inexperienced company, who never marketed a product before. This was a family owned company, where the thought of a product to be marketed came into existence from personal life experience. Here the product discussed was a medical device, a surface disinfectant, which can be used on surfaces like baby toys, pacifiers, dentures and other common household surfaces which had to be safe for kids as well. From that thought in mind, the owner decided to use natural ingredients in the product, which is safe for babies as well as serve its purpose.
Although, experiments were performed to test the product’s efficacy, the major challenge was to add validity and perform regulatory submission before actually marketing the product.
510 (K) submission to FDA, for Pre-market approval was needed
Opportunity
Initially our client didn’t have proper scientific consultation, and ended up spending money on unsubstantiated validation of the product. To add on to that, our client was misinformed/misguided by one of the regulatory agencies towards regulatory submission which was not needed in the first place and could have costed our client further.
Unable to decide, our client came to us for advice and requested for our service towards the regulatory submission and guidance. After hearing out the background story, we took it upon ourselves to help our client achieving the necessary goal. In addition, since we have in house science experts and regulatory submission experts, it was a good opportunity for us to showcase our abilities in helping our clients.
Solution: Strategic Guidance
Our inhouse team of experts from various disciplines sat together and discussed the whole issue. We divided the challenge into two groups where one group would deal with the scientific background and the other with the regulatory submission.
Our in-house scientific experts suggested for a revamped strategy where we would suggest the experimentatioal guidelines and layout a strategy to achieve valid results in a coherent fashion in accordance with industry and FDA standards.
The regulatory team decided to seek FDA opinion regarding the submission of pre maket approval for the said medical device. To achieve this, the regulatory team submitted 513 (g) form to the FDA. Upon FDA’s reply, we informed our client that based on the nature of the medical device (in this case general disinfectant) there are two options. Either to go for the 510 (K) submission, where we would require
extensive experimentation to prove that the medical device can be used as a deep cleaning agent/sterilization agent, which would also require our client to spend a lot of money in experimentation and 510 (K) submission. Or else, based on the goal and available budget, remodel the marketing strategy while adhering to the FDA guidelines.
Following are the services which was provided:
Help with expert scientific advice regarding validation of the product
Help our client file for 513 (g) submission
Educating our client regarding the 510 (k) submission
Develop a marketing strategy
Create appropriate label
Explain every aspect of our sevices in detail
Since our client was new in the market and was relatively inexperienced, one of the regulatory agencies misguided our client in submitting unnecessary regulatory submission and instilled a fear that negatively affected our client and delayed the product launch. We explained our client that since the medical device uses all the natural products, there is neither a question of any pesticide related toxicity nor there is any requirement of unnecessary regulatory submission by spending a large sum.
Additional Details of our Solution
Our team of multidisciplinary experts sat down with our client and discussed about every aspect of this project and tried to understand our client’s requirements.
Member of our teams discussed about the challenges and assigned relevant portions to the respective groups.
Science group conducted literature search and studied the background of the product.
Scientific experts also developed strategy and guidelines towards better scientific conduct.
Appropriate vendor (experimentational labs) were identified and quotations were discussed with our client.
Previous scientific data was analyzed in detail and corrective measures were suggested to the client.
Corrective and balanced composition for the product was suggested to the client after analyzing preliminary data.
513 (g) was submitted on client’s behalf.
510 (K) submission requirements and feasibility studies were conducted with respect to client’s medical device.
Client was educated regarding the requirement (or otherwise) of different/relevant regulatory submission processes, for example FDA, EPA..
Client was educated regarding the requirement (or otherwise) of “Proposition 65” and relevant suggestions were made.
A corrective labeling strategy was suggested in accordance with FDA guidelines, after discussing with the client.
An updated marketing strategy was suggested to our client for smooth market launch of the product.
Client was assured of long term healthy association, which helped instil confidence in our client.
Summary
When the client approached BCI (BRACANE Company Inc.) to get help with the product launch and all the related regulatory approval processes, we realized that we need to study the details of what has been done so far and what can be done to achieve client’s goal.
First step taken was to fill the knowledge gap, where lack of experience in experimental validation was
corrected with appropriate suggestion and strategic planning.
Next, for the regulatory submission, detailed study about the product and relevant regulatory guidelines was performed to establish the need (or otherwise) of appropriate regulatory submission under the correct product category. And the conclusion were shared with the client along with appropriate strategic advice from the industry experts.
Overall, we (BCI) realized that our client has been misguided/misinformed earlier by various parties, which resulted in delay as well as expenditure of large sum towards marketing/launch of the product. To overcome this situation, as a CRO, we helped our client with correct information, detailed study analysis, suggesting corrective measures, strategic planning, and solution which steered the project towards right direction and helped to achieve the desired goal of launching/marketing the product within shortest time possible, and the budget allowed.
A general purpose disinfectant as a medical device falls under the Class I device category (product code LRJ), under the FDA regulation 21 CFR 880.6890; and is exempt from 510 (K) submission. The medical device mentioned above doesn’t fall under the exemption category (under 21 CFR Parts 862-892) and is also excluded from “Limitation of Exceptions: 880.9”, in accordance with the FDA regulations.