Toddler’s near-fatal choking experience inspires mom to invent tool to aid in CPR process
BY EDITH G. TOLCHIN
I belong to many diverse groups on social media. I especially enjoy scouting and interviewing inventors with new products on the market.
Here is Tennessean Felicia Jackson’s story about inventing the potentially life-saving CPRWrap.
Edith G. Tolchin (EGT): How did CPRWrap come about? I understand your (then) toddler son and husband were involved.
Felicia Jackson (FJ): CPRWrap was born from a deeply personal experience that my family and I went through several years ago.
At the time, my son was just a toddler, full of curiosity and energy. During a family outing, he accidentally choked on a small object, and panic immediately set in. Despite my working in a hospital and being CPR trained, fear and distress clouded my ability to recall my CPR training.
In that critical moment, my husband, who was also present, reacted quickly, saving our son’s life. It was an eye-opening experience that made me realize the crucial need for a reliable and user-friendly tool to confidently guide individuals through the CPR process during medical emergencies.
Through extensive research, development and countless iterations, CPRWrap was born. CPRWrap combines visual hand placements for proper compressions, an attached one-way valve mouth barrier for added protection during rescue breathing and translated CPR instructions for global usage.
EGT: How did you create the first prototypes? How many prototypes did it take before you had a market-ready product?
FJ: Creating the first prototypes for CPRWrap was a challenging process. I actually had a dream of this product being used to revive someone, and I remember homing in on what was on the victim’s chest.
After waking up from that dream, I quickly sketched what I could remember in a spiral notebook I used to keep next to my bed. During that time, I also worked in a hospital surrounded by many multidisciplinary medical professionals and was able to get their expert thoughts on CPRWrap as I was developing it.
I was not tech savvy, could not draw very well, and I didn’t have the funding to pay someone to create my first prototype, but I was determined to develop a user-friendly and effective tool for the non-medical community.
I initially conducted extensive research on existing CPR training aids and studied real-life emergency response scenarios, then moved on to crafting a very rough prototype—combining visual hand placements, translated CPR instructions, and the one-way valve mouth barrier.
Throughout the development phase, I continuously tested and refined each prototype, seeking feedback from medical experts and conducting user trials to identify areas for improvement. This approach allowed me to address any shortcomings and fine-tune my design.
Creating a market-ready product was a meticulous journey that required a total of three prototypes. Each iteration brought me closer to my goal of creating a simple, effective and accessible solution for CPR. Finally, after countless hours of hard work, collaboration and dedication, CPRWrap was ready to be launched.
EGT: When did you open the business?
FJ: I opened my business in 2017, initially from my home, and eventually moved into my first office space inside the Incubator in downtown Chattanooga, Tennessee.
EGT: Are there any special regulations for manufacturing a health-related product such as this?
FJ: Yes, manufacturing a health-related product like CPRWrap involves compliance with specific regulations to ensure safety, efficacy, and adherence to industry standards. The regulatory landscape for medical devices and health-related products can vary, depending on the country or region of production and distribution. We had to get a “Medical Device Classification,” for which CPRWrap is categorized as a “Class 1” medical product.
This means our manufacturing partners have to adhere to “Quality Management Systems” as well as compliance with international standards to help ensure consistent product quality and safety. We also had to comply with regulatory agencies like the Food & Drug Administration, make sure our labeling and instructions were clear and accurate as a health-related product, and more.
It is crucial for manufacturers of health-related products like CPRWrap to engage with regulatory experts and consultants, and help guide us through the complex regulatory landscape. Ensuring compliance with applicable regulations not only guarantees the safety and effectiveness of CPRWrap but also enables smooth market entry and distribution.
EGT: Is CPRWrap quality control tested by any government safety agency?
FJ: Yes, manufacturers of health-related products are often required to establish and maintain a robust Quality Management System (QMS, as mentioned above). Compliance with international standards such as “ISO 13485” helps ensure consistent product quality and safety.
In the United States, the FDA oversees the regulation of medical devices. Other countries have their own regulatory authorities, such as the European Medicines Agency in the European Union and Health Canada in Canada.
EGT: Where are you manufacturing the product?
FJ: We were fortunate to partner with a family-owned manufacturing company, Global Product Sourcing, in Madison, Tennessee.
EGT: Do you use a distribution center, or are you fulfilling the orders yourself?
FJ: We distribute the CPRWrap kits from our office in Chattanooga and rely on our manufacturing partners in Nashville to ship our larger bulk orders worldwide.
EGT: Where are you selling? Retail? Amazon? Health care facilities?
FJ: We are selling our CPRWrap kits on our own e-commerce website as well as Amazon, Walmart.com and eBay. We recently started partnering with independent pharmacies to carry our kits in their brick-and-mortar locations.
EGT: Have you had any production issues or problems?
FJ: Unfortunately, problems come with the territory.
We have experienced delays in receiving raw materials or components from suppliers during the initial stages of product conception. We also had “Certification and Compliance” issues with meeting regulatory requirements and obtaining necessary certifications, especially in different countries. Further, designing efficient and protective packaging for the CPRWrap Kit and ensuring timely shipping was a big issue as well.
EGT: Are you planning any add-on products?
FJ: We will soon release CPRCanine, the groundbreaking CPR product designed exclusively for dogs. Our innovative solution will enable dog owners to confidently perform CPR, providing critical time to seek professional help for their beloved pets.
EGT: Is CPRWrap patented? Did you have any issues obtaining the patent?
FJ: In 2019, I successfully obtained a patent for CPRWrap, marking a significant milestone in our journey. While the application process itself proceeded without complications, the only setback I encountered was a temporary backlog that delayed the assignment of my application to an examiner.
Despite this minor hurdle, the entire patenting process was completed in a little over three years, solidifying CPRWrap’s unique position in the market.
EGT: Have you done any crowdfunding?
FJ: After attempting a Kickstarter crowdfunding campaign for my product, CPRWrap, I encountered a roadblock as it was not accepted due to its classification as a medical product. Undeterred, I decided to pursue an alternative route and launched a successful equity crowdfunding campaign with StartEngine.
This strategic move allowed me to secure the necessary funds and support to propel CPRWrap forward, making a significant impact in the market.
EGT: Do you have any advice for new inventors? For women inventors?
FJ: For new inventors, I would tell them to believe in their idea and tune out the naysayers, and connect with other inventors, entrepreneurs and industry professionals. Collaborating and learning from experienced individuals can open doors to valuable resources and insights.
For women inventors: I would tell them to surround themselves with supportive mentors, peers and advocates who can provide guidance, encouragement and opportunities. Don’t let gender stereotypes deter them, and let their innovation and expertise speak for itself—regardless of gender.
Details: cprwrap.com