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BMES High School Student Chapter Member

HS Poster

Poster 130 - Predictive Data-Driven Market Analysis and Commercial Viability of a Smart, Inflatable Dilator: Addressing Non-Adherence in Vaginal Dilator Therapy

Saturday, October 26, 2024
10:00 AM - 12:00 PM EST
Location: Exhibit Hall E, F & G

Introduction: Radiation therapy for gynecological cancers frequently results in radiation-induced vaginal stenosis (VS), a condition characterized by the narrowing and scarring of the vaginal canal. This condition impacts up to 88% of women who undergo pelvic radiotherapy in the United States, significantly affecting their comfort and quality of life. Vaginal dilator therapy (VDT) is the standard treatment for VS; however, non-adherence due to discomfort, inconvenience, and inadequate guidance often reduces its effectiveness. In response, Delilate has developed a smart inflatable dilator that integrates advanced technologies, including temperature and pressure control, progress tracking, and volume recording, to enhance patient experience and treatment efficacy. To evaluate the commercial potential of this innovative dilator, we performed predictive sales projections using Google Sheets to assess the profitability of the device over a 10-year period.

Materials and

Methods: The commercial viability of the smart dilators developed by the Center for Memory and Recording Research at UCSD was assessed using a sales forecast sheet. Two separate models were created: one for the clinical dilator, priced at $500 per unit, and another for the handheld dilator, priced at $200 per unit. Key variables included number of devices sold, price per device, commission percentage, commission fees, and fulfillment cost. These figures were instrumental in calculating total revenue, representing the company's earnings solely from product sales. For the initial two years, sales volumes of 100-200 units were projected to gather sufficient data to validate the product's benefits.

Using the aforementioned variables, total revenue, cost of goods sold (COGS), and gross profit were calculated. COGS was determined by adding beginning and current inventories and subtracting ending inventory over ten years. Gross profit was calculated by subtracting COGS from total revenue. To assess net profit, expenses, including depreciation (software, marketing, R&D, FTE, and payroll), were deducted from the total revenue. These expenses were allocated as percentages of total revenue, ensuring that the company maintained profitability and a viable gross margin. The financial outcomes were projected from Year 1 through Year 10.

Prior to evaluating commercial viability, research on market potential and adoption rates was conducted. The sales forecast predicts that by Year 10, approximately 16% of the national gynecological devices market will be captured, with an estimated 16,000 units sold annually out of 100,000 new patients entering the market each year.

Results, Conclusions, and Discussions: The analysis indicates that the net profit for the clinical dilator is projected to be $4,373 in Year 1, with a substantial increase to $1,482,212 by Year 10 as shown in Figure 1. Similarly, the net profit for handheld dilators is projected to grow steadily from $1,685 in Year 1 to $609,872 by Year 10. The return on investment (ROI) is calculated to be 151.68% in Year 1, escalating to 493.31% by Year 10. Additionally, the gross margin is calculated at 74.7% for clinical dilators and 65.6% for handheld dilators.

The ten-year time frame ensures sufficient time for the marketing, outreach, and testing of the product while also working towards achieving a positive net present value (NPV). A positive NPV, calculated at $920,216 by Year 10, suggests that the investment is strong and that the product is likely to be successful in the market.

Conclusion:
The predictive sales and financial analysis indicate significant commercial viability for both the clinical and handheld smart dilators, particularly in their ability to address the unmet needs of vaginal dilator therapy (VDT). With high projected returns on investment and strong gross margins, these products are well-positioned for successful market entry and long-term profitability. The next steps will involve securing regulatory approval and refining marketing strategies to maximize market penetration and patient adoption.
Future Directions:
- Exploring the application of the smart dilator for additional gynecological conditions beyond vaginal stenosis (VS) to expand its clinical utility and market potential.
- Conducting primary market research and utilizing advanced data analytics to better understand market demand and patient needs.

Acknowledgements (Optional): This work was supported by a generous gift from Beckman Laser Institute Inc. to LS. The high school students (*) participated in the UCSD IEM OPALS internship. Thanks to the expert guidance of Dr. Miao Jiang in business development and customization strategy. Special thanks to Dr. Shu Chien from UCSD Bioengineering and Dr. Lizhu Chen from CorDx Inc. for their donations.

References (Optional): (1) Chen PH, Li YM, Morris K, Makale MT, Mayadev J, Talke FE. Design and Material Characterization of an Inflatable Vaginal Dilator. Materials (Basel). 2024 Feb 24
(2) R. Simoes-Torigoe, P.-H. Chen, Y. M. Li, M. Kohanfars, K. Morris, C. W. Williamson, M. Makale, J. Mayadev, and F. Talke, “Design and validation of an automated dilator prototype for the treatment of radiation induced vaginal injury,” (2021), pp. 1562–1565, 2021 43rd Annual International Conference of the IEEE Engineering in Medicine & Biology Society (EMBC), 2021.