Business Plan for the Medical Alert Device

Formulation of a Business Plan for the Medical Alert Device Developed by the Biomedical Engineering Department at the Catholic University of America

Table of Contents
 

Abstract…………………………………………….……………..…….…………..3

1. Background………………………………………………..…….……………..3

2. Technical Overview of the Project……………………………………4

3. Business Plan…………………………..………………………….…………..5

4. SWOT Analysis…………………………………………….…………..………8

5. Conclusion……………………………………………………………………….10
 

Appendix.……………………………………………….……………….………….11

References………………….…………..………………………….………………12

Abstract

 Falls are a major issue for the elderly and physically disabled community, an issue that currently does not have a preventative solution but rather reactionary solutions. Preventing a fall in the elderly and physically disabled can be the difference in their survival if they are not monitored and cared for properly. The research and development of such a device that can help prevent falls and also serve as a Medical Alert Device by the Biomedical Engineering Department at the Catholic University of America will provide this vulnerable group an extra safeguard to ensure their safety. This report will present a business plan to supplement their research in the hopes to transition the project from the development phase to the production and distribution phase to assist the elderly and physically disabled.

1. Background

Falls are the leading cause of fatal injuries and the most common non-fatal trauma hospital admission for adults 65 and above. According to the National Council on Aging, 1 out of every 4 Americans aged 65 or older experience a fall during a year. This means that every 11 seconds, an adult is treated in an Emergency Room for a fall injury and every 19 minutes, an older adult (65+) dies from a fall injury ^[1]. The research done by the Biomedical Engineering Department at the Catholic University of America will equip wearable devices, also known as Medical Alert Devices, with accelerometers and custom tracking software and can record common movements of the clients and then be able to record a fall in real-time, automatically alerting the authorities and emergency contacts, saving valuable time for the clients. Other medical alert companies require the pressing of a button for assistance once a fall occurs, but if the client falls and is rendered unconscious, they will not be able to immediately call for help.  The development of a Medical Alert Device that automatically records and tracks movements of the client can register and even predict if the client is prone to a fall and can prevent injury to the client and alert the proper authorities and caretakers. Through the research and efforts of Biomedical Engineering Department at the Catholic University of America, the department is developing the technology to provide alternative options for patients in need of extra monitoring in their medical care and to prevent these patients from finding themselves in helpless situations where they will automatically receive assistance.

 The purpose of my involvement with this project is to develop a business plan and a “Strength, Weakness, Opportunity, and Threat” (SWOT) Analysis. Using both the business plan and the SWOT Analysis, it is my goal, through this Direct Study project, to introduce the potential of the software and hardware into an already existing marketplace for Medical Alert Devices as well as generate a plan to market this technology to potential clients and medical professionals to enhance the living conditions of the target audience for the Medical Alert Device developed by the Biomedical Department at the Catholic University of America.

 Section 2 will provide a Technical Overview of the project in development by the Biomedical Engineering Department at the Catholic University of America, providing some background data on the device/project. Section 3 will provide the Business Plan to give the project some direction as it moves forward from the development stage to the production and distribution stage. Section 4 provides the SWOT Analysis, a device used to define the current standing of the project in order to determine any future plans of advancement. Finally, Section 5 will conclude this report and provide recommendation for the project to move forward in order to reach their goal of assisting the elderly and physically disabled.

2. Technical Overview of the Project^[3]

 The device under development at the Biomedical Engineering Department to assist the elderly and physically disabled is comprised of 3 main components and a collection data program to detect falls. These components are the Sensor Module, Micro Control Unit (MCU), the Wi-Fi Module, and the Collection data program and they are used in tandem to sense the body orientation and activity data in a device names the Wireless Sensor System (WSS)^[3]. The Sensor Module uses both a triaxial accelerometer and a triaxial gyroscope to record the acceleration data used to determine whether a fall has occurred. The MCU is used to develop the control system and provides the computing power behind the entire device. The Wi-Fi Module is a stand-alone Wi-Fi module providing the communication between the components and the data collection program. The collection data program is connected to the WSS, where the acceleration and angular velocity values are collected, and sent in real-time to a computer through the 802.11 wireless protocols from the Wi-Fi module. During testing , the device was attached to the chest of each subject, to provide a central location in relation to each subject’s body

 The device uses a specifically developed algorithm that records acceleration vectors and angular velocity in the x, y, and z axes. When stationary, the acceleration magnitude is a constant 1G while the angular velocity is 0^o. When a fall occurs, the acceleration is rapidly changing, and the angular velocity produces a variety of signals along fall detection. To distinguish a fall from another quick movement (like sitting down quickly or running), two thresholds were established, the Lower Fall Threshold and the Upper Fall Threshold. If the recorded data values fall within either threshold, it can be determined if the movement is a legitimate fall versus a common, intentional movement. 

 The device is able to successfully detect falls with sensitivities greater that 85% and specificities between 88-94%. The testing phase comprised of 324 tests with 18 different subjects.

3. Business Plan

 The development of a Business Plan is vital for any organization to assess their current standing as a business, to help the organization define their long-term goals, to generate strategies to accomplish these long-term goals, and ultimately give direction for the organization to follow in their process of building a business. This allows organizations to focus their resources efficiently by clearly organizing the goals of the organization. A business plan typically requires a breakdown of the proposed business including an Executive Summary, Market Analysis and Industry Overview, a Sales and Marketing Plan, and a Financial Plan. Using these analyses, an organization can properly measure the status of their business operations and their future plans to advance their company.

3.1 Executive Summary

The device/software being developed by the Catholic University of America’s Biomedical Department would assist elderly or physically disabled persons who are unable to assist themselves in the event of a fall or injury in the absence of a caretaker. The project will address the helplessness the client experiences if they were to find themselves in a situation where they cannot help themselves and hope to eliminate this helplessness in order to save their lives. Not only will the project assist the elderly or physically disable if/when a fall occurs, but it will also use its devices and algorithms to predict and warn the user that a fall is likely to occur, potentially removing the clients from a life-threatening situation. This can prove invaluable to the survival of our clients with how frequent falls are likely to occur for our target market. This project solves this problem by automatically distinguishing a fall between a various movement uncommon for the client, a function that is not common in the current market for medical alert devices.

3.2 Market Analysis and the Competition and Business/Industry Overview

It must be recognized that a market already exists for the product and its functions, with a wide variety of services that each client must choose from. According to a report by the Grand View Research, Inc., the Medical Alert industry can reach up to $11.1 billion by the year 2025 ^[2]. Rise in the elderly population, improvement in the healthcare infrastructure, and increasing preference for aging in place are a few of the driving factors the market ^[2]. All of these factors promote growth in the industry, especially with the aging of the Baby Boomer generation and the increased demand of a Medical Alert Device with the pending surge in the elderly population. Below is a chart with the main competitors in the Medical Alert industry and their prices and unique features.

Table 1      List of Main Competitors in the Medical Alert Industry

It would also be significant to note that most insurance plans in the United States of America do not offer coverage for Medical Alert Devices, especially Medicare, Medicaid, and job-based Health plans ^[17]. However, there are some exceptions (like Medicare Advantage) that will look at each insured patient’s situation and assess whether or not the client is eligible for coverage for a medical alert device. Overall, most clients will not receive benefits from their healthcare provider to assist in payments of medical alert devices and their subsequent services.

3.3 Sales and Marketing Plan

The potential market for this project is the elderly or physically disabled, as well as their caretakers. The goal of the project is to save the lives of the clients by providing assistance when they cannot assist themselves. In order to do so, the project requires constant feedback from the clients and their caretakers in order to optimize performance for the product. The project may also consult with medical professionals (doctors, occupational therapists, physical therapists, nurses, etc.) to provide feedback, medical advice and recommendations for the clients. To gather more information on the potential of the project, select medical professionals and clients were interviewed and provided feedback on their experiences with other Medical Alert Devices (See Appendix).

With the provided feedback from the Consumer Interviews, it can be concluded that

As seen in Table 1, there are many competitors in a crowded market. However, this project provides a service that other Medical Alert companies do not and that is the tracking and recording of movements to determine whether or not a client is currently prone to a fall. This extra time given to the client through the use of our devices can be the difference between saving the lives of our clients or them suffering serious injury or death when compared to competing devices. This edge in the market will likely give favor to our project with the market and could potentially become a market leader in the industry. Promoting this edge in the market would be advantageous for the project to gain a foothold in the already crowded market and to potentially lure users from other devices.

Although the development phase for the CUA Medical Alert Device is still underway, it would be effective to preemptively consider the pricing for providing the service of the Medical Alert Device. Pricing the product versus the other participants in the market to remain competitive seems relatively simple. The average price per month for the medical alert companies in Table 1 is $23.25/month. The product and its services can be priced competitively at a range of $20/month (cheapest) to $24/month (slightly above average). It would be recommended to compete with “Mobile Help” ($20/month) as they provide many of the services the project would hope to provide at among the cheapest price for the compared medical alert companies above. Depending on how cheaply the devices and tracking algorithms can be developed and implemented and other costs considered, $20-$24/month should be the target cost charged for the project’s services, providing a competitive price while also maximizing revenues.

3.4 Financial/Investor Plan

 Due to still being in the early stages of development for the Medical Alert Device, it would be presently premature to determine a Financial/Investor Plan for the project. However, I can preemptively design a plan given the data present to me. The Biomedical Engineering research team requires funding to continue their development of their Medical Alert Device. When the team is ready to scale in size, a proper measurement of the required funding can be calculated given the costs of development and distribution. Given that the nature of the project may be software-based, it can be predicted that the costs of distribution will be lower compared to companies that manufacture and maintain hardware devices. Therefore, for investors, the potential to invest is enticing as the initial investment may not be as costly compared to other companies and the returns on investment can see exponential growth as the cost to scale software is much cheaper than to scale hardware devices. Potential investors that can be sought out can be Biomedical companies, venture capitalists, and potentially other Medical Alert Device companies that may want to incorporate the new technology into their already existing infrastructure.

4.1 “SWOT” Analysis

A SWOT analysis organizes and presents the Strengths, Weaknesses, Opportunities, and Threats for an organization and helps the organization assess their current situation and determine a strategy to move forward. Typically, Strengths and Weaknesses assess internal factors within the organization while Opportunities and Threats assess external factors outside of the organization.

The strengths of the project allow users access to an easily accessible device as the project hopes to develop software to be downloaded on to the client’s smartphone and tap into their cellular data capabilities and built in hardware to track the movements and detect falls in the user. This means that additional hardware is unnecessary for the user to wear or hold as it is assumed the smartphone will be on the user’s person, especially those knowing they are a fall-risk patient. Another strength would be the ease of use for the software, as it will have permissions to function and operate in the background of the smartphone, allowing the user to use the cellular device for other functions simultaneously with the primary function of the project. This feature does not inhibit the client the full function of their smartphone and may even operate during a voice or video call.

 A weakness of the project could be the potential loss of signal from the device, whether it be GPS, Wi-Fi, Cellular Data, or disruptions in the built-in Accelerometer. This disruption in signal could potentially cut off communication with monitors of the client and could pose a potential safety threat to the client and leave them vulnerable to a fall. A medical alert device requires non-stop monitoring for the safety of the clients and to ensure that no harm or injury can come to the client if communication is somehow interrupted. A factor that may affect communication to the monitoring centers can be loss of signal in an area that has poor data connections or a failure of the cellular towers in the area. Loss of Internet connection at the client’s residence may also sever communication to the monitoring centers.

 An opportunity of the project is the unique software capabilities on a 3^rd party devices, like smartphones. Most other Medical Alert Device companies develop their own devices to distribute to their customers. The implementation of software available for purchase on the appropriate application marketplace for smartphones allow for simple integration to a device that is assumed to be used throughout the day. Because of this potential, there is no need to manufacture or produce hardware for clients, saving the organization in manufacturing and distribution costs. These saving will give an opportunity to focus funds to other aspects of the organization to better serve their clientele more efficiently. Another opportunity for the project is the potential to introduce a new facet of Medical Alert Devices, in that the device being developed by the Biomedical Engineering team can track the client’s movements and distinguish whether or not the client is currently prone to a fall, depending on their erratic movements. While other companies do provide automatic fall detection, this project can offer preventative fall detection, a feature not yet seen in the market. The introduction of this new technology can eventually become the market standard, putting this project in a position as a market leader.

 A threat to the project is the entering of an already crowded market where there are numerous competitors to compete for members in a specific market. As seen in Table 1¸ many companies already own a share of the market and have established themselves with loyal customers. While this may be seen as a threat, the project’s potential to distinguish itself from the competitors in the market can shift this loyalty to the organization. Another threat to the project is the lack of a monitoring infrastructure that other companies possess. This requires dedicated manpower and facilities to monitor clients in case of injury and requires 24/7 monitoring to compete with other Medical Alert Device companies, an issue that the Biomedical Department team has not yet come across as they are still early in the development phase of their device.

Below is the 2×2 grid used to summarize the SWOT Analysis for the project.

Table 2      SWOT Analysis

 Using these analyses, it can be determined the exact position of where the Biomedical Engineering team is in their progress developing their medical alert device and the challenges they face in the future as they transition into providing their proposed services to their clients. That position can be concluded as one with vast potential, as the development of a new feature in movement tracking to predict falls has the ability to disrupt the current market and potentially become a new market standard.

5. Conclusion

 In conclusion, the Biomedical Engineering Department can utilize the business plan and SWOT Analysis prepared in this study to advance their research and to take the next step to providing their Medical Alert Device as a service to the people in need, namely the elderly and physically disabled. Given the nature of the device and its revolutionary technology in the market, the device being developed by the Biomedical Engineering team has the potential to disrupt the current market and eventually become a market leader in the industry. This type of disruptive entrance into the market translates into generated interest from potential investors to inject capital into the project, further developing the technology and the possibility to scale in its distribution, which ultimately meets the goals of the Biomedical Engineering research team to help those in need of constant monitoring and medical assistance should a fall occur.

Appendix

Customer/Medical Provider Interviews

To potential clients who already use a Medical Alert Device:

1. A Medical Alert Devices has positively affected my life.

Strongly Agree ——- Agree ——- Neutral ——- Disagree ——-Strongly Disagree

 5    4   3  2     1

2. Do you feel safer with a Medical Alert Device on when no one else is caring for you?

Strongly Agree ——- Agree ——- Neutral ——- Disagree ——-Strongly Disagree

 5    4   3  2     1

3. Your current Medical Alert Device is easy to use.
   Strongly Agree ——- Agree ——- Neutral ——- Disagree ——-Strongly Disagree

 5    4   3  2     1

4. Owning a Medical Alert Device allows you to be more independent.
   Strongly Agree ——- Agree ——- Neutral ——- Disagree ——-Strongly Disagree

 5    4   3  2     1

5. Would you recommend a Medical Alert Device to a friend or family member?

Strongly Agree ——- Agree ——- Neutral ——- Disagree ——-Strongly Disagree

 5    4   3  2     1

To medical professionals that can recommend Medical Alert Devices to patients

1. You often prescribe Medical Alert Devices to your patients that will likely benefit from them.
   Strongly Agree ——- Agree ——- Neutral ——- Disagree ——-Strongly Disagree

 5    4   3  2     1

2. You would recommend to a patient that may not “need” a Medical Alert Devices but still consider investing in one to ensure their safety.
   Strongly Agree ——- Agree ——- Neutral ——- Disagree ——-Strongly Disagree

 5    4   3  2    

3. Feedback you received from patients that you have recommended/prescribed Medical Alert Devices were they generally positive.
   Strongly Agree ——- Agree ——- Neutral ——- Disagree ——-Strongly Disagree

 5    4   3  2     1

4. You find that the Medical Alert Device industry is crowded and has many options for patients.
   Strongly Agree ——- Agree ——- Neutral ——- Disagree ——-Strongly Disagree

 5    4   3  2     1

5. You find Medical Alert Devices effective in their function of assisting patients when they are unable to assist themselves.
   Strongly Agree ——- Agree ——- Neutral ——- Disagree ——-Strongly Disagree

 5    4   3  2     1

References

1. Falls and Fall Injuries Among Adults Aged ≥65 Years. Bergen G, Stevens MR, Burns ER. United States, 2014.
2. Fall detection system using combination Accelerometer and Gyroscrope. Q.T. Huynh, U. Nguyen, S. Tran, A. Nabili, B.Q. Tran. 2013
3. “Personal Emergency Response System/Medical Alert System Market Analysis by Type (Landline, Mobile, Standalone), By End-use (Home-based Users, Nursing Homes, Assisted Living Facilities, Hospices), And Segment Forecasts, 2018 – 2025” Oct 2017. Grand View Research, Inc.
4. Wearable Devices as Facilitators, Not Drivers, of Health Behavior Change. M. Patel, D. Asch, K Volpp. 2015
5. SilverLink: Smart Home Health Monitoring for Senior Care. J. Chuang, L. Maimoon, S. Yu, H. Zhu, C. Nybroe, O. Hsiao, Shu-Hsing Li, H. Lu, and H. Chen. 2015
6. Monitoring of Vital Signs with Flexible and Wearable Medical Devices. Y. Khan, A. Ostfeld, C. Lochner, A. Pierre, and A. Arias. 2016
7. Purchasing and Using Personal Emergency Response Systems (PERS): how decisions are made by community-dwelling seniors in Canada. A McKenna, M. Kloseck, R. Crilly, J. Polgar. 2015
8. A smartphone-based fall detection system. S. Abbate, M. Avenuti, F. Bonatesta, G. Cola, P. Corsini, A. Vecchio. 2012
9. Fall Detection Devices and their Use with Older Adults: A Systematic Review. S. Chaudhuri, H. Thompson, G. Demiris. 2014
10. A survey on fall detection: Principles and approaches. M. Mubashir, L. Shao, L. Seed. 2013