Group 2, Senior Design, Spring 2020 - Clinical Problem and Target Market

Clinical Problem and Target Market

Need Statement

Medical trainees are trained for ultrasound-guided hip injections by practicing on patients, which risks discomfort if not done properly, using a cadaver, which is expensive and less accessible, and using models that have no substantial method of providing feedback to the user [1, 2]. Current models lack real-time feedback and require a physician present for training.

There exists a need to develop an ultrasound-compatible hip injection model that provides the user feedback.

Clinical Overview

The most common form of hip arthritis, osteoarthritis, occurs at relatively high rates in older individuals. 10% of men and 13% of women aged 60 or older have symptomatic osteoarthritis [3]. In addition, as one in four people could be at risk of developing osteoarthritis during their lifetime [4].

Currently, it is estimated 108 million hip injections take place annually [*]. The cost of a single hip injection is generally $100 to $300 in addition to costs from the visit itself. Patients that receive hip injections generally have multiple done per year because the pain relief only lasts a few months. The number of injections is generally limited to three to four per year in order to avoid excessive damage to cartilage [5].

Ultrasound-guided corticosteroid hip injections is one way to treat pain from osteoarthritis. In this procedure, an ultrasound probe is used to locate the target of the injection, the femoral head-neck junction. Figure 1 shows the anatomy of the hip . A 20-gauge 3.5 inch spinal needle is then guided by ultrasound to the target, followed by injection of the anesthetic [6]. Figure 2 below shows how the procedure is performed.

This procedure requires the clinician to use both hands to control the ultrasound probe and the needle. Proper hand-eye coordination is also needed to ensure the needle is guided to the correct location without damaging nearby nerves, blood vessels, and other anatomical features. Therefore, there is a high need for gaining hands on experience prior to performing the procedure. While there are multiple training methods currently available, they can be expensive, cause patient discomfort, and require a physician to be present.

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[*] Based on an estimate of 27 million osteoarthritis patients that each receive 3 to 4 injections per year [7, 8].

Figure 1: Anatomy of the hip joint [9]

Figure 2: Ultrasound (left) is used to guide the needle insertion (right). In the ultrasound image, (1) is the needle tip and (2) is the femoral neck. [6]

Problems with Current Solutions

Simulation Models

Extremely expensive (such as Blue Phantom Femoral Vascular Access and Regional Anesthesia Ultrasound Training Model) [10]
Not ultrasound-compatible (like Sawbones Hip Injection model) [11]
Do not survive multiple used of ultrasound gel [2]
Require trained physician to be present [1, 2]

Bovine and Human Cadavers

Expensive [2]
Not easily accessible [2]
Do not survive multiple injections [2]
Require trained physician to be present [1, 2]

Practicing on Patients

Can cause discomfort if not performed properly, especially when multiple injections are required [1, 2]
Exposes patients to unnecessary risk of hitting important anatomical structures and infection [1, 2]
Require trained physician to be present [1, 2]

Summary:

There exists a need to develop a cost-effective, ultrasound-compatible hip injection model with substantial feedback.

Target Market

This device will be marketed to medical hospitals and institutions that train students on hip injections.

Market Size Calculation

This device will be marketed to medical hospitals and institutions that train students on hip injections. There were 25,955 medical school graduates in 2018 [12]. About ⅕ of these students are trained on hip injections [13]. The average physician is paid $98.80 an hour. Training costs include the cost to perform an injection on a patient, purchasing a cadaver hip or simulation model or attending a training seminar. A patient hip injection is roughly $200. According to Dr. Oberstar, the cost of a cadaver hip is about $230 [2]. Training seminars cost a medical student about $2000. Current simulation models cost between $500 and $4000. Market analysis will use $2000 as the cost per model. A 2017 study in Brazil found that 8 practice sessions on a model was safe enough to start practicing fluoroscopy-guided facet joint injections on patients without risk of complications [14]. Dr. Konia noted individual students vary significantly in the number of practice sessions they need to be proficient [1] . 10 injections will be used as the number of attempts needed to become proficient. It is assumed it will take a physician at least one hour to train a student on the procedure.

If medical students practice these injections only on patients, then the annual cost for training will be,

(25,955 students)*(⅕)*(10 attempts for proficiency for each student)*($200 per injection)+(25,955 students)*(⅕)*(1 hour per student)*($98.80 physician cost per hour) = $10,894,870

If we assume medical students only train on cadavers and that each cadaver hip can be used twice (for one injection on each hip), then the cost of purchasing cadaver hips for training is,

(25,955 students)*(⅕)*(10 attempts for proficiency for each student)/(2 attempts per hip)*($230 per hip)+(25,955 students)*(⅕)*(1 hour per student)*($98.80 physician cost per hour) = $1,882,520

If we assume medical students would only train through a training seminar, then the annual cost for training will be,

(25,955 students)*(⅕)*($2000 per training seminar)+(25,955 students)*(⅕)*(1 hour per student)*($98.80 physician cost per hour) = $10,894,870

If we assume the average model can be used by 10 students before replacing, the annual cost if training was completed by simulation models alone would be,

(25,955 students)*(⅕)*(1/10)*($2000 per model)+(25,955 students)*(⅕)*(1 hour per student)*($98.80 physician cost per hour) = $1,551,070

Both companies of simulation models were contacted for their annual sales data but they were unable to provide this. The exact percentages of each training method is unknown so for a rough estimate 25% usage for each method was used. The market size will be the average of these four calculations. Therefore, the current market generates $6.3 million annually.

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