Effective Evaluation of Innovative Opportunities in Interventional Radiology Using Johns Hopkins CBID Model

Introduction

Interventional radiology (IR) is a rapidly emerging specialty that uses image-guided technologies to provide minimally invasive intervention to treat diseases and conditions in patients. As the need for interventional radiology increases, new opportunities for innovation may become apparent and drive growth within this specialty.

It is important to have an effective and robust evaluation process to identify, screen, select and further develop these opportunities to improve equitable patient care and increase value (cost-efficient care that promotes the best outcomes). One proven method, that incorporates best-practices from industry, academia, and professional design firms is the model developed by the Johns Hopkins Center for Bioengineering and Design (CBID). ?Using the CBID Spiral Iterative 4-Quadrant Innovation Model (the CBID Design Model) the highest potential needs in IR can be identified, assessments made of solution landscapes, and actionable guidance generated for effective problem-solving.

CBID Spiral Iterative 4-Quadrant Innovation Model (the CBID Design Model)

The CBID Design Model is a process to identify and understand needs in a given space in a comprehensive manner. It is also a process that can screen many needs to identify the one with the highest potential for clinical impact and commercial success. The method requires the innovator to consider carefully examine issues in all 4 categories known to be essential for success: clinical (example: how much of a problem it is for healthcare workers, doctors, patients, providers), commercial ?(example: market size, competitive landscape willingness-2-pay), organizational /strategic (example: team and resources needed, partners, company strategy alignment)), and technical ?(example: technically feasibility to solve problem, can problem be solved using existing science and technology). ?For this project, the method was applied in two iterations in increasing depth to identify a pressing unmet need in IR that has strong potential for clinical impact and commercial success.

Model Iteration 1 and 2

The first iteration analyzed 30+ need statements generated through primary and secondary sources, as seen in figure 1. Secondary sources consisted of scientific papers, implicitly and explicitly, stating unmet areas that require some novel solution. The remaining statements came from primary sources, which were the interviews done with the interventional radiologists. Through the utilization of the “5 Whys” method during the interviews, which is a series of “why-based” questions, the need statement can be uncovered that focuses not just on solving a symptom of the problem but the root cause of the problem. This analysis is often referred to as “root cause analysis”.? Once all need statements were compiled, each one underwent scrutiny through the lens of the 4Q model. A three-color coded system was used to provide ratings for each: green represented high significance/feasibility, yellow represented moderate significance/feasibility, and red represented low significance/feasibility. The first iteration using the method screened down the list to four main need statements with the highest ratings:

• Need Statement 1 (Biliary Drainage Removal): Interventional Radiologists need a more effective way to prevent the occurrence of peri-catheter leakage in patients with biliary drainage catheters.
• Need Statement 2 (Portal Hypertension): Hepatologists need a better way to monitor for portal hypertension non-invasively in liver cirrhosis patients to reduce complications/comorbidities.
• Need Statement 3 (Pediatric Clot Removal): Pediatric interventional radiologists need a better way to remove blood clots located in pulmonary vessels for pediatric patients suffering from pulmonary embolisms.
• Need Statement 4 (Pediatric Embolization): Pediatric neurointerventional radiologists need a better way to prevent blood flow in blood vessels located in the brain for pediatric patients suffering from arteriovenous malformations.

The second iteration of the model went into greater details for the four main categories to further reduce the list from four to one. The assessment of the need statements remained similar however a numerical system was used instead to rate the categories:

• 1 = Very low significance/feasibility
• 2 = Low significance/feasibility
• 3 = Moderate significance/feasibility
• 4 = High significance/feasibility
• 5 = Very high significance/feasibility

After completing the second iteration, the final need statement selected was the pediatric clot removal.

Pediatric Devices Landscape

There has been a strong push to develop medical devices that caters to the pediatric population, according to the US Food and Drug Administration. Many medical devices currently in the market are not well suited for children, as only 24% of medical devices developed within the last decade are indicated for pediatric uses[1]. There are many reasons that contribute to the lack of device development, but the main ones are difficulty designing around children who are rapidly growing and issues having children participate in clinical trials. However, with these difficulties there is still a need for pediatric devices, evident in the Pediatric Device Consortium created by the FDA. This consortium is dedicated in satisfying the unmet needs in pediatrics and has also pledged to allot $1 million to encourage safe and effective clinical trials. The development of this initiative highlights the dire need for innovation focusing on children, proving the significance of finding a solution to children suffering from pulmonary embolisms.

Current Solution Landscape

Currently, the main competitors in treating PE are the following: Inari Medical FlowTriever, Penumbra INDIGO System, and AngioDynamics AngioVac. These three devices offer unique solutions in removing clots within the pulmonary vasculature. The CBID Spiral Iterative 4-Quadrant Innovation Model evaluated each device based on its clinical, commercial, and organizational significance as well as its technical feasibility as seen in table 1. Concerning clinical significance, the FlowTriever thrombectomy system exhibited the best ranking due to having no major adverse events during their clinical study (FLARE) and having a wider range of patients treated with their device. However, the FlowTriever, along with the other devices, fail to test their efficacy on age group below the age of 18, neglecting the entire pediatric population group. Commercial significance was determined by how many patents protect the thrombectomy system as well as its 510k FDA clearance indicator. Again, the FlowTriever proved to be the most formidable in this space with 15 patents surrounding the device and having a 510k FDA clearance for it to be used for pulmonary embolism, the first thrombectomy system to get this indication as well as the only one in this list. This give them a competitive advantage by being more credible as a treatment option for PE compared to other devices. Technical feasibility was close between the INDIGO system and the FlowTriever. The former, even though it relies solely on aspiration and does not have a clear and obvious way of returning blood back to the patient, can use catheter sizes as small as 8F, compared to the large sizes seen for the FlowTriever (16F, 20F, 24F). FlowTriever however has a component called the FlowSaver that can return blood back to the patients, greatly reducing blood loss during the procedure. It also contains a catheter that offers better trackability within a tortuous anatomy like the pulmonary vasculature. Regardless, the blood loss issue seen in INDIGO and the relatively large catheter sizes seen in FlowTriever prevent them both from being viable options for the pediatric population. Lastly, organizational significance was determined by the various types of investors in the companies and some notable institutional shareholders. The more reputable the shareholders are and the size of their stake within the company is gives the company more credibility and may instill more confidence in other investors to join. Currently, Penumbra has the highest ranking in this space due to having a couple of notable shareholders, such as BlackRock and Vanguard, investing hundreds of million dollars to the company. This is a strong indicator that the sentiment for the company is generally positive and that they are still growing.

Future Considerations

It is clear that there is a need for a device that can better remove clots in pediatric pulmonary vasculature based on the CBID Spiral Iterative 4-Quadrant Innovation Model. This realization asserts the need to begin looking into brainstorming solution concepts that solves the problem. The final goals would be to select the best solution concept, begin CAD drawings and prototyping, and perform a final assessment looking at the risk and feasibility of putting a device of this nature into the market. Achieving these goals would be great progress in ultimately helping children suffering from pulmonary embolisms.

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