Sonosolve, one of the teams in the Spring 2016 Penn I-Corps Site Accelerator, has been documenting their experience so far.
Catheters are used widely in medicine and surgery. Indwelling catheters may become colonized by bacteria through biofilm formation or obstructed with blood clots, proteinaceous debris, or other bodily contents requiring flushing and/or surgical replacement. Catheter-associated complications result in hospital-acquired and nosocomial infections, further surgical procedures, and additional time spent in the hospital or acute care setting. According to CDC data, catheter-associated infections alone amount to billions of dollars in healthcare spending annually. Aside from the costs, the morbidities include infections requiring antibiotics, sepsis, and even death. Furthermore, institutional quality measures and healthcare reimbursements are tied specifically to catheter-associated complications.
Technologies have been developed to address these issues. However, clinical adoption has been limited due to a lack of adaptability with current standards of care. These technologies are built into each catheter, making the cost of implementation prohibitive. Current capabilities do not include lysis of clots or proteinaceous debris. Unlike our device, existing technology can expose the patient to undesired effects within the patient given the application of energy throughout the catheter.
Using sound, a team of Neurosurgeons and Faculty in the Department of Bioengineering at the University of Pennsylvania has developed methods to agitate regions within a catheter without violating the sterility of the catheter’s interior. This allows users of this device to safely remove obstructing matter from an externally-draining catheter without having to flush it.
The device is hand-held, easy to use, external to the patient and tube system, and adaptable to a variety of externally-draining catheters. It applies energy to the lumen of the catheter housed outside of the patient and clears obstructions. These obstructions may be focal (such as with blood clots or proteinaceous debris) or diffuse (such as with bacterial biofilms). In this way, the device could be used in both acute settings and in a prophylactic manner to prevent bacterial colonization.
SonoSolve welcomes two new Entrepreneurial Leads (ELs) to investigate the commercial landscape and research potential markets around the stated innovation and intellectual property. The company seeks to get a jump-start on conducting market research on their product. Given the ease of use of the device, Identified customers include physicians, nurses, visiting nurses, and patients within both the inpatient and outpatient settings. Catheter blockage and the formation of biofilms within catheters may take place in healthcare settings where patients are treated acutely and exposed to pathogens. Physicians and nurses often encounter situations where they have to perform flushing procedures to eliminate obstructions. Antibiotics are given and catheters are replaced in the case of infections. Infections can be extremely severe resulting in further severe illness or death. Patients sometimes go home with catheters and therefore self-maintain them or are assisted by visiting nurses or healthcare providers on an outpatient basis.
A special segment of patients was initially identified with chronic indwelling urinary catheters. These patients may be at home, but are many times hospitalized in nursing or senior care facilities. These patients are often affected by infections, usually stemming from bacteria such as Proteus Mirabilis, Staph Epidermidis, and P Acnes. Bacterial biofilm formation has been implicated in these infections. Together with Drs. Thawani and Pisapia, we will provide further data regarding the utilization rates and rates of complication related to these and other catheters.
The next phase of our market research is to validate whether our predicted customer segments exist and whether our product will effectively provide solutions to this issue set forth. To do this, interview sessions will be planned with Physicians and Nurses at the Perelman School of Medicine (including the Hospital of the University of Pennsylvania, Pennsylvania Hospital, and the Children’s Hospital of Philadelphia). These accounts will give us a more informed view on the applicability and utility of our technology and product.
This week, we interviewed two neurosurgeons at the Hospital of University of Pennsylvania. They commented on EVD catheters as these are frequently used on the Neurosurgery service. Our interview results showed that physicians encounter blockages and infection in EVD catheters frequently. The traditional methods used in their practices include flushing or replacement of catheters. Flushing has been closely associated with infection. Replacing catheters is risky and can lead to additional morbidity as the procedure requires anesthesia. Another physician emphasized that the patients usually feel uncomfortable during the process of replacing external ventricular drain catheters. With acute obstructions, leakage can happen where the EVD catheter inserts into the patient – this leakage is also associated with infection based on current studies. Based on these two interviews, we conclude that there is a market need for a medical device to remove blockages and biofilms in EVD catheters. Feedback from the I-Corps workshop regarding our presentation encompassed getting more information on different types of catheters, determining whether they can be used to prevent infection themselves, understanding how frequently catheter types are used, further understanding the ability of the device to prevent infection prophylactically, understanding the frequency of catheter replacement/cost to replace catheters, figuring out what are the common practices in adopting new devices in hospital, and lastly, learning about the possible alternative commercialization potential of our product. We are looking to expand our scope and address the questions from the workshop in the upcoming week. We hope to find out that our product would provide a non-invasive method to eliminate biofilm formation and blockage in catheters for the physician and help reduce patient complications, save cost and time, reduce discomfort for the patients, and increase the quality of treatment.
Three interviews were conducted this week, two from nurse practitioners and one from a neurosurgeon. We were asking similar questions from last week in order to validate the need of the market for our product. In the process, we learned that the level of product interest depends on the hands-on experience the individual has in handling catheters. The two nurse practitioners were responsible for ordering catheters for bedside nurses to use, but do not handle catheters physically themselves. Additionally, they work at Pennsylvania Hospital, which has a smaller Neurosurgery practice (they do not have as many patients with EVDs). For that reason, they did not provide good insight during our interview and seemed to be disinterested. We have learned a lesson to selectively contact interviewees who most likely work with catheters or have a knowledge of difficulties in their use. This week, we better defined our customer segments which are composed of users (physicians, nurses, and patients), a payer (hospital administrator or purchaser), a regulator (government official, such as U.S. Food and Drug Administration), hospitals and clinics, and insurance companies. We will better define which segments are relevant based on further interviews. In order for us to be successful, it is critical that our product satisfies the needs of all relevant customers. To do this, we will create a value proposition for each of the customer segments and determine which values would benefit from our product. In this process, we would be able to identify important key features that our prototype should have to satisfy customers in the market. Comments from the workshop include issues addressing market assessment attributes and product attributes. Questions were raised regarding the need for an attached disposable to keep the device clean between uses. The team continues to perform market research to address these comments and discuss values of adding disposable features to the device in order for it to be used between patients. These are important factors for sterility.
Two interviews were conducted this week; one with a Urologist and one with a Nephrologist. We are wanted to develop perspective outside of neurosurgery. Although we found that there is a great need for a medical device to remove obstructions and biofilms from EVD catheters, other fields may have greater utility in terms of numbers and impact. Chronic indwelling urinary catheters are one such type of catheter. The nephrologist was discussing dialysis catheters to begin with. He mentioned that there are existing routine cleaning procedures that are performed for catheters used in his practice, including flushing with tissue plasminogen activator (TPA) and using Hep-locks. The method of flushing between uses is convenient, but expensive in the case of TPA. The medical device should be cost-effective compared to TPA cost in order to raise significant level of interest from the hospital administrator to purchase it from hospital’s use. Although the application to dialysis catheters does not seem fruitful given that the bodily fluid (blood) recirculates, the discussion was helpful. Chronic indwelling urinary catheters and peritoneal dialysis catheters may be useful. Peritoneal dialysis catheters are increasing in use, as patients prefer to manage their disease with less time required in the hospital or a dialysis center. This is an exciting possible catheter type that could be used. His insights also raised questions about whether our product can eliminate biofilm and clog in catheters with a significant length placed in patients’ body. The team is working to design an in vivo experiment to confirm the effectiveness of the prototype. This week’s workshop focused on local funding resources for start-up and intellectual property. The team gained essential characteristics of start-ups that the venture capital (VC) companies would like to invest in. We paid attention to some useful tips from four expert panelists from PWC, Ben Franklin Technology Partners, Osage University Partners, and Bioadvance. Their advice will help us in continuing to improve on our market research and product development to meet the specs of venture capitalists.
The team agreed to expand the scope of interviewees. We are reaching out to bedside nurses, nursing homes, and hospital administrators. We are eager to learn more about how to improve our product to satisfy our customers in the market. Additionally, we will spend more time performing market research, evaluating potential competitors along with estimating the potential cost of the product. The mentor this week suggested that we examined already patented technologies that may enter our market space currently. Additionally, he suggests a potential for us to expand a market into catheters used in veterinary hospital. After the workshop, we contacted multiple veterinarians at Ryan veterinary hospital in the hope to get more insights whether our technology can be applied in veterinary hospital as well.