Jayne: I am absolutely thrilled to be here. We will be talking about the role of the rehabilitation professional, OT especially, and the path to getting assistive technology to market. It is an iterative path, which means that there are specific stages with outcomes all the way to market. There is a necessary step of integrating user needs into product development, and that is not a step to be taken lightly. I think another aspect of getting products to market that OTs tend to shy away from are the business aspects. These are all things that we will go over today. I want to disclose that I am the owner of Eve-n-Sol, which is a company that has brought the AquaEve urinal to market. I do not have any financial participation in the other products or services mentioned in this presentation.
Introduction
To put this in perspective, I want you to think about these three questions. Have you...
- had an individual client’s situation not met by current products on the market?
- made an item or an insightful change so that a product works for your client?
- thought about all the individuals who could benefit from the same?
I would like you to think about your skills as an OT in creating and adapting products. Could that be scaled? Could you get it to market? How do you get it to market? During this presentation, I am going to use my example of getting a product to market. I also want to look at the role of OT and how I see that it overlaps in this area. We will look at a problem that I was attempting to solve, how I developed my product, and the business models I used or wish I had used.
Entrepreneurship
Entrepreneurship gets a bad rap. In 2013, a 40% product failure rate was found (Castellion & Markham, 2013). While this rate is high, there may be certain factors that feed into that that we will explore. Data also may be skewed as businesses are a little remiss in discussing their failures. As a rehabilitation professional, we have an advantage. If you look at the literature on medical products, the failure rate is actually less than 40%, and I think that might be because the standard and the barriers to entry are so high in the medical profession. As occupational therapists, we use critical thinking and have experience in developing products, and I think that gives us a very distinct advantage. We look at evidence-based information, and we add that to our intervention skills. We are used to looking at data and integrating it into practice. These are the same skills that we may use to develop a prototype as well. We are already using this thinking process.
Entrepreneur
Who is an entrepreneur? It is defined as one who organizes, manages, and assumes the risk of a business or enterprise (Merriam-Webster Dictionary, 2017). The key is that there is risk involved. People can mitigate that risk by using certain procedures that I will share with you today. Additionally, having a business is necessary to bring the product to your customers.
Intrapreneur
There is a relatively new concept out there called intrapreneur. This is someone who has the business support or structure around them. An example would be somebody within a company that is putting out a new product. This person may be in charge of the budgeting, prototyping, beta testing, and all the gamut of bringing the product or service to market. The difference is that they have the financial support, but they are a salaried employee. In this case, they do not typically have the same financial risk.
Socialpreneur
Another form of entrepreneurship is a socialpreneur. I think this is very fitting for occupational therapists because socialpreneurs have a social impact goal in mind. These are individuals who are not necessarily focused on the product end of the service, but they are looking at the outcome. They are also not looking at making money per se, although they do have a long-term goal in mind, and this usually takes money. Socialpreneur is a subtype of entrepreneur (Sastre-Castillo, Peris-Ortiz, Danvila-Del Valle, 2012).
- Social impact goal
- Less of a financial goal focus
- Usually a program
As a socialpreneur, you have to have all the skills of an entrepreneur.
Entrepreneur Traits
- Strong Attributes
- Specific skills, knowledge
- Perseverance
- Positive relationship traits
- Foster
- Imagination
- Creativity
- Innovation
An entrepreneur has to have strong, specific skills and knowledge. Perseverance is another important trait. This feeds back into that 40% fail rate. The literature shows that they fail because they run out of runway or money. It takes x amount of time and dollars to get a product to market. Even if it is a great product, if they do not have the money to keep going, it is not going to happen. And, that is considered a failure. However, had they had more resources available, they might have made it. Having the ability to develop positive relationships is very important. You cannot do this alone. Our American culture is a cowboy culture. Everybody is used to doing it themselves. Alexander Graham Bell did not do it by himself. If you can foster those relationships, it will be a lot easier. Entrepreneurs also foster imagination, creativity, and innovation. It takes all those traits to be an entrepreneur, but also an inventor. There is a differentiation there. An inventor is someone who invents a workable idea, and then the entrepreneur is the one who brings it to market. You can be both.
Potential Pathway
One potential pathway to get a product to market, that I wish I had known, is from the Center on Knowledge Translation for Technology Transfer. It is a great resource sponsored by the University of Buffalo. They have a model specifically geared to bringing rehab products to market. They get federal grant monies as well. I have a link to their website in a later slide. If you need more information, you can email me.
Networking
- Professional associations
- Learn from others
- Team with others
- Other professions: High Tech Rochester
Networking is important very early on. If you want to learn how to do something outside of your current skill set, you probably take continuing ed courses, like this one. Another way to network is through professional associations as they are connected to businesses that bring products to market. For example, I joined High Tech Rochester. It is an "incubator" that brings infant businesses to sustainability. It has a conglomeration of resources that are there to support your business and help it to grow. One event they have is called a pre-seed workshop. Anyone can show up, and they give you a support team. I was there with a medical device product so they connected me with someone who had already brought similar medical products to market. A few students also joined my team because the local universities are also involved. I was able to access some technical support as well. We went through a two-day workshop where mentors and experts helped guide us through this program of developing our ideas along with a business plan. A panel of judges then gave us a thumbs up or thumbs down if we were ready to take it to the next step. There may be opportunities in your own back yard, and the internet is a way to find these resources.
Need to Knowledge Model
The Need to Knowledge Model, which is out of the University of Buffalo, focuses on an operational framework for knowledge translation all the way to technology transfer (Lane & Flagg, 2009).
1) Scientific Research methods generate Conceptual Discovery
2) Engineering Development methods generate Prototype Invention
3) Industrial Production methods generate Commercial Innovation
Their focus is to help researchers who are creating something or studying something. They looked at best practices and at the research and came up with a framework that has been able to help get products to market. The first step is that scientific research methods generate conceptual discovery. The next step in the model is to go to engineering to develop your prototype. Finally, you partner with industrial and commercial people like manufacturers and companies to distribute your product. You plan all of these steps ahead of time to get buy-in and information. For example, when I was developing a female urinal, I should have gone to distributors before I put a lot of money into developing the product to see if they were interested in the concept, would help to finance it, and would be open to distributing it. At this point, you may be thinking, "If I share my idea, they might take it." We will touch upon this a little bit later.
Knowledge Exchange Process
Knowledge has to be translated from your concept all the way to adding value. How do you communicate your value-add? Think of your daily practice. We are pretty good at this. When a client does not understand the value that we are trying to add, we figure out a different way of presenting it or use a different intervention or technique for success. It is kind of the same thing here. There has to be some clinical problem solving here. The technology transfer is where you are shifting the ownership and control of the prototype interventions so there is a shared ownership along this process. For this knowledge exchange process to be complete, there has to be a commercial transaction, and that is where ownership of the finished goods and services is exchanged for monetary compensation. Occupational therapy professionals are very social-minded and are giving and caring people. We are not really usually as interested in money, but this needs to happen to fuel the development of the product to be successful.
My Journey
I now want to put a face on some of that information by telling you about my journey. By doing so, perhaps I can save you some of the pitfalls that I had.
- Identification and verification of an unmet need
- My experience
- Personal
- Professional
- Nurse feedback
- Bedside practice
- Specialty rounding team
- Evidence needed
Women who are bed bound do not have adequate urination choices. When I was in high school, I had a slipped femoral epiphysis repaired. I had two pins in my hip, and I wanted to get out of bed to go to the bathroom. It was very painful to shift my hips over to the edge of the bed, and the nurse was helping me. She let go of my legs to catch the crutches that were falling. When she dropped my legs, I screamed. She lifted my legs back into bed, and I screamed again. Subsequently, I was rolled onto a bedpan. It was horrible. A therapist came and showed me how to get out bed pain-free and safely. My takeaway was to become an OT. Many years later, I still see clients being rolled onto a bedpan when they are perfectly continent. This impacted me both personally and professionally. I went to see nurses and rounding teams to get their input. I also started to look at the evidence to see if others were also seeing this need. Figure 1 shows the current options.
Figure 1. Current bedpan options.
On the left is a traditional bedpan. When you urinate, the urine runs down your body and into the pan. You then have to be rolled, and that is then slid out. Sometimes, it spills. On the right, we have the Millie, by Viscot. That is a feminized looking urinal. The little handle is very petite, but it has a wider mouth or inlet area than a regular urinal. I think the designers were thinking that the area in the female anatomy is a larger area so they had to make it bigger to catch the urine. However, it actually does not work very well for bed bound women who are in a supine position. You can tell that the shape of the urinal is slanted upward. You have to push that inlet opening low toward the bed. You can then urinate about a tablespoon full before you have to defy gravity and pee upward into the rest of the vessel. In my hospital, it is used for men who are swollen or for people who are standing up. This was some of my anecdotal evidence.
Initial Concept Ideation
Next, I started looking at the research on female urinals. Mary Fader has done a little bit (Fader et al.,1999). There were also some interesting urinals discussed in 2000, and one was a pump prototype (Tinnion & Jowitt, 2000). Additional research on urinals was completed by Newman, Fader & Bliss, 2004 and Macaulay et al., 2007, but little has been done since.
Defining the Problem
- Similar products on the market
- Product comparison chart
- Impact of current status: bedpans, diapers, indwelling catheters
Defining the problem includes looking at other products on the market besides what is in your own backyard. It is also a good idea to make a product comparison chart. I looked at all the features that were important to me, and looked at the current status. What was going on with customers? It is a good idea to look at the "who, what, and why." This is a good resource. Who is the customer? Who is buying your product? Is it the end user? Is it someone in bed, in a hospital, a skilled nursing facility, at home? Are they different? It might be the nurse leader or someone else. You have to think about what the value is to that person who is purchasing the product. It can be a very different need than I had as a teenager. Other things to consider are:
- Impact and influence of unmet need
- Potential impact of the product
- Know your customer
- Value
- What they will pay
- Stakeholders
Scoping
Scoping is a term that outlines what we specifically do to look at our area of concern.
- Standard of care
- Culture
- Regulation
Was the current standard of care adequate? Were there any concerns? The current standard of care for bed bound women is rolling them onto bedpans or putting them in diapers. This is for women that are continent. Is there any impetus to change? Looking at the culture, are women speaking out? Is this a problem of convenience, or are there other issues associated with it? The regulation became a big concern. We cannot experiment with clients or introduce new products without going through the proper regulatory steps of the FDA or the institution.
Potential Impact: Facilities
- Staff for micturition
- Hospital-acquired infection
- UTI
- ICAD
- Patient satisfaction
- Higher discharge independence
- Reduce cost of care
- Falls
