Pittsburgh CREATES was represented at the Eye & Ear Foundation’s April 23rd webinar, “An Engineer’s Perspective on Medical Innovation.” Co-Directors of CREATES, Peter Santa Maria, MD, PhD, and Carl Snyderman, MD, MBA, presented, along with CREATES’ lead engineer, Mohit Singhala, PhD.
Innovation
Dr. Singhala, Research Assistant Professor, described CREATES as “focused on improving the translational potential of the Pittsburgh healthcare ecosystem.” All three presenters have experience in this area. As an engineer, Dr. Singhala said it is important to know that an engineering solution is not always required when it comes to innovation. A lot of his more recent work has been trying to figure out how to improve workflows and have a greater impact on patients.
Dr. Snyderman, Professor, Departments of Otolaryngology-Head and Neck Surgery, Neurological Surgery, and Bioengineering, and Co-Director, UPMC Center for Skull Base Surgery, said innovation starts with everyday problems. Every day, he sees problems that need fixing; he recommended getting into the habit of viewing the world with open eyes and looking for problems. This is a skill that can be developed. He keeps a running list on his laptop and has about 30-40 folders of ideas waiting to be developed.
People who invent are naturally asking questions all the time. They ask, “Why?” and “What if?” They are never happy with the status quo. This curious kind of individual looks for opportunities and what people are doing in other areas. Often a different specialty has the same problem or has solved a similar problem in a different way; this knowledge can be brought back to your own specialty.
As an engineer, Dr. Singhala said nothing is assumed. This forces him to have a fresh perspective on a problem. He has learned to be grateful for the opportunity to talk to patients and shadow physicians. He makes sure he understands the problem before he thinks about how to solve it. A tool to use for this is coming up with a good set of criteria for what a solution should look like. Knowing when to step back is also a very important part of innovation. Just because Dr. Singhala has a background in engineering or robotics does not mean that every problem needs mechanical engineering or robotics.
How to Start
The model of developing a technology and then looking for an application is something referred to as tech push, said Dr. Santa Maria, Vice Chair of Clinical and Translational Research, Chief, Division of Otology/Neurotology, Professor, Department of Otolaryngology – Head & Neck Surgery, Director of Faculty Innovation, Office of Innovation and Entrepreneurship, and Director, SPARK Global. At Stanford BioDesign, he learned a different philosophy, which has now been tried, tested, and proven over the last couple of decades: starting with user research. This means immersion in the healthcare environment – not just the operating room and clinic, but in daily conversations with people. “That’s something we sometimes forget; healthcare is very universal,” he said. You want to make a good assessment of what providers and patients are struggling with and have this be the main guiding light.
Begin with the End in Mind
Bring in the human context, factor in health economics, and a target product profile. As an example, Dr. Santa Maria talked about chronic tympanic membrane (ear drum) perforation, a common problem that is the most common reason for hearing loss in the developing world. In his history of treating indigenous Australians, this was the highest incidence of chronic ear disease, with almost 50% of kids having it. In the U.S., it results in 170,000 surgeries a year, at almost $20,000 per surgery, which must be done under general anesthesia by a trained ENT surgeon.
A target patient profile, or a roadmap, would be to look for something topical that does not require surgery, anesthesia, or hospitalization.
Dr. Snyderman said we see lots of problems that do not require big solutions, so they never really get addressed because there is no market for them. One of the first questions he asks himself is, “Is this a big problem?” It may be a big problem for him but may not be one across his specialty or across medicine. If it is not a big problem, then it will be harder to get investors to support and therefore build a successful product. Another question he asks is, “Is it a practical solution?” There are a lot of problems that can be solved by throwing money at them, but they do not make economic sense. They might be very difficult to do and take decades. Dr. Snyderman looks for quick and easy solutions to his problems and asks, “Does it address a meaningful problem? Is there a market for it? Is it something people will use?”
Part of the CREATES system is to have a facility so physicians at the university (not just in ENT) can come armed with ideas and get help navigating the process. Trying to do it alone is a mistake. So is also trying to hold on to the idea for too long and not giving it up in a way that allows it to progress. The balance between sharing and not sharing is also difficult: you want to share your idea enough to get traction and help, but this can create anxiety because you don’t want companies to steal the ideas.
“All of us have so many ideas, but it’s the actual know-how of getting them executed that is the most important,” Dr. Santa Maria said.
Dr. Singhala has at least one such conversation weekly with a physician. One thing they have learned is that discipline is needed for translation, which means valuing your own time and effort. If a physician comes to him with an idea, he knows that person cares about innovation. It can be a good idea, but is it one they are willing to spend the next 5-7 years of their life bringing to fruition? Are there other problems that are also important? Which one should be attacked first? He teaches them how to objectively choose the problem to go after that has a good mix of market potential, patient impact, and satisfies the value signpost that the innovator has set for themselves.
Dr. Snyderman pointed out that all this takes a lot of effort. Most physicians are naïve about how much work it takes and how much time is expended getting a simple product to market. It cannot be done alone unless it is a full-time commitment.
Examples of value signposts include:
- Keep patients out of hospital
- Change care to less expensive area
- Shorten length of stay
- Reduce time or resource use
- Shift to a lower cost provider
- Reduce labor or number of interventions
- Earlier diagnosis, reduce complications, prevent progression
How to Make a Choice
Dr. Singhala uses filters to figure out what matters to him. Is patient impact important? If so, he creates an objective list. Does it affect 100,000 patients? A million? 10 million? Then he filters the level of impact it creates for a patient. Is there quality of life improvement? Morbidity improvement? Mortality reduction? He comes up with a set of 3-4 filters with objective ratings and then researches all the problems in his current ecosystem, doing the literature research to figure out what the problems solve. Some needs will naturally rise to the top because they have a good mix of all these factors.
The jam experiment is a good example of how choice overloads make consumers buy less. At a tasting booth for unusual jams at an upscale grocery store, A offered six jams, while B offered 24. What percentage of tasters later purchased one of the jams? Thirty percent purchased from A, while only 3% purchased from B. More information and choices increase the probability of success, but there is a limit.
Dr. Singhala often sees people are not receptive to feedback because they think it is a comment on the idea, as people are very protective of ideas. One concept being better than the other usually only leads to more friction than is needed, however. Realize your time is valuable. It is a matter of balancing the probabilities of success and resources you have at hand (i.e. time and money).
UPMC CREATES
If someone brings an idea to CREATES, these are things to consider:
- Unmet medical need
- Disease state/pathology – How and how often does the problem occur?
- Treatment options – What current solutions are available to address this problem? What are their strengths/weaknesses? What is the gap that the treatment options don’t currently meet?
- Stakeholders – Who are the people or groups of people who are involved in the problem? What is their perspective? How do they lessen/increase the problem? Will they be resistant to a new treatment?
- Market analysis – How many people have the problem? What are the health care costs associated with the problem or its treatment?
- Direct competitors
- Intellectual Property – any new emerging ideas that could compete with your product?
- Needs specification
Dr. Singhala likes to ask the fellows at CREATES to pick something they find innovative in their practice, think about how it reaches them, how much it might have cost, and how much it really improved standard of care.
Catalyzing Scientific Innovation with Design Thinking
These “conceptual collisions” mean applying known ideas from other disciplines and combine them in novel ways, expanding the problem to involve more experts than you think you need, consulting, and having an open exchange without hierarchy.
When it comes to innovation, key attributes are questioning, observation, networking, and experimentation.
Dr. Santa Maria pointed out that it is important to realize that you do not have to build the whole thing to test it. This is where engineers can help out. Dr. Singhala cautioned that an engineer might send you in the wrong direction. This is where you pick the right partners. Are you in service of the idea or are you in the service of patients? If you are in service of the idea, you will find an engineer or design firm to build your sketch. This is usually not the recommended pathway. If you are in service of the patient, then you work with a collaborator and discuss the actual pathophysiology – the why, why, why. Can you break down your problem? Open yourself up to brainstorming again. Park your idea on the side and give the problem the best shot. After that, if your idea still bubbles to the top and still seems like the best shot at translation, great.
The next steps are to establish proof of concept (device). When trying to describe your idea to others, come up with a “looks like” prototype. Then a “works like” prototype. This might cost a few hundred dollars to do. Then you get a homemade yet a little more sophisticated prototype to use in a hospital setting.
When Do I Stop?
How do you take the next step, or when do you know when to stop? How do you get people to take over or take on a co-developer role to go forward?
Dr. Snyderman said there are several avenues. If you are not ready to give up your day job and devote a lot of time to developing a company, hand over your idea to someone else so you can get a patent, and the university can shop it around and license to a company or startup. There are ways of getting your product out there without being directly involved, but you have to be able to sort of let go of it.
How much time do you have to pursue it? Since Dr. Snyderman is in the latter part of his clinical career, it is a good transition for him to invest more time in entrepreneurial activities. He hopes to continue to grow this part of his career and get more products on the market. “You never really stop,” he said. “You just look for different ways of getting it done.” He also brought up the option of partnering with an existing company.
Dr. Singhala said it is important to set strong milestones for yourself. Where do you see the project being at what point in time? If you are not achieving those, that might be a good indicator that you are spending time and resources you do not have. This is one of the hardest questions to answer because there will be a lot of struggles, which might compel you to stop. You have to resist this urge yet also have the confidence to stop when you know fundamentally that the project does not make sense.