As part of the Healing Innovation blog, we have been reaching out to physician inventors to learn how we can assist them in our tutorials and postings, connecting them with resources, as well as assessing their identified medical needs. In the process, we are realizing that many clinical innovators are more naïve than expected and don’t fully absorb the level of effort required to license a medical device idea to industry, never mind develop a medical device oneself.
A recent conversation with a young clinician with ideas for improving point of care diagnostic devices highlighted the voids in novice understanding. The epiphany of a better medical device is only the starting place for innovation. There are many steps from the starting line to licensing the idea and/or getting your new device into the clinic. But, before getting out of the starting gate, consider the following four “Don’ts”:
I. Don’t rush to create an invention when the problem statement is not well defined.
1) What are the current marketed devices limitations? Is your goal to save money, reduce time, or improve outcomes? Simply making a device more convenient or more comfortable for the patient will not necessarily lead to a marketable medical product unless you are lowering cost by allowing more patients to be treated in the same time period or the better outcomes lower cost (less medical follow-up, less medication, faster ambulation, fewer lost work days). Especially, with health care reform, unless a product will be paid directly by the patient and not insurance, you will need to demonstrate the economic benefit.
2) Does the culture of the hospital, clinic, or doctor’s office need to change to solve the problem? Although change may be needed for meaningful improvement to the system, it will be a higher wall to scale and the amount of effort is typically underestimated. The challenging reality is that doctors don’t like change.
3) Are you reducing pain or providing a new opportunity? Customers will run to relieve pain and tip toe towards opportunity. And, when we say customers, we mean medtech companies, physicians, insurance companies, patients, etc.
4) Has scientific data been published that supports your hypothesis for why the current device has insufficient outcomes? For example, if the diagnostic has too many false positives, do you have data that identifies the cause of the false positives? There is nothing worse than a great solution for a non-existent problem.
5) What must a successful solution include and what are the most desired features or outputs (weighted by impact on the product)?
II. Don’t rush to find collaborators before you have sufficiently documented your idea and you are protecting the confidential information.
1) Has your idea been documented in a bound notebook with sketches and drawings of various embodiments?
2) Can you sketch enabling features of your idea? If you cannot, then you probably do not have an invention.
2) Have you considered filing a provisional patent to put a stake in the ground with the US Patent & Trademark Office?
3) Do you have a standard nondisclosure agreement (NDA) that you are getting signed before disclosing your idea?
III. Don’t rush to find funding before you understand and have outlined the business case.
1) Do you know the following basic information: What is the cost of the market-leading product? How many of these devices are sold per year? How many patients are not treated but would be with the right device? Who pays for the device (insurance reimbursement)? Who are the likely acquirers of your product (i.e. the existing medtech players that distribute products to this specialty)?
2) What are the manufacturing cost targets? Are they feasible? Can your product be sold for less than the competition with 80% margins (i.e. selling price is 5x cost to manufacture)? In the very early stages, you may not have to know the precise answer, but if you are a magnitude off, then you are wasting your time.
3) What is your exit strategy? Are you looking to license the idea at an early stage or form a start-up company that takes the development to regulatory approval and potentially beyond? Licensing of an unproven concept is getting harder to do unless you are an opinion leader for a specific company and are working collaboratively as a consultant (i.e. it is the company’s product and you are solely a contributor).
IV. Don’t rush to approach MedTech companies until you have made a prototype.
1) Even the most basic mock-up of your concept will make the idea tangible.
2) There is an ocean between saying and doing. When you take action, you learn from the experience and can refine your concept.
OK. Now that you have addressed the easy stuff, you can start asking the hard questions: How do I find an engineer or scientist to help me develop early prototypes? How do I find other experts that can assist me with the regulatory nuances of testing my idea in the clinic? How do I get funding?
There are no stock answers to these questions that fit every situation. At a high level, the key is networking. Local universities, inventor groups, societies, medical device manufacturer conferences, LinkedIn and other Internet sites are opportunities to meet potential collaborators. And, find mentors that can connect you with experts and partners.
But, all the networking and hard work will be useless if you rush ahead without addressing the four don’ts outlined above.