A Proven Method to Invent Medical Devices: “Need Specification”

By Diane Dao and Jake Brenner, MD, PhD

When doctors think of invention, we think of the distinct moment when inspiration merges with need, discovery, and creation. In reality, the process of invention is like exercising any other “muscle” of the brain. Even though most doctors are not currently trained in innovation, the skills of invention can be taught.

All this starts with defining the need, which is the medical problem that needs a new solution. To find good needs to work on, do not simply ask practitioners in the field what are the problems, but instead, observe. The customer (physician) does not always correctly identify their own challenges, leading Henry Ford to once say, “If I asked my customers what they wanted, they would have said a faster horse.” Instead, observe patients, physicians, and other stakeholders to find the healthcare gaps demanding solutions.

After identifying a good need, the next task is to write a need statement, which is a sentence that concisely states the medical problem. The breadth of the need statement can determine whether an incremental solution or blue sky solution will develop.

Need specification is the next step in defining the attributes required to get to market and ultimately patients. The need specific is a short document which lists all the attributes a device must have in order to succeed in the market.  The attribute list includes clinical considerations, stakeholders, regulatory environment, competition, reimbursement structures, and the market. For example, how invasive should the procedure using my medical device be? Who will be administering the procedure? What are the expected clinical outcomes?  

It will be also important to consider FDA regulations, intellectual property, and patent laws while inventing. If there are competing medical devices, how will your device change or improve the market? In addition, reimbursement strategy will affect whether a medical device will be readily integrated into the health system. If a medical device is able to fit under an existing Current Procedural Terminology (CPT) code, the device will have a much easier time getting funding and quick market adoption. Defining the market will also help ensure that one’s device will reach a specific targeted population with a given need. While that population may change over time, the market will help make an initial case for the value of your device. After considering the need specifications, prototyping will help troubleshoot gaps and barriers to ensure success before scaling.

Every invention is hard to create, so investing in those ideas that have the best chance is crucial. If you do not have the right market size - which can be defined as patients affected times the severity - next steps will prove challenging down the road. Defining the technology gap will show which areas are available for improvement. Looking to current and past medical devices may provide some insightful wisdom on what has worked or failed in the past and why. Another classic method of inventing is “making a disease work for you,” such as solving fecal incontinence by looking at mechanisms of the opposite disease, constipation.  

We teach doctors how to think clinically about treating our patients. Why can’t we also teach doctors how to critically think about invention? Doctors are well positioned at the fulcrum between the patient bedside and health system.  Invention is not magic, but rather a series of logical and tangible steps to develop an idea to market to provide better solutions for patients. Think creatively, stay inquisitive, and have fun!

Diane Dao is a Candidate for Doctor of Medicine & Masters of Public Health at the Perelman School of Medicine at the University of Pennsylvania | dianedao@mail.med.upenn.edu

This post was adapted from a presentation by Jake Brenner, MD, PhD, Pulmonary & Critical Care Fellow, Hospital of the University of Pennsylvania

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