Nowhere is the opportunity to innovate as inviting as in the field of medicine, and no specialty has been as productive in the development of new technologies as cardiology. Because heart disease remains the most common cause of death in developed economies such as the United States (and is a growing threat in middle and low-income countries around the world), new developments in cardiology can affect an especially large population and have a tremendous impact. Advances in our understanding of human physiology, genetics, and molecular biology continue to define the fundamental mechanisms responsible for disease. Through these insights, we gain new perspectives and tools with which to create novel solutions. Regardless of the specific clinical problem to be solved, a common innovation process can be applied. It is this basic approach for creating new medical technologies that we hope to convey within this chapter.

Even though there are many revisions in the latest version of this book, we kept this chapter essentially intact from the first edition. This is because the skills required to innovate are enduring. They are typically not taught in medical school, yet they have been critical to the advancement of interventional cardiology. It has been difficult for people in medicine to learn formal principles of innovation, as they are usually taught only in engineering programs. However, this trend has begun to change, and numerous medical training programs have begun offering curricula targeted at this very issue. As history has demonstrated many times, clinicians and scientists make very good innovators. Although it is important for engineers to be skilled in the fundamental principles of innovation, clinicians and scientists have an essential role to play during the early stages of the innovation process (need finding and concept creation) and, as a result, they should learn these skills so they can participate fully in the important interdisciplinary work of creating new medical technologies.

Developing a new medical technology is a rewarding but often arduous process. The greatest success comes to those who understand the many necessary steps in the innovation process and can plan and execute a strategy to address each one efficiently and effectively.

Innovation is defined as the process of creating something new. As developers of a medical technology, we seek to address a real clinical need with the goal of not only creating something new, but also creating something better and/or more cost effective. The basic process of focused innovation is very simple and is summarized in Figure 75-1.

Although the innovation process is one that may be used by someone new to a field (top orange arrow), you may enter this process at any stage (orange arrows). In general, it is best to run this process rigorously from beginning to end without skipping steps to avoid the biases that come with arriving at a solution too soon. Regardless of where you enter, awareness of all steps and sensitivity to the need for iteration (blue arrows) can further improve on a good initial idea. As such, each step is briefly described below.

Step 1: Objective Definition

Starting with a clearly defined objective is critically important to keep you on the path to focused innovation. Being focused can prevent wasting time and energy on creative but tangential ideas that do not meet the intended objective. A well-defined objective limits one’s focus to a reasonably sized clinical area where the application of time, research, and creative energy is likely to yield a real outcome. An objective contains the general need area being addressed plus any goals or constraints such as a time horizon or resources that will be required (eg, to enable a significant incremental advancement in mitral valve repair within a 5-year timeframe). It is a good idea to write down this goal and refer back to it occasionally as a project takes shape so that the objective becomes a mission statement for the project. In some cases, it may become clear during the development of the project that the overall goal must change.

Although focus, at any one time, on a single objective is ideal, it is also important to engage people with different backgrounds in your investigation. Medicine itself is a broad field in which an in-depth understanding of different disciplines (eg, anatomy, physiology, pathophysiology) is required to understand a problem and arrive at meaningful solutions. However, a mastery of other fields (eg, physics, electronics, engineering, mechanics) and how they may be applied to solve medical problems can yield some of the most novel inventions with greater impact. For these reasons, the ideal team is a multidisciplinary one that is diverse but remains focused on the defined objective.

Another advantage of defining an objective at the start of the innovation sequence is a practical one—in general, innovators work best within a defined area of expertise. Although there are examples of wildly creative individuals^1,2 whose inventions span many disciplines and technologies, it is difficult with this type of approach to develop the depth necessary to reliably generate significant advances in medicine. More commonly, this broad style of inventorship results in patents that lie in wait for science to catch up to what has been proposed (“submarine patents”). This approach can be financially rewarding in some situations, but generally does not provide an effective pathway to technology innovation.

Step 2: Need Finding and Identification

Most successful medical technology inventors would say that identifying an important clinical need is the single most essential step in the innovation process. Clinical needs can be identified in many different ways. Often they are recognized by a clinician involved in patient care when a frustrated physician wishes for a better solution to a clinical problem (eg, “if only we could have repaired this mitral valve with a less invasive approach, sparing the patient major surgery”). Needs can also be recognized by those who are not within the field of medicine, or by those who are actively seeking unmet clinical needs (eg, an entrepreneur). Such an intentional innovator must do exhaustive research and observation to evaluate a clinical problem and all existing solutions to it, carefully understanding the strengths and limitations of each. Here again, it is often helpful to involve people of different backgrounds who may not have the biases of an expert deeply entrenched in the conventions of a particular specialty. An outsider to the field is likely to question even the most basic of assumptions and may uncover a true need that is not apparent, even to the specialist (latent needs).³ Finding clinical needs is a fundamental skill that improves with experience. Some of the most notable innovators in cardiology have demonstrated their abilities as serial need finders (Dotter, Simpson, Fogarty; see Chapter 74).

The characteristics of a “good” need depend on personal and professional objectives. If one were to have the opportunity to choose from an array of needs, the magnitude of the potential patient outcome benefit and the size of the available market/population would certainly top the list of considerations. Although one could list many other factors, such as accessibility of the market, reimbursement, or regulatory environment, having a burning passion for the need is probably the single most important factor for success.

Once a need area has been identified, it is critically important to precisely define the need by producing a need statement. A need statement can be deceptively simple: It is a one-line description of the clinical problem, stated as clearly as possible. Each need statement must explicitly identify the problem that requires solving, the patient population that it most directly affects, and desired outcome that population wants from a new solution. Although at first it seems like an unnecessarily formal exercise to write down a need statement, it is an absolutely essential step to really understanding the need and communicating it effectively to others. Following are some examples of need statements from interventional cardiology:

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  A less invasive approach to reduce mitral regurgitation in patients with congestive heart failure that enables patients who are poor surgical candidates to be eligible for the therapy.

  
  
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  A better technique for directing a guide wire safely and efficiently across a chronic total occlusion that allows a single operator to access 90% of CTOs within 30 minutes.

  
  
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  A minimally invasive method for restoring myocardial contractile function after myocardial infarction to prevent clinical heart failure.

It is important to differentiate carefully between needs and solutions, and focus on understanding the clinical need first. This includes paying close attention to the way in which the need and its attributes are described, as embedding a solution within the need statement can substantially narrow or bias subsequent steps in the innovation process. For example, the statement “The need for a more torqueable Teflon catheter to perform balloon angioplasty…” is heavily biased. Solutions to this need would clearly be restricted to catheter-based solutions and those using Teflon materials. More importantly, these solutions would exclude superior concepts that employ something besides a catheter. It is also a useful technique to write multiple versions of the need statement that both focus more narrowly on the central problem and/or the size of the population, as well as zoom back from them (called need scoping). The result should be a set of need statements that clearly outlines variations of the clinical problem and population, and suggest several pathways for creative improvement. An example of a narrowly focused need statement might be: “A way to prevent smooth muscle cell migration in response to stenting…”; whereas a more broadly scoped need statement may read more like: “A better way to prevent restenosis after stenting….” Finding the appropriate level of specificity of a need may take some time, and brainstorming at every level can be a very useful exercise. The most productive level of focus usually becomes clear only later, once solutions have been proposed and fertile ground for invention has been exposed.

Step 3: Need Validation and Screening

Once you have identified one or more unmet clinical needs, the need validation process begins. In this step, you must verify that the needs you found are indeed experienced by others. It is also important to characterize the features required of an ideal solution that would motivate key stakeholders to potentially change their behavior and adopt it. We call these characteristics need criteria. There are two types of need criteria—must-haves and nice-to-haves. Both types stem from your in-depth need research and should be objectively defined based on what matters most to the affected stakeholders. This includes parameters defined by the patient (eg, risk-benefit, comfort, efficacy, fit), physician (eg, ease of use, complications), hospital (eg, cost tolerance), payer (eg, cost versus future cost savings), as well as other stakeholders. With this constellation of information, the process of needs screening may now begin. The goal of this process is to identify objectively the most optimal need to be addressed, given the criteria developed during need finding and validation. One method is to define categories such as magnitude of patient impact, efficacy (or lack thereof) of existing solutions, etc., create a ranking system, and then allow the needs under consideration to “compete” against one another. A spreadsheet or database can simplify your assessment and enable you to make rapid updates as new information becomes available. Ultimately, your goal is to choose a single need to take forward that represents the best all-around opportunity for innovation.

Step 4: Concept Creation

With need validation and screening completed, it is time to create potential solutions. This stage of the process is widely misunderstood. The popular model for the concept creation process is some mystical “aha” by the lone, brilliant inventor. In fact, brainstorming is best done with a team. Selecting the right people to brainstorm with is one of the key determinants of success. Generally, such people should be highly creative, cooperative, and experienced in the technical and/or clinical area of interest. The team members should understand that they may be helping create some new intellectual property that may ultimately be of financial value, but that the brainstorming stage is only a small part of the process of invention, which includes the substantial work of need finding, verification, and specification that occurs before it.

There are several rules for successful brainstorming.⁴ Perhaps most important is that the participants should create a positive session that encourages open thinking and wild ideas. Critical comments and judgment should be held back until later in the process. Participants should build on the ideas of others; the collective strength of the team carries it much further than any individual can alone. Another important tip is to have the group focus on generating as many ideas as possible, regardless of how unrealistic they may seem; the goal at this stage is quantity over quality. A typical 60- or 90-minute brainstorming session should generate as many as a hundred or more different ideas, which may be grouped in clusters of concepts. Some groups like to use concept mapping techniques to record the branching pattern of new idea creation visually. It is certainly helpful to have a large whiteboard or other writing surface and encourage participants to draw their concepts. It may even be useful to have some materials on hand cardboard, clay, foam boar to create very quick and rough conceptual prototypes.

It may often be necessary to have several brainstorming sessions on a given need. It may also be useful to have different people involved in these sessions. Remember throughout the process of inventing that it is critical to document the evolution of new ideas and their anticipated applications. Any significant writing on a whiteboard should be copied or photographed; any rough models should be saved. This helps organize and build mature ideas and enables the inventors to substantiate their rights to intellectual property.

Step 5: Concept Evaluation and Screening

Successful brainstorming produces a large array of potential solutions to a need. The next step is to distinguish the ideas worth pursuing from those that are not. Although the brainstorming process is unconstrained and strives for quantity of ideas, concept evaluation and screening introduces reality into the equation. The goal is to have the winning solution emerge from the list and to understand the features of that solution that need improvement in order to become successful.

The most important mechanism for the first screening should already be at hand, and it is the need criteria (see Step 3). A simple rating of how well each of the concepts will potentially address the need criteria results in an initial ranking. If an idea does not seem to have the potential to satisfy the must-have need criteria, it should be immediately set aside (or reimagined to better address the criteria). Nice-to-have criteria can be used to further move concepts up or down the list of promising solutions based on how well you think each concept will perform against them. Often, this initial screening activity permits the inventor to reevaluate the merits of each solution, suggesting modifications or improvements. From the highest-ranking ideas, one can further screen out the best solution by imposing additional metrics. Some examples of these might include an assessment of the technical feasibility of the idea, the likelihood of adoption, potential ease-of-use, or the expected timeline of clinical trials and regulatory approval. Developing a reproducible scoring system helps keep this process objective. Some research may be necessary to support the scoring process, and often iteration of the process and idea is required.

Step 6: Concept Development and Implementation

Once you have selected your target concept, you can now begin the exciting journey toward making it a reality. Some important questions to pose at this stage are as follows: Is this an idea that is so significant that it could be the foundation of a company, or is it simply an incremental improvement that is better licensed to an existing manufacturer? Are the clinical and technical foundations established enough to justify bringing in investors, or is this still a research project that requires further development in an academic setting? To answer these questions, it is helpful to look at comparable companies or projects at similar stages. If you are working in a university setting, much of the work at this stage may be performed by the technology licensing office, but if you truly want to establish this invention as a reality, it is often necessary for the inventor to take a pivotal driving role. To move your idea from this point, it is now necessary to dig into your med-tech inventor’s toolkit (described next) and pull all the pieces into place.

Whatever approach the technology takes, the inventor has the opportunity to play a central role in the early development and implementation of the technology. The next section describes the essential tools to make this a productive experience.

The Team

Regardless of the fact that many famous and successful inventors like to work alone, the benefits of working with multidisciplinary teams have been extolled in many texts.⁵ Even those who choose to invent alone realize that a team is almost always necessary to take their invention to the next level. The most important thing you can do as an innovator is understand your personal strengths and weaknesses. Assemble your team based on how the additional members complement your abilities. It is also important that your team fit the task at hand. Initially, you may not need much help, but as the project moves forward, you must bring in other people to accomplish the next set of goals. Once you lay out a plan for your business (Fig. 75-2), the evolving set of requirements logically translates into a sequence of skills necessary to move the project forward, and you then can build your team on that basis.