Rifat Latifi, Peter Rhee and Rainer W.G. Gruessner (eds.)Technological Advances in Surgery, Trauma and Critical Care10.1007/978-1-4939-2671-8_7

7. The Lean Innovation Model for Academic Medical Discovery

Gabriel Gruionu¹ and George C. Velmahos¹

(1)

Division of Trauma, Emergency Surgery, and Surgical Critical Care, Department of Surgery, Massachusetts General Hospital, Boston, MA, USA

Gabriel Gruionu

Email: ggruionu@mgh.harvard.edu

Keywords

Lean innovationMedical productClinical needDesign input/outputInnovation directorClinician inventorAcademic entrepreneurship

Introduction

The goal of the present chapter is to provide a basic introduction to the innovation process in academia, based on our experience from four major US universities and a major US medical device company. Although there is a lot of information about industrial innovation, academic innovation—turning new scientific ideas into commercial products—is a very new endeavor for the academic scientist or clinician, and often diametrically opposed to the main goal of their career: basic scientific discovery, patient care, and education. To untangle the complicated process of academic innovation, we aim to offer some practical advice and exchange of information for academic scientists/clinicians about the steps they can take to turn their scientific ideas into innovative medical products. There could be differences among universities, but in general, the process described in this chapter applies to most US academic environments. For a more formal course in medical entrepreneurship, the reader can consult many specialized books and textbooks [1, 2]. Intentionally, the present approach is direct and personal, without the complicated lingo of business (text)books, in order to open the reader to the possibility that academic innovation is both fun and feasible for any scientist/ clinician with an entrepreneurial spirit and a useful idea.

The Medical Product

For illustration purposes, throughout this chapter we use a hypothetical new medical product, a classic Kelly hemostat locking forceps (in short the “forceps”). A forceps represents an example of a simple mechanical device defined as a “handheld, hinged instrument used for grasping and holding objects” (http://en.wikipedia.org/wiki/Forceps accessed on June 9th, 2014). Other surgical devices could contain electrical or electronic components (e.g., pacemakers), as well as biological or artificial biomaterials (e.g., biological surgical patches or vascular grafts). Although they are more complex, more expensive, and longer to develop, a similar methodology can be applied to develop these medical products.

Industry vs. Academic Innovation

One of the first questions that come up about academic innovation is why we cannot just apply the industry innovation model in academia? Why do we need to reinvent the wheel? To answer those questions we first need to understand how the two innovation environments compare to each other:

Industry has a system in place where all functions (engineering, marketing, sales, management, legal, manufacturing) work in tandem to accomplish the same goal, which is the commercialization of new products. For a manufacturer of forceps, a new forceps design is a line extension and a matter of engaging the new development team, receiving approval from the leadership, and starting the production. The details of the process are the same: prototype design and execution, business plan, production, etc., but the execution is much faster, based on previous experience of the company.

Academic innovation at the level of the university works almost in complete isolation from the rest of the university. Among their peers, academic innovators work on their own and often in secrecy. Therefore, an innovator of a new forceps design has to first recreate and build the forceps prototype. The scientist has then to learn everything about writing a business plan and all other business aspects of the business. In particular, defining the market for the product, and sales and regulatory scenarios are very difficult for academic inventors and very easy for established medical device companies that already have a distribution network and an established market.

There are many other finer differences between industry and academia that mainly arise from academia having as its main mission, education and research. Once there is a common goal of commercializing innovation, an increase in communication and collaboration between industry and academia could solve many of these differences, and accelerate the academic innovation process.

The Lean Innovation Model in Academia

Medical innovation is becoming more of an integral part of academic research. In both clinical practice and laboratory research, there are many innovative solutions that could and need to be translated into practice. The present work exemplifies some of our work in medical device innovation at the Massachusetts General Hospital. At the time when this chapter was written, our work was still in progress, so for the purpose of maintaining confidentiality we have picked a hypothetical medical product to illustrate our experience and practices.

Lean innovation was initiated in lean manufacturing. Lean Six Sigma was developed by the Toyota car manufacturer [3], then applied to IT innovation [4]. Briefly, lean manufacturing or just-in-time production refers to producing only to customer demand. An example from the car industry would be producing a car with only the features that are requested by the customers and testing the car design as it is developed rather than waiting until all of the features of the car are in place and then tested by the customers. “One of the main fundamentals of the Toyota System is to make ‘what you need, in the amount you need, by the time you need it’, but to tell the truth there is another part to this and that is ‘at lower cost.’ But that part is not written down” [5].

Similarly, in the IT industry, when designing software, the features of such software can be tested early in the development process, often during the beta version of the software [4]. The early adopter customers then offer feedback early in the process such that the necessary changes can be made before too much time and money is spent on developing secondary and potentially unnecessary features.

For the first time, we are applying the concept of lean innovation to academia for medical product development. We believe that the academic environment is well suited for early customer feedback, particularly as it concerns medical products for which the customers are the doctors and hospitals affiliated with the university. Therefore, testing an early prototype could be as easy as contacting a clinician colleague while covered by the university confidentiality agreements. We have applied this concept at the Massachusetts General Hospital to accomplish both early feedback on our products as well as to keep the cost of the prototype production to a minimum. The remaining of the chapter describes how one can implement the lean innovation process in academia.

The Innovation Social Network

An innovation social network is crucial to the implementation of lean academic innovation. It contains all the people involved in developing the invention into a commercial product. It contains people from the university and also from the outside world: the innovation director who coordinates several innovation projects, the scientist/clinician inventor who came up with the idea, and the support system.

The Innovation Director

The central player of the academic innovation process is the innovation director (ID) rather than the inventor. The ID is a multidisciplinary scientist with experience in both academic research and industrial product development. The ID is responsible for integrating and coordinating the clinical, scientific, and industry aspects of the product development. The ID asks the right questions related to the medical device clinical need and finds the right answers that can generate hypotheses to be tested. For example, what is the strength of the forceps to hold but not crush the vessel? What is the best material for the forceps to be able to sustain steam sterilization? At the same time the ID acts as an early CEO for the start-up company and writes grant proposals for funding; in other words, the ID carries out the entire process. In industry, a similar function is performed by the product manager or specialist. The difference is that the product manager acts within the company infrastructure whereas the ID has to build the infrastructure for each medical product project in academia.

The Clinician Inventor

Usually, a single scientist/clinician—the inventor—initiates the medical innovation. This is partially due to the academic culture of “secrecy” vs. collaboration. An idea belonging to a clinician is perceived as the solution to a major medical need and therefore tends to be protected by the inventor who is the originator of idea. Although the academic environment is usually governed by the confidentiality agreements signed by every employee at the beginning of their employment, the clinicians and in general the inventors do not share their ideas with their peers. This approach has advantages and disadvantages. The advantage is that the inventor maintains a sense of ownership and leadership in the development process. Although by university rules all new ideas, even remotely related to the work being done at the university, belong to the university, inventors feel that they need to protect their idea within their own academic institution. At the same time, they are motivated to work diligently on developing their idea.

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