Elsevier

Research Policy

Volume 34, Issue 9, November 2005, Pages 1283-1304
Research Policy

Emergent innovation systems and the delivery of clinical services: The case of intra-ocular lenses

https://doi.org/10.1016/j.respol.2005.01.015Get rights and content

Abstract

This paper is an exploration of the dynamics of technical change in medicine. We argue that innovation in medicine is a process that is distributed across time, space and epistemic and institutional domains; that it entails the entrepreneurial effort of creative individuals as well as the emergence of correlated understanding among heterogeneous agents whose rules of interaction are contingently instituted in socio-economic systems along unfolding scientific and technological trajectories. We illustrate our arguments through an in-depth analysis of a major ophthalmologic innovation – the intra-ocular lens – that has literally transformed the treatment of cataract in the developed world and has the potential to do so in many developing countries. We investigate the advancement of clinical knowledge about the disease, the development of effective technological capabilities and the co-evolution of the supply capacity and demand of a micro-innovation system emerged along a specific sequence of interrelated problems, and associated solutions, which engaged scientists, technicians, practitioners, regulators and patients alike over a period of around three decades.

Introduction

In this paper we trace the development of a radical innovation in the field of ophthalmology, the intra-ocular lens, an innovation that has already transformed the treatment of cataract in the developed world and has the potential to do so in many developing countries (Apple et al., 2000).1 The cost of this form of visual impairment is immense in terms of loss of human functioning and well-being and in terms of lost output in economies, many of which are seriously underdeveloped.2 The purpose of the paper is to recount the development of the intra-ocular lens not only in its own terms but rather as a peg on which to hang a number of central issues in our understanding of the central role that innovation and the accumulation of new knowledge play in modern capitalism.

We begin by emphasising the fundamental importance of personal and private knowledge existing as electrochemical patterns in individual minds and publicly represented and communicated as information which may or may not be appropriated by enforcement of property rights. What makes possible the co-ordinated action on which society and economy depend – we argue – is the spread of correlated knowledge between the relevant groups of individuals, that is to say, the emergence of understanding in common so that instructions and questions elicit common answers and common practices in the contexts where activities depends on social interaction (Metcalfe, 2002). The development of the intra-ocular lens is precisely a case of the growth of correlated knowledge in which the original idea and innovation have been diffused worldwide. Because this is a socio-economic problem, it reflects the organisational and instituted contexts in which knowledge grows, in laboratory and clinic, and in the wider society in which the application of knowledge meets a medical need. The several environments and rules of the game in which clinicians developed lenses and operating procedures have influenced greatly the rise to maturity of the overall technology, and we explore these influences in terms of the development of the invention and innovation systems for this procedure. Parallel to and inseparable from the growth of knowledge is the growth of a supply capacity to deliver a new medical service and this dimension connects, inevitably, to the growth of the market and the extension of the division of medical labour. Commercial investments in a new technology are only sustainable if the market supports the necessary returns, and so the development of demand and the role of regulation in instituting demand play an important part in the story.

Yet, as with all radical innovations, the full impact of the intra-ocular lens only follows from the development and the adoption of long sequences of innovations in materials, techniques, equipment and drugs. This sequence is generated within the context of an innovation diffusion process whereby diffusion induces further innovation to define an emergent trajectory of learning and discovery. This process lasted over 40 years from the first implant to the establishment of a standardised procedure on a large scale throughout the advanced nations. Why this was so reflects the nature of the problem sequence and the organisational, institutional and cultural context in which each solution opened up unintended consequences, and thus new problems toward the solution of which creative effort was allocated. Moreover, the context in which problems were identified was inseparable from the extension of clinical practice. Like all medical innovations, application to the human body is a matter of engineering not of science; as with all engineering innovations, feedback from practical application is of the essence of the development of reliable knowledge (Vincenti, 1991). Such knowledge grows in experimental and autocatalytic fashion, as one problem leads to another in the minds of the different individuals who compose the invention and innovation system. In the process, multiple competing solutions are generated and are selected vicariously or by practical trial and error processes.3 Thus, we employ a frame of reference in which the growth of knowledge is an evolutionary adaptive process, constrained and encouraged by instituted relationships that co-evolve with the growth of knowledge and its application.

It is also central to our argument that invention and innovation systems are not to be presumed, their emergent properties have to be explained. The organisations and individuals from which systems are constituted and the way in which these ‘components’ are interconnected, that is to say instituted, have to be explained with a purpose in mind. In many cases, connection arises through the self-organisation of knowledge generating processes among like-minded practitioners. In other cases, it arises through the leadership of firms, and in others through the role of government. What we find in the intra-ocular case is that the modes of organisation of the invention and innovation system evolved over time and that the principle cause of the reorganisation was the change in the nature of the innovation problem sequence.4

An emphasis on the distributed nature of invention and innovation processes has already had an impact on the study of medical innovation. Blume (1992) and Gelijns and Rosenberg (1995) have characterised the innovation process in medical devices in terms of the interaction between multiple disciplines and multiple agencies with close relations emerging between firms, clinicians and academic scientists. Similarly, Blume's study (1995) of the cochlear implant is concerned with the development of institutional structures to evaluate the feasibility of new devices when their efficacy is strongly contested. The subsequent work of Gelijns and Rosenberg (1999) on CRT scanners, magnetic resonance imaging and endoscopy, makes a clear distinction between the conditions of invention and the conditions that influence the translation of devices into a commercially viable industry. In their account, the strength of local science activity, intellectual property regimes and the characteristics of health care systems play the key explanatory roles.5

One rather systematic aspect of medical innovation is the pervasive role of science–industry interfaces. This is in its own rights an increasingly central theme in the innovation literature and although it is not the purpose of this paper to provide an extensive account of such a wealth of contributions, it may nonetheless be useful to recall a few points of relevance to this work as raised in recent studies. In his review of the literature, Carayol (2003) appreciates and explores the great variety of modes of science–industry collaborations. So does Murray (2002), who discusses the co-evolutionary nature of scientific and technological developments in tissue-engineering research. She finds that formal and informal interactions between universities and firms are very intense and contribute to the formation of relatively durable cross-community networks. This is consistent with Meyer-Krahmer and Schmoch's (1998) results on the role of informal and bi-directional knowledge exchanges between universities and industries. Etzkowitz (1998) explores the shifting attitudes of public science employees towards collaboration with industry and refers to the ongoing process of mutual adaptation linked to the emergence of entrepreneurial universities. The tacit, reciprocal, and vastly unrecorded component of science–industry interaction is stressed again by Meyer (2000) while McMillan et al. (2000), confirming the validity of previous studies (see for example Narin et al., 1997), provide quantitative citation-based evidence of an increasing reliance of technological developments on public science.

The case of intra-ocular lenses (hereafter IOL) points to the complexity of these interactions and their shifting nature along emerging, hence non-deterministic, trajectories of innovation (Dosi, 1982). In this case, however, while the changing private vs. public nature of the institutions involved in the innovation process reflects a fundamental aspect of science–industry collaborations mentioned above, institutions involved in the delivery of health services also appear to be fundamental components of the innovation system. We will therefore emphasise the role of clinical practice, which mainly resides in hospitals and heavily relies on direct experience, trial-and-error learning and personal knowledge, over abstract scientific knowledge. As a consequence, instead of focusing on university–firm interactions, and the relation between scientific and technological knowledge, we will stress the co-evolution of clinical knowledge and the technological capabilities, coupled with the supply capacity, of the medical innovation system.

We attempt to do so in the following way. The innovation problem sequence of the IOL serves as our probe, which we use to interrogate the technical literature, and guide the interview process with firms, clinicians, surgeons and hospital managers. The method is comparative and historical and combines qualitative and quantitative data extracted from a variety of primary and secondary sources. Beside the relevant medical literature and the interview materials, national surveys on technology diffusion have been consulted for the US and UK. Furthermore, two datasets, one of papers and one of patents, have been constructed by key-word searches and used to complement the analysis of the epistemic evolution of the problem sequence as profiled in appreciative accounts. The paper dataset includes papers on intra ocular lenses and procedures extracted from the Institute of scientific Information (ISI) covering the period 1965–1999. The patent datasets contains 707 documents of patents granted over the period 1976–2002 extracted from the US Patent Office. Finally, institutional sources (OECD, FDA and NHS documents6) have been used to investigate the regulation of ophthalmologic practice, the creation of demand and the nature and constraints of adoption decision.

Before embarking on the detailed account of the invention, innovation and diffusion of the intra-ocular lens, it may help to summarise the main points. The innovation of the IOL has radically transformed the conception, design and delivery of a major medical service, the removal of cataracts combined with their replacement by a functioning lens. This has brought great benefit to countless patients and has greatly increased the efficiency and effectiveness with which the clinical procedure is carried out.7 It has been achieved by the creativity of individual clinician inventors combined with the development of a transnational medical–industrial complex that has changed radically the innovation system in this field of ophthalmic medicine. A procedure originally based around pioneering ‘hero-surgeons’ deploying ‘craft technique’, has evolved into a ‘routine, quasi factory’ procedure capable of being effected in a local medical centre by clinician nursing staff, whose education and training have correspondingly changed.8 This is indeed a fundamental transformation of a service activity and its skill base. How this happened is the major concern of this paper.

The rest of the paper is arranged as follows. In part 1, we briefly outline the cataract condition, the ‘problem sequence’ that the IOL ‘solves’ and the innovative vision of the pioneer of the procedure, Harold Ridley. In part 2, we trace the evolution of the problem sequence from the work of Ridley's followers to the revolution of foldable lenses. In part 3, we highlight how the emergence of correlated understanding shapes the dynamics of the micro innovation system. In part 4, we explore the relevance of demand and regulation in the development of IOL. Part 5 reflects upon some of the wider implications for the study of sector specific innovation systems.

Section snippets

The problem of cataract and Harold Ridley's solution

Cataracts, the clouding of the eye's crystalline lens are the most frequent cause of defective vision in later life. Ultimately resulting in blindness, cataracts are severely disabling for otherwise active people and, between the ages of 52 and 64 there is a 50% chance of their occurrence while by the age of 75 some 70% of the population have cataracts. With an ageing population in the world, the significance of an effective cure is not easily overestimated.9

The next steps

No innovation takes place or diffuses in isolation and the determinants of success for new medical procedures often reside in the development of complementary techniques, drugs and devices. This is certainly the case for the IOL. Of all the developments that have transformed Ridley's innovation and operative method into a mass procedure, by far the most important has been the adoption of phakoemulsification techniques for cataract extraction, which in turn triggered the development of new kinds

Composition, substitution and complementarities

While there is no obvious way to infer the development of knowledge in the minds of individuals, we can follow systematically the growing body of codified representations of personal knowledge placed in the public domain. This information, in the form of papers, patents, device evaluations and professional demonstrations of method, can provide invaluable insights on the development of correlated understanding within the community of practitioners and the supplying firms. It must be remembered,

Part 4: the market for cataract surgery: demand, need and regulation

To the extent that the IOL is a story of increasing returns in the production and use of knowledge, we would expect that the scale of demand and the way demand is instituted play an important role in the unfolding of technique and practice. In this section, we explore the dynamics of the emerging IOL invention and innovation system and the forces in relation to the demand for IOL implants, the regulation of the practice and the development of commercial interests that shaped the system. This

Part 5: the wider questions

We find it helpful to conclude with some of the wider questions towards which this study points. Our interest in this case lies in part in it being an important example of the interdependence between the service economy and the manufacturing economy. The medical sector is properly regarded as one component of the service economy with primary and secondary care affecting most individuals at some stage in their lives, while innovation in the conception and delivery of new treatments is a central

Acknowledgements

The authors are extremely grateful to colleagues in CRIC, and to Nick Jones, Michael Lavin, Karen Partington and Paul Habib Artes of The Royal Eye Hospital, Manchester, Heather Waterman of the School of Nursing, University of Manchester and Gary Young of The Manchester Central Health Trust for their assistance in the prosecution of this research. Discussion with Dick Nelson and other members of the ‘Uneven Growth of Medical Knowledge’ group are also acknowledged. The comments of the referees

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