Although requests may also be more general in nature:

Data validity

The data was obtained in partial data sets, obtained from each Trust as shown in the T-shaped diagram in Figure 1, Chapter 1. Therefore, to truly achieve generalisability and validity, it was necessary to triangulate observations from any one collaborator with insights from other Trusts.

No pre-existing methodological research framework

As established earlier, there was no pre-existing methodological framework for such a study. The subject itself lies in a multitude of disciplines and could have been addressed from either an economical, operational, or clinical standpoint. Taking a systems or design-led approach provided a means by which various perspectives could be considered while still making a valuable contribution to design research in healthcare.

The specific way in which some of these challenges were addressed in implementing the research is addressed in design and methods in Section 3.2.3. The next section introduces the general research approach.

3.2.1 Research Paradigm

With reference to Thomas Kuhn‟s use of the word „paradigm‟ (Kuhn 1962) in his work, Guba later defined a research paradigm as “the starting points or givens that determine what inquiry is and how it is to be practiced”, whilst warning that these are „human constructions‟ and, therefore, “subject to all the errors and foibles that inevitably accompany human endeavours”. (Guba 1990)

Adopting a particular research paradigm fundamentally influences later decisions in the research process. These may differ greatly, and dictate different ontological, epistemological and methodological lines of thought and action in research. Generally speaking, the ontology refers to our ideas about what exists, whether there is truth „out there‟ waiting to be discovered and explained. Epistemology relates to the philosophic inquiry in the nature and grounds of knowledge – understanding how it is that we know what we know. Finally, the methodology refers to the conceptual and logical elements of the research process. These four paradigms, taking Guba‟s classification, are summarised below:

Table 5: Research paradigm characteristics, adapted from (Guba 1990)

Generally speaking, the first paradigm, positivism, is based on a belief of „how things really are‟. As Guba described, the nature of science is to “discover the „true‟ nature of reality and how it „truly‟ works” (Guba 1990). Generally speaking, classical sciences fall under such categories. Post-positivism is a modified version of the positivist stance, with an

understanding that although there is a reality „out there‟, given human frailty, the conclusions made about such realities will be flawed. Critical theory and constructivism stray further from this approach to a more subjective approach, which, in the extreme case, assumes that all our perception of knowledge is relative to the way we understand it and that our sense of „reality‟ can change according to this understanding.

At first glance, the research paradigm for this research sits closer to the less objective paradigms: post-positivist, critical theory, or constructivism. The ontological stance taken is close to that of „critical realism‟, where one can acknowledge the existence of a reality but at the same time take into account the extrinsic influences present in the individuals‟

perceptions and cognitions, and hence their responses (Bryman 2001). Given that the study is largely based on respondents‟ views on the process, and an inquiry into the need for future improvement, a positivist view is not the dominant view taken. However, while the aim is limited to assessing findings based on the stakeholders‟ accounts of current practice;

the study still aims to formulate a picture of current practice relating to the collective truth of what happens in practice. As noted by Robson, within the social sciences relativistic approaches are distinguished from the positivistic traditions (Robson 2002). These include

„constructivist‟, „naturalistic‟ or „interpretive‟ – all of which reject the view that „truths‟

about the social world can be established by using natural science methods. An extreme adherence to relativism may therefore imply a complete disassociation from natural science. As a potential solution, Robson introduces the term „realism‟ in a different way to Guba‟s definition above. He claims that „realism‟ can “provide a model of scientific explanation which avoids both positivism and relativism” (Robson 2002), quoting various studies where the potential for its utility has been shown in economics, criminology, international studies, geography, medical education, nursing, organisational analysis, political science and sociology, among others. Realism in this definition has been seen as particularly appropriate for research in practice- and value- based professions such as social work. For realists, in Robson‟s terms, there are social objects, which can be studied scientifically, but the methods chosen must fit the subject matter (Robson 2002). Generally speaking, a realist approach integrates both the subjectivist and objectivist approaches in social theory. This means that “social structure is at the same time the relatively enduring product, and also the medium, of motivated human action… Social structures such as language are both reproduced and transformed by action, but they also pre-exist for individuals” (Robson 2002).

In summary, for this study the ontological stance is closest to that of a realist (in Robson‟s terms), and the epistemology tends towards modified objectivist, since there are no pre-determined values on „how healthcare should be conducted‟ being assigned to the enquiry.

Similarly, the ideas behind systems engineering principles and approaches, although tested elsewhere, are also not claimed to be the „true‟ and only way of addressing the issues faced in healthcare purchasing; they are simply one method for putting forth the problems raised and discussing their potential for creating improvements.

The next section describes how the literature review created a starting point for „viewing the world‟ of purchasing practice in healthcare. The preliminary conclusions drawn at this stage served to draw up research questions.

3.2.2 Research Questions

The question that is investigated at the highest level in this study is repeated here:

What are the characteristics of a medical device purchasing process that effectively focus attention on patient safety?

A set of questions derived from this question is needed to facilitate the data collection process. Based on preliminary evidence gathered from the literature and direction described in the first chapter, two very general statements can be inferred from the literature, in light of some general topics or factors that influence current practice:

1. Challenges to current practice in medical device purchasing exist, because of wide