This blog entry is being written in real time as I really apply myself to developing the structure or methodology of my thesis. In essence it is the bare-bones outline of the dissertation.
The first part is to identify the issue that the dissertation will examine as this will define the area of the research topic(Gray, 2014). The area that I am specifically focused on is the impact of European Medical Device Regulation will have on Respiratory Inhalers(Council, 2017). Prior to Medical Device Regulations Pre-Filled Respiratory Inhalers were deemed Medicinal Products in Europe but with the introduction of MDR pre-filled respiratory products fall within the scope of some aspects of the MDR. What is not clear is how these elements will be managed.
Having identified an issue a research question can be developed. A Research Question links the issue to a relevant theoretical framework and the potential relationships between variables which can be measured(Kerlinger, 1986). A research question needs to be unambiguous and in a question format. I had developed a small mind-map outlining some of the issues I considered as issues.
These I used then to develop what I believe is an unambiguous research question.
“What is the impact of the EU Medical Device Regulations on the regulatory management of Respiratory Inhalers?”
This main question has subordinate questions which may be;
- What is the role of Notified Bodies?
- What is the expectation to achieve a Notified Body Opinion (and what is a Notified Body Opinion)?
- What is the impact on legacy respiratory inhalers regulated prior to MDR?
- What is the expected inter-relationship required between an Inhaler Manufacturer, the Competent authority and the Notified Body and how these relationships may impact on regulatory process going forward?
These research questions will lead to a wide range of possible answers and perhaps answers or subject areas that were not considered at this time as I plan out the research approach. The question is an extension of a Descriptive type question. A Descriptive question examines what is happening? An extension of this is a Normative question which examines what is occurring compared to what should be occurring (Gray, 2014). This has an impact on the research study. As indicated by Gilner the statistical analysis for the research depends on the category of question(Gliner, 2017). In Gilner’s approach the research would be termed associational as the purpose is to examine the intention of the MDR and the possible outcome for respiratory device manufacturers.
Figure 2 Schematic indicating the relationship between research question category and statistic approach (Courtesy of Gilner 2017)
Having identified the research questions I now need to consider the research hypotheses. Kerlinger and Lee indicate that a hypotheses is speculation between two or more variables(Kerlinger, 1986). The variables are the aspects that will be measured which requires variables to be measured . The proposed hypotheses is
“The introduction of the EU Medical Device Regulations will have an impact on the regulatory process for Respiratory Inhalers”
The variables in this hypotheses are the ‘EU MDR’ and the ‘regulatory process’. Variables should be identified as Independent variables (causes of the issue) or Dependent variables (resulting effects)(Gray, 2014). In this research it will be examining the various pathways available for respiratory inhalers and assess the impact these may have.
This has helped me focus more on the scope and possible approach to gathering the data that I will need. My plan is to have 7 to 10 interviews with a range of stakeholders. This I need to get cracking on as soon as possible.
Council, O. F. T. H. E. (2017). EU Regulation 745/2017 on Medical Devices, Official Journal of the European union 117/145, p. 1-175. 2013(June 1993).
Gliner, J. A. (2017). Research methods in applied settings : an integrated approach to design and analysis(Third edition.). Routledge, Taylor & Francis Group.
Gray, D. E. (David E. (2014). Doing research in the real world (Third edition.). SAGE.
Kerlinger, F. N. (Fred N. (1986). Foundations of behavioral research (3rd ed.). Holt, Rinehart and Winston.