engaging key opinion leaders (kols)new roles for key opinion leaders are emerging the pharmaceutical...

Engaging Key Opinion Leaders (KOLs) Identifying and Leveraging New KOL Groups to Drive Medical Marketing Strategy

GBI Research Report Guidance

GBIHC262MR / Published SEP 2012

© GBI Research. This is a licensed product and is not to be photocopied

GBI Research Report Guidance

Chapter three investigates the emerging trend to externalize research and establish productive relationships with academic laboratories and principal investigators.

Chapter four looks at the landscape for the traditional KOL – the healthcare professional – detailing changes to Codes of Practice guiding the pharmaceutical industry’s interactions with these individuals, trends in KOL management, and issues of relevance to emerging markets.

Finally, Chapter five examines the role of patients and their advocates in providing insights that should drive drug discovery and development in the future.


© GBI Research. This is a licensed product and is not to be photocopied

Executive Summary

Executive Summary

Key Opinion Leaders (KOLs) play important roles in drug discovery and development as well as in the marketing of new medicines. Traditionally, KOLs have been healthcare professionals with senior positions in the medical community of interest. They advise companies as to where unmet medical needs lie, choose drug targets, help to define potential product profiles and shape clinical programs, run clinical trials, and may be involved in a drug’s regulatory or reimbursement review process. KOLs from the academic science community are often involved in company-funded research projects, but may also provide scientific advice. Once a drug has reached the market, a wider group of KOLs may be required to drive the uptake of a new medicine and gain market share.

Engaging Key Opinion Leaders, Key Opinion Leader Activities During Drug Development, 2012

Research

Identify areas of unmet medical need

Drug Discovery/Preclinical

Reimbursement MarketingPhase I Phase II Phase III Approval

Brief regulators or payers on behalf of a company

Identify areas of scientific interest (e.g. drug targets,

discovery platforms)

Undertake company funded research

Provide Scientific advice

Build product awareness

Influence prescribing decisions

Advice on target product profile, differentiation and labelling

Advice on clinical research plans and locations of clinical

research sites

Access competitive products (current and future)

Source: GBI Research

This report describes these established KOL roles in more detail and the consequences of the changing healthcare environment on how the industry identifies and works with new groups of KOLs.

New Roles for Key Opinion Leaders are Emerging

The pharmaceutical industry is facing a number of challenges that will influence the way it works with KOLs. Clinical development programs are longer and more complex than in the past and this is increasing costs of R&D while sales revenues are falling. Companies have cut their internal workforces and are now looking externally for new products. The pressure on healthcare budgets from growing and aging populations and the rise in non-communicable diseases, such as cardiovascular disease and different cancers, as well as the increasing costs of some medicines, have led healthcare providers to pay much greater attention to the cost-effectiveness of new products as a condition of reimbursement. As a consequence, the focus on marketing medicines in emerging economies has also increased.

The definition of KOLs as professors of medicine within specialized areas is, therefore, changing. Indeed, Professor Brian Smith, Visiting Research Fellow at the Open University Business School in the UK, comments in an interview with GBI Research that “as the critical issues facing the pharmaceutical industry in developing a strategy are now much broader than clinical issues, so too must the definition of KOL broaden”. Academic scientists, individuals with responsibility for market access, and other groups of thought leaders including patients, representatives of patient advocacy groups, health economists, those involved in the evolution of healthcare systems and the development of new business models are all considered more influential to the future of the industry.

Key Opinion Leaders (KOLs) play important roles in drug discovery and development as well as in the marketing of new medicines


Page 5 © GBI Research. This is a licensed product and is not to be photocopied

Table of Contents

1 Table of Contents

1 Table of Contents................................................................................................................................. 5 1.1 List of Tables............................................................................................................................. 7 1.2 List of Figures............................................................................................................................ 7

2 Introduction......................................................................................................................................... 8 2.1 Key Opinion Leaders: A History.................................................................................................. 8 2.2 Established KOL Roles in Drug Discovery, Development and Marketing ...................................... 9 2.3 The Changing Environment for the Pharmaceutical Industry .....................................................11

2.3.1 Market Access: Reimbursement Authorities ......................................................................11 2.3.2 Market Access: Purchasing ...............................................................................................12 2.3.3 Generic and Specialty Medicines.......................................................................................12 2.3.4 Emerging Markets............................................................................................................13 2.3.5 Big Data: the Changing Environment for Science and Medicine..........................................14 2.3.6 Emerging Business Models ...............................................................................................14

2.4 Emerging KOL Roles .................................................................................................................15 3 Building Relationships for External Innovation .....................................................................................16

3.1 Introduction ............................................................................................................................16 3.2 Growth Close to Hubs and Clusters...........................................................................................16 3.3 Working with Academia...........................................................................................................17

3.3.1 Pfizer’s Centers for Therapeutic Innovation .......................................................................18 3.3.2 The California Institute for Biomedical Research................................................................19

3.4 New Funding Models to Support Innovation.............................................................................19 3.5 Drug Development Relationships .............................................................................................20 3.6 Key Opinion Leaders in the Emerging Drug Discovery and Development Landscape: Finding

Experts ....................................................................................................................................20 3.6.1 Knode ..............................................................................................................................21

3.7 Key Opinion Leaders in the Emerging Drug Discovery and Development Landscape: Building Relationships ...........................................................................................................................22

3.8 Conclusions .............................................................................................................................23 4 Building Relationships with Healthcare Professionals ...........................................................................24

4.1 Introduction ............................................................................................................................24 4.2 Identifying KOLs and Building Relationships..............................................................................25

4.2.1 KOL Management ............................................................................................................26 4.3 Healthcare Engagement: Codes of Practice...............................................................................27

4.3.1 US....................................................................................................................................27 4.3.2 The Office of Inspector General Guidelines ........................................................................28 4.3.3 EU ...................................................................................................................................30

4.4 KOLs in Emerging Markets........................................................................................................31 4.4.1 Emerging Markets: Compliance Environment....................................................................31

4.5 Key Opinion Leaders Online .....................................................................................................31 4.5.1 Examples of Best Practice in Digital Engagement ..............................................................32 4.5.2 Channels for Engaging Healthcare Professionals Online.....................................................33 4.5.3 Digital Literacy.................................................................................................................33 4.5.4 Regulating online engagement.........................................................................................34

4.6 Evolution of KOL Interactions ...................................................................................................35 5 Building Relationships with Patients ....................................................................................................36

5.1 Introduction ............................................................................................................................36 5.2 Patients’ Roles in Drug Development........................................................................................36 5.3 Overcoming Barriers to Effective Engagement ..........................................................................38

5.3.1 Increasing Patients’ Awareness of the Clinical Research Process ........................................38 5.3.2 Ethical Principles for Working with Patients ......................................................................38



Table of Contents

5.3.3 Transparency ...................................................................................................................39 5.4 Gaining Insights from Patients..................................................................................................39

5.4.1 Patients Online.................................................................................................................40 5.4.2 Working with Online Patient Communities........................................................................41 5.4.3 Patient Intelligence ..........................................................................................................43

5.5 Clinical Trial Recruitment .........................................................................................................44 5.6 Venture Philanthropy...............................................................................................................44 5.7 Conclusions .............................................................................................................................45

6 Appendix ............................................................................................................................................46 6.1 Abbreviations ..........................................................................................................................46 6.2 References ..............................................................................................................................46 6.3 Research Methodology ............................................................................................................49

6.3.1 Coverage .........................................................................................................................49 6.3.2 Secondary Research .........................................................................................................49 6.3.3 Primary Research .............................................................................................................50 6.3.4 Expert Panel Validation ....................................................................................................50

6.4 Contact Us...............................................................................................................................50 6.5 Disclaimer................................................................................................................................50



Table of Contents

1.1 List of Tables

Table 1: Engaging Key Opinion Leaders, Key Emerging Markets: Market Size and Growth, 2005–2018 ...13 Table 2: Engaging Key Opinion Leaders, Examples of Recent Collaborations between Academia and the

Pharmaceutical Industry, 2012 ................................................................................................17 Table 3: Engaging Key Opinion Leaders, Projects Funded by Pfizer’s Centers for Therapeutic Innovation,

2012.......................................................................................................................................18 Table 4: Engaging Key Opinion Leaders, Key Sources of Information for Physicians that Influence

Prescribing Decisions, 2012.....................................................................................................24 Table 5: Engaging Key Opinion Leaders, Examples of Potential Conflicts between the Goals of the

Industry and KOLs, 2012..........................................................................................................25 Table 6: Engaging Key Opinion Leaders, Status of Annual Certification of Companies Committed to

Abiding by the 2012 PhRMA Code of Practice (up-to-date June 11, 2012).................................29 Table 7: Engaging Key Opinion Leaders, Examples of Clinical Trial Finding Websites, 2012 .....................44

1.2 List of Figures

Figure 1: Engaging Key Opinion Leaders, Introducing the Key Opinion Leader: The Two-Step Flow Model, 2012........................................................................................................................................ 8

Figure 2: Engaging Key Opinion Leaders, Roles Held by Key Opinion Leaders, 2012 .................................. 9 Figure 3: Engaging Key Opinion Leaders, Key Opinion Leader Activities During Drug Development, 2012.10 Figure 4: Engaging Key Opinion Leaders, Emerging Key Opinion Leader Roles, 2012................................15 Figure 5: Use of Social Media by Different Groups, 2012 ........................................................................32 Figure 6: Engaging Key Opinion Leaders, The Social Media Course from Webicina, 2012.........................34 Figure 7: Engaging Key Opinion Leaders, Potential Barriers towards Patient Involvement: Results of the

PatientPartner Project Survey, 2012........................................................................................37



Introduction

2 Introduction

2.1 Key Opinion Leaders: A History

Gabriel Tarde first introduced the ideas of innovation and imitation to explain “buyer behavior” at the end of the 19th century, but his work was ignored for a long period and only revisited recently (Wärneryd, 2008). In the mid-20th century, the current idea of the Key Opinion Leader (KOL) was introduced following research into the influence of media on mass audiences. It was presumed, until that point, that media such as press, radio and television influenced consumers directly. However, research on behaviors during the 1944 US presidential election led to the proposal of two-step flow models of influence, in which media influences opinion leaders who then influence their network of contacts (Figure 1).

Figure 1: Engaging Key Opinion Leaders, Introducing the Key Opinion Leader: The Two-Step Flow Model, 2012

KOL4

KOL1

KOL2

KOL3

Media

Individual decision maker












Source: Adapted from Katz & Lazarsfeld (1955)

The 1962 publication from Everett Rogers, including his now famous Diffusion of Innovation adoption curve, described factors that affect the speed of innovation, listed below (Rogers, 1962):

Relative advantage compared with products or ideas already available

Compatibility with current activity

Complexity and ease of use

Trialability, or the ease with which a product can be assessed

Observability, or the visibility of others using new ideas or products, explaining how adoption of new ideas/innovations spreads and is influenced by usage and endorsement from opinion leaders.

These factors also include a specific reference to the influence of opinion leaders and this, in turn, has encouraged their use in marketing by a wide range of industries.

KOLs have traditionally been healthcare professionals in senior positions in the medical community



Building Relationships for External Innovation

3 Building Relationships for External Innovation

3.1 Introduction

Pharmaceutical companies have, over the past few years, stated their increasing interest in products conceived externally to fuel company pipelines. New business models are emerging to support this goal, many of which involve closer ties between industry and academia. Some of the key changes are discussed in the following sections including:

Moving company R&D operations to hubs or clusters renowned for their academic expertise

Entering specific partnerships with academic groups for drug discovery

Developing new funding models for innovative start-up businesses

3.2 Growth Close to Hubs and Clusters

Thus, despite the catalogue of workforce reduction and site closures that have occurred in recent years, some of the largest companies are constructing new buildings at these locations:

Pfizer and the Massachusetts Institute of Technology (MIT) broke ground on a new 180,000ft2 development in Cambridge, MA, that will house Pfizer’s Cardiovascular, Metabolic and Endocrine Diseases (CVMED) and neuroscience research units. The building, which is likely to be completed by the end of 2013, will be leased to Pfizer by MIT for a 10-year period.

In June 2012, Pfizer announced a further project to establish a laboratory in the same building as Harvard University’s Beth Israel Deaconess Medical Center and Boston Children’s Hospital. The company will invest $100m.

Novartis will start construction of two new buildings and one renovation totaling 550,000ft2 square feet in Cambridge, MA.

Biogen Idec’s new headquarters are in the Alexandria Center, Kendall Square, Boston. The new development will cost $500m and Biogen Idec will be the first of a number of companies located at the Alexandria Center.

Bayer Healthcare opened a new research facility in San Francisco, close to University of California San Francisco buildings.

New business models are emerging to support the greater externalization of drug R&D, many of which involve closer ties between industry and academia



Building Relationships with Patients

5 Building Relationships with Patients

5.1 Introduction

The pharmaceutical industry’s goal has always been to improve outcomes for patients through the development of truly valuable new medicines to meet currently unmet medical needs.

Patients and patient advocacy groups can play a number of different roles in drug development:

Inspiring drug development by identifying areas of unmet need

Matching patients with clinical trials

Paying for research

Lobbying governments and regulators to speed drug research

This chapter looks in more detail at the roles that patients and their advocacy organizations may have in the research process and how the industry can find and build effective relationships that will improve outcomes for both parties.

5.2 Patients’ Roles in Drug Development

An EU-based virtual network – the European Network of Patients Partnering in Clinical Research (ENCPR) – empowers, enables and mobilizes European patient organizations to interact with other European and international stakeholders in clinical trials. The ENCPR has developed a guide for sponsors and researchers that looks in detail at how to build effective partnerships. The guide highlights the fact that patients and their representatives are able to offer a unique perspective based on their own or collective experiential knowledge; knowledge acquired through dealing with the effects of their condition on a daily basis.

The ENCPR guide for sponsors and researchers discusses the different points at which patients and their representatives could be involved. The experiences and perspective of the pharmaceutical industry on patient involvement in clinical trials and research was surveyed as part of the project, and responses from XX individuals from 19 companies are reported below.

Patients are an increasingly influential group as drug reimbursement becomes more challenging and patients themselves participate more in healthcare decisions



Appendix

6 Appendix

6.1 Abbreviations

ABPI: Association of the British Pharmaceutical Industry

ALS: Amyotrophic Lateral Sclerosis

CALIBR: California Institute for Biomedical Research

CME: Continuing Medical Education

CMS: Centers for Medicare & Medicaid Services

CTI: Centers for Therapeutic Innovation

CTSA: Clinical Translation Science Award

EFPIA: European Federation of Pharmaceutical Industries and Associations

EMA: European Medicines Agency

ENCPR: European Network of Patients Partnering in Clinical Research

FDA: Food and Drug Administration

GNF: Genomics Institute of the Novartis Research Foundation

HTA: Health Technology Assessment

HCP: Healthcare Professionals

IFPMA: International Federation of Pharmaceutical Manufacturers Association

I-SPY2: Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging and Molecular Analysis 2

KOL: Key Opinion Leader

MIT: Massachusetts Institute of Technology

NHS: National Health Service

NICE: National Institute for Health and Clinical Excellence

OIG: Office of Inspector General

PhRMA: Pharmaceutical Research and Manufacturers Association

PRO: Patient Reported Outcome

6.2 References

AstraZeneca Innovation Survey. AstraZeneca, December 2010.

Bartels BL and Mutz DC (2009). Explaining processes of institutional opinion leadership. Journal of Politics; 71(1): 249-261.

Bosslet GT et al. (2011). The patient-doctor relationship and online social networks: results of a national survey. Journal of General Internal Medicine; 26(10): 1168-74.

Cegedim (2012). 2012 US Trends in Aggregate Spend and Disclosure Reporting. Results from an Industry Survey March 2012. Available from: http://crm.cegedim.com/Docs_Whitepaper/Compliance/Aggregate_Spend_Trends_Disclosure_Reporting_Whitepaper_2012.pdf [Accessed June 19, 2012]

Cegedim Strategic Data (2012a). Emerging Pharmaceutical Marketing Investments 2011. Available from: https://www.cegedimstrategicdata.com/Press/Documents/CSD_EmergingPharmaMarketingInvestments2011_eng.pdf [Accessed June 19, 2012]



Appendix

Cegedim Strategic Data (2012b). Pharmaceutical Marketing Investments 2011. Available from: https://www.cegedimstrategicdata.com/Press/Documents/CSD_PharmaceuticalMarketingInvestments2011_14032012_eng.pdf [Accessed June 19, 2012]

Coyle A and Hajjar K (2011). Acceleration of Innovative Science into the Clinic through a New Partnership. Centers for Therapeutic Innovation (CTI). Presentation to the Partnering for Cures meeting 2011. Available from: http://www.partneringforcures.org/2011_program/presentations/Broadway/2011/Pfizer.pdf [Accessed May 25, 2012]

DeMets DL and Califf RM (2011). A historical perspective on clinical trials innovation and leadership: where have the academics gone? Journal of the American Medical Association; 305(7): 713-714.

DiMaggio PJ and Powell WW (1983). The Iron Cage Revisited: Institutional Isomorphism and Collective

Rationality in Organizational Fields. American Sociological Review; 42(2): 147-160. Doshi P et al. (2012). The imperative to share clinical study reports: recommendations from the Tamiflu

experience. PLoS Medicine; 9(4): e1001201.

Economist Intelligence Unit (2011). Fostering innovation-led clusters: A review of leading global practices. A report from the Economist Intelligence Unit. Available from: http://www.managementthinking.eiu.com/sites/default/files/downloads/EIU-ATIC_Report2_Web_Revised.pdf [Accessed June 19, 2012]

EFPIA (2011). EPFIA Code on the Promotion of Prescription-only Medicines to, and Interactions with, Healthcare Professionals. Available from: http://www.efpia.eu/Content/Default.asp?PageID=559&DocID=11731 [Accessed June 19, 2012]

Eichler HG et al. (2012). Open clinical trial data for all? A view from regulators. PLoS Medicine; 9(4): e1001202.

Evans I et al. (2011) Testing treatments: Better research for better healthcare. Second Edition 2011. Available from: www.testingtreatments.org [Accessed June 19, 2012]

FDA (2011). Draft Guidance for Industry: Responding to Unsolicited Requests for Off-Label Information about Prescription Drugs and Medical Devices. Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM285145.pdf [Accessed June 19, 2012]

Flynn LR et al. (1994). The King and Summers Opinion Leadership scale: Revision and Refinement. Journal of Business Research; 31(1)@ 55-64.

Fox (2011). Fox Shows How Internet Is Changing Health Care. NIH Record. LXIII(19) Available from: http://nihrecord.od.nih.gov/newsletters/2011/09_16_2011/story2.htm [Accessed June 19, 2012]

Fornai F et al. (2008). Lithium delays progression of amyotrophic lateral sclerosis. Proceedings of the National Academy of Sciences U S A; 105(6): 2052-7.

GBI Research (2012). Pathways to Efficient Drug Development.

Gøtzsche PC (2011). We need access to all data from all clinical trials [editorial]. The Cochrane Library 2011 (5 Oct). Available from: http://www.thecochranelibrary.com/details/editorial/1359903/We-need-access-to-all-data-from-all-clinical-trials.html [Accessed June 19, 2012]

Huse L (2010). 2009 Roche Social Media Summit Recap presented at the 2010 Roche Social Media Summit. Available from: http://askmanny.com/2010/07/diabetes-social-media-summit-2010-my-thoughts/ [Accessed June 19, 2012]

Jonnalagadda S et al. (2012). Discovering opinion leaders for medical topics using news articles. Journal of Biomedical Semantics; 3: 2.

Kaitin KI (2010). Deconstructing the drug development process: the new face of innovation. Clinical Pharmacology and Therapeutics; 87(3): 356-61. Erratum in: Clinical Pharmacology and Therapeutics. 2011;89(1):148.



Appendix

Katz E and Lazarsfeld PF (1955). Personal influence: the part played by people in the flow of mass communication. New York: Free Press.

King CW and Summers JO (1970). Overlap of opinion leadership across consumer product categories. Journal of Marketing Research; 7(1): 43-50.

Kroes M et al. (2011). Beyond KOL management: Communities of practice as a new perspective on pharmaceutical market penetration. Journal of Medical Marketing; 11: 71-83.

Ledford H (2011). Drug buddies: The pharmaceutical industry is seeking stronger ties with academia in a bid to speed up drug development. Nature; 474: 433-434.

Levy D (1994). Chaos theory and strategy, theory, applications and management implications. Strategic Management Journal; 15: 167-178.

Moore GA (1991). Crossing the Chasm: Marketing and Selling High-Tech Products to Mainstream Customers. New York: Harper Collins.

Nair H et al. (2008). Asymetric Social Interactions in Physician Prescription Behavior: The Role of Opinion Leaders. Stanford University Graduate School of Business Research Paper 1970.

Nature Editorial (2011). With strings. Researchers should shrug off their fears and welcome the concept of venture philanthropy. Nature; 475: 266.

Nature Medicine Editorial (2012). A marriage of convenience. Nature Medicine; 18(4): 469-470.

Office of Inspector General (2003). Office of Inspector General’s Compliance Program Guidance for Pharmaceutical Manufacturers. Available from: http://oig.hhs.gov/authorities/docs/03/050503FRCPGPharmac.pdf [Accessed June 19, 2012]

Ornstein O, Weber T, Nguyen D (2010). Docs on Pharma Payroll Have Blemished Records, Limited Credentials. ProPublica, October 18, 2010. Available from: http://www.propublica.org/article/dollars-to-doctors-physician-disciplinary-records [Accessed June 19, 2012]

PatientPartner (2009). Experiences and Perspective of the Pharmaceutical industry on Patient Involvement in Clinical Trials and Research. Available from: http://www.patientpartner-europe.eu/en/the-project/survey-pharmaceutical-industry [Accessed June 19, 2012]

PhRMA (2011). Survey of Physicians About Pharmaceutical and Biotech Research Company Activities and Information. Nationally representative survey of 508 physicians conducted by KRC Research on behalf of PhRMA. Available from: http://www.phrma.org/sites/default/files/987/krcsurveyofphysicians_1.pdf [Accessed June 19, 2012]

QuantiaMD (2011). Doctors, Patients, Social Media. Available from: http://www.quantiamd.com/q-qcp/doctorspatientsocialmedia.pdf [Accessed June 19, 2012]

Rogers EM (1962). The Diffusion of Innovations. 1st Edition, New York: Free Press.

Rogers EM (1976). New product adoption and diffusion. Journal of Consumer Research; 2(4): 290-302.

Rothman SM et al. (2011). Health Advocacy Organizations and the Pharmaceutical Industry: An Analysis of Disclosure Practices. American Journal of Public Health; 101(4): 602-609.

Royal College of Physicians (2009). Innovating for health: patients, physicians, the pharmaceutical industry and the NHS. Available from: http://bookshop.rcplondon.ac.uk/contents/76673804-76c5-4ab3-89a0-92d44e45edc3.pdf [Accessed June 19, 2012]

Sermo Research (2011). Utility of Social Networks For Physicians and Life Sciences Companies. Available from: http://www.sermo.com/free-resources?type=2 [Accessed June 19, 2012]

Smith B (2009). An exploratory study of key opinion leadership management trends among European pharmaceutical companies. Journal of Medical Marketing; 9(4): 291-300.

Smith BD (2011). The Future of Pharma: Evolutionary Threats and Opportunities. Gower Publishing, Farnham, UK.



Appendix

Steiner M et al. (2007). The Continuing Evolution of the Pharmaceutical Industry: Career Challenges and Opportunities Available from: http://www.pharmawealthmanager.com/pdf/RegentAtlantic%20Pharma%20Paper%20Dec-07.pdf [Accessed June 19, 2012]

Stokburger-Sauer NE and Hoyer WD (2009). Consumer advisors revisited: What drives those with market mavenism and opinion leadership tendencies and why? Journal of Consumer Behaviour; 8(2/3): 100-115.

Van Dongen N (2010). Are you patient intelligent? PMLive Available from: http://www.pmlive.com/find_an_article/allarticles/categories/General/2010/april/features/are_you_patient_intelligent_212979 [Accessed June 19, 2012]

Wärneryd KE (2008). The psychological underpinnings of economics: Economic psychology according to Gabriel Tarde. Journal of Socio-Economics; 37(5): 1685-1702.

Webcinia (2012). Open Access Social Media Guidelines for Pharma. Available from: www.webicina.com/solutions/pharmaSM/ [Accessed August 5, 2012].

Wenger E et al. (2002). Cultivating Communities of Practice. Boston, MA: Harvard Business School Press.

Wicks P et al. (2010). Accelerated clinical discovery using self-reported patient data collected online and a patient-matching algorithm. Nature Biotechnology; 29(5); 1837.

6.3 Research Methodology

GBI Research’s dedicated research and analysis teams consist of experienced professionals with a pedigree in marketing, market research, consulting backgrounds in the medical devices industry, and advanced statistical expertise.

GBI Research adheres to the codes of practice of the Market Research Society (www.mrs.org.uk) and the Strategic and Competitive Intelligence Professionals (www.scip.org).

All GBI Research databases are continuously updated and revised. The following research methodology is followed for all databases and reports.

6.3.1 Coverage

The objective of updating GBI Research’s coverage is to ensure that it represents the most up-to-date vision of the industry possible.

Changes to the industry taxonomy are built on the basis of extensive research of company, association and competitor sources.

GBI Research aims to cover all major news events and deals in the medical industry, updated on a daily basis.

The coverage is further streamlined and strengthened with additional inputs from GBI Research’s expert panel (see below).

6.3.2 Secondary Research

Secondary research was carried out on internal and external sources to obtain qualitative and quantitative information in the report.

The secondary research sources that are referred to in this report include but are not limited to:

Company websites, annual reports, financial reports, investor presentations and SEC Securities and Exchanges Commission filings.

Industry trade journals, scientific journals and other technical literature.

Relevant patent and regulatory databases.

National government documents, statistical databases and market reports.

News articles, press releases and webcasts specific to the companies operating in the market.



Appendix

6.3.3 Primary Research

GBI Research conducts hundreds of primary interviews each year with industry participants and commentators in order to validate its data and analysis. A typical research interview fulfills the following functions:

It provides first-hand information on the market size, market trends, growth trends, competitive landscape, future outlook, etc.

Helps in validating and strengthening the secondary research findings; and

Further develops the analysis team’s expertise and market understanding.

Primary research involves email correspondence and telephone interviews, as well as face-to-face interviews for each market, category, segment and sub-segment across geographies.

The participants who typically take part in such a process include, but are not limited to:

Industry participants: CEOs, VPs, marketing/product managers, market intelligence managers and national sales managers;

Hospital stores, laboratories, pharmacies, distributors and paramedics;

Outside experts: investment bankers, valuation experts, research analysts specializing in specific medical equipment markets; and

Key Opinion Leaders: physicians and surgeons specializing in different therapeutic areas corresponding to different kinds of pharmaceutical drugs.

6.3.4 Expert Panel Validation

GBI Research uses a panel of experts to cross-verify its databases and forecasts.

GBI Research’s expert panel comprises marketing managers, product specialists, international sales managers from medical device companies, academics from research universities, KOLs from hospitals, consultants from venture capital funds and distributors/suppliers of medical equipment and supplies.

Historic data and forecasts are relayed to GBI Research’s expert panel for feedback, and adjusted in accordance with their feedback.

6.5 Disclaimer

All Rights Reserved.

No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form by any means; electronic, mechanical, photocopying, recording or otherwise, without the prior permission of the publisher, GBI Research.