Thesis advisor: Charles Murry / This dissertation addresses questions in the pharmaceutical and medical device industries. In the first chapter, I study the welfare effects of price discrimination in the medical device industry. In the second chapter, I document shifts in the marketing and prescription behavior for a drug after it is acquired. In the third chapter I study the reputation spillover effects of a major medical device recall. Chapter 1: Implantable medical device manufacturers are able to directly price discriminate by setting different prices for the same product in different hospitals. I analyze the welfare effects of this form of price discrimination in the case of Implantable Cardioverter Defibrillators (ICDs). I find that if ICD manufacturers were forced to switch to uniform pricing, prices increase on average, which causes a decline in hospital welfare and manufacturer profits. Allowing manufacturers to indirectly price discriminate by strategically delaying the exit of old products to target their elastic consumers can cause an increase in product variety, which can lead to different welfare predictions. If we fail to account for a manufacturer's ability change their product offerings in response to a uniform pricing policy, we can overestimate the effects of uniform pricing on hospital welfare, underestimate the effect of uniform pricing on the take up of older, lower quality products, and we may overestimate or underestimate the effects of uniform pricing on manufacturer profitability. Chapter 2: In this chapter, Motaz Al-Chanati and I document novel evidence of a shift in marketing and prescription behavior for a drug after its acquisition. Network size is highly relevant for this industry, as advertising to physicians (known as detailing) typically involves in-person meetings between sales representatives and physicians. We use 10 drug acquisitions in 2015-2016 to document patterns in the data consistent with firms leveraging their existing physician-sales representative networks to market a drug after they acquire it. We also show that this shift in marketing strategy translates into prescription behavior, i.e. after a drug is acquired, physicians that have prior relationships with the acquiring firm increase their prescriptions of it. Chapter 3: I analyze the effects a major product recall in the implantable medical device industry on the sales of other products manufactured by the recalling firxm. I find that after the recall, consumers substituted away from the recalling firm's other products that were not recalled, and toward the products of the recalling firm's rivals. I also quantify the heterogeneity in the response to this recall based on two consumer characteristics: firm loyalty and exposure. I construct proxies for these characteristics, and I find that while consumers that were more exposed to the recall did not have a significantly different response to it, consumers that were more loyal to the recalling firm had smaller responses to it. / Thesis (PhD) — Boston College, 2022. / Submitted to: Boston College. Graduate School of Arts and Sciences. / Discipline: Economics.

Up to date, the biggest challenge of Taiwan¡¦s medical device industry is that the major market was occupied by international companies which directly hold the research and development, manufacture and selling. In addition, the medical devices have the properties in producing few products with diverse forms, research and development with complicating technology and high threshold in the application of product license. As the domestic market in Taiwan is quite small, small and medium-sized enterprises are the mainscales of Enterprises' Operating Capacity here. The chosen of joint venture of two enterprises through strategic cooperation may be one solution to survive in such ecology and play their good in order to create the core value supporting the goal of sustainability for business management. According to the policy considerations, the biotechnology and medical treatment industry are as the important issue in ECFA agreement between Taiwan and mainland China in 2010. All together, there are hundreds and thousands of opportunities for merger, acquisitions and strategic alliance within this industyin the foreseeable future. This study was based on the study case of the 32-years-old Excelsior. It began with dialysis market-oriented industry and then branched out into all the medical equipment industry. Through strategic co-operation, it expanded to become a medical integration platform providing services regarding to comprehensive roles from trade to hospital management. It accommodates the full range of downstream applications for Medical Engineering Services, Pharmaceutical warehousing and logistics, Procurement and supply, and health care management. Although the Excelsior has been to China ten years ago, it fails to succeed and returns back. In 2011, Excelsior makes the joining venture cooperates with the biggest pharmaceutic distributor in China, Sinopharm focuses on four major medicalterritory that are dialysis, medical cosmetic, dentistry and health-check, and approaches the 5000 billion market in Health-Care-Reform offered by the 12th-Five year-plan of China. However, this time it attempts a come back to become the most valuable of the integrated medical and health industry in Asia. Through study on the history and outcome of joining venture between Excelsior and Sinopharm in the field of medical device industry, this thesis addresses factors that will affect business innovation integrated and product line expression. Through studying the case of Excelsior on its background, history of Strategic cooperation¡B integrated product line¡Bfinancial management and experience of success or failure in the past may provide the reference for the development of Taiwan medical device industry.

<p>This licentiate thesis uses descriptive, mainly official,Swedish statistics to analyse industrial structure, productionand foreign trade in an industry that is traditionallydifficult to describe in numbers, that of medical devices. Forthe purposes of the thesis, the Swedish Medical Device industryis defined as companies classified in the SE-SIC manufacturingcodes 33101 (medical equipment and instruments, etc), 33102(dental products) and 35430 (invalid vehicles). Also otherbranches contribute, notably parts of SIC 51460 (wholesale inmedical equipment and pharmaceutical goods) and 73103 (medicalresearch and development) although their medical device volumecannot be specified. Additional items have been identified interms of specific product groups rather than as "belonging" toa specific SIC industrial code.</p><p>Taken together, this is considered to correspond reasonablywell to the scope of the field as defined by the Global MedicalDevice Nomenclature (GMDN), a new European standard forclassifying medical devices in a more generic way than do theEuropean Medical Device Directives (or other pieces oflegislation). No quantification according to GMDN can be madeas yet, however, as that requires changing reporting habits inindustry as well as in official statistical classification andnomenclature regimes.</p><p>With the manufacturing code SE-SIC 33101 as main object, thestudy for the first time presents data on the regionaldistribution, size classes of employment, company starting timeand company dynamics, in the form of entries to and exits fromthe code, over a six-year period. The latter analysis includesa follow-up of the "exits", some firms reappearing in otherparts of industry and others disappearing–surprisinglyfew among them being limited companies. Although this industryis comparatively mature, considerable mobility among themid-sized companies is indicated for reasons of real changes or(to some degree) factors inherent in the industrialclassification system. Some structural changes in companies inthe ≥50 employees bracket are identified. It is notedthat American actors, directly or indirectly, are increasinglyinvolved with the medical device industry in Sweden, and that anumber of technology-based companies that were started mostlyin the early eighties have recently reached the 50+ employeelevel.</p><p>The analysis of identifiable production and internationaltrade in medical devices spans a period of 17 years based onofficial statistics following the HS/CN nomenclatures. Adatabase has been built, bottom-up, from the 8-digit CN levelwith production, exports and imports values for close to 100items collected in 12 product groups, for presentation purposesgrouped under three main headings. Compound annual growth ratesfor the latter are presented for three five-year periods1985-2000, showing that Swedish production and exports have hadan overall growth of 10 per cent p.a. This has kept Swedenahead of the international overall growth of 6- 7 per cent p.a.in recent years, products in the main group "Aids&Implants" growing more than 20 per cent p.a. Growth rates inthe most recent five-year period are lower, however. Healthynet exports figures are presented, the figure for 2002nominally representing 40 per cent of the production value incurrent as well as constant prices.</p><p>Production figures are given at industry (local unit) levelas well as at product group level. The product-based figuresidentified for Production 2001 are estimated to SEK 13,3billion, Exports to SEK 13,7 billion and Imports to SEK 9,7billion. Figures for the Apparent Domestic Market arecalculated for the corresponding entities. It is obvious,however, that the statistics do not capture the real productionvalue as exports exceed production both at overall level and inmajor product groups, particularly those on a high systemstechnology level. The situation is not uncommon for a number ofreasons; further, cases in the statistics methodologyliterature confirm that medical instrument-related codes areliable to this phenomenon. Corrections, including adjustmentsof both production and exports values, are possible butdemanding already at one individual 4-digit HS/CN level. This,therefore, must be considered outside the scope of an academicstudy.</p><p>The basic tablework developed for this thesis will be madefreely available to external parties for their own use providedthe author, with contact details, is named as the source.(Processing for commercial purposes is not expected, however.)Any suggestions for improvements are welcomed.</p>

This record of study details the experience and the knowledge applied by an engineering doctoral candidate during two internships with two separate organizations in the cardiovascular device industry. The first internship was with an early startup company with a large focus in early research and design. The second was in a more mature organization with a focus in process control and increasing efficiencies. The startup company provided the appropriate dynamic for applying engineering design methods such as generating customer requirements, generating product functional requirements, building a quality function deployment, and proposing a basic high level design approach. With the mature company the focus was on investigating procedural inefficiencies through root cause analysis and mitigating the inefficiencies through integrated software solutions. The detailed accounts of these experiences provide a broad overview of the many challenges facing the cardiovascular device industry and the organizations involved. These accounts also illustrate the importance and value of engineering design principles and systems based engineering management in the industry.

This licentiate thesis uses descriptive, mainly official,Swedish statistics to analyse industrial structure, productionand foreign trade in an industry that is traditionallydifficult to describe in numbers, that of medical devices. Forthe purposes of the thesis, the Swedish Medical Device industryis defined as companies classified in the SE-SIC manufacturingcodes 33101 (medical equipment and instruments, etc), 33102(dental products) and 35430 (invalid vehicles). Also otherbranches contribute, notably parts of SIC 51460 (wholesale inmedical equipment and pharmaceutical goods) and 73103 (medicalresearch and development) although their medical device volumecannot be specified. Additional items have been identified interms of specific product groups rather than as "belonging" toa specific SIC industrial code. Taken together, this is considered to correspond reasonablywell to the scope of the field as defined by the Global MedicalDevice Nomenclature (GMDN), a new European standard forclassifying medical devices in a more generic way than do theEuropean Medical Device Directives (or other pieces oflegislation). No quantification according to GMDN can be madeas yet, however, as that requires changing reporting habits inindustry as well as in official statistical classification andnomenclature regimes. With the manufacturing code SE-SIC 33101 as main object, thestudy for the first time presents data on the regionaldistribution, size classes of employment, company starting timeand company dynamics, in the form of entries to and exits fromthe code, over a six-year period. The latter analysis includesa follow-up of the "exits", some firms reappearing in otherparts of industry and others disappearing–surprisinglyfew among them being limited companies. Although this industryis comparatively mature, considerable mobility among themid-sized companies is indicated for reasons of real changes or(to some degree) factors inherent in the industrialclassification system. Some structural changes in companies inthe ≥50 employees bracket are identified. It is notedthat American actors, directly or indirectly, are increasinglyinvolved with the medical device industry in Sweden, and that anumber of technology-based companies that were started mostlyin the early eighties have recently reached the 50+ employeelevel. The analysis of identifiable production and internationaltrade in medical devices spans a period of 17 years based onofficial statistics following the HS/CN nomenclatures. Adatabase has been built, bottom-up, from the 8-digit CN levelwith production, exports and imports values for close to 100items collected in 12 product groups, for presentation purposesgrouped under three main headings. Compound annual growth ratesfor the latter are presented for three five-year periods1985-2000, showing that Swedish production and exports have hadan overall growth of 10 per cent p.a. This has kept Swedenahead of the international overall growth of 6- 7 per cent p.a.in recent years, products in the main group "Aids&amp;Implants" growing more than 20 per cent p.a. Growth rates inthe most recent five-year period are lower, however. Healthynet exports figures are presented, the figure for 2002nominally representing 40 per cent of the production value incurrent as well as constant prices. Production figures are given at industry (local unit) levelas well as at product group level. The product-based figuresidentified for Production 2001 are estimated to SEK 13,3billion, Exports to SEK 13,7 billion and Imports to SEK 9,7billion. Figures for the Apparent Domestic Market arecalculated for the corresponding entities. It is obvious,however, that the statistics do not capture the real productionvalue as exports exceed production both at overall level and inmajor product groups, particularly those on a high systemstechnology level. The situation is not uncommon for a number ofreasons; further, cases in the statistics methodologyliterature confirm that medical instrument-related codes areliable to this phenomenon. Corrections, including adjustmentsof both production and exports values, are possible butdemanding already at one individual 4-digit HS/CN level. This,therefore, must be considered outside the scope of an academicstudy. The basic tablework developed for this thesis will be madefreely available to external parties for their own use providedthe author, with contact details, is named as the source.(Processing for commercial purposes is not expected, however.)Any suggestions for improvements are welcomed. / NR 20140805

<p><strong><strong>Purpose and Execution –The purpose of this paper is to seek feasible suggestions and recommendations to the Chinese medical device industry under the new current market situation—Chinese health care system reform. In order to achieve this aim, we will start with introducing the background of current status of related issues. The next part will be the preparation of further analysis, which contains the theory and descriptions of the health care system reform histories of China, Sweden, the USA and UK. We will consequent present the environmental potential influential aspects. The main discussion will take place around medical device market analysis, together with three representative company case studies. After identifying the opportunities and challenges of the industry, we will draw the conclusions which are the recommendations for Chinese health care industry and also some suggestions for the Chinese government. <strong></strong></strong></strong></p><p><p>Design/Methodology/Approach – To explore these issues, besides literature reviews on market analysis (five forces, SWOT analysis), this paper applies generic competitive strategy, value-based service and service innovation as well. In addition, it also illustrates with 3 mini cases. We acquired both secondary data from related databases and primary data through questionnaires. <strong></strong></p><p>Limitation – Due to the restricted access to the specific database, the acquired information is limited to analyze the paper. Furthermore, according to the fact that the data we obtained is mostly on the basis of the whole medical device industry and it is quite difficult to be classified into particular parts, we decided to limit our research to the medical device industry that caters to both medical equipments and disposable tools when doing the analysis. In addition, since the design of questionnaire includes open questions, the research quality is heavily dependent on the individual skills of the researcher. <strong></strong></p><p>Findings – The new health care system reform will definitely boost the growth of medical device industry, but also create fiercer competition. Chinese Medical device companies need to enhance abilities of marketing, research and development, and aim at meeting customer needs to exploit new profit alternatives.</p></p>

Purpose and Execution –The purpose of this paper is to seek feasible suggestions and recommendations to the Chinese medical device industry under the new current market situation—Chinese health care system reform. In order to achieve this aim, we will start with introducing the background of current status of related issues. The next part will be the preparation of further analysis, which contains the theory and descriptions of the health care system reform histories of China, Sweden, the USA and UK. We will consequent present the environmental potential influential aspects. The main discussion will take place around medical device market analysis, together with three representative company case studies. After identifying the opportunities and challenges of the industry, we will draw the conclusions which are the recommendations for Chinese health care industry and also some suggestions for the Chinese government. Design/Methodology/Approach – To explore these issues, besides literature reviews on market analysis (five forces, SWOT analysis), this paper applies generic competitive strategy, value-based service and service innovation as well. In addition, it also illustrates with 3 mini cases. We acquired both secondary data from related databases and primary data through questionnaires. Limitation – Due to the restricted access to the specific database, the acquired information is limited to analyze the paper. Furthermore, according to the fact that the data we obtained is mostly on the basis of the whole medical device industry and it is quite difficult to be classified into particular parts, we decided to limit our research to the medical device industry that caters to both medical equipments and disposable tools when doing the analysis. In addition, since the design of questionnaire includes open questions, the research quality is heavily dependent on the individual skills of the researcher. Findings – The new health care system reform will definitely boost the growth of medical device industry, but also create fiercer competition. Chinese Medical device companies need to enhance abilities of marketing, research and development, and aim at meeting customer needs to exploit new profit alternatives.

Background: Medical device companies must consider different laws and regulations when developing new products. Not just laws and regulations put on themselves, but also laws and regulations put on the market, including the public sector. New product development consists of what is known as the fuzzy front end (FFE) of innovation, where companies must make ill-defined decisions with limited information. Problem formulation: There is a vast number of studies within the FFE of innovation, many of which focus on what causes the fuzziness, namely uncertainty, complexity and equivocality. There are, however, limited studies focusing on the FFE within the medical device industry, emphasising the public sector. Purpose: The purpose of this thesis is to explore the FFE of innovation within the Swedish medical device industry, where the public sector is prominent. The aim is also to highlight industry-specific aspects of the whole FFE for medical device companies to consider when commercialising their products to the public sector, which is arguably an even fuzzier market. Method: To be able to answer the research question, this thesis is built upon a qualitative, multiple case study with an abductive approach to theory development. Five interviews were conducted with four different companies within the medical device industry in Sweden., and two interviews were conducted with two different county councils in Sweden. Findings: The main findings of this thesis are that the public sector creates higher amounts of uncertainty and complexity within the medical device industry. Thus, the FFE of innovation is industry-specific and also depends on what type of product is being developed. Equivocality as well is found to have other dimensions within FFE in the Swedish medical device industry. Conclusion: Many aspects of the FFE of innovation from previous studies exist in the medical device industry in Sweden, but the FFE seem to contain higher amounts of each cause of fuzziness.

The medical device industry has for a long time lagged behind other industries in terms of adopting new tools for process improvements. Despite showing promising results from various industries, some more heavily regulated than others, modelling and simulation has not yet gained traction within the medical device industry for performing production improvements. The industry has instead relied upon proven improvement philosophies which are believed to generate a desirable outcome. With the purpose of investigating how this novel tool can be combined with current improvement efforts as well as understanding why it has not yet been accepted, a case study was conducted at the Uppsala facility of Johnson &amp; Johnson Vision. A mixed methodological approach was used, where quantitative and qualitative data was analyzed in combination. Semi-structured interviews and structed observations provided empirical evidence for a thematic analysis and a simulation-based bottleneck analysis. Rather than proving that a simulation-based bottleneck was possible in this particular setting, it was used to confirm its applicability in combination with other tools and improvement philosophies. The study concludes that the issue is not strictly related to the use of modelling and simulation but is rather related to the reactive mind-set which has become a consequence of the rigorous regulatory landscape that the industry is encompassed by.

Innovation fuels American business. Commonly, innovation is judged as good. Yet, many of the new medical devices that come on the U.S. market every year are later deemed unsafe. Regulation is distorted in that 98% of medical devices are never evaluated in human trials before being introduced to the marketplace. Instead, the U.S. Food and Drug Administration (FDA) approves a new medical device through a designated 501(k) process, based upon the identification of a predicate or substantially equivalent (SE) device. This is an investigation of the tension between product innovation, government regulation, and public safety in the American healthcare industry. It is a research project in two parts. The first draws upon established methodologies and utilizes the FDA’s 501(k) database to provide an illustrated example of the sequence and dependency between generations of implanted surgical mesh devices. The analysis reveals that the 501(k) approval process reliance on predicate devices facilitates medical device innovation that is problematic in several aspects, including patient safety. To further examine medical device innovation and patient safety, the second study develops a proof-of-concept exercise to evaluate data on recorded adverse events (AEs) found in the FDA’s Total Product Lifecyle (TPLC) database for surgical mesh products. The adverse events were mapped to the Association for the Advancement of Automotive Medicine’s (AAAM’s) Abbreviate Injury Scale (AIS), following precedents found in the medico-legal literature and military injury biomechanics standards. This approach forges a path forward to determine the relative frequency and severity of adverse events of a specific medical device, compared to that of the overall FDA product category. These two research projects combine to contribute to the understanding of safety of the FDA’s approval process and by extension the medical device industry’s innovation practices. / Business Administration/Accounting