Chapter III Research Methodology
3.1.2 Information Collection
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informed consent were carefully read to figure out the reason why a given patient was assigned to a given procedure. Medical expense of each case was obtained from the administration section, and the medical expenses between the two groups were compared.
In-depth interviews with two surgeons working with the case hospital and seven industry persons were conducted. According to the literature review and the research framework, the researcher developed the following six questions as the interview guideline:
1. How many years have you been working as a surgeon or in the medical product industry? What is your field of specialty ?
2. How do you promote the EVAR-related products in the market? Do you need any knowledge or skill different from those you used to promote other products in the past?
Is there any new business model?
3. Does EVAR have any influence on the behavior of medical product suppliers?
4. Does EVAR have any influence on the behavior of payers (in this aspect it means mainly the national health insurance system), medical service providers, or patients?
5. Whether EVAR (endovascular stentgraft) is a successful operation (product) and why?
6. Please describe the essential features of a successful operation (product).
The research finally used the combination of the analysis of the information from the medical records, the information from the in-depth interview, and the results and theories in the literature reviewed to generate the final conclusion and future perspective.
3.1.2 Information Collection
The interviewees were from both the medical service provider, that is the case
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hospital, and the medical product supplier, that is the industry. One of the two senior cardiovascular surgeons who performed the majority of these cases in the studied hospital was interviewed. Another young vascular surgeon who joined the group recently was also interviewed. Seven business men from two major medical product supplier system in Taiwan were also interviewed. Table 3.1 listed the interviewees‘
position, location, and years in the field, and interview methods.
Interviewee Specialty Years in
the field
Interview method Dr. T, Chief surgeon Cardiac and vascular
surgery
22 Personal Dr. H, Attending surgeon Vascular and endovascular
surgery Table 3.1 Interviewees‘ background and interview methods. ＊Mr. D had another 11 years‘ experience in orthopedic product, and ＊＊MR. L had been a senior sales representative in an international pharmaceutical company before he joined the present company. (source: the study)
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Chapter IV
Case Description and Analysis
In this chapter, the author will first briefly describe the current features of the medical service in Taiwan as background information for readers not familiar with it.
The process of the conduct, or the business model, of the new endovascular aortic repair and the traditional open surgical repair was then explained. This chapter will finally be focused on analysis and description of the reasons that the case hospital started to introduce the innovatively new surgical procedure and soon adopted the new procedure in almost every single patient, if not contraindicated.
4.1 Current Features of Medical Service in Taiwan
Concerning the overall provision of medical services in Taiwan, there has been a significant change after the commencement of the national health insurance system in March 1995. As the finance of national health insurance system continued to deteriorate, the National Health Insurance Bureau started the ―global budget system‖
in July 2002 to control the increase of global medical expenditure. This resulted in the decrease of hospital revenue, yet increase in cost. In addition, competitors continued to join in the already saturated market. Efficiency and quality, which medical service providers emphasized the most in the past nowadays failed to overcome the changing environment. It has become a key issue for medical service providers to survive this environment of extremely limited resources with innovation in medical services.
Wang et al. (2005) cited Abernathy and Clark‘s (1985) innovation types and reported in their seminar paper that the majority of medical service providers now in Taiwan focus on regular innovation that can be easily imitated. They suggested that
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medical service providers should aim at niche innovations, architectural innovations, and revolutionary innovations. (Fig. 4.1) Small-scale medical service providers are supposed to adopt the niche innovations strategy because of their insufficient resources. Those large-scale medical service providers with ample resources can adopt the architectural or revolutionary innovation strategy to offer new products or services to their existing customers or even to attract new customers.
Figure 4.1 Abernathy and Clark (1985) Innovation types
4.2 Current Status and Strategy of the Case Hospital.
The case hospital is Buddhist Tzu Chi General Hospital, Taipei Branch. There
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have been successively four cardiovascular surgeons. Currently two senior surgeons, amongst who the researcher is one, work with the hospital performing a large variety of major cardiac and vascular operations. A brief description of the case hospital as written by the superintendent Dr. You-Chen Chao is provided here.
―In the 1960s, life was extremely hard in Taiwan and people‘s living standard was low. Moreover, people who living in the east coast of Taiwan were very impoverished. Master Cheng Yen with great compassion responded to the suffering of the poverty-stricken and vowed to pour great love into the ‗medical desert‘ of eastern Taiwan .In 1986, the first Tzu Chi General Hospital was established in Hualien. Yuli, Kuanshan, Dalin, Taipei and Taichung branches were opened accordingly. Tzu Chi medicine mission, just like the blossoming flowers of happiness and wisdom, spread from poverty-stricken east coast to the rest of Taiwan and formed a strong force of compassion that lives on endlessly.
Tzu Chi General Hospital, Taipei Branch was inaugurated on May 8, 2005.
Under the collective support of Master Cheng Yen and global Tzu Chi volunteers, Tzu Chi built the first quakeproof hospital in Taiwan and well-known around the world.
With the state-of-the-art, our hospital is designed to withstand the destructive forces of earthquake for thousand years. It is not only a new milestone for Tzu Chi medicine mission, but also a new ideal for humanistic medicine in the medical field of Taiwan.
In the congested and chaotic medical environment, Tzu Chi General Hospital, Taipei Branch is an oasis of spirit brimming with tranquility, humanism and harmony.
Tzu Chi General Hospital, Taipei Branch is a large-scale hospital built to become the medical center filled with humanity. Besides of establishing the various medical specialties, exceptional fundamental, and state-of-the-art clinical services, we develop micro-invasive operations to minimize patients‘ suffering. In addition, it integrates with Tzu Chi massive network of community volunteers. With their great support, the
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and public hygiene work. The hospital also provides medical diagnosis, medical treatment, rehabilitation, and parent-children education for physically and mentally challenged children and their families.Despite of the constant advanced medical technology that unravel the secrets of life, the innovation can only do so much to help the patients who still have to face the impermanence and unpredictability of life and the accompanying emotional suffering.
In most of the situations, the patients need medicine treatment as well as spiritual comfort. Tzu Chi medical team comes together with the community volunteers to form a comprehensive team with the full of humanity. It highlights the spirit of empathetic love in ―when others are hurt, we feel the pain; when others suffer, we feel the sorrow‖. More than 220 Tzu Chi volunteers serve at the Taipei Branch daily at various locations, no matter of rain or shine throughout the year. They communicate Tzu Chi great love to every patient and the families. This unceasing stream of selfless compassion flows through the whole hospital. Every year, over 70 thousand Tzu Chi volunteers become great resources for this medicine team and witness the precious life.
Life is priceless. Life and death are unexpected. Tzu Chi medical team always serves patients with humbleness and cherishes every second to safeguard life with vigilance. From doctors, nurses to volunteers, we devote ourselves to the mission of
―guarding life, health, and love‖ with sincere ―gratefulness, respect, and love.‖
Having weathered through many obstacles and challenges, Tzu Chi General Hospital, Taipei Branch stands firmly in the Taipei metropolitan landscape, brimmed with its humanistic spirit, first-rate medical team, and advanced medical technology.
I anticipate every member of extraordinary team to embody our founder Master Cheng Yen‘s great compassion in carrying forth her dharma of relieving human
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suffering, saving lives, and to sow the seeds of love in every community and around the world.‖
4.3 Endovascular Aortic Repair (EVAR) in the Case Hospital
4.3.1 Introduction of EVAR into the Department of Cardiovascular Surgery The innovation strategy of our hospital is not only to establish various medical specialties, exceptional fundamental, and state-of-the-art clinical services, but also to develop micro-invasive operations to minimize patients‘ suffering. The department of cardiovascular surgery, following this strategy, has been providing both conventional major cardiac and vascular surgery and minimally invasive cardiac surgery including off-pump coronary artery bypass grafting (OPCAB), videoscopically-assisted cardiac operations (eg. EndoACAB, videoscopic mitral valve repair, and etc), and traditional cardiac operations though small wounds. Every effort had been exercised to make the organization an efficient and safe one. This is our regular innovation strategy.
As afore-mentioned in the first section of this chapter, for a 750-bedded regional hospital with sufficient resources and supporting system and located in the metropolitan area full of competition, we must consider periodic revolutionary innovation on top of continuous regular innovation to keep the hospital from stagnation. Though the two senior cardiovascular surgeons, amongst whom the author is one, were trained in the traditional ways in their residency and have been practicing accordingly for a long time, we agreed to this point of view and decided to embrace the chance to adopt a revolutionary surgical technique, that is EVAR, early in 2009.
We simultaneously started our thoracic endovascular repair (TEVAR) program. While TEVAR shared many similar technical requirements with EVAR, it is not included in the study.
At the same period of time, in our daily practice, we treated patients with
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abdominal aortic aneurysm larger than 5.0cm routinely with transperitoneal open abdominal aortic aneurysm resection and grafting, which had been the traditional and well-established treatment modality. As part of the innovation program, we had to prepare the whole surgical team for the necessary knowledge and surgical techniques through off-line lectures and on-line practice. The two surgeons attended several simulation courses and had been practicing peripheral vascular interventions to train themselves with the catheter techniques mandatory to the new procedure. An experienced endovascular surgeon was invited to supervise the first five cases.
Not only EVAR in comparison to the traditional open surgical repair (OSR) is an innovatively new procedure, but also the devices (endovascular stentgraft) to be implanted are much more complex and expensive than the vascular prosthesis used in the traditional open surgery. To cope with these challenges, a new business model between the industry and the medical service providers (including the case hospital) in Taiwan has been developed.
4.3.2 Conduct of EVAR in Regional Hospitals (including the case hospital) in Taiwan
For several decades, cardiac and vascular surgeons are trained and required to be familiar with both their surgical techniques and the characteristics of those medical devices to be implanted. In the hospital settings, a whole range of prosthesis or devices of different models and sizes should always be available on shelf for elective and emergent operations. During an operation, a surgeon can modify his/her surgical procedures upon observation of the particular anatomical variation and the actual model and size of the prosthesis most of the time is determined after assessment of the patient‘s anatomy during the operation.
In the daily practice of the open surgical repair, a patient sees a doctor for
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surgical consultation and performance of the operation. The surgeon provides recommendation on choices of treatment and conducts the operation with his surgical team in the operation theater. After the operation, the surgeon also takes care of the patient in the ward and later in the out-patient department. Patients generally don‘t need to have further computed tomography angiography after open surgical repair unless specifically indicated in certain circumstances. The fee for medical services and expenditure on prosthesis are reimbursed separately by the insurance company (in Taiwan‘s case, the national health insurance system). The business model of the traditional surgery melieu is demonstrated in Fig. 4.2.
Figure 4.2 Business model of the traditional surgery melieu. (source: the study)
The service process of EVAR is slightly different from OSR. Before each operation, surgeons have to read the reconstructed computed tomography angiography (CTA) to make a surgical planning, comprising steps of procedures and the proposed choices of model, size and length of the endovascular stentgraft to be implanted.
During the operation, the whole procedure is conducted under real-time fluoroscopy and angiography guidance. Postoperatively, patients are followed up closely on
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out-patient basis and must undergo periodic computed tomography angiographies according to the institute policy and protocol. During each operation, the steps of procedures can vary because of anatomical and technical consideration and the actual model, size and length of the endovascular stentgraft to be implanted can also vary a lot. Traditionally the vascular prostheses are supplied on the shelf. This can be a problem for endovascular surgery considering the complexity and high price of the devices.
To conquer this situation, the industry and the medical service providers have developed a new business model. The industry has now a ―technical sales specialist‖
who is well trained in the knowledge of endovascular surgery and very much familiar with its devices. While surgeons are performing the operation, the technical sales specialist will be in the operation room carrying ample supply of a wide range of models and sizes of the endovascular stentgraft and to offer detailed information on those devices to the operating surgeons. Instead of a sales specialist, he/she also serves as a technical specialist when it comes to the special features of the devices.
The business model of the EVAR melieu is demonstrated in Fig. 4.3. Details of the development and operation of the business model will be prescribed further in the section of analysis of the in-depth interview.
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Figure 4.3 Business model of the EVAR melieu. (source: the study)
4.4 Paradigm shift in surgical treatment of abdominal aortic aneurysm
The endovascular stentgraft used in EVAR had not been reimbursed by the national health insurance system till February the 1st, 2010. Before that date, patients consented to EVAR had to pay an extra expenditure of approximately 500,000 NTD on the endovascular stentgraft. We started our EVAR program early in 2009, while only one out of the 6 patients with abdominal aortic aneurysm treated surgically in 2009 consented to EVAR. On the contrary, yet not surprisingly, the numbers of patients treated with EVAR soared in 2010 as the implementation of reimbursement.
The numbers of patients treated with EVAR or OSR over these 6 years are demonstrated in Fig. 4.4.
From Fig. 4.4 we found that there was an evident paradigm shift in the modalities of surgical treatment of abdominal aortic aneurysm in our institute.
Patients were treated solely with open surgical repair (OSR) from 2005 to 2009. From 2010 till now, most of our patients were treated with EVAR.
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Figure 4.4 Numbers of EVAR and OSR (source: the study data)
When we looked at the patient data listed in Tab. 4.1, there was a definite male dominance (M/F = 42/1). Patients treated with open surgery (OSR) were slightly younger than patients treated with EVAR, though there was no statistical significance (73.3 vs 78.4, p=0.088). The length of hospital stay was significantly shorter in the EVAR group (10.9 vs 23.1, p=0.003). Nevertheless, the medical expenditure of the EVAR group is more than doubled that of the OSR group (633,146 vs 313,400, p<0.001).
EVAR OSR p
Age (years) 78.4(55~93) 73.3(55~87) 0.088
Male/female 17/1 25/0 -
Length of stay (days) 10.9 23.1 0.003
Medical expenditure (NTD) 633,146 313,400 <0.001
Table 4.1 Patient data (source: the study data)
0 2 4 6 8 10 12 14
OSR
EVAR
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The previously mentioned questions were used as a guideline in interview. Three persons from W. dealer company and G. medical product company were interviewed through phone interview and written questionnaire. The others were interviewed in person.
The chief surgeon Dr. T, who has been working in the cardiac and vascular surgery profession for 22 years, responded and reported that he started performing minimally invasive cardiac surgery, mainly traditional operations through smaller wounds in the 1990‘s. He aborted these so-called minimally invasive operations later on when he thought that the invasiveness of these operations was not really reduced dramatically merely because of the smaller wound while there still being cardiopulmonary bypass. (author‘s note: The invasiveness and thus its possible adverse consequences of open heart surgery come mainly from median sternotomy and cardiopulmonary bypass.) Recently he concentrates on EVAR since he thinks that it is not just a modification of the traditional operation; on the other hand, it not only avoids the large laparotomy wounds, but also prevents the time of aortic clamping and thus a certain period of tissue ischemia. He believes that this is a true minimally invasive approach. However, the different surgical techniques and complexity of those devices did add difficulties in learning and adopting the new operation. Though the emergence of a technical sales specialist from the industry could compensate to a certain degree for the complexities, that is, the gap between the endovascular surgeon and the devices, he somewhat worried about the increasing importance of the role of the technical sales specialist. After all these successful operations and superb experiences, he stated that he could hardly recommend a patient to have open surgery again.
The young attending surgeon Dr. H was trained to be an endovascular surgeon in
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his residency. He is competent in endovascular techniques and takes it for granted to first advising patients to have EVAR. He does not consider whether or not to do EVAR, but how to do it perfectly using state-of-the-art techniques and devices. Open surgery is not in his armamentaria unless endovascular surgery is not possible.
G. medical product company and M. medical product company are two of those major EVAR device suppliers in Taiwan. W. dealer company and M. dealer company are responsible for distribution of products.
The promotion strategies were different from before, said General Manager D from G. medical product company, who had 20 years‘ experience in marketing and distribution of surgical, dental and vascular surgical prosthesis and 11 years‘
experience in orthopedic surgery prosthesis. Mr. D reported that G. company‘s strategy was to promote the product in conjunction with its dealer and surgeons interested in this field. The G. company focused on branding and marketing.
Experienced technical sales specialist from the G. company and the W. company offered expedite and comprehensive clinical technical support to surgeons both proactively and upon request. It was of equal importance both to offer official
Experienced technical sales specialist from the G. company and the W. company offered expedite and comprehensive clinical technical support to surgeons both proactively and upon request. It was of equal importance both to offer official