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.

Delivering drugs to effectively treat diseases of the back of the eye can be a challenging task. Although pharmacological therapies exist, drug delivery devices and techniques are not very effective at targeting delivery of drugs to the diseased tissues. This work introduces a novel approach to effectively deliver drugs to target tissues such as the choroid and retina. The approach involves a device, a hollow microneedle, to administer the drug formulation into a unique location in the eye, the suprachoroidal space. This new route of administration and a device to accomplish the delivery may provide an effective way to treat diseases of the choroid and retina. The first part of the work determines the ex-vivo feasibility of delivering materials within the suprachoroidal space. The results show that fluids and particles can be delivered into the suprachoroidal space of rabbit, pig and human eyes using a hollow microneedle. It further examines the important parameters for injection of the particles within the suprachoroidal space. The data shows that injection pressure and microneedle length are important parameters for effective delivery of particles. The results lead to a theory on the mechanism by which the particles are delivered into the suprachoroidal space. The second part of the research aims to develop a reliable in vivo delivery device and study the surface area coverage of materials injected into the suprachoroidal space. A hollow glass microneedle device is developed and for the first time shown to be effective in delivering a fluid into the suprachoroidal space in vivo. Up to 100 µL of India ink could be delivered into rabbit eyes in vivo and the spread within the suprachoroidal space is characterized. The results show that a single microneedle injection can cover a significant percentage of the available suprachoroidal space. This is the first study to examine the spread of a material injected into the suprachoroidal space of a live animal. A hollow metal microneedle device is also developed and shown to be effective. The device was able to inject up to 150 µL of latex into suprachoroidal space of fresh human cadaver eyes. The spread of latex is characterized and the results also show that a significant portion of the suprachoroidal space can be covered. The final part of the study examines the clearance of materials injected into the suprachoroidal space of rabbit eyes in vivo. First a comparison of a suprachoroidal injection to a conventional intravitreal injection shows that a suprachoroidal injection is more targeted to the chorioretinal tissues. In addition hollow microneedles are shown to effectively target macromolecules and a therapeutic antibody to the chorioretinal tissues. A study of the clearance kinetics show half lives within the suprachoroidal space on the order of several hours. Nano- and microparticles were also injected into the suprachoroidal space and showed very effective targeting. These non-degradable particles are shown to be present in the suprachoroidal space for months. Basic visual safety assessments identified no adverse effects from the injection of these materials. This represents the first study to compare intraocular clearance kinetics between a suprachoroidal injection and an intravitreal injection. It is also the first study to examine the clearance of a variety of materials from within the suprachoroidal space. Overall this work shows that microneedles have the capability to deliver a variety of materials into the suprachoroidal space of rabbit, pig, and human eyes. The injection can be done in a minimally invasive way with the proper design of an injection device and can target the chorioretinal tissues more effectively than the currently used method. In addition particles have long residence times in the suprachoroidal space, so a particle based drug formulation could provide sustained delivery to the eye. This work represents the first comprehensive study on using the suprachoroidal space as a drug delivery route and also the first study to use hollow microneedles to deliver formulations into the eye in vivo.

Thesis Title: Applying customer involvement in B2B Sales – Case study on a medical device company Date: 10th of June, 2012 Subject, Course: Business Administration, 15 hec. Enterprising and Business Development, 2EB00E. Author: Anna Degrell, 25-01-1989 6647 Advisor: Magnus Forslund Examiner: Richard Nakamura Keywords: Customer Involvement, B2B, Sales, Organize, Apply, Value, Case Study, Medical Device Company Purpose: The purpose of this thesis is to increase the understanding of how customer involvement can be applied in business to business (B2B) sales. Method: the method of choice for this thesis will be within a qualitative approach and contains a case study, with semi structured interviews based on Operationalization of theoretical concepts, and analyzed by grounded theory. Result: Customer Involvement can be presented in several ways within B2B sales; the case study on the medical device company in this thesis has applied the involvement in so-called Sight-visits and as a concept called doctor-to-doctor.

<p>A clinically viable brain-machine interface (BMI) requires a fully-implanted wireless neural acquisition system to limit the impediments of percutaneous connections. For an implanted system with an appreciable telemetry range, and where significant</p><p>neural signal processing is performed continuously, a major obstacle for clinical application is the need for a power source. Existing battery technology and wireless power delivery systems have not addressed the need for a mid-range power supply, capable</p><p>of 1-3 W delivery, that limits both induced noise and temperature rise. These factors are crucial for the succesful operation of a fully-implanted neural acquisition system. This work seeks to fill this void, and presents both a wireless power solution suitable for a neural recording device, and a system capable of real time monitoring of tissue temperature rise.</p><p>During this research, a 2 W transcutaneous energy transfer system (TETS) was designed, built and tested. The TETS was designed specifically for a 96-channel implanted neural data acquisition system, which requires continuous power. The major design constraints were tolerance to coil misalignment, low induced noise,</p><p>and reasonable efficiency. The design of the primary circuit consists of an H-bridge switching network driving a planar spiral Litz wire primary coil. The primary also incoporates a novel circuit for detecting the presence of the secondary. The implanted secondary components include a complimentary planar spiral coil connected to a voltage doubling rectifier. The key approach to mitigating axial coil misalignments was the use of step-down switching regulators in the secondary. With this approach, link efficiency remained nearly constant at 40%, for axial coil displacements of up to 2 cm.</p><p>Noise in the recorded neural signals was minimized using two techniques. First, the 250 kHz operating frequency of the system was tuned, such that the aliased harmonics of the switching frequency lay above the bandwidth of the amplifier used for neural recording. The second approach was to limit the impact of induced displacement currents in the body by physically separating the recording front end from the power supply components. A large titanium enclosure was used to house some of the secondary electronics, and provided a low impedance return path for further</p><p>reduction of current-induced noise.</p><p>Limiting the temperature rise of internal components was also a critical design constraint. The need for real time temperature information led to the design of a six channel temperature measurement system and incorporation of the temperature data into the acquisition system data transmission scheme. This system consisted of bead thermistor temperature transducers, and an off-the-shelf microcontroller with a built-in instrumentation amplifier.</p><p>The TETS and temperature system was fully tested in an ovine model during several acute studies. Recorded temperature rise was limited to approximately 5.5&deg C when the system was implanted at an adequate depth in muscle. The TETS was able to successfully power the 2 W neural acquisition system during a data processing task. Received rectified voltage in the secondary ranged from 14.86 V to 20.2 V, while link efficiency remained virtually constant. Acquired neural data was examined for TETS switching noise. The measured RMS noise increased by less than 1 &mu V, averaged over several experiments. These results demonstrate the first mid-range TETS solution for powering a fully implanted neural acquisition system.</p> / Dissertation

Seven empirical equations were developed for the prediction of seal strength for medical device trays. A new methodology was developed and used for identifying burst and peel locations and comparing burst pressure and peel force. Multiple linear regression was used to fit 76 models, selecting the best models based on the Akaike Information Criterion (AIC) and adjusted R2 (R2 adj) value of each model. The selected models have R2 adj and prediction R2 (R2 pred) values of .83 to .94. Factors investigated for the peel force response were sealing pressure (3 levels), dwell time (3 levels), sealing temperature (3 levels), and adhesive. Additional factors investigated for the burst pressure response were restraining plate gap, and tray volume, height, length-to-width ratio and area. Polyethylene terephthalate-glycol (PETG) trays with Tyvek 1073B lids and two popular water-based adhesives were used. Trays were selected to yield three levels of area and three levels of length-to-width ratio, defining nine package configurations. Packages for burst testing were sealed under a fractional factorial design with 27 treatments. Packages for peel testing were sealed under a 17-point face-centered central composite design. Packages were tested using peel testing following the ASTM F88-07 standard and restrained burst testing with three gap distances following the ASTM F2054-00 standard. All possible subsets of the factors were evaluated, with the best models selected based on AIC value. Equations were developed to predict peak and average peel force based on sealing process parameters (R2 pred =.94 and .92), burst pressure based on tray and sealing parameters and gap (R2 pred =.94), and four peel force responses based on burst pressure and gap (R2 pred =.83 to .86). Models were validated through cross-validation, using the prediction error sum of squares (PRESS) statistic. The R2 pred was calculated to estimate the predictive ability of each model.

The development and the utility of high-tech medical equipments are increasing relative to the health expenditure growth. These high-tech equipments do not necessary benefit the quality of patient care but increase the service utilization for hospitals. This study aims to describe the difference of equipments distribution between academic medical centers and metropolitan hospitals and to examine the association between the change of the kinds, number, and utility of high-tech medical equipments and the health service utilization. Two databases were used in this study. First, a secondary data from the annual hospital survey published in 2003 and 2004 by Taiwan Hospital Association was used. The data contained information on 8 health service volumes, kinds, number and utility of 17 kinds of high-tech medical equipments, 4 hospital characteristics, and 3 kinds of staff ratio. Second, Statistical Yearbook of Department of Social Affairs, Ministry of Interior provided data on Tthe percentage of 65+ years old population in every location. The 8 kinds of health service volumes varience were designed as dependent variables and the 3 independent variables were separately change of kinds, number and utility of high-tech medical equipments. There were 59 samples, 8 academic medical centers and 51 metropolitan hospitals, included. The t-test showed differences between academic medical centers and metropolitan hospitals in change of kinds, number, utility of high-tech medical equipments and health service volumes varience. Person correlation presented how these variables correlated to each other. Regression analyses predicted the health service utilization from those variables. Generally speaking, the academic medical centers only had significant higher varience of average daily emergency roomvisits¡]t = 3.59, p = 0.01¡^than metropolitan hospitals did but there was no significant difference in 3 independent variables. Besides, correlation among medical equipments, health service utilization and themselves shows that the change of total high-tech medical equipment kinds was significant positive correlated with the change of total number of high-tech medical equipments¡]r = 0.44¡^; the change of total number of high-tech medical equipment was significant positive correlated with average daily emergency roomvisits varience¡]r = 0.28¡^and average daily physical examination of outpatient department visits variance¡]r = 0.30¡^; the average utility of high-tech medical equipment was significant positive correlated with average daily outpatient department visits varience¡]r = 0.27¡^. However, the 3 independent variables have no overall significant effect on change of health service utilization. Based on the above findings, although literature indicated that the kinds and number of high-tech medical equipments somehow might stimulate the demand for health service, we did not find the same results. It could be concluded that hospitals¡¦ purchasing of equipment do not impose a significant impact on raising the medical service utilization. Thus, acquisition of high-tech medical equipment might make a hospital a technological leader or give the public a more professional image whether it can help a hospital raise the service quantity is still left to its management.

<p>Background: Businesses are traditionally valued with the so called Discounted Cash Flow-model. When valuing newly-started businesses, surrounded by high uncertainty, and whose capital mostly consists of unrealized business opportunities, the Discounted Cash Flow-model needs to be complemented if the total value of the business is to be captured. A valuation with the help of real options is capable of valuing these unrealized opportunities, which often exist in newly-started businesses. The unrealized opportunities are to be found in the business plan of the business, why this needs to be valued to capture the total value of a newly-started business. </p><p>Purpose: To demonstrate what the use of real options can result in when valuing businesses. </p><p>Realization: The fulfillment of the purpose was achieved by gathering information from a case company. Thereafter the case company was valued by putting the gathered information and made assumptions into suitable theoretical valuation models. Finally, an evaluation of the result was made. </p><p>Findings: A valuation model, which includes real options can give a higher value on the business, but to beable to use real options one need to undertake some assumptions. These make the real option value uncertain to some extent. Real options can however function as a strategic tool. Firstly, the estimated option values can serve as indicators as to which decision to undertake within the business. Secondly, using real options can change the business management’s way to look at what creates value.</p>

Commercial sterilization of medical devices may be performed using electron beam irradiators, which operate at various electron energies. The potential for activating components of the devices has been discussed, with current standards stating that an electron energy greater than 10 MeV requires assessment of potential induced radioactivity. There does not appear to be a literature citation for this energy limit, but it is the accepted default assumption within the industry. This research was directed at evaluating potential activation in medical products sterilized in electron beam as a function of the electron maximum energy. Monte Carlo simulation of a surrogate medical device was used to calculate photon and neutron fields resulting from electron irradiation, which were used to calculate concentrations for several radionuclides. The predominant mechanism for inducing radioactivity is photoneutron production in metal elements. Other mechanisms, including photoneutron production in deuterium with subsequent neutron capture, neutron capture of the photoneutrons produced in metal elements, and isomeric excitation, are all possible means of inducing radioactivity in similar conditions, but none made a perceptible contribution to activation in these experiments. The experiments confirmed that 10 MeV is a conservative assumption that any lower energy does not create significant activation. However, in the absence of a limited number of elements, the amount of induced radioactivity at 11 MeV and 12 MeV could also be considered insignificant. When based on an estimate of the amount of metal present in a medical device, the sum-of-fractions comparison to the US Nuclear Regulatory Commission exempt concentration limits is less than unity for all energies below 12.1 MeV, which suggests that there is minimal probability of significant induced activity at energies above the generally-accepted standard 10 MeV upper energy limit. / text

Tuberculosis is a major concern in low- and middle-income countries, but may be diagnosed using standard chest x-rays. Conventional film-screen x-ray detectors require more maintenance than digital x-ray detectors and need a good supply chain of developer chemicals and film, which make them difficult to maintain in low-infrastructure areas of the world. Current digital x-ray technology is prohibitively expensive for this market, although it brings the possibility of tele-radiology and tele-medicine, quicker diagnosis time, and virtually no cost per test compared to other diagnostics for tuberculosis. This thesis examines the requirements on a small-sized, low-cost digital x-ray detector for this application. Two small x-ray detectors were integrated into x-ray systems, then characterized for detector performance using metrics known as modulation transfer function, noise power spectrum, and detective quantum efficiency. The system designs and the results of the experiments are shown. Details are also shown about the setup of the x-ray lab, including the door interlock system for a lead-lined x-ray cabinet. To determine whether a smaller x-ray detector is diagnostically accurate enough for tuberculosis diagnosis compared to full-size chest radiography equipment, a medical study was designed and run using a web-based survey of radiologists in Pakistan, where tuberculosis is a recognized disease. In an attempt to compare x-ray detector performance, MATLAB code was written to measure the modulation transfer function, noise power spectrum, and detective quantum efficiency of x-ray systems. The details about this code, and challenges in simulating the performance of physically different detectors are explained in the thesis.

Real options analysis has been recommended to identify and quantify opportunities where managerial flexibility can influence worth. However, real options models in the literature have become increasingly sophisticated, and managers have cited their reluctance to use such models due to their level of complexity and lack of transparency. Presented in this thesis is a real options model that can be easily incorporated into the current project selection methodology of a firm; the model uses managerial cash flow estimates to price real options on tangible investment opportunities in a financially consistent manner. Next, to demonstrate the application of real options analysis in practice, five real options models, including the proposed model, are applied to value a medical device project. The models all price the real option differently, due to the differences in their underlying assumptions, but they all yield the same investment conclusion: the medical device project has value.