Background and Aim: In order to lead to the commercialization of medical devices, intellectual property (IP) created in the study must have been evaluated quantitatively under the consideration of ...clinical situation. Thereby, there is the possibility to promote technology transfer (TT) from academia to industry. In current generic IP evaluation in Japan, patentability and business feasibility are positioned as key indicators. In the case of TT of medical devices, it should also be considered the medical significance beyond the above two indicators. The objective of this study is to develop and use a score tool, which evaluate IP for TT specifically for medical devices. Methods: To develop the evaluation tool, a committee consisting of TT researchers of the National cerebral and cardiovascular center (NCVC) and experts outside NCVC (including patent attorney, business coordinator, academic researcher) was established, and these subjects were discussed in meetings for the past three years. Results: To assist in the review and decision making process of IP deliberation, a scoring evaluation tool consisting of three major criteria (1. patentability, 2. business feasibility, and 3. social aspects), which were organized into eighteen minor criteria, was developed and proposed as the guideline of IP evaluation for medical devices. This evaluation tool was implemented to improve on the objectivity of the decision making process of service invention in NCVC. Conclusions: The scoring tool which evaluate IP for TT specifically for the medical devices was developed and implemented.
Aim: To promote the development of medical devices with new clinical concept, assessment guidelines would be useful for stakeholders; clinicians, manufacturers, patients and regulators. The ...guidelines would contribute to the acceleration of the approval process and safe clinical application. While government-led guidelines could not reflect the actual situation, few guidelines have been established by people in R&D field. In Japan, using ECMO for longer than approved periods (off-label use) increases, which can raise various risks for the stakeholders. To reduce the risks and enhance the development of next-generation ECMO system for long-term use, we propose new assessment guidelines. Methods: We compiled guidelines of ECMO system for long-term use via discussion at a committee which consisted of experts of medical devices, including ECMO; academic experts, clinicians, manufacturers, and regulators. Results: We drafted the assessment guidelines of ECMO system for long-term use. Academic experts examined non-clinical and clinical test issues. Clinicians shared the current clinical needs. Manufacturers showed the market situation and hurdles to approval application. Regulators requested that the guidelines be a reference for the review. Despite different backgrounds and standpoints, experts expanded their views and developed consensus towards the appropriate ECMO use. Conclusions: Partnerships with all experts play a prominent role in establishing "reasonable" assessment guidelines of long-term use ECMO in Japan.
Left ventricular (LV) diastolic function is 1 of the determinants of exercise tolerance. However, the relation between early diastolic velocity of the mitral annulus (Ea) obtained by tissue Doppler ...imaging and exercise tolerance is unknown in patients with impaired LV systolic function. To investigate the feasibility of evaluating exercise tolerance using tissue Doppler imaging, we studied 53 consecutive patients (mean age 58 ± 14 years) with a LV ejection fraction of <50% (mean 37 ± 9%). We measured the peak early diastolic velocity of transmitral flow (E) and Ea at the lateral border of the mitral annulus and then calculated the E/Ea ratio. After echocardiography, we measured the peak oxygen consumption and anaerobic threshold (AT) by cardiopulmonary exercise testing. Of all the echocardiographic parameters, the best correlation for AT was the E/Ea ratio (r = −0.74, p <0.001). Peak oxygen consumption correlated well with Ea and the E/Ea ratio (r = 0.64 and r = −0.68, respectively, p <0.001). The AT and peak oxygen consumption did not correlate with conventional Doppler indexes. Using an AT of 8 ml/min/kg as the cutoff to separate severe exercise intolerance from normal, mild, or moderate exercise intolerance, a receiver-operating characteristic curve showed that an E/Ea ratio of >11.3 had the best combination of sensitivity (88%) and specificity (86%). Exercise tolerance correlated with the E/Ea ratio in patients with impaired LV systolic function. In conclusion, the evaluation of LV diastolic function using tissue Doppler imaging is useful for predicting exercise tolerance in patients with heart failure.
Objectives: To develop new medical devices such as ventricular assist devices, which will be used in clinical practice, it can be considered that industiy-academia collaboration had better to be ...conducted to lead by medical research institute. Medical research institutes in Japan had not generally conducted industry-academia collaboration activities organizationally, whereas industry-academia collaborations have become active in accompanied by shifted to independent administrative agency in the universities. The objective of this study is to clarify the current status of industry-academia collaboration in Japan including National cerebral & CardioVascular Center (NCVC), owing to promote technology commercialization on medical device development Methods: The present activities of industry-academia collaboration of NCVC was compared with that of universities which were surveyed by the Center of the Ministry of Education, Culture, Sports, Science and Technology of Japan. To compare the activities of industry-academia collaboration, the number of joint research contracts and patent royalty income were selected as indicators. Results and Conclusions: The number of joint research contracts of universities in Japan during the last year (within the top 10) was about 300-1000 and patent royalty income was 340-1, 100 thousand U.S. dollars. On the other hand, a department of intellectual asset management was established with the independent administrative agency shift of NCVC on April 2010, and promoted industry-academia collaboration activities. Under this new organization, NCVC entered into 52 joint research contracts and patent royalty income was 70 thousand U.S. dollars during the last year. NCVC has only about 200 researchers and medical doctors, whereas these universities have about 2,000-4,000 faculty and researchers, and hence these universities hold about 10-20 times manpower of NCVC. Considering manpower, our performance of joint research and patent royalty income is equal to within the top 10 universities. These suggest that NCVC can be propelled industry-academia collaboration effectively.
Objectives: As for medical device business, harmful rumors often cause withdrawals of existing companies or entry barriers for new companies. Many Japanese manufacturing companies, especially small ...and medium enterprises, hesitate to enter into medical device business due to the fear for harmful rumors although they can provide high quality technologies. The objective of this study is to investigate the public attitudes toward the medical device field in Japan. Methods: We designed an internet-based questionnaire providing basic information on current status of the medical device field and assessing the public opinion on the issue; necessity, self-sufficient rate, approval, review periods, recalls, information, corporate images of the companies entering into medical device business from other business fields and attitudes toward Japanese medical device companies. The survey included a nationally representative sample of 5,155 adults excluding health care workers. The study period was from March 8, 2011 to March 9, 2011. Results: Among the respondents, 94% recognized the growing necessity of medical devices; 83% required self-sufficient rate improvement of medical devices. As for regulation and safety, 27% poorly understood that medical devices were approved by a government organization; 63% expected shorter review periods; 90% realized that recalls contributed to the safety. Of the respondents, 80% expected to be provided with technical information. Concerning medical device companies, 63% considered that corporate image of the companies which entered into medical device business from other fields would improve; 99% supported for the domestic medical device companies. Conclusions: The study revealed the wide acceptance for domestic medical devices in Japan. Japanese highly recommended contributions of domestic companies to medical device development. The public attitudes may motivate Japanese manufacturing companies to enter into medical device business.
Neointimal hyperplasia influenced by intravascular hemodynamics is considered partly responsible for restenosis after endovascular stenting. To evaluate the effect of stent configuration on fluid ...flow behavior, we visualized flow near stents, and measured the proliferation of cultured endothelial cells (ECs). A single-coil stent (coil pitch; CP = 2.5, 5, or 10 mm) was inserted into a glass tube and perfused at 30-90 ml/min, while the flow pattern was determined by particle imaging velocimetry. The reduction of the flow velocity near the wall was correlated with the decrease in the coil interval of the stent. In perfusion cultures with stents, the proliferation of ECs was influenced by the local flow velocity distribution. When a stent with a CP value of 10 mm was used, the doubling time of ECs was 30.7 h, while the doubling time was 38.5 h when the CP was 5 mm. The doubling time of ECs was shorter at sites upstream of the stent wire where the velocity was higher than downstream of the wire. In conclusion, a single-coil stent can be used to modify hemodynamic factors, suggesting that improved stent design may facilitate rapid endothelialization after stent implantation.
The receptors for human interleukin-3 (hIL-3R) and granulocyte–macrophage colony-stimulating factor (hGM-CSFR) consist of an α subunit, specific for each cytokine, and a β subunit, common to IL-3, ...GM-CSF, and IL-5. We cloned genomic DNA covering 1.5
kb of the 5
′ flanking region of the hIL-3Rα gene and identified multiple transcription start sites by 5
′-RACE and primer extension analyses. By use of transient transfection experiments, two regions (nt −363 to −331 and −106 to −92) of the hIL-3Rα promoter appeared to have significant transcription-enhancing activities. Electrophoresis mobility shift assays revealed the binding of Sp1 and unidentified proteins to these regions. Deletion of a putative PU.1 binding site did not affect the promoter activity. We then analyzed 2.5
kb of the hGM-CSFR α gene and found the proximal PU.1 binding site to be important for transcription-enhancing activity, as previously reported. These results suggest that different transcriptional activation mechanisms are employed for the transcriptional regulation of hIL-3 and hGM-CSF receptor α genes.
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