Japan Medical Device Digest - August, 2011

Crimson Life Sciences

Local news from the Japanese medical device market – provided as a service to Crimson clients and prospective clients

Lower Costs for Artificial Limbs
The Social Security Council’s Medical Insurance Panel agrees to new provision which will lower the cost of artificial limbs (legs, hands), medical corsets, etc. in consideration of patients’ economic situation. This will ease the cost burden of patients and also lower the number of false insurance claims.
Direct Aortic Observation Developed by Kanazawa University
Kanazawa University’s Lab of Biomedical Instrumentation and Control Engineering develop new system which allows direct observation inside the aorta without stopping patient blood flow. This groundbreaking robotic technique may be used to make thoracic and abdominal procedures less strenuous on the patient.
Nipro Leverages Yen Strength to Purchase Amcor Subsidiaries
Nipro purchases French, Belgian, and American subsidiaries of Amcor for ~$100 million.
Abbott Commences Sale of PCA Balloon Catheter
Abbott Japan to begin sale of NC TREK PCA balloon catheter for coronary disease treatment.
Nipro Seals Russian Joint Venture
Nipro finalizes joint-venture contract for medical-use glass manufacturing in Russia.
Nipro Leverages Yen Strength to Purchase Indian Manufacturer
Nipro purchases controlling interest in Indian manufacturer Tube Glass Containers Ltd.
MHLW Halts Operations of Kobayashi Medical
MHLW suspends business operations of Kobayashi Medical (Osaka). When applying for device approval for a bone fracture treatment device, Kobayashi Medical supplied falsified data.
Nipro Expands to Honduras
Nipro opens new business offices in Honduras (Tegucigalpa) and Mexico (Monterey and Puebla).
GE Healthcare introduces Cell Analyzer
GE Healthcare Japan to release IN Cell Analyzer 6000. The IN Cell Analyzer 6000 becomes the first cell imaging analyzer in Japan to be equipped with three imaging modes.
Terumo Introduces Skin Stapler
Terumo begins marketing new Leukosan Skin Stapler. Suggested retail price will be 18,375 JPY. Terumo is aiming for two-hundred million yen in sales for this new product.
Toshiba Acquires Joint Venture Interest
Toshiba Medical Systems to buy out all shares of Toshiba-Sumiden Medical Information Systems. Toshiba-Sumiden was a joint venture between Toshiba Medical Systems and Sumitomo Electric.
New Procedure Acknowledged by Central Social Insurance Medical Council
The Central Social Insurance Medical Council has reported and acknowledged two new procedures allowing small intestine donation from donors who suffered brain death. This small intestine transplant is indicated for patients with bowel dysfunction.
JMS Begins Dialysis Manufacture in China
JMS subsidiary Dailan JMS (China) to begin full scale manufacture of dialysis tools and needles.
Battery Malfunction Prompts Teijin Recall
Teijin recalls US-manufactured oxygen concentrators due to battery malfunction.
Penumbra Performs Surgical First
Penumbra System used to successfully perform first acute cerebral thrombus removal in Japan.
New Health System Introduced by Hitachi Solutions
Hitachi Solutions introduces the Hellseher Next health check support system.
Severe Adverse Event Caused by Guide Wire
Guide wire placement during central venous catheterization causes patient death in Yamagata prefecture.
Thromboembolisms Diagnosed by Hamamatsu Medical School
Hamamatsu medical school develops new examination kit which allows doctors to quickly diagnose patients with venous thromboembolisms.
Trial Begins for Coronary Stents with Absorbable Scaffolding
Japanese portion of clinical trial evaluating coronary stents with absorbable scaffolding (BVS) has begun. Patient registration is still ongoing.
Physician Survey Results Published by Nikkei Medical
Nikkei Medical surveyed Japanese medical professionals and asked them what they were dissatisfied with, and what they would like to see improved, concerning products they use every day. Nikkei has published the results of a survey related to stethoscopes and blood pressure gauges.
Responce Number of Physicians
Hurts my ears             24
Won't fir in my coat pocketand/or is heavy             22
Not durable, rubber wears out easily             19
Use of stethoscopes is limited to only subjective evaluations             18
Can't hear anything             15
Physician Dissatisfaction Summarized:
Biaural stethoscopes are the norm, but lead to complains such as “they hurt my ears, “they won’t fit in my coat pocket,” “the tubing wears out easily,” etc. Doctors would like to see a product that allows for better sound adjustment.
Physician Suggestions:
“A stethoscope that fits easily in a coat pocket, allowing doctors to conduct examinations even during times of disaster.” – 50-year old physician
“A chest piece that isn’t flat, that would allow doctors to conduct examinations regardless of patient body type or position.” – 40-year old endocrinology/metabolism specialist
“A stethoscope that can digitally record heart and breathing sounds and automatically produce a diagnosis.” – 60-year old geriatrics physician
Blood pressure guages
Responce Number of Physicians
Device has measurement errors               46
Measurement takes too long               16
Gauge cuff is troublesome to use                7
Difficult to carry                6
Applies too much pressure                5
Physician’s Dissatisfaction Summarized:
Depending on the patient’s build, or if the cuff is put on too high on the patient’s arm, measurement is not accurate. Many doctors also doubt the accuracy of automatic gauges. Additionally, many doctors also said that the device applies too much pressure or cannot accurately measure blood pressure in small children.
Physician Suggestions:
“A blood pressure gauge which combines the simplicity of an automatic gauge and the accuracy of a mercury gauge.” – 50-year old cardiac vascular surgeon
“A blood pressure gauge that, like an oximeter, can provide accurate measurements by attaching the device to a patient’s finger.” – 40-year old orthopaedic surgeon
Nikkei Medical surveyed Japanese medical professionals and asked them what they were dissatisfied about concerning medical device manufacturer and distributor organization and administration. Those surveyed were free to select one or more of 10 total choices (multiple choices allowed).
Manufacturer and Distributor Organization and Administration
Responce Percentage
Medical device pricing is not clear     46.6%
Japanese clinical trials are slower than clinical trials performed outside of Japan     32.1%
Lack of training and support from manufacturers/suppliers following purchase     25.5%
Lack of negotiation with regulatory bodies concerning introduction of new products from overseas and concerning device approval process     24.2%
Scarcity of new products and research related to rare illnesses     23.0%
Attitude toward research and development mainly focused on profit     21.3%
No particular concerns     14.6%
Excessive advertising and promotions     10.0%
Quality or speed of information relayed to customer before purchase      9.8%
Other/no answer      2.1%
Opinions from those surveyed:
“Pricing is too vague. There doesn’t seem to be an established price.” – 30-year old oral surgeon
“National Health Insurance (NHI) points are decreasing, but we’re still obligated to carry out inspections and maintenance. This is leaving us with quite a price hike.” – 50-year old gastroenterological specialist
“I want some devices that have cheap, simple to understand prices. Something is always added (to the device I want) to make the price go up, and I can’t afford it.” – 50-year old optometrist
Crimson Life Sciences, a division of TransPerfect Translations, is the only translation practice to be exclusively dedicated to the medical device industry and the only practice to be registered to ISO 9001, ISO 13485, and ISO 14971. For nearly 20 years, Crimson has provided translation and labeling risk management support to device manufacturers in the US and abroad. To support our clients’ growth in Japan, Crimson recently established production in Tokyo with additional linguistic support in Kyoto.




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