Contributing to Society through Pride and Sense of Responsibility as Expert Manufacturing Group Interview with Ventilator Production Support Team
October 27, 2020
In May 2020, amid concerns about a shortage of mechanical ventilators to treat patients suffering from COVID-19 infection, Sony Corporation ("Sony") expressed its intention to cooperate with the Japanese government (the Ministry of Economy, Trade and Industry and the Ministry of Health, Labour and Welfare) and support ventilator production as part of its social contribution.
Sony Global Manufacturing & Operations Corporation ("SGMO") assumes this responsibility as an expert group in manufacturing. Having years of experience and skills in electronics products, the company joined forces with ACOMA Medical Industry Co., Ltd. (hereafter "ACOMA") to produce 500 ventilators in just 2 months.
We spoke with the project manager Shiro Asashima, the manufacturing technology and customer representative Kazuyuki Tamamura, and the QMS representative Rika Nakashima to hear about SGMO and Sony's first ventilator production through collaboration with ACOMA.
Deputy Senior General Manager, Client Relation Division
Sony Global Manufacturing & Operations Corporation
Medical Department 1,
Sony Global Manufacturing & Operations Corporation
Medical Quality Assurance Department, Medical Center
Sony Global Manufacturing & Operations Corporation
──First, please tell us your brief background.
Shiro Asashima：I was originally in charge of designing panels and mechanisms in the Television Business Division for a total of 23 years, including overseas assignments. After that, I thought I needed to take on a broader challenge beyond a single product category or a field of mechanics, so in 2015, I established an organization to deal with new businesses, which later became the basis of our current organization. It has been five years since then, and as part of it, I've become involved in supporting the manufacture of this ventilator.
Rika Nakajima：I was engaged in a project to promote globalization at the Inazawa site in Aichi Prefecture. After the project was completed, it was decided to introduce the manufacturing of medical devices in the Koda site in Aichi Prefecture. The way of thinking and culture to deal with medical devices is very different from consumer products, and in order to make it firmly established among members, I organized the educational system, built the quality management system (QMS), and worked on management and maintenance of them.
Kazuyuki Tamamura：I was a mid-career recruit, and I used to design car parts. Since I wanted to work on final finished products, I decicded to join SGMO (Sony EMCS at the time). After designing products for Cybershot and Handycam, I have been in charge of manufacturing technology for medical devices since 2015.
Sony Offers Support in Response to Government's Request
──What made you decide to support the production of artificial ventilators?
Asashima：Around March of this year, when the new coronavirus started to spread in Japan, there was a lot of news about the lack of ventilators at medical sites. In fact, almost all the ventilators distributed in Japan are imported from overseas, and it was difficult to import such equipment when the whole world was facing a severe shortage of ventilators.
In an effort to increase the domestic production of ventilators, the Japanese government (the Ministry of Economy, Trade and Industry and the Ministry of Health, Labour and Welfare) held a business matching event for medical device manufacturers and manufacturers from other industries to call for cooperation, in which Sony also participated. After talking with several medical device manufacturers, we finally confirmed that the support ACOMA needed and what SGMO was able to do matched, which realized our collaboration.
Trust and Confidence in Sony
as Manufacturer of Medical Devices
──What was the decisive factor for SGMO to undertake contract manufacturing?
There are three main points. The first one is our experience in external business. Actually, what surprised everyone was that Sony can make other company's products. People thought it was impossible for Sony to produce anything other than Sony products, and it was also surprising to them that we already had a large number of experiences in not only manufacturing but also providing schemes for design and parts procurement.
The second point is that we are producing medical devices and holds ISO 13485 certification. ISO 13485 is an international standard for quality management systems specialized for the medical device industry, and our acquisition of this certification is a significant advantage in that we will be recognized as being able to provide safe and high-quality medical devices.
The third point is our capacity of mass-production. ACOMA's ventilator business is based on small-volume production with about 100 units per year. In order to respond to the government's request for 500 units in 2 months, they thought that our capacity was indispensable. Some big companies raised their hands to support production, but I think Sony was the only company that was able to offer this all-encompassing support.
Starting with "No Parts!"
──What difficulties did you have when cooperating with ACOMA to support production?
Tamamura：Of course, we are different companies, and we have different ways of doing things. For example, if it's within Sony, we can exchange parts based on the same part numbers through the same system, but ACOMA's part numbers are unique to ACOMA, so parts must be managed manually. What was even more difficult was the model we are supposed to produce. It was designed and developed by ACOMA 20 years ago, and its production ended 10 years ago. Some parts are no longer distributed in the world, and we started by searching for stock in the market.
Establish the Mass Production System by Quantifying Craftsman's Sense of Touch
Tamamura：As for production, the design was made 20 years ago, and the tightening torque for parts was not described in numerical values. It was left to the feeling of the person who made it. This time, we quantified all those senses, and established standards. At first, it was difficult to determine the balance and how much torque could appropriately tighten parts. In the process of trial and error, we sometimes applied too much force and happened to break parts.
Asashima：So far, ACOMA has produced ventilators, about one unit a day, using the skills and knowledge of experienced employees. However, when it comes to producing 500 units in a short range of time, it is important to set a procedure so that anyone who handles it can achieve the same quality.
Tamamura：While preparing an operation manual to ensure it, we calculated the tact time and designed the process so that we could produce 500 units in 2 months, that is, 15 units per day. These are the areas in which we excel, and that's what ACOMA expected most from us.
From ACOMA, on the other hand, we learned a lot about the design of ventilators. A ventilator blends air and oxygen and then sends it into a patient's body. The amount of this air supply and timing of pressuing the air into the lungs are ACOMA's own know-how accumulated over many years, which is well integrated into their products. It was a great learning to us.
Unprecedented Wall of Class Ⅲ
(Specially Controlled Medical Devices)
Nakajima:：Medical devices are classified according to the degree of risk to the human body based on laws and regulations in each country. Under the Pharmaceuticals and Medical Devices Law in Japan (Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices), there are four classifications from Class Ⅰ (lowest risk) to Class Ⅳ (highest risk). The ventilator we manufactured this time falls under Class Ⅲ. In the United States, some medical devices manufactured by Sony are classified as Class Ⅱ, but in Japan, we had only experience on Class I devices (general medical devices). So, when our contract manufacturing was decided, the first words that came out of our mouths were, "Do we handle Class Ⅲ immediately from the start?" The Class Ⅲ devices are categorized as "specially controlled medical devices," which raise the hurdle higher all at once. In the mid-term perspective, we were planning to try a higher class, but all of a sudden we faced Class Ⅲ without experience of it. We were at a loss as to how to tackle this challenge.
Normally, the manufacturer that solely manufactures products and the marketing company that takes final responsibility for the products work together to bring medical devices to the market. Therefore, the quality management system (QMS) of SGMO is designed so that it can effectively coordinate with the QMS of Sony's business companies.
This time, however, the product must function based on ACOMA's specification, so it took a long time for us to make adjustment. To manufacture the product itself, parts and operation standards are provided by ACOMA, but the requirements for the processes around product realization are different from our rules, so we worked so hard to seek how we should put those process requirements into our rules in order to help produce ventilators in a short period of time without inconsistency.
In terms of our efforts, there was a change in the policy in the middle of the project and we had to register the Koda Site as a manufacturing facility of medical devices.
In Japan, under the Pharmaceuticals and Medical Devices Law, a manufacturing site where medical devices are manufactured must be registered with the health ministry. But, from the standpoint of production support, ACOMA first judged that our manufacturing registration would not be necessary. However, after the project started and in the course of repeated meetings, a considerable part of the production had to be conducted by SGMO, and since it corresponds to "main assembling" defined in the law, we immediately applied for registration in response to ACOMA's request.
Nakajima:：The application procedure itself was not that difficult, but in order to respond to the situation quickly, the person in charge had to make every effort by running around to prepare necessary documents to submit to the authority. This registration of our manufacturing site increased our responsibilities. Furthermore, we hear that the Pharmaceuticals and Medical Devices Agency (PMDA), which is under the jurisdiction of the health ministry, conducts very strict inspections for compliance with the Class Ⅲ criteria. That's why we said in astonishment, "Do we handle Class Ⅲ immediately from the start?" as I mentioned earlier
──What kind of awareness and learning did you gain by working with ACOMA?
Tamamura：As we expected, it was a very good experience to know about another company. For example, if we think how to meet the Class III requirements, we tend to make excessively strict rules. The more we do, the more it costs us. We thought it would be difficult to enter this filed. However, through our collaboration with ACOMA, we were able to obtain hints on how to create a system and mechanism without spending much cost: that is, if we do proper management in a stratified manner by strictly controlling where risk is high and taking drastic actions where it is not, we can achieve the goal.
Asashima：It was a big realization to me that Sony's standards we have designed so far do not necessarily apply to every situation. The Medical Center is an organization that is responsible for manufacturing medical devices in Sony, and we thought that its know-how would be greatly useful in the medical field, but most of our ideas and ways of doing things were quite unique to Sony, regardless of whether it is good or bad. In that sense, ACOMA's example may not apply to future cases, and I'd like to make effort every effort with sincere mind of learning things from other companies.
Tamamura：ACOMA said that they learned a lot from us in terms of quantification and SGMO's process design. During the mass production phase, ACOMA members worked on site at our factory to check the quality of products and make judgment. According to ACOMA, they dispatched their young members to the factory to study Sony's manufacturing. This collaboration was mutually beneficial, and we have received positive comments from the Plant Manager of ACOMA saying that they would really like to work with us again.
Fill the World with Emotion through Useful Things for People
──Lastly, could you tell us your thoughts on manufacturing, based on the experience of producing artificial ventilators?
Nakajima:：Medical care is indispensable in our social infrastructure, and I am proud that I work as a part of it. As the QMS, I believe that my mission is to provide a mechanism to ensure stable quality not only for Sony products but also for other companies' medical devices so that we can support many doctors and patients.
Tamamura：As I said in the beginning, I joined this company with the desire to produce final products, and through designing digital cameras and video cameras, I was able to experience feeling joy by delivering excitement or deep emotion to people. When I thought I wanted to do something useful for people next time, SGMO was expanding its business in medical devices and I ran for it.
When I was a student, I lost a friend to cancer, and I was shocked to find that there was such a young person who couldn't live. Since then, I've always felt that I wanted to be involved in medical care someday. I was unexpectedly given a chance in this company, and it was very rewarding to be involved in producing ventilators that are needed in the world today. Sony is a company that creates emotion and I believe that such emotion can also be realized by creating "what people need to live" and "things that can help health care workers." As an engineer, my goal is to contribute to society through Sony's power of creativity and technology.
Asashima：As a professional manufacturing group, we'd like to always take on new challenges. This time, the request from the government gave us a big power to move forward, and I think the experience of dealing with what I initially thought was impossible, including responding to class III requirements, has allowed us to gain confidence. When we start doing something new, or when we're hesitating to do something difficult, I think it's important to take a step forward anyway without fear.
Also, when I heard about the distribution of artificial ventilators, I leaned the fact that most of the medical devices were manufactured overseas because of their costs. I think there are many things we have to deal with by ourselves in Japan, expecially something that is related to people's lives, and I've realized that it is very meaningful for a company like Sony to have a system to take an immediate action for unpredictablee situations like this. I hope we can continue to contribute to society, even if it does not lead to immediate profits.
■ACOMA Medical Industry Co., Ltd.
Since its establishment in 1921, ACOMA has been a leading player in the manufacture and sale of medical equipment, mainly anesthesia machines and ventilators. It is delivering innovative products to the medical fields, such as Japan's first aneroid blood pressure meter and the "annespilator," which has been originally developed with functions of the anesthetic machine and ventilator.
ACOMA Medical Industry Co., Ltd. Website：https://www.en.acoma.com/
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