J.
Eng.
Technol.
Scien.
Vol.
No.
5, 2020, 765-778
Lessons Learned from Rapid Development of CPAP Ventilator Vent-I during Covid-19 Pandemic in Indonesia Syarif Hidayat1,2.
JamAoah Halid2.
Tatacipta Dirgantara3,*.
Mipi Ananta Kusuma4.
Hari Utomo2.
Reza Widianto Sudjud5.
Ike Sri Rejeki5.
Sandro Mihradi3.
Sri Raharno3.
Dadang Rukanta2 & Hari Tjahjono6 School of Electrical Engineering and Informatics.
Institut Teknologi Bandung.
Jalan Ganesha 10.
Bandung 40132.
Indonesia Rumah Amal Salman.
YPM Salman ITB.
Jalan Ganesha 7.
Bandung 40132.
Indonesia Faculty of Mechanical and Aerospace Engineering.
Institut Teknologi Bandung.
Jalan Ganesha 10.
Bandung 40132.
Indonesia Staff of the Board of Trustees.
Institut Teknologi Bandung.
Jalan Dipati Ukur 4.
Bandung 40132.
Indonesia Faculty of Medicine.
Universitas Padjadjaran.
Jalan Raya Bandung Sumedang KM 21.
Jatinangor 45363.
Sumedang.
Indonesia SESAMA.
Technology Development and Concern for Community.
Bandung.
Indonesia *E-mail: tdirgantara@ftmd.
Hightlights:
This paper describes the process of a rapid development of the CPAP ventilator AoVent-IAo during the COVID-19 pandemic using appropriate technology and locally available components.
It was found that noble values and spirit are very important success factors, gotong royong, social entrepreneurship, pioneering and volunteerism.
Public trust was a very valuable social capital during the development and Collaboration between academic institutions, industry and the relevant authority from the very beginning will speed up the development and certification process.
Abstract.
Here, lessons learned during the development of the CPAP ventilator AoVent-IAo, aimed to help COVID-19 patients with breathing difficulties, are Within only weeks, the Vent-I was developed, complying with functionality, safety and reliability requirements and passing the clinical trial.
was then distributed to hospitals all over Indonesia.
Two billion rupiahs were raised through crowdfunding within one week.
When the project was officially closed, more than one thousand Vent-I devices had been distributed and more than twelve and a half billion rupiahs had been raised.
Currently, commercialization and mass production of the device have been started.
From this project several lessons can be learned.
First and foremost, the spirit of gotong royong Ae sincere collaboration within the community to help each other Ae is still firmly rooted within the people and the society of Indonesia.
Noble values, i.
Received August 31st, 2020.
Revised September 10th, 2020.
Accepted for publication September 17th, 2020.
Copyright A2020 Published by ITB Institute for Research and Community Services.
ISSN: 2337-5779.
DOI: 10.
5614/j.
Syarif Hidayat, et al.
sensitivity and concern about the needs of the community, willingness to serve voluntarily and public trust, made the team dare to try and face failure.
The spirit of social entrepreneurship, willingness to listen to the user and collaboration with the relevant authority can accelerate development process.
The availability of knowledge and skills that constitute an innovation ecosystem in Bandung, supported by business, social institutions and government, was also a key success Keywords: CPAP ventilator.
COVID-19.
noble values.
regulatory sandbox.
Vent-I.
Introduction On the 2nd of March, 2020, the first positive COVID-19 patients in Jakarta.
Indonesia were announced by the government .
Two weeks later schools and universities in Jakarta .
and Bandung .
were closed down, including Institut Teknologi Bandung.
Teachers, lecturers and students were requested to conduct all teaching and learning activities from home .
Soon afterwards, large-scale social restrictions were implemented .
At the time, it was observed that the COVID-19 virus caused breathing difficulties in patients and hence there was suddenly a shortage of medical ventilators available in hospitals .
Many countries tried to procure these ventilators, but they were not available in the market.
On 23rd of March, 2020, having deep concern about the shortage of this medical equipment.
Ms.
JamAoah Halid requested Dr.
Syarief Hidayat to make an emergency ventilator to ease the The request was accepted and within a week, a multidisciplinary team was formed.
The team consisted of lecturers and students from Institut Teknologi Bandung, who immediately started to develop the ventilator, medical doctors from the Faculty of Medicine.
University of Padjadjaran, who gave insight to the developers about the function and specifications needed to fight the pandemic, supported by a crowdfunding campaigner from Rumah Amal Salman.
It was then decided that the name of the ventilator would be AoVent-IAo (Ventilator Indonesi.
It turned out that the project made history in terms of the extremely rapid development and deployment of a medical device during a pandemic crisis in Indonesia.
Hence, it is important that the process, the spirit and the lessons learned from this project can be shared with a wider audience.
In this paper, the rapid development process of the Vent-I and the lessons learned from this project are presented.
Development of the Vent-I At the beginning of the project, there was information about several open source ventilator designs, such as a ventilator based on an ambu bag plus several 3D Rapid Development of CPAP Ventilator AoVENT-IAo in Indonesia 767 printed components, and ventilator sharing .
At the very beginning, the team decided that the Vent-I should become available in large quantities in a very short time and that the functionality and specifications should be based on what was requested by the doctors involved.
Hence, the selection of the appropriate technology, the mechanism, the mechanical and electrical components, the sensors, and the production process was conducted carefully to ensure that this aim could be achieved.
In this emergency situation, it was very difficult to obtain critical components, especially medical related.
Hence, the technical team had to find some available alternatives for the parts and components, or a workshop that could manufacture the parts and components.
Therefore, one of the important design criteria was that, as much as possible, the components should be available locally or able to be manufactured by local vendors and assembled quickly without special training.
Air Reservoir Mask Breathing Circuit Air Filter Pump Figure 1 The first prototype of the Vent-I made of non-medical components available in the market.
The first prototype of the Vent-I, shown in Figure 1, was demonstrated to the doctors on the 30th of March, 2020.
It had three main functions: continuous positive airway pressure (CPAP) .
, continuous pressure control (CPC), and synchronized pressure control (SPC).
The doctors then suggested that the team should focus on the CPAP function only, which is for patients at an intermediate stage Ae still conscious but starting to have breathing difficulties.
This was because more patients were admitted to the hospital at this stage than at a more critical If patients can be treated at this stage, they can be prevented from entering ICU.
The other consideration was that a CPAP ventilator can be operated by general practitioners and nurses at a standard ward, since the number of doctors specializing in anesthesiology and intensive care is very limited .
Syarif Hidayat, et al.
It was then decided that the main blower of the Vent-I was going to be the continuous centrifugal type with a BLDC motor and equipped with an H13 HEPA filter, with CPAP/PEEP pressure 5-15 cmH2O, medical oxygen input pressure 24 bar, oxygen content FiO2 52-55%, mixed air flow rate 30-35 lpm, mixed air temperature 34-37 CC, and humidity 100%.
The PEEP mechanism was developed using hydrostatic water mixed with disinfectant.
Initiation Clinical Trial Closing 23/3 Ae Initialization 27/3 Ae Review by doctors 30/3 Ae Named The Vent-I 16/5 Ae Pass Clinical trial 19/5 Ae Distribution Permit 20/5 Ae Launced by the President 24/7 Ae 1000 March May April Certification Jun 14/4 Function test 16-17/4 Endurance test 22/4 Certified by BPFK Jul Production & Delivery 5/6 Ae First delivery, joint production with industries, polytechnics, vocational schools Figure 2 Time line of the project.
As shown in Figure 2, within days, coordination meetings with several ministries were held and in the first week of April, a team from Balai Pengamanan Fasilitas Kesehatan (BPFK Ae Health Facilities Security Cente.
Jakarta.
Ministry of Health visited the team and provided technical assistance to ensure the conformity of the Vent-I specifications to the regulations so that it could be certified.
On the 14th of April, 2020 the certification process of the Vent-I CPAP started at BPFK Jakarta.
The Vent-I was tested for functionality, electrical safety, emergency features and endurance.
On the 22nd of April, 2020 the Vent-I had passed all of the tests .
A clinical trial was then started for ethical clearance, followed by a series of tests on COVID-19 patients at hospitals.
By the 16th of May, 2020 the clinical trial had been passed and a distribution permit was Figure 3 shows the different types of the Vent-I that were developed, produced and distributed.
Finally, as shown in Figure 4, at the celebration of National Awakening Day, 20th of May, 2020 the Vent-I was officially launched by the President of Indonesia.
Mr.
Joko Widodo .
Rapid Development of CPAP Ventilator AoVENT-IAo in Indonesia 769 Figure 3 Several types of the Vent-I developed and delivered.
Figure 4 President Joko Widodo officially launched the Vent-I.
Syarif Hidayat, et al.
Figure 5 Classroom and mosque function hall converted to factory.
Parallel to that, preparations for production had started.
Several classrooms were converted to workshops and the main function room of the university mosque held an assembly line, as depicted in Figure 5.
Several vocational higher institutions and high schools were eagerly involved in the project, led by someone from the industry.
Many details were taken care of, from the casing design, noise reduction, development of production procedures, finding vendors and suppliers that were still operating, and many others.
Some critical components, such as the blower impeller and the pressure sensor, were designed and manufactured locally.
Finally, on the 5th of June, 2020 the first Vent-I was delivered to a hospital.
When the project officially closed by 24th of July, 2020 about 1000 Vent-I devices had been delivered to hospitals all over Indonesia .
Figure 6 shows the distribution of Vent-IAos to hospitals in Indonesia.
From the moment the crowdfunding started in early April, the response from the public has been extraordinary, far beyond the initial expectations.
Within days, about two billion rupiahs were raised and when the project closed, about twelve and a half billion rupiahs had been raised from about 2000 donations, both from private and institutions/corporations.
Rapid Development of CPAP Ventilator AoVENT-IAo in Indonesia 771 It turns out that the pandemic provided an excellent opportunity to rapidly develop, certify and distribute a medical device, which might have taken years in a normal situation.
Although the Vent-I was developed using appropriate technology available locally during the pandemic situation, several creative ideas emerged, and eight patent requests from this project have been submitted.
Figure 6 Distribution of the Vent-I when it reached 784 deliveries.
Lessons Learned from the Project Noble Values and Spirit It was later realized that the prime mover of the team, so it could be formed and function immediately, were sincerity and noble values, as mentioned by Dipojono.
Chairman of the Academic Senate of ITB during the centennial commemoration of this technical higher education institution .
The traditional Indonesian spirit of gotong royong Ae sincere collaboration within the community to help each other Ae is still very firmly rooted in the people and the society.
Social-entrepreneurial Spirit The spirit of being sensitive and concerned about the situation of the people, the willingness to try to solve problems, the capability to see the issue as a great opportunity, and the courage to face failure moved this project forward at the When most people stayed at home to avoid crowds, the team dared to do the opposite: go out, meet, think, and work tirelessly to face the challenge.
Syarif Hidayat, et al.
Pioneering and Volunteerism During the formation of the team, it was not easy to invite lecturers and students to join, since the situation at the beginning of the pandemic was still very However, a handful of them were really looking for an opportunity and a way to contribute.
Some lecturers and students came forward enthusiastically and joined the team immediately.
Also from the beginning it was declared that this project was purely social and all individuals would contribute voluntarily.
It was found later, especially for the students, that although they spent a lot of time and effort voluntarily they gained much more in developing their character, skills and knowledge.
The students learned how to work collaboratively, in a multidiscipline environment, under a lot of constraints, time limitations and pressure due to the high expectations from the public.
The students experienced one full cycle of product development, not only related to the technical aspect of the product but also related to the supply chain of parts and components, regulations, the certification process, production, crowdfunding, distribution and public accountability.
The students learned how to design an experiment and build a prototype.
They learned how to present their ideas, take initiative, propose different solutions.
They also faced failures and had to deal with unexpected This has been a once-in-a-life-time experience for those who dared to face the challenge, which will influence their future greatly.
Figure 7 shows several of the students involved in the project, during the closing of the project.
Figure 7 Student volunteers with the Vent-I series Public Trust as Valuable Social Capital During the crowdfunding campaign it was learned that trust was one of the main contributing factors to the success of the campaign.
The combination of Rumah Rapid Development of CPAP Ventilator AoVENT-IAo in Indonesia 773 Amal Salman, a registered charity run by the university mosque foundation, which coordinated the campaign, fully supported by SESAMA, the ITB alumni movement for technology development and concern for the community, and two well-known universities in Bandung: Institut Teknologi Bandung and Universitas Padjadjaran, as the developers of the Vent-I, gave the team the trust of the public.
The public was immediately willing to donate, even before the product was ready and working as expected.
Public trust is very valuable social capital, which made the team dare to face potential failure .
The Importance of Being Self-sufficient As also mentioned by Dipojono in his speech .
, this pandemic raised awareness that the country should hold key and strategic technologies and production capability.
It is very important for a country to have human resources and institutions that acquire and maintain specific skills and knowledge.
In an emergency situation like this pandemic, these skills and knowledge can be collectively implemented to provide an immediate solution.
In this project, several universities, polytechnics, vocational high schools and local industries collaborated with each other, where each institution contributed their skills and expertise to the project.
This innovation ecosystem, comprising academics supported by practitioners .
edical doctors and industry professional.
with specific knowledge and skills available in Bandung, was shown to be one of the key success factors of the In addition, support from the government in Jakarta, which is three hours away, as well as from the community and businesses, was also very important.
This kind of innovation ecosystem should be maintained and duplicated in other When mobility and logistics were disturbed by the pandemic, being located in the same area was a great advantage.
Collaboration from the Start Listening to the User Understanding what is really needed is very important and it can be obtained by listening to the user and to experts.
The involvement of medical doctors in this project was essential, since they provided significant information and contributions to the project.
Empathize, the first step of design thinking, is one of the key success factors in product development and was well implemented in this The design process, from the specification to the encasement of the VentI, was conducted jointly by engineers, product designers and doctors.
Figure 8 shows the discussion between engineers and doctors during the development of the Vent-I.
All aspects were looked at, from technical aspects, availability of components, safety features, ergonomics, comfort of the patient, user-friendliness Syarif Hidayat, et al.
of the control panel as well as some clinical aspects .
terilization of the product, humidity and temperature of the pressurized air, oxygen content, etc.
All were conducted rapidly, within several days.
Figure 8 Discussion between designers, engineers and doctors in informal meetings in the early days of the development.
Regulatory Sandbox in a Process of Innovation During their first visit, the authority still treated the Vent-I as a full-feature ventilator that should be certified according to the standards for full-feature ventilators, while it actually was not one.
Through several discussions between the engineers, doctors and the authority, a common understanding and an agreement were reached.
It was found that through intensive communication and trust between institutions, not only the product itself was developed but also the standard, the requirements and acceptance criteria were developed in order to get a safe, functional and reliable product.
This also shows that collaboration between institutions is a must.
The Vent-I development process can be seen as a case study on how a regulatory sandbox, as described by Brodjonegoro .
, can be directly implemented in a process of innovation.
Concluding Remarks It can be seen through this project that the traditional Indonesian spirit of gotong royong Ae sincere collaboration within the community to help each other Ae is still very firmly rooted in the people and the society of Indonesia.
Noble values and spirit were shown by the trust given to the project, as reflected by the sum of the fund that was immediately donated, even before the prototype was ready and working as expected.
The same spirit was also shown by the lecturers, students, doctors and professionals who volunteered, spent their time and contributed their expertise to the project.
This is an excellent social capital which should be always be maintained.
Rapid Development of CPAP Ventilator AoVENT-IAo in Indonesia 775 It was also seen that a social-entrepreneurial spirit that sees problems and challenges as a great opportunity made this work possible under high constraints and pressure.
Understanding what is really needed by listening to the users and to experts was also a key success factor in this project.
Intensive communication, collaboration, and trust between academics/engineers, government/authority, doctors and industries made it possible to overcome many hurdles in this project.
Not only that, this project also built the self-confidence of the team and opened up many new networks and future opportunities.
Acknowledgements It would have been impossible to deliver more than one thousand Vent-I devices without all the support and donations received.
The Vent-I team would like to acknowledge and extend their gratitude and appreciation to these individuals, institutions and corporations who have supported this project in many ways and many forms, especially to: Institut Teknologi Bandung.
Universitas Padjadjaran.
YPM Salman ITB.
Ministry of Health.
Ministry of Research and Technology.
Ministry of State Enterprises.
Ministry of Defense.
Ministry of Education and Culture Ae Republic of Indonesia.
National Disaster Management Authority.
COVID-19 Response Acceleration Task Force.
Health Facility Security Center Ae Jakarta.
West Java Provincial Government, 3rd Military Regional Command/Siliwangi.
West Java Regional Police.
Bandung City Government.
ITB Alumni Association.
Yayasan Solidarity Forever.
Syamsi Dhuha Foundation.
SESAMA Ae Pengembangan Teknologi dan Kepedulian.
PT Mobar Sarana Energi.
PT Pura Barutama.
Politeknik Manufaktur Bandung.
Politeknik Negeri Bandung.
Universitas Pendidikan Indonesia.
Politeknik Negeri Batam.
Institut Teknologi Nasional.
Universitas Nurtanio.
Universitas Komputer Indonesia.
Universitas Diponegoro.
Politeknik TEDC Bandung.
PT Dirgantara Indonesia.
PT Bukaka Teknik Utama.
PUDAK Scientific.
Eastern Pro Engineering.
Elcoprs.
RS Hasan Sadikin.
RS Santo Borromeus.
RS Advent Bandung.
RS Paru Dr.
Rotinsulu Bandung.
Melinda Hospital.
Dinas Pendidikan Provinsi Jawa Barat.
SMKN 1 Cimahi.
SMKN 4 Bandung.
SMKN 6 Bandung.
SMKN 8 Bandung and all volunteers who made a significant contribution to this project.
The Vent-I team would also like to express their appreciation to all individuals, communities and institutions who have donated to this project, especially to:
Bank Indonesia.
BUMA Peduli.
Kliring Penjaminan Efek Indonesia.
Indonesia Stock Exchange.
Indonesia Central Securities Depository.
Triputra Grup.
Indonesia Power.
PT Herba Penawar Alwahida Indonesia.
Telkom Indonesia.
Yayasan Hasanah Titik.
Terminal Peti Kemas Surabaya.
Komatsu Indonesia.
Majelis Telkomsel Taqwa.
Pertamina Hulu Energi.
PT Trans Pacific Petrochemical Indonesia.
Enerren Technologies.
BNI Syariah.
BCA.
Dompet Syarif Hidayat, et al.
Dhuafa.
Badan Pengelola Keuangan Haji.
DT Peduli.
Mastel.
PGS ITB & Rekan.
Alumni Mesin 85 ITB.
Alumni ITB PLN.
Alumni ITB 79.
Yayasan Indonesia Bright.
Alumni Bimbel Karisma.
Alumni IKMP Bandung.
Mabrur 77.
ICTA USA.
Alumni Elektro 87 ITB.
Piobio Indonesia.
IA SMAN 3 Bandung.
MT Madinah.
MT Makarresh.
IA ITB ANTAM.
Alumni Mesin 84 ITB.
Group Lasykar Sepuh Jakarta.
IA Tambang 2009 ITB.
UMI Wellington.
Alumni GRIPS Tokyo.
MT Al Islah.
Pensiunan Dosen Tambang 1957.
Pengurus YKPI & PPYKPI.
Alumni SMAN Tegal 1976.
IA ITB Yogyakarta.
PPI Shizuoka Ae Jepang.
IC Magnet School.
POMG TK-SD Mutiara Bunda Bandung.
Macrology Indonesia.
Alumni Haji Salman 2017.
Jamaah Masjid IKEA Alam Sutera.
Komunitas Motor Benelli Indonesia.
Road Pirates MC Indonesia.
DPW AGBSI.
Alumni SMAN Garut 1971.
DPW KLHK.
Serabut Kelapa and 1983 other individual donors.
References