This case study explores one company’s challenges with this most widely used COVID-19 test methodology.
Successful new product introductions (NPIs) require flexibility, speed and global expertise – and even more so during times of crisis. When the Brazilian Ministry of Health put out a call for manufacturing support in response to the global pandemic, we answered swiftly. We were confident that our local facility could reconfigure part of its assembly area to meet the urgent need.
The teams at our manufacturing site in Sorocaba, Brazil produced the first unit in a record 21 days from contract signing – and delivered life-saving medical equipment as a result.
RESPIRA Brazil forms to increase ventilator production
Brazil has a very large medical device market and some local manufacturing. With the onset of COVID-19, the Brazilian Health Minister announced an initiative to increase the country’s ventilator manufacturing capacity in mid-March. The initiative, known as RESPIRA Brazil (BREATHE Brazil), matched ventilator companies with manufacturing partners to increase capacity from 200 units per month to 4000.
Collaboration and commitment
The Health Minister invited Flex to participate in the new task force. As the largest electronics manufacturing services (EMS) and contract manufacturing service provider in Brazil, we assembled an expert team that included representatives from government affairs, operations, finance and business development to better understand the needs of each ventilator company.
The team spent the first week creating detailed action plans for each company. We had the opportunity to assist other companies, but Magnamed, a family-owned Brazilian ventilator company, quickly became our primary project. Impressed by the team of experts sent to assess their needs, they chose us as their manufacturing partner.
Adjusting our manufacturing facility
Our full production EMS contract with Magnamed was set to begin on April 1, so we went to work preparing for a totally new product assembly. The Sorocaba site regularly produced more than 30 products, including POS (point of sale) machines, printers, personal computers, servers and solar panels – but never a medical device.
First, we partnered with a compressed gas supplier to make the infrastructure changes needed to get a large oxygen tank on site. We then installed the tank for testing and validation of ventilator products in just three days. Our teams also set up production lines, completed training and learned a new quality system through video conference calls and site visits from Magnamed.
A novel approach to regulatory compliance
Once we had the right infrastructure and equipment to produce the ventilators, our manufacturing site still needed regulatory certification for medical device production. Without clearance from ANVISA, the Brazilian regulatory agency, any products created at the site would be ineligible for patient use.
The regulations used by ANVISA are virtually identical to those of the FDA, and clearance normally takes 12 months. Given our timeframe, we coordinated with both Magnamed and ANVISA to expedite the process in an emergency approach. Both parties visited the site to validate our processes, system integration, assembly and final testing in real time, allowing us to achieve certification in a matter of days.
Delivering critical patient care
With certification in hand, and training conducted on a compressed schedule, all that was left to do was execute. Our dedicated teams in Sorocaba received 100% of the subassemblies from Magnamed, and the first unit was ready to ship on April 20. In under 30 days, our team went from never having manufactured a medical product to completed production of the first clinical unit.
Since then, we have shipped 1000 units in May – the equivalent of one full year of production at Magnamed. Our target is to ship 500 units a week until the end of July for a total of 6,500 units.
Helping others through our greatest asset: our people
With a life-saving product on the line, all of our teams in Brazil made the RESPIRA initiative their top priority. Together, we consider it a privilege to continue supporting healthcare workers and patients globally.