Developing a safe mouth nose mask for care in 4 weeks

How did Panton and Auping do it?

There has to be another way, thought Ingeborg Griffioen, owner of design studio Panton, which specializes in healthcare innovations. On Friday 20 March she called several people from her network with the question whether they would like to cooperate in the development of a face mask that could be produced quickly within the Netherlands. “Already that evening we organized a conference call with experts, including Royal Auping, who also turned out to be thinking about the production of face masks “, Ingeborg says. In the days before, it became clear that personal protection equipment was rapidly becoming in short supply in the healthcare sector. One hospital had even started making masks by hand with its own staff. That situation was the spark for Panton to take action. It soon became clear to Ingeborg Griffioen that she could contribute with the expertise of her design studio. But how can you develop a safe face mask in a very short time?

The first thing that stands out in the development process is the shared sense of urgency among all involved. “We saw the increasing shortages and we were eager to help with our expertise. We realised that it is not easy to develop a face mask. When Panton called, it made sense for Auping to team up.” remembers Wouter Dijkman, R&D manager at Royal Auping. In addition to the designers of Panton and Auping, independent experts * in the field of medical devices joined the project. The bar was set high. The plan was to develop a certified medical mask, level FFP2, which could be produced in large numbers in the Netherlands in the short term.

FFP2 masks protect health care professionals from the smallest particles that can transmit the coronavirus.

“It was really great to hear how much happened every day,” says Jasper Brands, creative director at Panton. He led daily online status meetings at 9:00 PM for everyone to stay on track. Thanks to the clear mission in combination with the urgency, everyone contributed from his or her knowledge and conviction about the right steps to take.

Both Panton and Auping showed guts by starting this project. Panton by investing their time selflessly and Auping by developing a medical product for the first time. Panton has an extensive network in healthcare and knows its way in medical innovation and CE certification. Auping contributed its knowledge about product development, textile products and its production network. The networks proved crucial to success. Experts quickly contributed their knowledge and skills. Everyone wanted to cooperate selflessly to make this ambitious project a success.

“Our focus on key success and failure factors from the start has made a significant contribution to the success of the project,” says Brands. “It is the pieces of the puzzle that form the big picture.” Consider: 1) finding the right material in large quantities, 2) understanding the use of the mask, 3) ensuring medical safety and CE certification and 4) organizing scalable production. Putting puzzles like this together is a core quality of innovative companies such as Panton and Auping.

The search for the right material

Material that meets specific requirements and was in stock in the Netherlands in the correct quantities was found at Schaafsma Paper Group and DSM. A combination of materials could have the required properties for a medical FFP2 mask. Demonstrating those properties requires measurements that meet the standard for FFP masks. The standard describes tests that could not be performed in the Panton design studio or at Auping. Authorities and companies in the Netherlands that make test equipment were contacted immediately. On Friday 27 March, less than a week after the start of the initiative, there is the first breakthrough: the right combination of materials has been found. At 98%, the value of filtering aerosols with a size of 0.3 µm is more than sufficient for the minimum filter requirement of FFP2 masks, which is 94%.

For the wearer

“We have all seen the images of healthcare professionals with stretch marks on their faces due to wearing face masks for too long,” says Jasper Brands. For the designers of Panton and Auping it is self-evident that the user should be at the centre of innovations. In this very short process, the right balance was sought between the fit, tensile strength of the fastening elastics and flexibility of the aluminium nose bridge. A good fit is not only more comfortable but also necessary to prevent air from leaking past the mask, which could lead to inhalation of contaminated particles.

Demonstrable safety

To guarantee the quality of the newly developed masks, these must have a CE mark. For an FFP2 mask – which falls under Personal Protective Equipment (PPE) – this means certification by an accredited test house, a so-called notified body. The government was given space by the European Commission to institute a shortened certification procedure for personal protective equipment that is developed for and used during the corona crisis. The Ministry of Health, Welfare and Sport made agreements with notified body BSI about a shortened CE procedure of only a few weeks. Panton and Auping were able to deliver the technical file, the required risk analyzes and sufficient samples of the mask for the shortened procedure to the BSI test laboratory in time. BSI also made every effort to carry out the required tests as quickly as possible.

Together with the government

In the meantime, the government made an inventory of promising initiatives in the Netherlands for the production of face masks. More than 100 parties registered with the national consortium, LCH, which is responsible for the national procurement and distribution of medical devices and protective equipment. Four parties were selected by LCH and asked to submit a concrete proposal. Friday, March 27, Panton and Auping submitted their proposal. Elements of this proposal were: 1) an action plan to obtain CE marking on the mask, 2) the numbers that could be produced and 3) an estimate of the cost price. In the meantime, the ideas about production at Auping were at an advanced stage. Specific machines were developed with two machine builders. Martijn van Haaf, operational director at Auping: “The design of the product was closely aligned with the design of the machines to create a face mask that could be produced in large quantities.”

The collaboration had shown to the government that it managed to get a grip on the most important success and failure factors in a short time. In the meantime, no government order was forthcoming. The development team held its breath. Preference was given to an assignment from the government so that the masks can be distributed across the Netherlands via LCH. If this assignment was not forthcoming, plan B would be executed: direct delivery to healthcare institutions. Several healthcare administrators and hospital buyers had already contacted Panton and Auping with purchase guarantees. Mark Groot Wassink, new business developer at Auping: “It was great to hear that there is a lot of confidence in the FFP2 mask that Auping and Panton were developing.”

Unprecedented speed of innovation

The government had completed their pre-selections on April 7, and gave Auping the verbal order to supply 4 million face masks that same day. A huge boost for everyone involved. With the order, Auping was able to start production. The week after, the contract with the government came through and notified body BSI gave the green light for CE marking on the product. All this was fantastic news, exactly 4 weeks after the start of the innovation process. Production started immediately and since the beginning of May, the masks have been supplied to healthcare institutions via LCH. The intrinsic drive and the sense of urgency were so strong in the team that mutual trust was enormous: “We’re in this together”. With every setback, the team quickly got back on track with one sentence: “We’re doing it for the healthcare professionals.” Jasper Brands: “It is satisfying that many healthcare professionals can now work safely with face masks from Dutch origin. And that Panton could contribute by playing the role that it is so good at: taking on healthcare challenges based on expertise and collaboration.”

Opportunities for the future

This urgent situation has made the development team and many others realize that the Netherlands is too dependent on foreign producers for the supply of personal protective equipment. Ingeborg Griffioen of Panton: “There are now opportunities to prevent this situation in the future. At the same time, this situation has shown how much we are capable of if we, healthcare, the creative and manufacturing industry and the government, all work together.”

*) Auping and Panton have collaborated with various partners for the development of this face mask: Royal DSM, Schaafsma Paper Group, Jeroen de Geus (Expert Sterile Medical Devices – UMC Utrecht), Addie Bouwman (Expert Medical Devices), Wellcome Engineering & Consultancy and Gemeas Patents (patents)

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