[Now updated with new information. Note: An earlier version of this story incorrectly said that Avery had said his IV flow controller was not being used in hospitals.]
Prominent New Zealander Sir Ray Avery wants to raise $4 million in public donations to manufacture low-cost infant incubators to send to developing countries. That’s on top of the more than $2 million already raised for the project via school kids, online crowd-funding, charity auctions and philanthropists.
But several people who’ve been involved with the incubator and other previous projects of Avery’s question whether he can deliver on his effusive promises. Seven people who’ve aided the Medicine Mondiale charity’s work at various stages say they parted from Avery in disappointment, after questioning his methods.
Sir Ray Avery lives in a spotless, nice house that doubles as his fundraising office and triples as a garage-cum-laboratory that you reach via a downstairs bedroom. I can’t see a finished prototype of his nascent LifePod incubator when I visit – several are in India for a six-month clinical trial, he tells me, while others are with engineers in Christchurch and Australia, being tested.
Instead I get a photo of four egg-shaped blue-and-white cocoons lined up, alongside their manufacturers, outside the factory in Chennai where the first prototype was assembled in sweltering weather in January 2017. Soon, Avery hopes, these plastic ovals will contain real babies.
The need for more and cheaper incubators is compelling. In a 2015 documentary for Avery’s charity, Nepalese doctors and nurses speak about their anguish at having to send delicate, premature newborns on perilous long-distance road journeys. The babies had to travel to reach incubators because their parents couldn’t afford to use nearby private hospitals. Often, they died.
Avery speaks passionately about these babies at his many speaking appearances. A charming, blunt and round-faced gent, he’s in-demand as a speaker for his take on can-do Kiwi ingenuity and his startling backstory: that of rising from an alcoholic, abusive and neglectful home in England to live under a bridge and later study and work at Wye agricultural college in Kent. He came to New Zealand in the early 1970s to work in pharmaceuticals. Often, Avery finishes his talks by calling for help from the audience and engineers, designers, marketers, and others will offer to work for free.
Right now, his focus is producing a cheap, warm, sterile and hard-to-break infant incubator for distributing in poorer countries – the LifePod. So far he estimates it’s absorbed $4.5 million in actual spending (a multinational, he stresses, would have invested much more) and $10-12 million in unpaid labour by designers, engineers and others. About $2 million has been raised in donations from the public. Now he wants to raise an additional $4 million with a final, spectacular fundraising push anchored by a Waitangi Day concert at Eden Park. The controversial concert, to be headlined by an original LiveAid performer, has drawn him into a public spat with nearby neighbour and former Prime Minister Helen Clark.
The bust-up has been framed in terms that suggest that concert opponents must be against saving babies. But it isn’t the first dispute Avery has been in since launching Medicine Mondiale. Newsroom spent a month reading reports and documents and speaking to more than a dozen people who’ve been involved in the incubator project, the IV drip controller that came before it and others of Avery’s projects. We exchanged dozens of emails with Avery checking events spanning more than two decades.
Those who’ve aided him with his projects describe him as a clever, excellent salesman with an exceptional ability to raise money and enlist people. In the Nepal documentary, Avery talks about the benefits of donating time to him. “Everybody who gets involved becomes a better person,” he says.
Some former helpers did leave projects feeling fulfilled. Others spoke of feeling bruised or withdrawing their support after becoming disquieted by a lack of transparency or logical process. “He’s so adversarial. If he had any sniff that I was talking I think he would come after me like a Rottweiler,” said one person who was previously directly associated with Avery’s projects. Others still fear litigation, and Newsroom has agreed not to name some sources.
The Fred Hollows years
To understand how Sir Ray, as he’s known, became a New Zealand legend you need to go back to the Fred Hollows years, in the early 1990s. A book about the Hollows Foundation, Through Other Eyes, recounts how the philanthropist and eye doctor Fred Hollows decided to commit to building low-cost lens factories in Nepal and Eritrea, to lower the cost of implanting the lenses used by the charity’s doctors in cataract eye operations.
The money was raised with the help of the then-Australian Ambassador to Nepal. Avery - who’d left a job at Douglas Pharmaceuticals and was employed as a contractor by the Australian branch of the Fred Hollows Foundation - was given the job of steering the factories to completion.
For Avery (the foundation’s technical director) and the engineers working on the project it was extremely difficult building sterile, high-tech factories in cities where even getting reliable electricity couldn’t be taken for granted. It became even more challenging when it became apparent that the lens manufacturing equipment Fred Hollows had commissioned wasn’t going to work. Avery worked with others to make a replacement lathe that worked, and the factories succeeded. They opened in 1994 and still make lenses today.
Opening the factories was a major achievement, and Avery was personally thanked with a hand-written note from the head of the foundation at the time. But the factories also produced something else. Publicity for Avery’s 2010 New Zealander of the Year award says that, by 2020, he will have saved the sight of 30 million people. The often-repeated number is hard to reconcile with figures on the Fred Hollows Foundation website, which says that, as of 2017, the two factories combined had made about four million lenses.
“He’s so adversarial. If he had any sniff that I was talking I think he would come after me like a Rottweiler."
The remainder of the benefit to the world’s poorest people rests on Avery’s devising of a faster, more accurate and automated manufacturing method. The new lathe used vacuum suction to hold lenses, rather than the old method of wax. Avery says the technology was “adopted and improved upon by a large number of generic and multinational manufacturers”.
Asked how the 30 million figure was reached, Avery adds that he also developed a lens polishing process using zirconium beads. He acknowledges that the “the absolute numbers are hard to validate”.
The lead engineer working for Fred Hollows at the time remembers the episode more modestly. Richard Combe was originally employed by Avery, then became Avery’s boss after being appointed general manager of technologies. Combe found Avery to be a generally supportive colleague, who was passionate about helping people in Nepal. He recalls some differences of opinion, but says emotion and heat were par for the course at the charity in those days.
Combe downplays the level of invention associated with making the lathe. The novel part – the vacuum aspect – wasn’t disruptive technology, he says. Although the foundation put a provisional patent on it, they let the patent lapse because it wasn’t worth maintaining, he says. “It would be something a room full of engineers would think of in a few hours.”
Other aspects of the design were “just good engineering, there wasn’t anything Earth-shattering,” says Combe. “The hard part is getting it to work, and that’s where the engineers came in,” he says. “All the R&D was done in Adelaide.”
Combe is cautious when asked about the 30 million figure: “If you put me on the spot in a court of law, I’d say I had a part in making maybe four-five million lenses for people in developing countries.”
Meanwhile, Avery left the foundation and switched his attention to making technology for the developing world, founding Medicine Mondiale in 2003.
After he was named New Zealander of year – and knighted, in 2011– it became more difficult for people to countenance publicly expressing concerns about his projects. Despite being successful people themselves, several former associates said they felt they’d be hounded if they ever spoke publicly.
Today there are three products listed on Medicine Mondiale’s website: a protein bar, an IV drip controller and the incubator. None of them are yet in production, but we asked Avery for an update on each.
First, there’s the Amigo Bar, which has received upbeat media coverage for its use of kiwifruit enzymes. Right now it’s being taste-tested, says Avery, after being tweaked to get the sugar content down. Essentially, on reading the ingredients, it’s a muesli bar with added claims to healthiness on account of amino acids and vitamins. The ingredients list starts with oats, sunflower seeds, berry puree, vegetable oil, sugar, chicory, wholemeal wheat flour and oat bran, with added amino acids, vitamins and minerals.
Avery says that unlike a normal muesli bar it contains much of a day’s essential nutrition for a child. He plans to launch it for commercial sale in October, focusing on low decile New Zealand schools. An old blurb on the Medicine Mondiale website says it will be launched throughout the Pacific in 2017, but this hasn’t happened.
Medicine Mondiale’s website describes the bars as containing “a novel nutritional ingredient called Amino Natural which is made from whole proteins that have been hydrolysed using natural Kiwifruit enzymes ... these molecules are so small they can be absorbed without the need for digestion and are rapidly incorporated into muscle tissue. The natural immunogenic peptides in Amino Natural also help to repair the damage to the child's stomach lining and because Amino Natural is very high in branched chain amino acids, this means more protein may be absorbed from other local dietary foods”.
We asked if there was any clinical data to back these claims up. Avery says it’s not required, because the bars are not a “therapeutic food”. “The Amigo Bars are a healthy alternative to traditional muesli bars and contain all the essential amino acids that the body cannot produce ... children in low decile schools may have sub-optimal diets ... and Amigo Bars provide a healthy supplementary 'top-up'," he says.
Right now the Amigo bars website invites people to donate to get the bars to New Zealand and Pacific kids, starting with a $25 donation “to feed five kids for a week”. Avery has also prepared fundraising packs for schools asking them to help raise money to buy bars for children.
The website – and media stories – also list other initiatives. One is called the Ethical Science Group, which the Medicine Mondiale website describes like this: “Independent assessments show that there is a large gap between public statements made by NGOs and what is realized in practice. Medicine Mondiale has established the Ethical Science Group and an independent panel of experts and student volunteers who conduct Quality Analysis of Global Healthcare Initiatives to determine the effectiveness and efficiency of healthcare initiatives deployed in the developing world setting ... Our research results will be published in medical journals and distributed to NGOs and the international media.”
Newsroom asked if anything had been published, but Avery said the intention was to work behind the scenes. “The Ethical Science Group does not publish research articles but lobbies other agencies to improve their operational standards,” he says. “We do this outside the public eye otherwise the perpetrators would focus more on disclaimers rather than fixing the problems.”
A different plan previously reported in the Herald – “to raise $11.2 million to build another factory somewhere in the Third World to make cheap Aids drugs” – was abandoned because the aerosol cans it relied on weren’t practical after 9/11.
That leaves the LifePod and one other product – the Acuset. Before Avery began to focus on the incubator, it was this device that was taking much of the charity’s time, goodwill and money.
After Avery opened the lens factories, United States non-profit Design that Matters approached him with an idea for an IV drip controller. The charity wanted help to make a cheap, easy-to-use device that would deliver medicines and rehydration fluid more reliably to people in cash-strapped developing nations, a replacement for the cheap 50c roller clamps that were often being used in place of the pricey electronic drip devices used by hospitals in wealthy countries. Ideally, they wanted something that a cholera patient could use themselves if there were not enough trained medical staff to help them. Design that Matters already had a design, said Avery in reports at the time.
Avery approached an experienced medical manufacturing and development company, Adept, which is based in Auckland, and they agreed to help at no charge. Adept’s Murray Fenton looked at the original idea and didn’t think it would work, but he had an alternative way he thought he could make the device function. Employing the hard work of a young designer at Adept, the company and Fenton spent almost two years working on the device and managed to get it functioning.
"We can not allow Adept’s name ... to be used for a product that has not had the necessary regulator work completed.”
An account of the design process for tech students on a Ministry of Education website records that Trade Me founder Sam Morgan offered to fund the die-making tooling required to produce the device, now called the Acuset. The same account says the device was being evaluated in a study at Auckland Hospital and field trials in Nepal.
Some samples were produced but Adept’s relationship with Avery was souring over Fenton and his colleagues' feelings that Avery was making claims that the device could not support.
“I am deeply concerned,” Fenton wrote to Avery in 2008, “…we can not allow Adept’s name ... to be used for a product that has not had the necessary regulator work completed."
Adept handed over the tools and removed their name from the product.
Avery’s relationship with Morgan then soured, too. Morgan’s philanthropic foundation had granted $600,000 to various Avery projects by that stage, as well as extended a $100,000 loan for patent costs associated with the Acuset. Morgan offered to forgive the debt in return for details of how money was being spent and moved by Avery’s entities. However, relations deteriorated and Avery’s charity repaid the $100,000 loan. For his part, Avery says the Medicine Mondiale board had advised him he shouldn’t have signed the loan deal as the interest clause breached a legal requirement that people must not profit from charities. Avery says he paid the interest himself.
In 2013, a Design that Matters pamphlet said the Acuset controller had completed clinical trials in 2007, and volume production began in 2008... "Medicine Mondiale’s simple and cheap Acuset controller is a breakthrough”.
Speaking to Newsroom this month, Avery confirmed production hadn’t started. However, he said it had been in use for a number of years in two hospitals in Nepal and to dose water tanks with chlorine. Newsroom is attempting to contact those hospitals.
Asked about reports of clinical trials happening in Auckland, Avery said they had related to an IV bag that connects to the Acuset, not the Acuset itself.
He described how the device had since changed from the original, planned reusable IV flow controller that would have fit on any drip set, to a device that would “fit only our drip set”, to provide ongoing revenue from the sale of single use drip sets.
“When you’re doing marketing you pick some figures out of the air."
- Sir Ray Avery
Avery is now raising money to launch the Acuset through a spin-off company, AIS. An investment brochure shows that in 2010, the pharmaceutical giant Baxter was interested in partnering on the Acuset, even completing clinical trials in the US. By 2011 it had decided not to proceed. Avery showed Newsroom a letter showing Baxter pulled out “despite a technical evaluation having found clinical benefits”, citing regulatory hurdles regarding the materials the device was made of - hurdles that Avery says have since been cleared by regulators.
As of today AIS is seeking minimum investments of $10,000 for a total of 17.5 per cent of the company, which it has valued at $7.1 million. Production is planned for late 2019, and, by 2021 – the brochure projects – the company will be earning $27.5 million.
The LifePod’s journey, as recounted by Avery, started when he kept seeing broken-down incubators sitting in corridors in Nepal. Determined to do something about it, he started tinkering in his garage.
Unlike a lens or a muesli bar, an incubator is a high-stakes medical device, whose failure could result in death. The working parts are essentially a heater and humidifier, but, because it is so easy to overheat a baby in a contained capsule, the testing standard for the machine is extremely high. Avery himself mentions this frequently, when talking about the testing he’s been orchestrating on the LifePod.
Yet Medicine Mondiale itself is a skeleton operation. For the most recent three years for which detailed accounts are available on the charities register, the only paid staff was a part-time book-keeper, and, in a roundabout way, Avery and his wife Lady Anna. The disclosure of related party payments show a consulting company majority-owned by the couple earned $149,000, $178,000 and $188,000 annually in the three years covered by the records, with Lady Anna earning another $20,000 (2016) and $25,000 (2017) for fundraising. Avery also earned money for the charity – for example pitching in $33,000 in 2017 speaking fees.
The heavy fundraising workload takes time, given that New Zealand is small and people’s funds are limited. Keeping the buzz going relies on a steady stream of media announcements.
In 2014, Avery launched what was then a campaign to raise $2 million to get the LifePod to to the point of production. Twenty-five prototypes had been built, it was reported, and the $2 million was to get the project to the production stage by financing the work to obtain medical-device certification from the ISO.
In September 2015, the Herald reported that the LifePod had reached the manufacturing stage and Avery hoped to have it on the market in early 2016.
In April 2016, Stuff reported that “by the end of 2016 Avery hopes to have 20 LifePods operating in the Pacific Islands”.
The plan now is to launch it in February 2019. Avery points out that multinationals also take many years to develop medical devices, working with vastly greater resources.
As with the Acuset, Avery enlisted experts who knew what they were doing, and were willing to work for free. Some of them were left concerned, however.
An early designer to work on the project, who produced designs for the now-distinctive egg shape, says he was left feeling gutted when, after thousands of dollars worth of unpaid time - and what he felt was a disorganised process - his then-fledgling business was removed from the project after beginning to work on a paid basis.
A consultant who worked on a different project around the same time recalls having a similar feeling. “There were a lot of promises of benefits in the future. We did a vast amount of work and we just woke up one morning and Ray was working with someone else. In the end, I started to doubt everything.”
The next designer to work on the LifePod was a former Fisher and Paykel engineer named Kip Marks.
After collecting the design files from his predecessor he helped an AUT design student play around with the composition and layout of the various working parts. At that stage the air in the pods was going to be filtered by a ceramic cartridge.
For his part, Kip Marks says he withdrew from the project after becoming concerned that Avery was overly focused on the look and form of the incubator ahead of completing the working motor and functional parts. In design terms, he says, the function has to be finished first as that determines the shape and size of the outer shell. He described Avery as an “enthusiastic amateur” and expressed doubts that a working incubator would be ready to manufacture by February.
However, Avery remains resolutely confident that the incubator will work – in fact he claims it has better temperature and humidity control than other incubators on the market.
And he says that each time he’s fallen out with someone it has been for good reason.
Right back in the project’s infancy Medicine Mondiale paid $25,000 to Design that Matters, the same charitable outfit that had approached Avery about the Acuset. The money was for a scoping study in hospitals in Nepal and it also attracted significant funding from other donors.
Matt Eckelman, who wrote the initial report with Design that Matters’ chief Timothy Prestero, recalls he helped lead a team of Stanford design school students to Nepal in 2007 for about a week to do initial project development for the incubator project, including interviews and observations in hospitals. They presented a report to Avery, along with some different low-cost options for keeping babies warm.
One of the rough prototypes they produced was a fully functional, cheap incubator, then known as a Liferaft. It was boxy and didn’t look anything like the sleek egg shape of today. Another was a portable, sleeping bag-like wrap called the Embrace, which, Avery commented at the time, failed the commercial distribution test because, he said, “home births are not really the target market given it’s not clear who will pay”.
One of the Stanford groups went their own way and developed their own product and company called Embrace, which won several awards, Eckelman recalls.
Meanwhile, Medicine Mondiale and Design that Matters had parted acrimoniously.
Avery says that, using information his charity paid for, and without telling him, they came up with their own incubator. (Newsroom tried and failed to reach Prestero before this story was published).
Design that Matters’ incubator, the NeoNurture, was made using old car parts and won Time magazine’s number one spot in the 50 best inventions of 2010.
In a popular 2012 TED talk Timothy Prestero explains why the design failed spectacularly in the real world. “The only baby ever put inside a NeoNurture incubator was this kid for a Time magazine photo shoot .... I don’t think this kid was even in it long enough to get warm,” he says. “It turns out there’s a whole constellation of people who have to be involved in a product for it to be successful, manufacturing, financing, distribution, regulation. Who will choose, use and pay the dues?”
A New Zealander who’s worked for charities in overseas health settings warns there’s a danger of simply plonking devices in developing countries because people in richer nations think it’s a good idea. A different neo-natal expert suggested that, because peri-natal deaths were caused by so many interconnected things, it was important to look at the whole healthcare system.
Avery says the NeoNurture’s failure was simple: a machine made with car parts could never meet the international safety standards needed to manufacture an incubator. “Despite spending millions of donors dollars on their NeoNurture…they abandoned the project because the design and materials of construction did not meet ISO 13485 standards,” he says. The project was doomed because Prestero didn’t understand the requirements to manufacture medical devices. Avery suggested Design that Matters used other issues like no NGO buy-in to explain its failure.
“Nobody will use one of these until it’s been used in developing countries for probably a decade.”
In his home workshop he shows me an early, crude shell of a LifePod. This one is rough – no hinge, just a lid just loosely sitting on top. You wouldn’t put a baby near it. Avery shows me a steriliser unit, and various parts they’ve tested like a hardy fan. He talks in a rapid English-accented patter. He huffs on things, pulls things out, and, at one point, throws the pod’s roof on the floor with a loud crack. “When we did that the first time it just shattered. We had to go back to the plastic man and say, ‘We needed a stronger polymer’.”
He explains his goal for the LifePod: it will purify its own water, in case the supply is contaminated, keep the air around the baby sterile and at the correct humidity and temperature. It will be very even-temperature, and won’t collect bacteria the way he says traditional incubators do. Expensive incubators have two ports for the nurses to insert their hands through when they need to perform tasks for the baby, while the LifePod has a flip top lid.
Avery says his observations and the students’ notes from Stanford found that, in reality, nurses open incubators right up anyway because the ports are so awkward. The LifePod, he says, is designed to reheat after opening in less than a minute. The battery will survive voltage fluctuations and power cuts. “This is the most sophisticated power supply in the world.” All the electronics sit in one tray near the bottom, which can be pulled out. If something breaks, rather than trying to repair it, hospitals can send the unit back to the factory in Chennai for a replacement, he says.
The manufacturing of the first prototypes was overseen by engineer Andrew Sinclair, who’s working as a project manager to get the manufacturing started. After a search, Avery has found an Indian manufacturer, Phoenix Medical Systems, that is already making a different incubator and has the all-important accreditation to meet the European and international standards to manufacture a medical device. It’s the factory that will be responsible for securing the relevant ISO standards, says Avery, but first they are re-fitting their factory and including an dedicated area where roughly 180 LifePods could be manufactured in a week. “It’s going to take six-eight months for us to be comfortable that we can launch to scale which really fits in with the concert.”
Sinclair has blogged about watching the first prototype being assembled in January last year. The heat was sweltering and it was tough work, he told Newsroom, but apart from the factory having ceiling fans instead of air conditioning it was as high-tech as a similar plant would be if it were in New Zealand. The next step was tweaking parts of the pods to make them easier and faster to assemble, to shrink the manufacturing time.
Sinclair was impressed by Phoenix Medical Systems, which Avery plans to offer a five-year exclusive manufacturing contract, and exclusive distribution rights to sell the incubator in some countries, at a price to be determined by the factory. It’s envisaged that Medicine Mondiale will be able to buy incubators to give to charity at just over cost, and, for commercially-purchased incubators, Phoenix will pay Medicine Mondiale a royalty of a few hundred US dollars each.
The plan is to raise money for 2000 incubators and give the first 203 LifePods to hospitals in Pacific countries, including Fiji, Samoa, Tonga, Niue and Vanuatu. Of those, the first 50 will go to 20 hospitals in Fiji. As for the other 1798, they’ll be given out according to a plan that’s yet to be developed in conjunction with Phoenix Medical Systems.
Newsroom asked to speak to hospitals or administrators who were keen to use the devices, but was told it would cut across an exclusive TV production deal, and potentially create sensitivities for doctors by highlighting a lack of incubators. Instead, Avery suggested we watch the Nepalese documentary, which shows the film-maker struggling to get Nepalese hospitals to trust him with access to their struggling wards.
There’s no special reason for giving away 2000 incubators, says Avery, except that it adds up to an imagination-capturing million babies, based on his estimate that each one will save 500 babies over its 10-year, low-maintenance lifetime – each baby spending on average a week inside the pod. He admits the figures aren’t precise. “When you’re doing marketing you pick some figures out of the air. The reality is that it gets confusing but we’ve said with the technology we’ve invented it’ll run for 10 years without any major servicing.”
He doesn’t think anyone will buy them in a hurry unless they see them already out there, working. Hence his plan to sell the first 2000 to the people of New Zealand. “My experience with these things is it will take years to get these incubators out at scale if we just wait for people to place an order. The real customers for these things are often hospitals who don’t have money to buy them.”
As for researchers in New Zealand, Avery used the bioengineering team at Christchurch Hospital to make a small part of the LifePod. About five staff volunteered to work after-hours for about six months to make a device to reliably measure the water level in the incubator, a process engineer Michael Sheedy says was tricky but rewarding. Avery is “inspirational” he says, and it was nice to be able to work on a worthwhile project that was outside the norm.
At his workshop I asked Avery if he’d collaborated with the Liggins Institute, the peri-natal researchers at Auckland University, or other similar researchers. “There’s no point (using) somebody at the Liggins Institute, they’ve never seen a baby at 350 grams, and have no idea how to look after them, you find the world expert who knows about looking after those babies,” he says. As for trying the LifePods here, DHBs will never co-operate to look at something like that, he says. “Nobody will use one of these until it’s been used in developing countries for probably a decade.”
It’s also unlikely that New Zealand ethics boards would give approval to trial the device here, since they haven’t got FDA approval, he says. That’s one reason why he’s going to hold a clinical trial in Chennai. The trial will be six months long, he says, and compare 10 donated LifePods made by Phoenix Medical to other incubators.
The babies will wear ankle straps monitoring their vital signs and the incubator itself is alarmed to alert nurses if anything goes wrong, he says. Newsroom wanted to speak to the hospital, but Avery said that would expose the doctors to unfair pressure and scrutiny. If anything breaks, the technicians at the factory are only a short drive away, he says.
Not that he expects anything to break. In fact, he says he doesn’t strictly need to run a trial with babies to gain accreditation to sell the devices – but he wants to make sure he hasn’t overlooked anything before going from 10 to 2000 incubators. There might also be feedback from nurses about little things, like the night lights.
“We’ve done all the testing which shows it complies with the [ISO] standard so we don’t expect anything to go wrong, in fact the accuracy of the incubator is better than a normal incubator in terms of maintaining temperature and humidity. It also produces a sterile environment inside which normal incubators don’t do. We did a lot of in-house testing in Australia and Chennai so from our perspective there isn’t any risk really. We have about 10-15 sensors that are measuring heating and humidification in all parts of the incubator.”
Avery shows me the results of the humidity and temperature testing an Australian expert, Ross Ramm, did in Australia in March. The object was to show the latest version of the incubator has sufficiently accurate temperature and humidity control that it would meet the ISO standard. It did.
But a source with medical manufacturing knowledge said humidity and heat testing was only a tiny part of the testing needed to achieve CE Mark and ISO standards. That’s where Phoenix Medical will come in, says Avery – its job is to demonstrate compliance with the CE Mark and ISO Standards. An auditor from the UK will come and check a commercial production run of at least 100 incubators, before the devices can carry a CE Mark, he says.
By then, the trial results will be in. “My failure would be if a baby dies in one of my incubators, so I do six months real time, real conditions, as used, testing ... it’s a safety thing for me. Then we just launch it.”
Will he publish the trial data? Again, he says he doesn’t need to. But he’d show it on TV, and give the report to hospitals that wanted it, he says. “The guy from Chennai will say we’ve been using them for six months. We’re going to launch at scale knowing they are going to work.”
If the data was unexpectedly bad, would he cancel the concert? It won’t be, he says. “By the time we get to Waitangi Day, the testing will be completed. By now, we’re talking by email. “Eloise, I love your natural failure mode cause effect analysis (FMCEA) thinking. (You’re not a Virgo are you?). We have life cycle tested each invidual component and validated various iterations of the incubator … so we are 100 per cent confident the incubator will work under the most hostile conditions.”
In fact, having spent so many hours looking at international regulatory standards, Avery felt moved to offer some advice to a rival developer.
Last week, he emailed the UK team behind the Mom incubator, an electric, low-cost, inflatable device that won a James Dyson innovation prize in 2014 - a task Avery says he undertook under the auspices of the Ethical Science Group. He alerted them to some problems he thought they would have meeting international standards using the materials they planned to. They replied that they were aware of the issues, and would be doing detailed testing.
Avery replied to them that he was glad they were aware of it: “I do worry about those 'not practised in the art' generating concepts … wasting donor funds and captivating the imagination of those less informed.”