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NY Needed Ventilators for Coronavirus. They Developed One in a Month.

The nudge came in an email in early March from an Italian friend alarmed by how fast the deadly coronavirus was spreading in his country.

A shortage of ventilators, he told Scott Cohen and Marcel Botha, was a critical problem in Italy, and he warned that it soon would be in the United States, too. He urged the pair to apply their skills to the ventilator challenge.

Both Mr. Cohen, co-founder of a technology center for researchers and start-ups, and Mr. Botha, chief executive of a product design and development company, were skeptical. A standard ventilator, with thousands of parts requiring a complex global supply chain, was hardly a device that could be manufactured quickly and affordably.

“I was dismissive at first,” said Mr. Botha, whose company is called 10XBeta. “It looked impossible.”

But they soon found a design for a basic ventilator that could serve as their core technology. Since then, they have orchestrated from New York a far-flung collaboration of scientists, engineers, entrepreneurs, physicians and regulatory experts and accomplished in a month what would normally take a year or more.

Image
Credit…Gabby Jones for The New York Times

The result are machines known as “bridge” ventilators, or automatic resuscitators, priced at $3,300. They are mainly meant to help less critically ill patients breathe. If patients become sicker, with lung function more compromised by the disease, they still need to be placed on standard ventilators, which typically cost more than $30,000.

On Friday, the Food and Drug Administration approved the new device, the Spiro Wave, to be used on patients in hospitals, under an expedited process called emergency use authorization.

The project was initially targeted at New York City as a stopgap solution for what only a month ago appeared to be a looming, life-threatening shortage of ventilators in the city.

But the urgency has receded for now. While the city’s coronavirus death toll continues to mount, hospital admissions are trending down, and intensive-care units seem to have enough ventilators.

But health experts say a machine like the Spiro Wave should be a valuable tool in the arsenal of treatment. It can, they say, expand access to breathing assistance in other parts of the country as the pandemic spreads, and especially to rural communities without major medical centers. And capable, low-cost machines could greatly expand access to treatment in developing countries in Asia, Africa and Latin America.

The New York group has fielded inquiries from across the United States and from companies and governments worldwide. It plans to license its design for free.

The project is one of several pushes in America and abroad to streamline ventilator design and lower costs. This month, Medtronic got F.D.A. approval to offer in the United States a ventilator that it sells in 35 other countries for an average price of less than $10,000. The company is also making the machine’s blueprint freely available to other manufacturers.

The hurry-up engineering feat relied on human networks; two in particular stand out. The original design came from a classroom project at the Massachusetts Institute of Technology a decade ago. Since the coronavirus outbreak, M.I.T. professors and students have worked to upgrade the design in collaboration with outside groups. And several key contributors to the project are M.I.T. alumni.

The other network is the government and business community of New York, where Mr. Cohen and Mr. Botha are based. The city government took on the role of a risk-taking venture investor, first with a $100,000 research grant and then a nearly $10 million agreement to buy 3,000 of the basic ventilators.

“It’s essentially a start-up that has made unbelievable progress in a short time,” said James Patchett, chief executive of New York City’s Economic Development Corporation, which backed the project.

The New York ventilator effort got underway after widespread warnings of shortages. In mid-March, Mayor Bill de Blasio held a conference call with top staff members. Mr. de Blasio recalled that the looming ventilator shortage was “scary as hell.” New York had no ventilator producers, but he told his staff to do and spend what it took to solve the problem.

The city’s economic development chief, Mr. Patchett, who was on the call, knew Mr. Cohen and his technology center, New Lab, which is in the Brooklyn Navy Yard. Mr. Cohen told him about the ventilator-design project that he was putting together. It sounded promising, and the city made its initial grant.

Later, on March 25, after further development of the M.I.T. design, critical care physicians from city’s public hospitals and two private hospitals saw the most recent version of the machine. That evening Mr. Patchett called Dr. Mitchell Katz, who leads the Health and Hospitals Corporation, which operates the city’s public hospitals.

“We should definitely do this,” Dr. Katz recalled telling Mr. Patchett.

The project had launched about 10 days earlier, after Mr. Cohen, on the recommendation of a scientist friend in San Francisco, got in touch with Alex Slocum, a renowned mechanical engineer at M.I.T. whose class created the design in 2010.

Image

Credit…Gabby Jones for The New York Times
Image

Credit…Gabby Jones for The New York Times

A group of faculty and students — Mr. Slocum led hardware design, and Daniela Rus, a professor and robotics expert, led software development — worked to upgrade the design to help coronavirus patients. The device would have to be able to push air into badly impaired lungs at several times the force used to resuscitate a normal lung.

“This was going to take a serious machine,” Mr. Slocum recalled.

The New York group began closely collaborating with the M.I.T. team. Dr. Albert Kwon, an M.I.T. graduate and a medical adviser on the project who is an anesthesiologist at the Westchester Medical Center, and Mr. Botha, also an M.I.T. alumnus, and others from New York made several trips to Boston for joint work and testing.

The M.I.T. academics’ goal has been mainly to develop designs and share information on a website. But the mission for the New York group was to make the low-cost ventilators quickly. The hub of that effort is a former perfume factory in Long Island City, Queens, that is now home to a high-tech manufacturer, Boyce Technologies.

The temperature of everyone who enters the brick building is taken, a precaution against infection. The 100,000-square-foot facility combines engineering and production with robots, a clean room, and circuitry and software design departments.

Manufacturing, engineering and medical experts have worked side by side for three weeks. Dozens of versions of the machine have been carted off to the dumpster, as upgrades and improvements were made. In recent days, M.I.T. engineers traveled to Queens to help with last-minute software tweaks.

“There’s a lot you can’t see in a model,” said Charles Boyce, the founder and chief executive of Boyce Technologies. “And if you can’t manufacture something at scale, it doesn’t matter. It’s not going to have an impact.”

Producing thousands of machines means lining up sometimes scarce supplies. One of those parts was an air-pressure sensor to ensure that a patient’s lungs were not overinflated, which could cause damage. Mr. Cohen knew that Honeywell was a leading producer of the sensor, and he tapped his network of personal contacts to secure it in volume.

Late one night, Mr. Cohen called Kathryn Wylde, chief executive of the Partnership for New York City, a business group of the city’s top executives. Kevin Burke, a former chief executive of New York-based Con Edison, is a Honeywell board member. Introductions were made, and after a series of calls to Honeywell executives in America and Asia, a supply of the sensors was secured.

The New York ventilator project was intended to address a seemingly urgent need before large-scale initiatives — such as a Ford-General Electric partnership — began to produce ventilators.

While New York’s crisis has eased, Dr. Katz cautioned that pandemic viruses are unpredictable and mutate. A later variant, or second wave, in the fall could be less lethal or more, as was the case with the second wave of the 1918 flu pandemic.

“This is still a useful option to have, even if there is not the urgency there was,” he said.

The low-cost ventilator, Mayor de Blasio said, is an “invaluable tool” and part of the stockpile of medical equipment and supplies the city needs as “insurance against a Phase 2” of the pandemic.

“We have to get through this first,” he said. “But for the future, we have to have an ongoing self-sufficiency effort in New York. What we’ve gone through should be a never-again moment.”

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New York Needed Ventilators. So They Developed One in a Month.

The nudge came in an email in early March from an Italian friend alarmed by how fast the deadly coronavirus was spreading in his country.

A shortage of ventilators, he told Scott Cohen and Marcel Botha, was a critical problem in Italy, and he warned that it soon would be in the United States, too. He urged the pair to apply their skills to the ventilator challenge.

Both Mr. Cohen, co-founder of a technology center for researchers and start-ups, and Mr. Botha, chief executive of a product design and development company, were skeptical. A standard ventilator, with thousands of parts requiring a complex global supply chain, was hardly a device that could be manufactured quickly and affordably.

“I was dismissive at first,” said Mr. Botha, whose company is called 10XBeta. “It looked impossible.”

But they soon found a design for a basic ventilator that could serve as their core technology. Since then, they have orchestrated from New York a far-flung collaboration of scientists, engineers, entrepreneurs, physicians and regulatory experts and accomplished in a month what would normally take a year or more.

Image
Credit…Gabby Jones for The New York Times

The result are machines known as “bridge” ventilators, or automatic resuscitators, priced at $3,300. They are mainly meant to help less critically ill patients breathe. If patients become sicker, with lung function more compromised by the disease, they still need to be placed on standard ventilators, which typically cost more than $30,000.

Last Friday, the Food and Drug Administration approved the new device, called the Spiro Wave, to be used on patients in hospitals, under an expedited process called emergency use authorization.

The project was initially targeted at New York City as a stopgap solution for what only a month ago appeared to be a looming, life-threatening shortage of ventilators in the city.

But the urgency has receded for now. While the city’s coronavirus death toll continues to mount, hospital admissions are trending down, and intensive-care units seem to have enough ventilators.

But health experts say a machine like the Spiro Wave should be a valuable tool in the arsenal of treatment. It can, they say, expand access to breathing assistance in other parts of the country as the pandemic spreads, and especially to rural communities without major medical centers. And capable, low-cost machines could greatly expand access to treatment in developing countries in Asia, Africa and Latin America.

The New York group has fielded inquiries from across the United States and from companies and governments worldwide. It plans to license its design for free.

The project is one of several pushes in America and abroad to streamline ventilator design and lower costs. This month, Medtronic got F.D.A. approval to offer in the United States a ventilator that it sells in 35 other countries for an average price of less than $10,000. The company is also making the machine’s blueprint freely available to other manufacturers.

The hurry-up engineering feat relied on human networks; two in particular stand out. The original design came from a classroom project at Massachusetts Institute of Technology a decade ago. Since the coronavirus outbreak, M.I.T. professors and students have worked to upgrade the design in collaboration with outside groups. And several key contributors to the project are M.I.T. alumni.

The other network is the government and business community of New York, where Mr. Cohen and Mr. Botha are based. The city government took on the role of a risk-taking venture investor, first with a $100,000 research grant, and then a nearly $10 million agreement to purchase 3,000 of the basic ventilators.

“It’s essentially a start-up that has made unbelievable progress in a short time,” said James Patchett, chief executive of New York City’s Economic Development Corporation, which backed the project.

The New York ventilator effort got underway following widespread warnings of shortages. In mid-March, Mayor Bill de Blasio held a conference call with top staff members. Mr. de Blasio recalled that the looming ventilator shortage was “scary as hell.” New York had no ventilator producers, but he told his staff to do and spend what it took to solve the problem.

The city’s economic development chief, Mr. Patchett, who was on the call, knew Mr. Cohen and his technology center, New Lab, which is in the Brooklyn Navy Yard. Mr. Cohen told him about the ventilator-design project that he was putting together. It sounded promising, and the city made its initial grant.

Later, on March 25, after further development of the M.I.T. design, critical care physicians from city’s public hospitals and two private hospitals saw the most recent version of the machine. That evening Mr. Patchett called Dr. Mitchell Katz, who leads the Health and Hospitals Corporation, which operates the city’s public hospitals.

“We should definitely do this,” Dr. Katz recalled telling Mr. Patchett.

The project had launched about 10 days earlier, after Mr. Cohen, on the recommendation of a scientist friend in San Francisco, got in touch with Alex Slocum, a renowned mechanical engineer at M.I.T. whose class created the design in 2010.

Image

Credit…Gabby Jones for The New York Times
Image

Credit…Gabby Jones for The New York Times

A group of faculty and students — Mr. Slocum led hardware design and Daniela Rus, a professor and robotics expert, led software development — worked to upgrade the design to help coronavirus patients. The device would have to be able to push air into badly impaired lungs at several times the force used to resuscitate a normal lung.

“This was going to take a serious machine,” Mr. Slocum recalled.

The New York group began closely collaborating with the M.I.T. team. Dr. Albert Kwon, an M.I.T. graduate and a medical adviser on the project who is an anesthesiologist at the Westchester Medical Center, and Mr. Botha, also an M.I.T. alumnus, and others from New York made several trips to Boston for joint work and testing.

The M.I.T. academics’ goal has been mainly to develop designs and share information on a website. But the mission for the New York group was to make the low-cost ventilators quickly. The hub of that effort is a former perfume factory in Long Island City, Queens, that is now home to a high-tech manufacturer, Boyce Technologies.

The temperature of everyone who enters the brick building is taken, a precaution against infection. The 100,000 square-foot facility combines engineering and production with robots, a clean room and circuitry and software design departments.

Manufacturing, engineering and medical experts have worked side by side for three weeks. Dozens of versions of the machine have been carted off to the dumpster, as upgrades and improvements were made. In recent days, M.I.T. engineers traveled to Queens to help with last-minute software tweaks.

“There’s a lot you can’t see in a model,” said Charles Boyce, the founder and chief executive of Boyce Technologies. “And if you can’t manufacture something at scale, it doesn’t matter. It’s not going to have an impact.”

Producing thousands of machines means lining up sometimes scarce supplies. One of those parts was an air-pressure sensor to ensure that a patient’s lungs were not over-inflated, which could cause damage. Mr. Cohen knew that Honeywell was a leading producer of the sensor, and he tapped his network of personal contacts to secure it in volume.

Late one night, Mr. Cohen called Kathryn Wylde, chief executive of the Partnership for New York City, a business group of the city’s top executives. Kevin Burke, the former chief executive of New York-based Con Edison, is a Honeywell board member. Introductions were made, and after a series of calls to Honeywell executives in America and Asia, a supply of the sensors was secured.

The New York ventilator project was intended to address a seemingly urgent need before large-scale initiatives — such as a Ford-General Electric partnership — began to produce ventilators.

While New York’s crisis has eased, Dr. Katz cautioned that pandemic viruses are unpredictable and mutate. A later variant, or second wave, in the fall could be less lethal or more, as was the case with the second wave of the 1918 flu pandemic.

“This is still a useful option to have, even if there is not the urgency there was,” he said.

The low-cost ventilator, Mayor de Blasio said, is an “invaluable tool” and part of the stockpile of medical equipment and supplies the city needs as “insurance against a phase two” of the pandemic.

“We have to get through this first,” he said. “But for the future, we have to have an ongoing self-sufficiency effort in New York. What we’ve gone through should be a never-again moment.”

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Jeffrey Epstein Gave $850,000 to M.I.T., and Administrators Knew

Over 15 years, the convicted sex offender Jeffrey Epstein repeatedly donated to the Massachusetts Institute of Technology. Top administrators knew about the gifts, felt conflicted about them, and accepted them anyway. The university’s president even signed a thank-you note.

But on Friday, months after the campus was roiled by revelations of Mr. Epstein’s financial ties to the school’s prominent Media Lab program, investigators hired by the school absolved M.I.T.’s leadership of breaking any rules.

The law firm Goodwin Procter spent four months compiling a report on M.I.T.’s dealings with Mr. Epstein, who killed himself in his Manhattan jail cell in August while awaiting trial on federal sex trafficking charges. The investigation found that Mr. Epstein made 10 donations — totaling $850,000, slightly more than M.I.T. had previously disclosed — from 2002 to 2017. Mr. Epstein also visited campus at least nine times from 2013 to 2017, a period that followed his conviction on sex charges involving a minor in Florida.

The university took action against only one person still connected with the school: Seth Lloyd, a mechanical engineering professor who previously acknowledged accepting money from Mr. Epstein, was placed on paid leave. The report found that Mr. Lloyd had “purposefully failed” to inform M.I.T. of multiple donations from Mr. Epstein, including a $60,000 gift deposited into his personal bank account.

The report concluded that Mr. Epstein’s visits, along with any donations made after his 2008 conviction in Florida, had been enabled by Mr. Lloyd or Joichi Ito, the former director of the Media Lab who stepped down in September. (Mr. Ito also resigned from The New York Times Company’s board.)

The 61-page report, based on dozens of interviews and a review of more than 610,000 emails and documents, cleared others of wrongdoing, including the university’s president, L. Rafael Reif. Mr. Reif acknowledged last year that he had signed a letter thanking Mr. Epstein for a donation in 2012, but the report said he “had no role in approving” the donations.

One current and two former M.I.T. vice presidents who learned of Mr. Epstein’s donations in 2013 and began quietly approving them were rebuked in the report, but not disciplined because it concluded that they had not broken any university policies.

The three vice presidents — R. Gregory Morgan, Jeffrey Newton and Israel Ruiz — made “significant errors in judgment that resulted in serious damage to the M.I.T. community,” according to the report.

Mr. Ruiz is the school’s executive vice president and treasurer, although the university announced last month that he would step down this semester for a career outside of academia. The announcement made no mention of the Epstein scandal.

Mr. Ruiz said in a statement that he was confident that the university’s leadership and broader community would “create an effective and successful path forward.”

Mr. Morgan and Mr. Newton have retired from the university. They did not respond to requests for comment.

According to the report, the men debated whether to accept Mr. Epstein’s money “in the absence of any M.I.T. policy regarding controversial gifts.” They reached a compromise: Under “an informal framework,” the school would accept the donations while insisting that the gifts be small and unpublicized to prevent Mr. Epstein from using them to improve his reputation or gain influence at the university, the report said.

Efforts to reclassify Mr. Epstein’s donations as anonymous “made it impossible for all but a select few to see the number or amount of Epstein donations,” the school’s executive committee said in a statement. The committee called for university employees “to take steps to protect and ensure the integrity and factual accuracy of the donor database.”

Denis A. Bovin, a member of the executive committee, said at a news conference that M.I.T. had not thought it would need a policy concerning gifts from someone with Mr. Epstein’s past.

“We never thought in our history that we’d have this kind of problem,” he said.

Mr. Lloyd, the professor, is now under review in the mechanical engineering department, with proceedings “moving swiftly,” Alan G. Spoon, a member of M.I.T.’s board of trustees, said during a conference call with reporters.

Mr. Lloyd, who was introduced by his book agent to Mr. Epstein in 2004, declined to comment.

The report focused heavily on Mr. Ito, the former Media Lab director, who acknowledged raising $1.7 million from Mr. Epstein for the lab and his own outside investment funds. The disclosure raised an uproar at a program that prides itself on its contrarian culture.

Mr. Ito, a master networker who raised at least $50 million for the Media Lab, met Mr. Epstein in 2013 at a TED conference in California and then “cultivated” the financier as a donor and a link to other wealthy people, according to the report.

Mr. Ito resigned from the Media Lab in September. He also stepped down from several other boards and a visiting professorship at Harvard. He did not respond to a request for comment.

The report found that Mr. Epstein’s presence on campus had disturbed Media Lab staff members — investigators were told that Mr. Epstein was sometimes accompanied by young female assistants — and that Mr. Ito probably sensed their nervousness. In 2013, Mr. Ito expressed concern that a proposed campus visit from Mr. Epstein and the director Woody Allen could result in a public relations headache, investigators found. A Media Lab communications employee distributed photos of one event to other people at the lab, writing in an email that they should “feel free to post on social media — as long as Jeffrey Epstein does not appear in any of the photos!”

News reports about other internal emails previously demonstrated how Media Lab officials had obfuscated Mr. Epstein’s relationship with the program. The emails included references to donations from other wealthy figures that purportedly involved Mr. Epstein.

In one 2014 email, Mr. Ito wrote that a $2 million gift from the Microsoft co-founder Bill Gates had been “directed by Jeffrey Epstein.” In a subsequent email, another lab official wrote that “for gift recording purposes, we will not be mentioning Jeffrey’s name as the impetus for this gift.” In another email exchange, Mr. Ito discussed how Mr. Epstein was helping to connect the lab to Leon Black, the founder of Apollo Global Management, a prominent private equity fund. One email indicated that Mr. Black had given the lab $4 million.

Mr. Gates has denied that Mr. Epstein directed grant-making on his behalf. A representative for Mr. Black said he could not immediately be reached for comment.

Roberto Braceras, a Goodwin Procter partner who led the investigation, said on the conference call that his team spoke with representatives of Mr. Gates, who “deny that any Gates donation had any relationship to anything regarding Epstein.” He said Mr. Black’s representatives could not be reached, but added that “there’s no evidence that Black’s donations were the result of Epstein’s encouragement.”

The university has already set up two faculty-led committees to work on new policies for gifts and the vetting of donors. Those committees are expected to deliver their recommendations in the spring, and the executive committee said administrators should work closely with them to put such policies in place as soon as possible.

Crystal Lee, a graduate student at M.I.T., said she was relieved that Mr. Lloyd was no longer teaching students. But she said the report did not answer all the questions she had.

“I am still troubled by many of the specific details of the case that will go unresolved with the report’s air of finality,” she said.

For example, she said, the university offers only “woefully inadequate” support for mental health, despite the circumstances of the scandal.

“I am optimistic that M.I.T. can and should change, if only because of my fellow students, who have done so much work to make this campus a better place,” she said.

Kate Kelly contributed reporting. Sheelagh McNeill contributed research.