We need more ventilators. Here’s what it will take to get them

  
Via:  Nerm_L  •  2 months ago  •  16 comments

By:   James Temple -- MIT Review

We need more ventilators. Here’s what it will take to get them
To begin manufacturing devices suited for an escalating pandemic—which require different standards, features, and batteries—Callaghan says they would need to raise additional funds, lock in contracts, and secure fast-track regulatory approvals from the US Food and Drug Administration and other authorities.

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There isn't going to be 30,000 ventilators for New York.  Politicians want the Federal government to wave a magic wand, spend whatever it takes, and get it done.  But that isn't reality.

Focusing attention on ventilator producers is short sighted.  What would be required is increasing the capacity of the entire supply chain.  Everything begins with a hole in the ground.


S E E D E D   C O N T E N T



As a Stanford postdoc a decade ago, Matt Callaghan created the designs for a streamlined, low-cost ventilator that hospitals could stockpile, to prepare for the possibility of a global pandemic.

But when he went on to cofound a company,   One Breath , he and colleagues determined that the immediate need was producing cheaper ventilators for critical care in the developing world, where chronic respiratory illnesses are among the leading causes of death.

The company raised several million dollars, set up manufacturing in Southeast Asia, and finally expected to begin production for its initial markets within the next 12 months.

But as the very sort of outbreak Callaghan originally had in mind takes hold, One Breath is now exploring whether it can rapidly retool to meet the acute needs of regions overwhelmed by the coronavirus, including the US. To begin manufacturing devices suited for an escalating pandemic—which require different standards, features, and batteries—Callaghan says they would need to raise additional funds, lock in contracts, and secure fast-track regulatory approvals from the US Food and Drug Administration and other authorities.

Even with that support, the best-case scenario is that production for US hospitals would start about 11 months from now. That “makes us a second-wave solution when you’re looking at the current outbreak,” says Callaghan, who is now chief medical officer of the Palo Alto startup and an adjunct surgery professor at Stanford.

Mechanical ventilators are essential for those suffering severe cases of Covid-19, ensuring that patients can continue to breathe when their lungs fail. Health systems in regions where the coronavirus has already spread widely, including parts of China, Iran, and Italy, have struggled to provide necessary care as critical cases outstripped supplies of the machines. The US could soon face similar constraints. As of last month, the nation had around 170,000 ventilators that could be immediately put into service—a fraction of what might be required in severe scenarios, according to earlier   studies .

That One Breath took a decade to get to the point of manufacturing ventilators at all, and would need nearly another year to begin production for US hospitals, highlights the obstacles companies will face in seeking to address the critical shortage of these machines.

Medical device manufacturing is highly regulated, depends on proprietary global supply chains, and requires significant expertise to ramp up and run. It’s absolutely critical, of course, that the machines function safely. So the suggestion of   some politicians   that UK car makers or other major manufacturers could swing into action and save the day is almost certainly over-optimistic.

Even­ existing ventilator manufacturers with deep experience and approvals in hand still face crucial limits in ramping up production. Constraints include the size of manufacturing plants and the availability of critical components, many of which originate in China.

Adding factory capacity also costs a lot of money up front, creating real risks for these businesses, since it’s possible hospitals won’t need as many ventilators as the worst-case scenarios suggest.

“Who will pay for all the extra ventilators even if the company can ramp up?” said Kenneth Lutchen, dean of Boston University’s College of Engineering and a professor of biomedical engineering, who is focused on   developing safer mechanical ventilators , in an email. “Presumably at some point this crisis will play itself out and the hospitals will have far more ventilators than they need until the next crisis.”

“There needs to be an incentivized business model to hit the go button for ramping up manufacturing, and government likely needs to figure out how to successfully engage,” he added.

People in the business also assert that governments need to step in to provide the necessary certainty for companies to accelerate production.

Chris Kiple, chief executive of the Washington-based ventilator company Ventec Life Systems, said in an article published by Forbes on Sunday that they could   boost production five-fold   over the next three to six months. But he stressed that they’d need the contracts to do so. And while orders have spiked in China, Italy, and Germany, it hasn’t happened yet in the US.

That may soon change. During his press conference on Wednesday, President Donald Trump   said he would invoke   the   Defense Production Act of 1950  to boost manufacturing of critical medical supplies. That act, passed during the Korean War, grants the president broad powers to direct businesses to produce specific goods that are critical to the national defense.

Major manufacturers, including GE Healthcare and Medtronic, have said they’re making efforts to step up production or distribution of ventilators, but they haven’t yet provided any details on volume or timing.

“GE has robust business continuity plans, and we are increasing our manufacturing capacity and output of equipment that is important in the diagnosis and treatment of Covid-19 patients, all while ensuring safe operations,” the company said in a statement to MIT Technology Review.

But amid the rising fears over coming shortages, others are already making contingency plans:   do-it-yourselfers   are developing their own machines and sharing designs online, while some hospitals are testing out ways of rigging respirators to   enable more than one patient to use them   at a time.


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Nerm_L
1  seeder  Nerm_L    2 months ago

The pandemic will be over before the capacity of the supply chain can be expanded to meet political demands.  Manufacturing doesn't run on magic.  And the supply chain is global.  A single government, even the Federal government, cannot overcome the international dispersion of production capacity.

The response of the United States to the global pandemic depends entirely upon the weakest link in the supply chain.  And the weakest link isn't located in the United States.

 
 
 
Nerm_L
2.1  seeder  Nerm_L  replied to  loki12 @2    2 months ago
Maybe if we can get out of our own way,

Matt Callaghan, the subject of the article, has already invented a new portable ventilator.  That's what the seeded article is about.  

New technology and new inventions won't overcome the limitations of the supply chain.  Magical thinking isn't going speed up the process.

 
 
 
loki12
2.1.1  loki12  replied to  Nerm_L @2.1    2 months ago

Neither will over regulating them. 

 
 
 
Nerm_L
2.1.2  seeder  Nerm_L  replied to  loki12 @2.1.1    2 months ago
Neither will over regulating them. 

True.  But that isn't the greatest obstacle at this point.

 
 
 
loki12
2.1.3  loki12  replied to  Nerm_L @2.1.2    2 months ago

I just saw a demonstration of a guy making a set of bagpipes out of a trashcan and his kids recorders, (those plastic flute things) I guess i have, Maybe misplaced, faith that we can accomplish miraculous things if we are just challenged and unshackled. 

 
 
 
Dulay
2.1.4  Dulay  replied to  Nerm_L @2.1    2 months ago

This is 3 days old and should be authorized TODAY! In 2 weeks they could start pump out 2500 a week. Judging from the models, Florida is going to need every one of them. 

https://markets.businessinsider.com/news/stocks/bwmg-s-blu3-submits-manufacturing-proposals-to-utilize-existing-blu3-product-in-response-to-increasing-global-demand-for-ventilators-due-to-covid-19-1029024818

 
 
 
Nerm_L
2.1.5  seeder  Nerm_L  replied to  loki12 @2.1.3    2 months ago
I just saw a demonstration of a guy making a set of bagpipes out of a trashcan and his kids recorders, (those plastic flute things) I guess i have, Maybe misplaced, faith that we can accomplish miraculous things if we are just challenged and unshackled. 

Making a single bagpipe may be innovative and creative.  But making 30,000 bagpipes based on that model requires a lot more than creativity.

Creativity isn't the problem, either.  The obstacle is practical application of that creativity.  We don't need a new, innovative design.  We need 30,000 units of a proven design that we know works and we know we can produce.

 
 
 
Nerm_L
2.1.6  seeder  Nerm_L  replied to  Dulay @2.1.4    2 months ago
This is 3 days old and should be authorized TODAY! In 2 weeks they could start pump out 2500 a week. Judging from the models, Florida is going to need every one of them. 

You still don't get it.  We need 30,000 ventilators.  We need a lot more than a single prototype.

Each ventilator will need a power cord, 3 ft in length.  We need 90,000 linear feet of power cable.

Each ventilator will need six inches of  ribbon cable to connect the electronics to the display.  We need 15,000 linear feet of ribbon cable.

Each ventilator will need about 20 fasteners to hold the components in place.  We need 600,000 fasteners.

Each ventilator requires 4 ft of polymer tubing to deliver air.  We need 1.2 million linear feet of polymer tubing.

We need 30,000 lcd displays, circuit boards, transformers, switches, battery packs, and housings.

We need a supply chain capable of producing 100 times normal supply.  And President Trump cannot order a circuit board manufacturer in China to increase production, cannot order a fastener manufacturer in Mexico to increase production, cannot order a lcd producer in South Korea to increase production, cannot order a wire manufacturer in Japan to increase production.

BWMG can produce a prototype based on their Blu3 model pretty quickly.  But we need 30,000 gee whiz ventilators; not a single prototype.  We need a supply chain.  And the United States has no control or power over that supply chain.

 
 
 
Dulay
2.1.7  Dulay  replied to  Nerm_L @2.1.6    2 months ago
You still don't get it. 

Actually, I do. I GET that a manufacturer has stated that they can switch from making diving respirators to making medical ventilators. I presume that they have sourced out the necessary components to make that happen. 

Oh and BTFW, if they CAN do what they say and they DO need components I suggest Trump get on it...

Also, I'm sure that the company in Florida isn't the diving gear producer in the country that can retool. 

Whatever other products use those components can go pound sand. Confiscate inventory if necessary. 

After all, Trump invoked the Defense Production Act, now he has to actually USE it. 

 
 
 
MUVA
2.1.8  MUVA  replied to  Dulay @2.1.7    2 months ago

That is a good idea and should have already been put in place years ago.

 
 
 
Nerm_L
2.1.9  seeder  Nerm_L  replied to  Dulay @2.1.7    2 months ago
Actually, I do. I GET that a manufacturer has stated that they can switch from making diving respirators to making medical ventilators. I presume that they have sourced out the necessary components to make that happen.

No, I don't believe you do get it.

The problem isn't the design of respirators.  Proven designs are already available.  Even portable respirators are available for transporting patients.  Ambulances are equipped with portable respirators.

The problem is production capacity in the supply chain.  Someone hawking an unproven gee whiz design will be competing for components and supplies which will divert resources away from producing proven designs.  BWMG can pound sand while the recreational diving suppliers switch production to supply resources needed for proven designs.

The United States has no control over the supply chain.  The Federal government can build factories to put together ventilators.  But that won't accomplish much without government control over the supply chain, too.  The Federal government would need to build factories to produce circuit boards, lcd screens, wire, switches, tubing, motors, and the myriad other components that are needed.  The Federal government would need to create an entire industry; not just a factory.

What BWMG is asking for is a pass on regulatory requirements so it's products can be used for medical purposes.  BWMG is proposing to cut corners on safety requirements and certification requirements so it's products can be used in a new market.  But that issue was addressed in the MIT Review article that was seeded.

After all, Trump invoked the Defense Production Act, now he has to actually USE it. 

Trump has been using the Defense Production Act.  If a business voluntarily agrees to a request then it isn't necessary to order the business to switch production.  And when a business makes a big deal about volunteering for PR value, it doesn't mean the administration didn't use the authority of the Defense Production Act.

 
 
 
Dulay
2.1.10  Dulay  replied to  Nerm_L @2.1.9    2 months ago
No, I don't believe you do get it.

In order to believe that you're ignoring the content of my comments. Intentional? 

 
 
 
Nerm_L
3  seeder  Nerm_L    2 months ago

I would think CPAP and BiPAP machines could be converted to a basic ventilator with the addition of a regulator.  CPAP and BiPAP machines supply a constant air pressure to open airways.  A ventilator cycles between positive and negative pressure to assist inhalation and exhalation.  Seems to me the only thing that would be needed is a regulator to cycle air pressure.

Of course, there wouldn't be a monitor for vitals.  That would need to be done the old fashioned way.

 
 
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