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Symmetric Newsletter - Feb 27, 2021

Dear Readers,

Between warmer weather and lower cases, it's hard not to feel at least a little hopeful.  And despite reports of new variants in the US alongside variants from other countries on US shores, there is tangible progress to be hopeful about.  Vaccines seem to be making a big dent in cases and deaths, both in countries like the UK and here at home.

We hope the weather is warming up wherever you're reading from, too!

Best,
The Symmetric team


--
 
Vaccine Awareness

 

On device identification:
A discussion of US and global UDI systems

This month our team hosted a conversation between Terrie Reed, Director of Partner Relationships at Symmetric and a former senior advisor to the FDA, and Rich Kucera, our CEO.

The conversation covered a range of topics:
  • How problems in medical device identification gave rise to the UDI System in the US
  • What issues remained after its introduction (hint: catalog numbers are one of them)
  • Why a global UDI system will be most effective if regulations are in harmony around the world

A snippet: "Having a standard label and barcode format was new to the healthcare supply chain [under the UDI system], having a repository of items and properties to identify them was brand new to the healthcare supply chain. There had been an attempt in the 90's at doing this within the industry. That didn't really take off."

Bottom line: UDI has helped tremendously with the identification of medical devices, but there are many improvements that can be made -- among them, making sure that global regulations are in harmony with one another.

Read the full conversation here, and email us if you have other topics you'd like to hear the team discuss!

For more on device identification, check out our UDI primer and a roadmap for providers interested in adopting UDI.
Vaccine bottlenecks remain

Vaccine production is hitting three key bottlenecks, writes Kaiser Health News:


1. Production of specialty fatty lipids
2. Availability of vials
3. Sterile assembly line capacity
 

Some key takeaways:

  • The administration has invoked the Defense Production Act on 23 vaccine-related contracts at a minimum
  • Operation Warp Speed, the federal vaccine initiative, allocated $14 billion to vaccine development and manufacturing
  • mRNA vaccines are so new that there was no large-scale supply infrastructure to produce them

But: US pharmaceuticals face some criticism for not entering "co-production" deals where they partner with another large pharma to help boost production.  And "at the current rate of production, Pfizer and Moderna will miss their targets of providing at least 100 million doses each by the end of March, let alone 200 million more doses each has promised by July."
 

Bottom line: even the Defense Production Act has limits.  Pharmaceuticals will need to ramp production quickly to fill promised vaccine orders.

Can distributed domestic manufacturing
help mitigate demand shocks?

"Local suppliers were often able to respond more rapidly and flexibly to changes in need than centralized supply sources,"  writes Douglas Hannah for Harvard Business Review.

Hannah lays out six ways providers can harness domestic manufacturing in the event of crises that generate demand spikes: 

  • Respond to offers of help in a coordinated way.
  • Document and vet equipment designs to ensure quality.
  • Identify alternative suppliers before they’re needed.
  • Hold disaster-preparation drills that test supply availability.
  • Cut the red tape that prevents facilities from paying for supplies.

Our thought bubble:  More preparedness is better. To that end, last May we published a checklist to help providers vet alternate suppliers.

However, the Business Review article raises a number of questions.  In particular, will domestic manufacturing receive enough sustained demand post-pandemic to support itself?

If providers continue relying on domestic suppliers during normal times or the government explicitly supports them as a critical industry, then perhaps.  But already, many US-based manufacturers have seen drastic drops on demand, leaving them with vast unsold inventories.

As the New York Times reported earlier this month, "many of the nearly two dozen small American companies that recently jumped into the business of making N95s are facing the abyss." 

What we're watching: whether providers continue to buy domestic and whether the federal government introduces domestic purchasing programs.

Read more.
More from around healthcare
Thanks for reading! 

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