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Stratasys Helps: Responding to the COVID-19 Crisis.

Face Shields Shipped:

275,000

Nasal Testing Swabs

Stratasys has added to its efforts to fight the pandemic and ongoing testing requirements to include Origin who is producing field ready, individually packaged, sterile 3D printed nasopharyngeal swabs.

Face Shield Frame Files.

We are sharing our design files and invite and encourage those in the 3D printing community to join us as we work to keep our medical community safe. Download the Face Shield Frames below.

Download

Stratasys, along with our partners across the globe, have come together in unprecedented ways to combat the COVID-19 pandemic.

All Origin nasal swabs are now sterilized.

While the COVID-19 pandemic has begun to ease in the United States and governments similarly move from stay-at-home orders to an easing of restrictions, testing remains key to limiting the spread of the virus, and Stratasys is working hard to help testing centers gain access to the nasopharyngeal (NP) swabs they need.

According to the COVID Tracking Project, new tests across the country have been above 300,000 nearly every day since mid-May, with a new high of 545,690 tests reported on Friday, June 5. This is more than twice the rate of testing reported in mid-April. The demand continues to grow.

Since early May, Stratasys has been marketing and promoting Origin 3D-printed nasal swabs to healthcare providers and other testing centers in the U.S. And now, all these NP swabs (NP-01-S) are sterile, individually packaged, and ready to use out of the box.

The Origin 3D-printed NP swab (NP-01-S) has been tested in a clinical trial and is considered an FDA Class I Exempt Device. The trial was conducted by Beth Israel Deaconess Medical Center, an academic medical center affiliated with Harvard Medical School.

Stratasys Face Shield Coalition Celebrates Milestone: 100,000 Shields Shipped

Celebrating Our “Honor Roll” of COVID Coalition Members

In mid-March, a few of us at Stratasys initiated some conversations with organizations like the Mayo Clinic and Medtronic about what healthcare providers needed most as they faced a growing number of COVID-19 patients, and we also assessed what 3D printing would let us produce best. We decided to focus on face shields.

masks-2.jpg

So we iterated designs and started 3D printing visors as fast as we could. Medtronic and Dunwoody College of Technology helped us with cutting the initial clear shields. A few of us made runs to Office Depot to scoop up their supplies of overhead transparencies.

We asked hospitals and emergency responders how many they needed: Thousands. Ultimately hundreds of thousands.

We asked companies and colleges, large and small, to help us in this effort. They quickly became the Stratasys COVID Coalition and more than 100 teams across the U.S. and around the world went to work, 3D printing dozens, hundreds, thousands, and tens of thousands of shield visors.

Look at the difference this has made, in about six weeks! Friends, this week, we will hit 100,000 face shields shipped. We’ve successfully used 3D printing to get us to where injection molding can help boost production. And we’ve received heart-warming thanks from heroes on the front lines of this pandemic.

masks-3.jpg

As we all feel our way towards a new normal that is hopefully easier on everyone than the last few weeks have been, we’re hoping that soon our shields are no longer needed, so our COVID coalition can focus on building planes, teaching students, racing cars, making prosthetics, powering our world, winning high school robotics competitions, and all the other amazing things that we all “normally” do.

However, as long as the need for shields remains critical, Stratasys will continue to ship face shields to where they are needed. But as we reach peak scale of this effort, it’s time to thank all the coalition members who have played a part and have been willing to be named.

The "Honor Roll":

  • Advanced Tek
  • AMNI Additive
  • Andretti Autosports
  • Arrow McLaren
  • Bayer Crop Science
  • Blue Origin
  • Boeing
  • Boom Supersonic
  • CATI
  • Danfoss Power Solutions
  • Don Schumacher Racing
  • Dunwoody College of Technology
  • General Atomics
  • GoEngineer
  • Indy Performance Composites
  • Jay Leno’s Garage
  • Kirkwood Community College
  • Limbitless
  • Medical Alley
  • Medtronic
  • Protostudios at the University of Iowa
  • Raytheon
  • Robin Industries
  • Schlumberger
  • Unity Precision Manufacturing
  • University of Central Florida
  • University of Minnesota
  • Vermont Sports Car
  • Winnebago Industries

Nasal swabs and COVID-19 testing - the next step in the Stratasys pandemic response

3D printing answering the next supply shortage

The need for widespread COVID-19 testing of millions of people has surfaced another shortage, nasal swabs. Stratasys has added to its efforts to fight the pandemic and ongoing testing requirements by marketing and promoting Origin 3D-printed nasopharyngeal (NP) swabs to healthcare providers and other testing centers in the U.S. The Origin 3D-printed nasopharyngeal swab has been tested in a clinical trial and is considered an FDA Class I Exempt Device.

The clinical trial was conducted by Beth Israel Deaconess Medical Center, an academic medical center affiliated with Harvard Medical School, and Origin reports their results performed highest with regard to concordance to control swabs compared to two other 3D printed swabs. In addition, in subjective feedback, Origin swabs were preferred over the other 3D printed swabs for comfort.

Download clinical trial

Are FDM materials biocompatible?

We’re often asked about the biocompatibility of our FDM materials, and recent events have only accelerated the influx of questions. In an effort to make as much information about biocompatibility readily available, this blog post provides the facts we have to-date.

Stratasys has performed multiple tests to determine biocompatibility and the capability for sterilization for the following materials:

  • ABS-M30i – ABS (acrylonitrile butadiene styrene) thermoplastic
  • PC-ISO – Polycarbonate thermoplastic (white)
  • PC-ISO-T – Polycarbonate thermoplastic (translucent)
  • ULTEM 1010 resin – PEI (polyetherimide) thermoplastic

Table 1 below summarizes the results for biological endpoints and testing standards for each material. Table 2 identifies the details of the test coupons. Tables 3 through 6 provide current information about the sterilizability of these materials.

An important fact to remember is that this information represents results on post-printed test coupons (cubes), not on raw thermoplastic pellets or filament. Should you want to produce your own test coupons, we’ve included the protocol for preparing the printer and making the coupons with ABS-M30i and/or PC-ISO material. Access the test procedure here.

You can also review the biocompatibility and sterilizability supporting documentation currently available.

* Controlled refers to the specific printer preparation and cleaning that can be found in the test sample preparation document. This includes post-processing as appropriate.

Stratasys is responding to the current global COVID-19 (coronavirus) pandemic in many ways. One way we are responding is to provide additional information about our products. Stratasys has obtained a report, titled “Biocompatibility of MED610 as a Component in Gas Path Devices”, dated 30 March 2020, published by Nelson Labs A Sotera Health company and is sharing this information with you. Note, this is for informational purposes only. While the information is deemed accurate, you may not rely on this information, but must complete your own analysis or obtain your own advice. Stratasys does not warrant product selection and you are solely responsible for the same. You are responsible for determining the appropriateness and use of materials, whether there are any governmental rules, regulations, laws or requirements for use of materials or the products derived from materials, and informing others of these requirements. Medical devices, including those manufactured from MED610, may be subject to additional rules and regulations. Stratasys is not responsible for the biocompatibility assessment of any part or medical device printed with MED610 or use of a printing option. Final product classifications are not discussed in this document. Stratasys retains no and disclaims all liability for any claims of any kind made by any person, either as a result of use of or as related to this information and the relevant materials. STRATASYS, FOR ITSELF AND ON BEHALF OF ITS AFFILIATES, OFFICERS, DIRECTORS AND EMPLOYEES, DISCLAIMS ALL WARRANTIES RELATED TO THIS INFORMATION OF ANY KIND, EXPRESS AND IMPLIED, INCLUDING BUT NOT LIMITED TO ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR USE OR A PARTICULAR PURPOSE; NON-INFRINGEMENT; COMPLIANCE WITH ANY REGULATORY STANDARDS; AND COMPLIANCE WITH ANY OTHER LAWS.

Biocompatibility update in response to COVID-related inquiries.

Stratasys engaged a third-party laboratory that conducted a MED610 material evaluation and found minimal biocompatibility risk in use for gas pathway components in respiratory and ventilator equipment.

The evaluation was performed by experts in the field who based their conclusion on a set of biocompatibility tests for which the material was already approved and assessed the residual risk to meet ISO 18562-1 (Biocompatibility evaluation of breathing gas pathways in healthcare applications).

The risk assessment is specific for COVID-19 emergency scenarios when the material is used to print minority components in a dry or humidified gas pathway, where the part is not expected to be submerged in liquids.

MED610 material usage.

MED610 is available for use on Stratasys Polyjet systems: Objet30 Prime™, Objet30 Dental Prime™, Objet260 Dental™, Objet Eden260VS™, Objet Eden260VS Dental Advantage™, Objet260/500™ Connex1, Objet260/500 Dental Selection™, and Objet260/350/500™ Connex3. The official report is available upon request and will soon be available on the Stratasys website.

Click here for more information: https://www.stratasys.com/materials/search/biocompatible

Note: Stratasys is formally not responsible for the biocompatibility assessment of a particular final medical device printed with any of our biocompatible materials. Final product classification and chemical or biological evaluations remain the sole responsibility of the final medical device manufacturer.

Stratasys is responding to the current global COVID-19 (coronavirus) pandemic in many ways. One way we are responding is to provide additional information about our products. Stratasys has obtained a report, titled “Biocompatibility of MED610 as a Component in Gas Path Devices”, dated 30 March 2020, published by Nelson Labs A Sotera Health company and is sharing this information with you. Note, this is for informational purposes only. While the information is deemed accurate, you may not rely on this information, but must complete your own analysis or obtain your own advice. Stratasys does not warrant product selection and you are solely responsible for the same. You are responsible for determining the appropriateness and use of materials, whether there are any governmental rules, regulations, laws or requirements for use of materials or the products derived from materials, and informing others of these requirements. Medical devices, including those manufactured from MED610, may be subject to additional rules and regulations. Stratasys is not responsible for the biocompatibility assessment of any part or medical device printed with MED610 or use of a printing option. Final product classifications are not discussed in this document. Stratasys retains no and disclaims all liability for any claims of any kind made by any person, either as a result of use of or as related to this information and the relevant materials. STRATASYS, FOR ITSELF AND ON BEHALF OF ITS AFFILIATES, OFFICERS, DIRECTORS AND EMPLOYEES, DISCLAIMS ALL WARRANTIES RELATED TO THIS INFORMATION OF ANY KIND, EXPRESS AND IMPLIED, INCLUDING BUT NOT LIMITED TO ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR USE OR A PARTICULAR PURPOSE; NON-INFRINGEMENT; COMPLIANCE WITH ANY REGULATORY STANDARDS; AND COMPLIANCE WITH ANY OTHER LAWS.

Face shield initiative adds capacity and partners.

In response to the COVID-19 pandemic, Stratasys has initiated a global effort to rapidly produce disposable face shields for use by medical personnel. This coalition includes over 150 companies and universities, as well as Stratasys, GrabCAD, MakerBot, and Stratasys Direct Manufacturing.

This coalition includes over 150 companies and universities, as well as Stratasys, GrabCAD, MakerBot, and Stratasys Direct Manufacturing. Some of our partners include General Atomics, Medtronic, Mattel, Dunwoody College of Technology, the University of Central Florida, and the University of Minnesota.

Collectively, we have supply commitments for over 14,000 much-needed shields weekly. We’ll need to continue to grow capacity in the coming weeks to meet the demand for more than 40,000 per week, and ultimately, we expect injection molding to take over much of the production (but that is still 3 weeks away). The dozens of deliveries sent so far go beyond hospitals to also include clinics, academic medical centers, fire stations and nursing homes with a complete 3D printed visor and clear plastic shield that covers the face.

There are two ways to join the effort:

Materials List

Suggested materials for successful build.

Make it together

For any 3D printing shop that can print over 100 visors and send them to us, Stratasys will combine these with the clear plastic face shield and elastic bands. We will then distribute to hospitals and healthcare facilities that have reached out to us and requested them.

Here are some next steps:

  • Feel free to download the Face Shield Manufacturing Package and do a test print. We've provided a list of suggested materials where Stratasys or a Stratasys partner has completed a print that resulted in a successful build.
  • We will need to know your available printer types and the print quantities you are willing to donate per week. Then, if you qualify based on technology and capacity to donate, we will send you an invitation to register for GrabCAD Shop where you will be able to access your Shop orders. GrabCAD Shop will enable us to create a distributed manufacturing system where Stratasys can submit jobs to you and you can submit updates. Send us an email and we will get you set up.

Make it yourself.

For anyone who wants to produce face shields on their own, both visors and shields, we have printing and assembly instructions available for your use. You can download the Face Shield Manufacturing Package to get started. You can still sign up for GrabCAD Shop and Stratasys can distribute these for you or you can deliver them yourself.

Recruit others.

We are working to catch up to the demand for face shields. Please encourage others to sign up to help using our form at https://go.stratasys.com/lp-stratasys-helps.html

FAQ on how to help.

There are three current ways to help:

1. Printing - We are publishing files you can print and donate to your local hospitals and care facilities at your scale. If you can print more than 100 visors and don’t have local needs, please continue reading for instructions to send to Stratasys.

2. We will consolidate and distribute to hospitals within our network. It is imperative that supplies have all components prior to shipping to hospitals.

If you’re only printing one component, please send to the address listed at the bottom of this document.

3. Spread the word. The more people who know about this initiative, the more help and ideas we can gather. We encourage anyone and everyone to help save lives. If you know of a caregiver in need, please have them submit their request at https://go.stratasys.com/lp-stratasys-helps.html

4. Do you know companies that manufacture filters, plastic shields and other items currently in short supply that could be used to help? Please have them reach out to stratasyshelps@stratasys.com.

Q. Where can I find all information related to this initiative?

Q. How do I express what I am able to do to help?

Visit https://go.stratasys.com/lp-stratasys-helps.html and select how you’re able to contribute. Please use the comments field to indicate how you plan to contribute including quantities, types of printers and materials available. The process to accept your contributions and distribute is triggered by your input into this website.

Q. What files are available to be printed?

  • We are working on several initiatives. The most immediate are face shields. Designs for face masks and other medical components are being evaluated and may be shared as soon as they are available.
  • Face Shield
    https://go.stratasys.com/lp-stratasys-helps.html
  • Face Masks
    Design is being evaluated
  • Medical Components
    Designs are being evaluated

Technologies.

Q. I can print visors. Where do I get shields? Or, I have shields, where can I get visors?

  • You can ship shields or visors to our warehouse in multiples of 100, and we will distribute to hospitals that have submitted requests. The shipping address is listed at the bottom of this document.

Q. What technologies can I use to print files?

  • We have tested various technologies and found that FDM/FFF, MJF and SLS technologies have successfully printed the visor.

Q. What Stratasys FDM Systems can I use?

  • Any Stratasys FDM system can be used, as long as the build tray size is 7x8” or larger.

Q. What materials can I use to print the files?

  • Please refer to the matrix below:

Frame specs.

Q. Is the material limited to the biocompatible list on chart #9 (ULTEM 1010; ABS-M30i or PC-ISO)? Or what other material can be used?

  • Any materials can be used, if you are ordering more material to make visors, please order ABS-M30i.

Q. Is the size of the visor frame compatible with a 380?

  • Yes, it is compatible with a 380.

Q. What is the rough estimate of volume and run time for a frame?

  • It depends on your printing system, you can review the full estimates for day and night builds in our manufacturing package with the “Visor Production Plan Template” excel file located within the file instructions.

Q. We want to ensure the requirements are met on material, cleanliness, packaging and dimensions. Is there a source of confirmation of those requirements so we can assure we deliver proper equipment?

  • Hospitals have their own policies as to how to disinfect. Some are choosing to bathe all shipments received in isopropyl alcohol. For packaging we are asking that you ship in bundles of 10 visors/bag and 100 visors/box. Hospitals are doing their own assembly and cleaning to minimize touch points.

Q. Do we have an FDA, NIOSH etc. spec for face shields?

  • No, the face shields are considered consumer products and not medical devices.

Q. What is the demand for medical products that Stratasys is hearing from hospitals nationwide?

  • 330,000 masks are needed each month at this time, and we anticipate this demand to continue to grow as we receive more requests for help form hospitals and care facilities. Please encourage anyone you know in the healthcare field that needs assistance to visit the site to request supplies. https://go.stratasys.com/lp-stratasys-helps.html

Q. How can I connect with other customers who are helping to see if we can partner together on this initiative?

  • We are developing a forum for cross-organizational collaboration and will send the invite out as soon as it is available. We will have moderators who will help answer questions and provide guidance on this forum.

Q. Can you share my companies name when publicizing this effort? We are proud to contribute to the greater good.

  • Absolutely! Please e-mail gina.continenza@stratasys.com with your permission to use your companies name when we share the collaborative effort publicly.

Q. How do I stay updated if I am actively contributing to this initiative?

  • Stratasys will be hosting a coalition call each week. To join this call you would have already submitted your intent to help via https://go.stratasys.com/lp-stratasys-helps.html. Your e-mail address will automatically be added to the invite for this call.

Q. I have product made. Where should I send it?

  • We are asking for minimum shipment lots of 100. Visors should be packaged in plastic bags, with quantity 10 per bag. Please ship to:

    MVP Logistics
    Attn: Ryan Flinck
    14600 21st Ave N
    Building #2
    Plymouth, MN 55447

Q. I have more questions, who should I contact?

Please direct all questions to stratasyshelps@stratasys.com. This inbox is monitored 7 am-10 pm CT, and your question will be distributed and answered by the appropriate team. Please refrain from reaching out to direct contacts with generic information unless you have already had a dialogue about a specific topic. We are consolidating questions and will continue to update this document to keep you well informed.

COVID-19 response.

Dear Americas Customers,

We know that many of you depend on Stratasys for your design to manufacturing needs. As we closely monitor the rapidly changing COVID-19 (coronavirus) situation worldwide, we are taking steps to prioritize the health and safety of our employees while ensuring business continuity to minimize disruptions for you, our valued customers.

Please note the following:

  • Customer Service, Operations, and Logistics are continuing without disruption and we have contingency plans in place should our teams need to work from home.
  • We continue to provide onsite service to customers who are allowing visitors and are rescheduling appointments for those who have implemented onsite restrictions.
  • We are in a strong inventory position and do not anticipate any stockouts on systems or materials in the coming weeks.

Given that AMUG and other events have been postponed, we are offering a webinar series March 30 - April 3. You will be able to register for live webinar sessions that would have been featured at AMUG, including:

  • Deploying and Sustaining AM in Your Organization: A Guide for Transformation with Blueprint
  • Implementing High End Additive Jigs, Fixtures and Tooling with General Motors
  • J750™ Digital Anatomy™ Printer: Materials and Software with the Stratasys Healthcare Team
  • Employing AM for Tooling Applications within the Racing Industry with Andrew Miller from Penske Motor Sports

We anticipate adding more online events soon, both for education and to share information about new products. Stay tuned for more details on where you can watch and participate.

We will continue to monitor the situation and provide regular updates as important information becomes available. In the meantime, for the most accurate and up-to-date information, visit the World Health Organization (WHO) website (https://www.who.int/) and The Centers for Disease Control and Prevention (CDC) website (https://www.cdc.gov/) or your local Health and Human Services websites.

As always, we appreciate and value our business together. Let us know if you have any questions or if there is any way we can further support you through this time.

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