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افتراضي Rapid Medical Device Manufacturing for COVID-19 Response: Interview with Vicki Holt,

Rapid Medical Device Manufacturing for COVID-19 Response: Interview with Vicki Holt, CEO, Protolabs
The COVID-19 pandemic rumbles on, and the response to contain and delay the virus is astronomical, with billions of dollars and enormous levels of labor and material resources being deployed to meet the challenge. One of the major bottlenecks in combatting the virus is a lack of testing supplies and essential equipment, such as respirators, ventilators, and personal protective equipment.

Companies involved in manufacturing and those that provide essential services to manufacturers have been stepping up to meet the incredible demand for these items, and the rapid turnaround required has posed significant challenges.

For instance, in a recent Medgadget interviewwe featured the work of Bright Machines, who are helping companies involved inmanufacturing COVID-19 response equipment to automatetheir manufacturing processes inan effort to increase the speed of production.

In this latest interview, we look at Protolabs, a firm that provides rapid prototyping and digital manufacturing, and which is also stepping up to the challenge. The company is willing to waive the fee normally charged for expedited orders to help those manufacturing tests and equipment in the fight against the virus, to help quickly bring these products to market.

For instance, Protolabs is working with NeuMoDx Molecular Systems to produce COVID-19 tests for use in testing centers in California. They aim to get as many as five million tests to market as soon as possible. Similarly, the company is working with the University of Minnesota to prototype ventilator designs before manufacturing a finalized product.

Protolabs has an advantage in rapidlyproducing components for such devices, as they have the capability to performinjection molding, which allows them to produce tens of thousands of parts in avery short time.

Medgadget talked to Vicki Holt, Protolabs CEO, about the COVID-19 pandemic and the efforts the company has made to address it.

Conn Hastings, Medgadget: Please give us an overview of the services that Protolabs provides for medical technology developers.


Vicki Holt, Protolabs: For nearly 21 years, Protolabs has been a leadingdigital manufacturing source for rapid prototyping and on-demand production. Weproduce custom parts and assemblies in as fast as one day with automated 3Dprinting, CNC machining, sheet metal fabrication, and injection moldingprocesses Customers utilize our services to accelerate time to market, reducedevelopment and production costs, and minimize risk. Protolabs serves manyindustries, including medical, automotive, aerospace, consumer electronics, andmore. During this pandemic, we’ve seen an influx of COVID-19-related medicalcomponents needing urgent production; ranging from test kits to ventilators torespirators. We are urgently putting internal protocols in place to be able toprioritize these orders ahead of all others and waiving expedite fees in orderto quickly get critical medical supplies into the market. Most, if not all, areusing our injection molding services because that’s the only manufacturingservice capable of producing tens of thousands of parts in days.

Medgadget: How does the prototyping and manufacturing process work at Protolabs? Typically, how rapidly can Protolabs create a working prototype for a client, and what techniques make this possible?


Vicki Holt: Our platform automates many aspects of the entire processfrom design submission through manufacturability analysis and feedback,quotation, order submission, mold design, tool path generation, mold or partmanufacture and digital inspection. To utilize our platform, a prospectivecustomer uploads a 3D CAD file of their required part through our website.Often within minutes of design submission, our software analyzes the design,assesses the manufacturability of the design and our ability to make the part,and returns a firm price quotation with any recommendations for designmodifications.

Manyof our customers find this analysis particularly helpful, as it diagnoses andprevents potential problems prior to manufacturing. We can also provide a flowanalysis to identify design flaws that limit the ability to manufacture aquality part. Our quoting system is highly interactive, enabling ourprospective customers to change the material, finish, quantity or shippingschedule of orders, and to instantly receive an updated quotation. Once anorder is received, our software automates much of the manual engineering andskilled labor that is normally required to manufacture parts. As a result, inmany cases we are able to quote orders in minutes and ship parts as soon as thesame day ordered.

Medgadget: During the current pandemic, has it been a challenge to balance the increased demand for labor at your facilities with employee safety? Is Protolabs considered an “essential service,â€‌ and therefore exempt from the current shut down affecting many businesses?

Vicki Holt: Protolabs was deemed an essentialbusiness and will remain open during this crisis for our customers. Right nowwe are operating normally for all medical and non-medical orders—whileprioritizing medical orders. Employee health and safety is our number onepriority, and we have put the CDC and WHO-recommended guidelines in place atour plants and other facilities throughout the world.

Medgadget: How has Protolabs responded to the current pandemic?

Vicki Holt: Protolabshas established a COVID-19 leadership team which is led by myself, site leadersfrom each of our facilities and global functional leaders. Given the fluidnature of the pandemic, we are formally meeting twice per day to assessCOVID-19 developments, its implications to our employees, customers, andoperations, and determine appropriate courses of action.

Thefollowing mindset guides Protolabs’ response to the COVID-19 crisis:
  • Keep our employees, customers, and communities safe
  • Contribute to slowing the spread of the virus by practicing CDCrecommended guidelines
  • Monitor and quickly adapt to the fast-changing crisis
  • Transparent and on-going communication with employees and customers
  • We will be guided by our core values of Teamwork, Trust and Achievement
Wehave implemented the following safety measures:
  • No travel for all employees
  • No visitors to any of our sites
  • Deployed employees that can remote to work-from-home
  • All meetings are being conducted via Skype
  • Working to ensure the employees working on-site are appropriatelydistanced from each other
  • Implemented new cleaning regiments at all sites
  • Identifying employees considered “high riskâ€‌ as defined by the CDC andworking to ensure these individuals take the necessary precautions
The pandemic hasnot changed the way we interact with customers, as we are an e-commerce-enabledcompany. However, we are prioritizing projects which are needed to equip ourmedical system to treat patients with COVID-19 and providing these customerswith additional consultative design assistance to rapidly get these partsproduced. Additionally, most of our manufacturing operations are digitized andautomated meaning we have fewer labor requirements than conventionalmanufacturers.

Medgadget: Please give us some details on the medical technologies Protolabs is helping to produce to respond to the COVID-19 pandemic.


Vicki Holt: Protolabsis honored to be able to do what we can to help fight this virus and as youmentioned, we are working nonstop to develop some of the components needed forthe critical medical supplies needed for treating patients, such as ventilators,respirators, test kits, and shields. The following are just a few of the waysthe company is using our expertise to support:
  • Universityof Minnesota medical doctors reached out to us to help them quickly manufacture sixdifferent prototype components for their low-cost ventilator in order toaccelerate its FDA approval and quickly get to mass production. Their story canbe seen in this video: https://vimeo.com/399505511
  • NeuMoDx, amolecular diagnostics company worked with us to expedite the production of5,000 components needed for COVID-19 test kit production. They will be leaningon us for tens of thousands of additional units over the coming weeks.
  • Solaire Medical, a company that producesmedical carts and other equipment related to the transportation of medicalsupplies, is relying on Protolabs to produce parts that go in procedure cartsto store medical supplies in the fight against COVID-19. They needed to fulfillquick ship requests from facilities as a result of ICU’s ramping up capacity.
  • ISINNOVA, an Italian researchinstitute, turned to Protolabs to produce valves that will go into 100 3Dprinted kits that will convert snorkeling masks into hospital ventilator masksfor frontline medical staff.
  • OptoGlo reached out to usto help expedite an urgent order for 10,000 clips that will enable a faceshield to be attached to the front of any baseball cap. These are urgentlyneeded by many hospitals around the country. OptoGlo anticipates they willplace additional orders for them.
  • Sensidyne, an industrialhealth and safety instrumentation manufacturer, was faced with a spike indemand for their micro-air pumps used in ventilators amidst the COVID-19pandemic. They sought out Protolabs as a very viable source to producenearly a million parts for this critical application where time is of theessence.
Medgadget: How has Protolabs been able to produce this equipment so rapidly, and in such huge volumes?

Vicki Holt: As mentioned, we are receiving orders for components that will go into critical medical products to help fight COVID-19, all of which are being prioritized and expedited with fees being waived. Protolabs has over one thousand mills, presses, printers and other equipment that enable us to service large amounts of orders at once. Protolabs’ proprietary software automates many aspects of the entire process from design submission through manufacturability analysis and feedback, quotation, order submission, mold design, tool path generation, mold or part manufacture and digital inspection. This enables Protolabs to quickly produce customer parts. Additionally, since Protolabs’ manufacturing is done in house, not brokered out, we’re able to provide the quality and consistency (both in the parts and in turnaround time) that is so vital to this cause.


Link: Protolabs homepage…


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