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 interview
we featured the work of Bright Machines, who are helping companies involved in
manufacturing COVID-19 response equipment to automate
their manufacturing processes in
an 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 rapidly
producing components for such devices, as they have the capability to perform
injection molding, which allows them to produce tens of thousands of parts in a
very 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 leading
digital manufacturing source for rapid prototyping and on-demand production. We
produce custom parts and assemblies in as fast as one day with automated 3D
printing, CNC machining, sheet metal fabrication, and injection molding
processes Customers utilize our services to accelerate time to market, reduce
development and production costs, and minimize risk. Protolabs serves many
industries, including medical, automotive, aerospace, consumer electronics, and
more. During this pandemic, we’ve seen an influx of COVID-19-related medical
components needing urgent production; ranging from test kits to ventilators to
respirators. We are urgently putting internal protocols in place to be able to
prioritize these orders ahead of all others and waiving expedite fees in order
to quickly get critical medical supplies into the market. Most, if not all, are
using our injection molding services because that’s the only manufacturing
service 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 process
from design submission through manufacturability analysis and feedback,
quotation, order submission, mold design, tool path generation, mold or part
manufacture and digital inspection. To utilize our platform, a prospective
customer 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 design
modifications.

Many
of our customers find this analysis particularly helpful, as it diagnoses and
prevents potential problems prior to manufacturing. We can also provide a flow
analysis to identify design flaws that limit the ability to manufacture a
quality part. Our quoting system is highly interactive, enabling our
prospective customers to change the material, finish, quantity or shipping
schedule of orders, and to instantly receive an updated quotation. Once an
order is received, our software automates much of the manual engineering and
skilled labor that is normally required to manufacture parts. As a result, in
many cases we are able to quote orders in minutes and ship parts as soon as the
same 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,” and therefore exempt from the current shut down affecting many businesses?

Vicki Holt: Protolabs was deemed an essential
business and will remain open during this crisis for our customers. Right now
we are operating normally for all medical and non-medical orders—while
prioritizing medical orders. Employee health and safety is our number one
priority, and we have put the CDC and WHO-recommended guidelines in place at
our plants and other facilities throughout the world.

Medgadget: How has Protolabs responded to the current pandemic?

Vicki Holt: Protolabs
has established a COVID-19 leadership team which is led by myself, site leaders
from each of our facilities and global functional leaders. Given the fluid
nature of the pandemic, we are formally meeting twice per day to assess
COVID-19 developments, its implications to our employees, customers, and
operations, and determine appropriate courses of action.

The
following 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 CDC
recommended 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

We
have 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 appropriately
distanced from each other
Implemented new cleaning regiments at all sites
Identifying employees considered “high risk” as defined by the CDC and
working to ensure these individuals take the necessary precautions

The pandemic has
not changed the way we interact with customers, as we are an e-commerce-enabled
company. However, we are prioritizing projects which are needed to equip our
medical system to treat patients with COVID-19 and providing these customers
with additional consultative design assistance to rapidly get these parts
produced. Additionally, most of our manufacturing operations are digitized and
automated meaning we have fewer labor requirements than conventional
manufacturers.

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

Vicki Holt: Protolabs
is honored to be able to do what we can to help fight this virus and as you
mentioned, we are working nonstop to develop some of the components needed for
the critical medical supplies needed for treating patients, such as ventilators,
respirators, test kits, and shields. The following are just a few of the ways
the company is using our expertise to support:

University
of Minnesota medical doctors reached out to us to help them quickly manufacture six
different prototype components for their low-cost ventilator in order to
accelerate its FDA approval and quickly get to mass production. Their story can
be seen in this video: https://vimeo.com/399505511
NeuMoDx, a
molecular diagnostics company worked with us to expedite the production of
5,000 components needed for COVID-19 test kit production. They will be leaning
on us for tens of thousands of additional units over the coming weeks.
Solaire Medical, a company that produces
medical carts and other equipment related to the transportation of medical
supplies, is relying on Protolabs to produce parts that go in procedure carts
to store medical supplies in the fight against COVID-19. They needed to fulfill
quick ship requests from facilities as a result of ICU’s ramping up capacity.
ISINNOVA, an Italian research
institute, turned to Protolabs to produce valves that will go into 100 3D
printed kits that will convert snorkeling masks into hospital ventilator masks
for frontline medical staff.
OptoGlo reached out to us
to help expedite an urgent order for 10,000 clips that will enable a face
shield to be attached to the front of any baseball cap. These are urgently
needed by many hospitals around the country. OptoGlo anticipates they will
place additional orders for them.
Sensidyne, an industrial
health and safety instrumentation manufacturer, was faced with a spike in
demand for their micro-air pumps used in ventilators amidst the COVID-19
pandemic. They sought out Protolabs as a very viable source to produce
nearly a million parts for this critical application where time is of the
essence.

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.