3D Printing Offers New Risk Challenges
As commercial 3D printing advances from occasional to routine use, the product liability landscape will shift around it. Defective and counterfeit product exposures, among others, will arise for all participants along the manufacturing continuum, industry experts said.
In an adverse incident, said Rob Gaus, product risk leader, Marsh, liability will be apportioned among participants in the manufacturing and distribution stream: product manufacturer, printer manufacturer, software designer, feedstock supplier, distributor (especially if it modifies the product) and retailer (if the manufacturer is not well capitalized). No case law exists yet.
In 3D printing, a computer sends the software containing a product design to one or more printers, which builds the product, layer by layer, from many kinds of materials — plastics, metals, drugs, paints and even human tissue.
David Carlson, U.S. manufacturing and automotive practice leader, Marsh, said 3D-printed products are treated the same as any other new operation that poses new risks.
Underwriters and brokers must first assess the company’s risk management profile and risk appetite. When production, research and development teams look at technology, “they should loop in risk management. Risk management should be part of the continuum, or the company could get into sticky situations.”
The emerging risks include unregulated manufacturing, said Mark Schonfeld, a partner at Burns & Levinson LLP in Boston specializing in business and intellectual property law.
If 3D printing enables production of, say, just 100 hip implants or 100 hearing aids, such work will generally take place outside of a traditional mass-production factory, which is subject to government regulation and inspection.
“Insurance companies like FDA oversight of manufacturing because it makes products safer and helps identify responsibility when things go wrong,” Schonfeld said.
To protect themselves and their clients, Schonfeld advises insurers to keep abreast of technological developments, consult with a creative and knowledgeable attorney about how to address liability exposure, and adjust existing policies to be fair to consumers and prevent injury to the insurance company.
3D printing also raises the risk of counterfeit products, said Peter Dion, line of business director-product liability, Zurich Insurance. The digital “recipe” in the software design, and is vulnerable to capture, he said.
Although there is no encryption mechanism for the software, one solution might be to transfer the digital file in pieces only as they are needed by the printer to prevent capture of the entire design signature, Dion said.
Manufacturers have always struggled with counterfeit products, but 3D printing magnifies the risks because it can slash the time from product development to market-ready product to a matter of hours and requires no molds or prototypes. “Hackers can take the proprietary blueprint or software, send it to a third-world country, and have the product ready for market tomorrow,” said Carlson. “That’s a business disruption issue. Counterfeiters can put a company out of business.”
Drug manufacturers may subvert counterfeiters by adding tracer elements and watermarks to their formulations, which protects their reputations, profits and public health. “If the counterfeiters get the recipe wrong, they might not produce high-quality drugs for public consumption,” Carlson said.
Other manufacturers can also use watermarks and digital rights management (DRM) software to prevent file sharing. Still, Carlson said, counterfeiting is an old problem. “Bad guys have always exploited new technologies for their personal gain.”
The materials used by manufacturers present a greater potential loss exposure than the 3D printer itself, said Dion, noting that it is just another piece of equipment, like a pencil or a lathe.
For example, if a 3D printer is used to replicate a cupcake, the manufacturer should be as careful of contaminants in the mix as traditional bakers need to be. “When 3D printer manufacturers purchase materials from suppliers, they need to perform due diligence on their supplier’s products also.”
This summer, at one of California’s numerous wildfires, the appearance of a drone over Interstate 15 forced firefighting aircraft to back off for about 20 minutes until it flew away.
Instead of 40 or 50 acres burning before that fire was controlled, a few thousand acres, along with about 20 vehicles, were destroyed, as drivers ran from the area, according to reports.
In July alone, there were about a half-dozen similar incidents in California. Anywhere from two to five drones appeared at fire sites, sometimes chasing after the air tankers and helicopters, and forcing the aircraft to delay dropping retardant or even calling off operations until the areas could be cleared.
“It has hampered our efforts,” said Dennis Brown, chief of flight operations at the California Department of Forestry and Fire Protection (Cal Fire), which has about 50 air tankers and helicopters that respond nearly daily to wildfires from March through November.
“The size of the drones, even though they look small, could cause significant damage to any of our aircraft,” Brown said. The tail rotor of a helicopter is particularly vulnerable and a tail rotor strike could be catastrophic. “We had one helicopter pilot coming in to land to drop off a crew and there was a near miss by a drone,” he said. “It was 20 to 30 feet away, right in the windscreen.”
Sometimes, the drones are operated by homeowners checking for damage to their property. Sometimes it’s just curiosity or a desire to photograph the scene and post it to social media that prompts the drone operators.
“The size of the drones, even though they look small, could cause significant damage to any of our aircraft.” — Dennis Brown, chief of flight operations, California Department of Forestry and Fire Protection (Cal Fire)
But regardless of the reason, interference from drone operators is obstructing firefighting efforts and increasing danger to the pilots and their aircraft.
“The pilots are flying low and they are flying fast,” said John Glenn, chief of fire operations for the Bureau of Land Management. “There are a lot of hazards there. You throw drones or UAVs into the mix and there have been a number of cases where we have shut down operations until we can clear the air.”
Open Season for Drones
Public safety hazards due to drones aren’t limited to firefighting. The Federal Aviation Administration reports about two dozen drone sightings per month at airports throughout the nation, according to reports.
In one reported case, a plane headed from Washington, D.C. to LaGuardia Airport in New York had to pull up about 200 feet to avoid a collision with a drone in its path as it tried to land.
UAVs have buzzed French nuclear plants, landed on the roof of the Japanese prime minister’s residence (with radioactive material, no less), and even landed on the White House lawn. In August, a riot broke out in an Ohio prison yard after a drone dropped a package containing significant quantities of marijuana and heroin.
Drones have flown over sporting events and city parks — to sometimes deadly effect. One 19-year-old man died in a New York park when he lost control of his drone helicopter and the fast-moving blades cut him and killed him.
Drones have been sighted during a game of the Texas Longhorns football team and at a Philadelphia Phillies game. A triathlete in Western Australia had to be taken to the hospital just yards from the finish line after a drone fell on her.
“They take a pretty decent picture and they are fun and cute, but it’s not real smart to be flying a drone in an arena,” said J. Matthew Ouellette, owner/general adjuster at Ouellette & Associates in Indiana.
“The drone could fall out of the sky … and into somebody’s lap or into their beer,” he said. “Right now, it’s open season and people are flying them all over the place. There are just some idiots out there.”
And some people don’t take kindly to it, with reports surfacing of people shooting drones out of the sky. Of course, the reverse is also a grim prospect: One teenager was arrested after creating a drone that shoots a gun.
As for insurance coverage, the typical general liability, property or homeowners’ policy does not cover aircraft, experts said.
Insurance policies covering drone use are generally purchased by either the owner/operator of the drone or the manufacturer, said Patton Kline, senior vice president, Marsh Aviation. “Obviously, the risks for those two groups are very different.”
And, in the end, he said, it is the manufacturers that may face the greatest liability.
“If there is a significant event, we are concerned that litigation will come back to the UAS [unmanned aerial system] manufacturer because they will have the deep pockets,” he said.
“If you have a weekend warrior flying a drone for fun, they don’t necessarily understand the risks and if they are involved in a significant loss, they may not have insurance to pay for damages.”
“Right now, it’s open season and people are flying them all over the place. There are just some idiots out there.” — J. Matthew Ouellette, owner/general adjuster, Ouellette & Associates
For large aerospace companies that use or manufacture drones, it’s fairly easy for them to work with their insurers to add drone coverage to current policies or to add a stand-alone policy, Kline said.
Coverage may include physical damage to the UAS, propulsion units, payload/cargo (imaging, sensors or specialty equipment that may be more expensive than the UAS itself), ground station control units, spare parts and transit coverage.
All of that is available, he said, from up to a dozen insurers including AIG, Global Aerospace, Allianz, Starr Aviation, United States Aviation Underwriters and Berkley Aviation, as well as insurers that do not historically provide aviation coverage.
In addition, ISO has crafted a drone endorsement as a coverage extension to some of their commercial general liability (CGL) policy forms for insureds that seek to add drone coverage to CGL policies, he said.
The cost of physical damage coverage (also known as hull coverage) can be expensive, particularly for new or unproven unmanned aerial system platforms. Insuring $1 million in value could cost up to $100,000, depending on the UAV platform, with many policies typically in the $50,000 range, experts said.
Third-party liability, such as for bodily injury or property damage due to drones is also available, and is much less expensive, experts said. Product liability coverage would also be an important coverage to consider for UAV manufacturers.
A commercial stand-alone UAV liability policy for $1 million could start as low as $1,000, said Vikki Stone, senior vice president, Poms & Associates.
She said she has seen interest in such coverage from organizations that use drones in their business, such as entertainment, aerial mapping, residential construction and pipeline construction.
“We are seeing a lot of individuals who may have been hobbyists or pilots who are seeing an opportunity to start up a business,” she said.
“The bigger concern is rogue flyers. The industry has not yet really had enough time to assemble any sort of loss experience. As that evolves, we are likely to see changes in the marketplace, but it’s too new yet.”
Another issue that carriers and brokers are still grappling with is invasion of privacy, which could offer potential litigation concerns. That coverage is currently excluded by all drone insurers, according to Marsh’s recent report, “Dawning of the Drones: The Evolving Risk of Unmanned Aerial Systems.”
Eamonn Cunningham, chief risk officer, Scentre Group, said the first step to purchasing coverage would be to analyze meaningful gaps between what is in existing policies and what is needed.
“Absolutely do your homework in advance and sometimes you might need experts from outside the organization to understand what’s appropriate and what’s not,” he said.
“The processes that you go through in trying to determine what this relatively brand new risk means to you — it’s a real challenge.”
An organization may not need bespoke coverage once a gap analysis and risk assessment is performed, he said.
He compared drone coverage today with the purchase of cyber coverage a half-dozen years ago. At that time, many companies ended up buying a commodity — the typical cyber policy — instead of coverage that protected the specific risks faced by the organization.
“If you know exactly what you are buying, there’s less chance you will be disappointed when something happens and you find it doesn’t fit the specific manner in which you use, operate, sell or manufacture the drone,” he said.
Ella Atkins, associate professor, aerospace engineering at the University of Michigan, said federal regulations have hampered the safe use of drones because Congress exempted hobbyists flying under 500 feet from FAA rulemaking in the 2012 FAA reauthorization act.
“The problem is … the FAA’s policies focus on unmanned aircraft operating near airports,” she said.
“You need people on the ground to enforce low-altitude airspace flight, not the FAA. They have no presence away from airports [to control the situation].”
While Atkins doesn’t expect it to happen, some others are anticipating that the FAA may issue final regulations related to drone use by the end of this year.
But, if the FAA puts its focus on bans or strict regulations for low-altitude drone use away from airports, the effort will come to naught, she said. Instead, local and state governments and private landowners should be empowered to apply disorderly conduct and trespass laws as ways to control the hazards of rogue drone use.
“We need to start realizing that it’s a matter of what the person does with the drone, not the drone itself that is bad or good,” Atkins said.
In addition, she said, the FAA is ignoring a 1946 federal legal case that ruled property owners have control over the airspace immediately above their land.
Current rules mean that a farmer could be struck by a drone on his own property and have no recourse, or that Amazon.com could fly 10 feet over a home on its way to deliver a package and owe the property owner no compensation for use of the airspace.
“We need to start realizing that it’s a matter of what the person does with the drone, not the drone itself that is bad or good.” — Ella Atkins, associate professor, aerospace engineering at the University of Michigan
Recently, Amazon suggested a separate airspace lane for commercial drone delivery flights, which called for UAVs to fly between 200 feet and 400 feet. The air traffic control for that space would be handled by an automated computer system.
About 100 companies, including Amazon, Google and Verizon Communications, have agreed to work with NASA to help devise that air traffic system, according to reports.
There are no firm answers to the problem, said Jeff Power, regional aviation officer, U.S. Forest Service. He noted that one current law that could apply to firefighting is a restriction on interfering with public officials in the course of their duty.
But, he said, it’s very difficult to track down the drone operators.
“A large part of it is education of the drone operators,” Power said, although he noted that one day soon it may be emergency service organizations that are operating drones to help combat hazardous situations.
In fact, Texas A&M University held a seminar this summer about the way drone technology could be used to help deal with deadly flooding.
“We understand the capabilities,” Power said, “but when we have the recreational drone operator who isn’t necessarily familiar with the FAA’s requirements and flight restrictions — that’s the big issue. It’s a matter of educating them and hopefully no one gets hurt in the meantime.”
The Quality Assurance Journey
Not too long ago, if you were planning a trip, you would buy a map or an atlas and draw out the route you would take. If you continued to drive this route repeatedly, you might discover better ways to avoid a heavily congested area or take advantage of a new highway.
Similarly, a third party administrator (TPA) draws on years of experience to develop best practices for claims handling, discovering better routes and avoiding areas of delay. Payers trust their TPA to formalize these best practices, and to develop a Quality Assurance (QA) program that helps ensure claims are effectively managed. Like a roadmap, a QA program tracks the journey to the desired destination.
Mark Siciliano defines a quality assurance program.
With today’s technology, a cumbersome map is replaced with a GPS; just follow the step-by-step instructions. Sometimes the technology works flawlessly, and other times, it doesn’t deliver the best route.
Likewise, many QA programs have developed a checklist mentality, listing the steps to take. Such QA programs typically involve a small team reviewing a limited number of claims to ensure that key standards are consistently applied. While important, this doesn’t necessarily guarantee claims are optimally handled, or uncover ways to improve claim workflows and performance.
Mark Siciliano explains how Helmsman’s QA approach differs from the industry’s standard “checklist” mentality.
A New Process
Helmsman Management Services LLC, a third-party claims administrator and a member of Liberty Mutual Insurance, began to re-examine its QA program with the help of its clients several years ago. In doing so, they developed a new methodology that is a welcome departure from robotic checklist behavior.
“Our QA program dives deeper to find actionable ways we can improve claims outcomes, the performance of claims professionals, and the entire claims management process,” noted Mark Siciliano, vice president and managing director of Helmsman Management Services. “We conduct more in-depth reviews on a higher volume of claims – more than 80,000 each year – at key points in the lifecycle. We involve over 800 field claims professionals and engage individual claims handlers and their managers through an online dashboard that reports performance and highlights opportunities to improve performance through additional training and coaching.”
Mark Siciliano discusses the Helmsman approach to quality assurance.
The new approach to QA was successful, enabling Helmsman to improve the overall quality of its clients’ claims by eight points in 2014. In fact, 92.7 percent of the claims Helmsman managed met or exceeded the TPA’s service standards in the fourth quarter of 2014, up from 84.5 percent in the first quarter of that year.
“Re-engineering our QA program and moving it beyond the standard industry checklist approach took our claims management from really good to great,” said Siciliano. “And, it is helping us drive further improvements.”
One of the reasons for that improvement is Helmsman’s QA process keeps adjustors focused on what works best.
“We looked at the common characteristics of really great outcomes and worked backwards,” said Siciliano. “We found that when our claims professionals start with an empathetic approach, they are better able to connect with the injured employee and deliver better outcomes, both for the claimant and her or his employer.”
Like blindly following GPS instructions, a claims professional can easily fall into a pattern of completing tasks and forget that an injured person may be experiencing a very challenging time in their life. Helmsman trains its claims professionals to treat the injured worker as if they are dealing with a family member. It’s not just asking questions and moving through a checklist; it’s answering an injured worker’s questions, providing important information, and doing so with a level of compassion.
Once a conversation has begun and the injured worker is more at ease, the claims professional can ask questions beyond what might be in the process to really understand the injury, the individual, and the claim, and to find that best route to the ultimate destination of return to work. This inquisitive nature of the claims professional also allows for early discovery of any specific challenges in the claim – such as co-morbid conditions or psycho-social issues – paving the way for intervention to get the claim back on track.
“We call it humanistic common sense,” said Siciliano. “We know we have to ask the tough questions and protect our clients’ financial interests, but when we do so through a positive and supportive lens, it permeates throughout the entire process, facilitating the journey.”
Building a relationship with medical providers using this same approach can also assist the claim.
“Re-engineering our QA program and moving it beyond the standard industry checklist approach took our claims management from really good to great. And, it is helping us drive further improvements.”
— Mark Siciliano, Vice President and Managing Director, Helmsman Management Services
In the case of light duty restrictions, instead of ‘check’ and move on after the initial call with the treating physician, Helmsman asks for more details on what the injured worker can do, and helps the physician understand the claimant’s duties and the temporary jobs available. Helmsman might ask the doctor to join them for a site visit to better understand the work environment.
As a result, light duty jobs become gainful and meaningful work for the injured worker because they are tailored to their capabilities.
“We’re not just asking for medical information and work capacity; we’re actually working with our clients and the physicians to create a return-to-work environment that works for the injured worker, employer, and physician,” said Siciliano.
Evolution of Change
A QA program that delivers a high level of value to the employer and improves outcomes for the injured worker is just the beginning. QA is more than a program—it’s a process. Quality assurance programs are critical for tracking and improving performance. It’s a continuous cycle of training, learning, client feedback, and process improvement.
“Our enhanced QA program helps us better service our clients, but we know it’s an ongoing process,” said Siciliano. “Our continuous improvement process is built around the investment that we put in our people, systems, and technology. It’s also response to the changing landscapes around us, and how well we adapt to them.”
Mark Siciliano describes characteristics of effective quality assurance programs.
As a result, quality assurance programs are not working towards just a destination; they’re working towards the evolution of change, and how risk managers, brokers, and TPAs respond to it. The QA process becomes that journey.
This article was produced by the R&I Brand Studio, a unit of the advertising department of Risk & Insurance, in collaboration with Helmsman Management Services. The editorial staff of Risk & Insurance had no role in its preparation.