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Prosthetics Manufacturers Insurance Policy Information

Prosthetics Manufacturers Insurance

Prosthetics Manufacturers Insurance. Prostheses can broadly be defined as products that aim to replace natural structures within the human body with artificial versions. Such prosthetic products may be removable or permanently attached to or embedded in the user's body, and include solutions as varied as dentures, prosthetic limbs, and artificial joints.

Prosthetic manufacturers produce replacements for amputated, disfigured, or missing body parts, including breasts, craniofacial, neck, upper or lower joints and limbs. The process includes making casts of the patient's body part to which the prosthesis will be attached, producing individual component parts, and then assembling these into the final product.

Refinements are often needed to increase the attractiveness, comfort, fit, or functionality of the prosthesis. The component parts can be made of acrylics, aluminum, carbon fiber, fiberglass, polymers (plastic, rubber, or silicone), stainless steel, titanium, or wood. The finished prosthesis can be cosmetic, mechanical, myoelectrical, or robotic.

Many manufacturers have significant investments in research and development of these parts. While prosthetics have been generally limited to human use, more are being developed for animals.

Because the field of prosthetics has advanced considerably in recent times and a breathtaking range of natural elements of the body can now successfully be replaced, materials used in this field of manufacture are highly diverse as well. They include stainless steel, aluminum, titanium, carbon fibers, and numerous polymers.

As a manufacturer of prosthetic products, you play a vital role in improving patients' quality of life, and modern prostheses are frequently made exactly to a patients' unique specifications.

The field of prosthetic manufacture is highly-skilled as well as valued, but it is important not to lose sight of the fact that companies that manufacture prosthetic products are vulnerable to a multitude of potentially catastrophic perils, just like any other commercial venture.

That is why you need prosthetics manufacturers insurance coverage designed to fit your needs. To find out more about the kinds of insurance companies that make prostheses need, keep reading.

Prosthetics manufacturers insurance protects your manufacturing business from lawsuits with rates as low as $97/mo. Get a fast quote and your certificate of insurance now.

Below are some answers to commonly asked prosthetics manufacturing insurance questions:

What Is Prosthetics Manufacturers Insurance?

Prosthetics Manufacturers Insurance is a type of liability insurance that provides coverage for manufacturers of prosthetic devices, including artificial limbs and orthopedic braces.

It protects the manufacturer against any claims or lawsuits that may arise from the use of their products. This type of insurance covers the cost of legal defense, settlement, and damage awards if a customer or third party sues the manufacturer for any harm caused by their prosthetic device.

The coverage may also include product recall, product liability, and errors and omissions insurance.

How Much Does Prosthetics Manufacturers Insurance Cost?

The average price of a standard $1,000,000/$2,000,000 General Liability Insurance policy for small prosthetics manufacturing businesses ranges from $97 to $139 per month based on location, size, revenue, claims history and more.

Why Do Prosthetics Manufacturers Need Insurance?

Insurance For Manufacturers

As a manufacturer of prostheses, you will strive to deliver the quality products your customers can rely on, often for a lifetime. In the process, you are exposed to a variety of threats that could have a disastrous impact on your finances - and without the right insurance, you would be responsible for shouldering all the associated costs.

Some risks are common to any business, regardless of its field of industry. Criminal acts such as vandalism and theft could cause enormous damage to your manufacturing facility, forcing production to grind to a halt. Tragedies like earthquakes or wildfires, referred to as acts of nature, can rarely be planned for and also have bankrupting results.

Any manufacturer further has to consider the possibility that an employee might suffer on-the-job injuries, as well, and the same is true for a third party attending your facility. In both cases, the company can be held responsible.

One unique risk prosthetic manufacturers have to consider is that a prosthetic malfunctions, whether because of a manufacturing error or a cause related to the composition of the prosthesis. Such a malfunction could have far-reaching health consequences for the user, but also for the company that made the prosthesis.

Protected by the kind of prosthetics manufacturers insurance coverage that takes all the hazards companies in your industry are exposed to into account, you are able to focus on what you are best at - making prosthetic products.

What Type Of Insurance Do Prosthetics Manufacturers Need?

As every manufacturer of prosthetics makes unique products designed for specific purposes, each company's insurance requirements will differ, too. The best path toward peace of mind lies in an in-depth consultation with a commercial insurance agent who specializes in medical devices and understands the sensitive nature of your business.

Nonetheless, companies that make prostheses are universally going to have certain prosthetics manufacturers insurance needs, which include:

  • Commercial Property: This is a type of insurance that any business with physical assets absolutely needs. In the event of circumstances beyond your control, like fires and thefts, it covers your building and the contents within it. Lost revenue can also be compensated for.
  • General Liability: If third parties become injured or suffer property damage as a result of your company's activities or within your manufacturing facility, this kind of insurance helps cover your legal expenses, which include attorney fees and settlement costs. Medical bills or repair costs can fall under commercial general liability insurance as well.
  • Product Liability: This type of prosthetics manufacturers insurance covers third party injury claims relating to the products you manufacture. As such, it is essential to manufacturers of medical devices, including prostheses.
  • Workers' Compensation: Employees who suffer work-related injuries are likely to incur medical costs, as well as in some cases being unable to return to their duties for a time. Workers' comp exists to cover their medical expenses as well as any lost wages.

These are some examples of the kinds of prosthetics manufacturers insurance that are needed. The exact coverage and cost will vary, and that is why you are recommended to talk to a seasoned commercial insurance agent for further information.

Prosthetics Manufacturing's Risks & Exposures


Premises liability exposures depend on the extent of testing at the facility. Visitors may be injured by slips, trips, or falls. If testing is significant, visitors may aid in assessing new product usefulness.

As they may have limited mobility, they must be provided with medical oversight and assistance during the process. Their records must be stored in a manner that complies with the Health Insurance Privacy and Portability Act (HIPPA). Any on-site fitting or custom work can also increase the hazards.

Products liability exposures are significant due to the potential harm that could be caused by malfunction of the prosthetic. In the event that a prosthetic device supporting the weight of a patient fails, the patient can fall and injure him or herself, exacerbating the original condition.

Should a prosthetic arm fail, a patient can drop what they were lifting, causing injury to another person or property. Cosmetic prostheses may cause skin irritation. All prosthetic devices must carry warning labels, instructions, and information.

Communication with the client is critical in gauging the effectiveness of the device. Because prostheses are made to client specifications, the manufacturer may try to limit exposure contractually.

Nevertheless, quality standards, research documentation, and the training given to the prosthetist will likely be held by courts to a high degree of care. Some prostheses have a longer period of use than others do. Older items made before improved safety features were introduced may still be in use.

Professional liability exposure arises from the design work. While some work is done to specifications provided by others, a high degree of expertise is involved in taking measurements and recommending appropriate materials and design elements.

Environmental impairment exposures can be light to high, depending on the materials and processes used and the potential for contamination of air, surface or ground water, or soil. For plastics, the raw materials may be toxic and are flammable, the catalysts may be caustic, and the final product is usually not biodegradable.

For wood and metal, contaminants may come from the chemicals, paints, and solvents used. Adherence to federal and state guidelines in disposing of wastes is critical.

Workers compensation exposures vary depending on the processes used to manufacture the prostheses. Common hazards involve injuries from production machinery, minor cuts, slips, trips, falls, foreign objects in the eye, hearing loss from noise, repetitive motion injuries, and back injuries from lifting.

Areas that generate dust require respiratory protection devices, eye protection, and eye wash stations. Flammable liquids and chemicals can cause skin and eye irritation as well as long-term occupational disease hazards.

Workers should be made aware of early warning signs of damage. The testing staff may sustain injuries when lifting or aiding clients being fitted for a prosthetic.

Property exposures consist of an office, plant, and warehouse for raw materials and finished goods. Ignition sources include electrical wiring, heating and cooling equipment, overheating of production machinery, and buildup of static electricity. Heat-producing activities such as welding and soldering should be conducted away from combustibles. Flammable lubricants and cleaning agents may be stored on premises.

Unless there are properly maintained dust collection systems, dust from plastics, metals, and wood can ignite, resulting in explosion. Nearly all materials used are susceptible to damage by fire, and some are easily damaged by water.

Devices that have electronic circuitry can be damaged by smoke or similar sources of contamination. Plastic and polymer devices will warp if exposed to intense heat.

Equipment breakdown exposures include malfunctioning production equipment and electrical control panels and other apparatus. A lengthy breakdown to production machinery could result in severe loss, both direct and indirect, notably time element.

Crime exposure comes from employee dishonesty and theft as the metals used can be very valuable. Employees may act alone or in collusion with outsiders in stealing money, raw materials, finished stock, or proprietary information such as new product research or emerging technological solutions.

Background checks should be conducted on all employees. There must be a separation of duties between persons handling deposits and disbursements and handling bank statements.

Inland marine exposures are from accounts receivable, computers (which can include CAD programs or computer-run production equipment), goods in transit, and valuable papers and records for customers' specifications, research and development notes, patent applications, and suppliers' information.

Accounts receivable are often paid by insurance companies and foundations. Documentation can be time consuming, and if destroyed, the receivable may become uncollectible.

Finished goods are normally shipped by common or contract carrier; liability depends on the terms of the contracts or shipping agreements. The primary perils are fire, theft, overturn, and water damage.

Commercial auto exposures are moderate. Finished goods are often shipped by contract carriers. Delivery of finished goods, particularly special orders or deliveries on demand, may increase the exposure. Manufacturers generally have private passenger fleets used by sales representatives.

There should be written procedures regarding the private use of these vehicles by others. Each driver should have an appropriate license and an acceptable MVR. All vehicles must be well maintained with documentation kept in a central location.

What Does Prosthetics Manufacturer Insurance Cover & Pay For?

Prosthetics Manufacturer Insurance Claim Form

Prosthetics manufacturers can be sued for several reasons. Each scenario presents unique risks and potential financial losses, all of which can be mitigated through proper insurance coverage. Here are some examples:

1. Product Liability: One of the most common reasons for lawsuits against prosthetics manufacturers is product liability. If a prosthetic device fails, and this failure leads to injury, the manufacturer could be held liable. In this case, product liability insurance can protect the manufacturer. The insurance policy would cover the financial costs associated with legal defense, as well as any damages awarded to the claimant if the manufacturer is found to be at fault. Without such insurance, the manufacturer would have to bear these costs themselves, which could be financially devastating.

2. Defects in Design or Manufacturing: If a prosthetic device is designed or manufactured in a way that makes it unsafe and this leads to injury, a lawsuit could ensue. In such instances, product liability insurance or errors and omissions insurance would come into play. These policies would cover the legal costs associated with the lawsuit and any damages awarded. They also typically cover costs associated with product recalls, which may be necessary if a design or manufacturing defect is discovered.

3. Breach of Warranty: If a manufacturer makes certain promises or guarantees about a prosthetic device (e.g., its lifespan, its performance under certain conditions), and fails to meet these guarantees, they may be sued for breach of warranty. In this case, commercial general liability (CGL) insurance, which often includes coverage for breach of warranty claims, would protect the manufacturer. The insurance would cover legal defense costs and any damages awarded.

4. False Advertising: If a manufacturer makes false or misleading claims in its advertising, and a customer relies on these claims when purchasing the device, the manufacturer may be sued for false advertising. Commercial general liability insurance typically includes coverage for advertising injuries, so it would protect the manufacturer in this case, covering legal defense costs and any damages awarded.

Insurance is an important risk management tool for prosthetics manufacturers. By transferring the financial risk of lawsuits to an insurance company, manufacturers can protect their financial stability and ensure they are able to continue operations, even in the face of significant legal challenges.

Commercial Insurance And Business Industry Classification

Description for 3842: Orthopedic, Prosthetic, And Surgical Appliances And Supplies

Division D: Manufacturing | Major Group 38: Measuring, Analyzing, And Controlling Instruments; Photographic, Medical And Optical Goods; Watches And Clocks | Industry Group 384: Surgical, Medical, And Dental Instruments And Supplies

3842 Orthopedic, Prosthetic, And Surgical Appliances And Supplies: Establishments primarily engaged in manufacturing orthopedic, prosthetic, and surgical appliances and supplies, arch supports and other foot appliances; fracture appliances, elastic hosiery, abdominal supporters, braces, and trusses; bandages; surgical gauze and dressings; sutures; adhesive tapes and medicated plasters; and personal safety appliances and equipment. Establishments primarily engaged in manufacturing surgical and medical instruments are classified in Industry 3841. Establishments primarily engaged in manufacturing orthopedic or prosthetic appliances and in the personal fitting to the individual prescription by a physician are classified in Retail Trade, Industry 5999.

  • Abdominal supporters, braces, and trusses
  • Absorbent cotton, sterilized
  • Adhesive tape and plasters, medicated or non-medicated
  • Applicators, cotton tipped
  • Atomizers, medical
  • Autoclaves, hospital and surgical
  • Bandages and dressings, surgical and orthopedic
  • Bandages: plastics, muslin, and plaster of paris
  • Belts: sanitary, surgical, and corrective
  • Braces, elastic
  • Braces, orthopedic
  • Bulletproof vests
  • Canes, orthopedic
  • Cervical collars
  • Clothing, fire resistant and protective
  • Colostomy appliances
  • Corn remover and bunion pads
  • Corsets, surgical
  • Cosmetic restorations
  • Cotton, absorbent: sterilized
  • Cotton, including cotton balls
  • Crutches and walkers
  • Drapes, surgical: cotton
  • Dressings, surgical
  • Ear stoppers
  • Elastic hosiery, orthopedic
  • Extension shoes, orthopedic
  • First aid, snake bite, and burn kits
  • Foot appliances, orthopedic
  • Fracture appliances, surgical
  • Gas masks
  • Gauze, surgical: not made in weaving mills
  • Grafts, artificial: for surgery-made of braided or mesh artificial fibers
  • Gynecological supplies and appliances
  • Hearing aids
  • Helmets, space
  • Hosiery, support
  • Hydrotherapy equipment
  • Implants, surgical
  • Infant incubators
  • Intrauterine devices
  • Iron lungs
  • Life preservers, except cork and inflatable
  • Ligatures, medical
  • Limbs, artificial
  • Linemen's safety belts
  • Models, anatomical
  • Noise protectors, personal
  • Orthopedic devices and materials
  • Pads, incontinent and bed
  • Personal safety appliances and equipment
  • Plugs, ear and nose
  • Prosthetic appliances and supplies
  • Radiation shielding aprons, gloves, and sheeting
  • Respirators
  • Respiratory protection equipment, personal
  • Restraints, patient
  • Safety appliances and equipment, personal
  • Safety gloves, all materials
  • Socks, stump
  • Space suits
  • Splints, pneumatic and wood
  • Sponges, surgical
  • Sterilizers, hospital and surgical
  • Stockinette, surgical
  • Stretchers
  • Suits, firefighting: asbestos
  • Supports: abdominal, ankle, arch, and kneecap
  • Surgical appliances and supplies, except medical instruments
  • Suspensories
  • Sutures
  • Swabs, sanitary cotton
  • Tongue depressors
  • Traction apparatus
  • Trusses: orthopedic and surgical
  • Welders' hoods
  • Wheel chairs
  • Whirlpool baths, hydrotherapy equipment

Prosthetics Manufacturers Insurance - The Bottom Line

Prosthetics manufacturers insurance policies vary widely in coverage, costs and exclusions. To find out if your prosthetics manufacturing operation has the best fit insurance policies - talk to an experienced business insurance broker.

Often they are able to save you on premiums and offer you better policy options than you currently have.

Additional Resources For Manufacturing Insurance

Learn all about manufacturing insurance. Manufacturers face many unique risks such as product libility and/or product recall exposures due to the nature of their business operations.

Manufacturing Insurance

The manufacturing industry is a vital part of the economy and plays a significant role in the production of goods and services. However, it is also an industry that is prone to risks and accidents, which can result in costly damages and lawsuits. Therefore, it is essential for businesses in the manufacturing industry to have insurance to protect them against potential losses.

Business insurance can cover a wide range of risks, including property damage, liability, and worker injuries. For instance, if a fire were to break out in a manufacturing facility and destroy equipment or inventory, commercial insurance could cover the costs of replacing or repairing the damages. Similarly, if a worker were to be injured on the job, business insurance could cover medical expenses and lost wages.

In addition to protecting against physical damages, insurance can also provide financial protection against legal liabilities. If a customer were to sue a manufacturing business for a faulty product, the commercial insurance could cover the costs of legal fees and settlements.

Overall, insurance is essential for the manufacturing industry as it helps to mitigate risks and protect against unexpected costs. Without it, businesses in the industry could face financial ruin in the event of an accident or lawsuit.

Minimum recommended small business insurance coverage: Building, Business Personal Property, Business Income with Extra Expense, Equipment Breakdown, Employee Dishonesty, Accounts Receivable, Computers, Goods in Transit, Valuable Papers and Records, General Liability, Employee Benefits Liability, Environmental Impairment Liability, Umbrella Liability, Hired and Non-owned Auto Liability & Workers Compensation.

Other commercial insurance policies to consider: Earthquake, Flood, Cyber Liability, Employment-related Practices Liability, Business Auto Liability and Physical Damage and Stop Gap Liability.

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