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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:

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.

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.

Types Of Small Business Insurance - Requirements & Regulations

Perhaps you have the next great idea for a product or service that you know will appeal to your local area. If you've got a business, you've got risks. Unexpected events and lawsuits can wipe out a business quickly, wasting all the time and money you've invested.

Operating a business is challenging enough without having to worry about suffering a significant financial loss due to unforeseen and unplanned circumstances. Small business insurance can protect your company from some of the more common losses experienced by business owners, such as property damage, business interruption, theft, liability, and employee injury.

Purchasing the appropriate commercial insurance coverage can make the difference between going out of business after a loss or recovering with minimal business interruption and financial impairment to your company's operations.

Small Business Information

Insurance is so important to proper business function that both federal governments and state governments require companies to carry certain types. Thus, being properly insured also helps you protect your company by protecting it from government fines and penalties.

Small Business Insurance Information

In the business world, there are many risks faced by company's every day. The best way that business owners can protect themselves from these perils is by carrying the right insurance coverage.

The The National Association of Insurance Commissioners (NAIC) is the U.S. standard-setting and regulatory support organization. Through the NAIC, state insurance regulators establish standards and best practices, conduct peer review, and coordinate their regulatory oversight.

Commercial insurance is particularly important for small business owners, as they stand to lose a lot more. Should a situation arise - a lawsuit, property damage, theft, etc. - small business owners could end up facing serious financial turmoil.

According to the SBA, having the right insurance plan in place can help you avoid major pitfalls. Your business insurance should offer coverage for all of your assets. It should also include liability and casual coverage.

Types Of Small Business Insurance

Choosing the right type of coverage is absolutely vital. You've got plenty of options. Some you'll need. Some you won't. You should know what's available. Once you look over your options you'll need to conduct a thorough risk assessment. As you evaluate each type of insurance, ask yourself:

  • What type of business am I running?
  • What are common risks associated with this industry?
  • Does this type of insurance cover a situation that could feasibly arise during the normal course of doing business?
  • Does my state require me to carry this type of insurance?
  • Does my lender or do any of my investors require me to carry this type of policy?

A licensed insurance agent or broker in your state can help you determine what kinds of coverages are prudent for your business types. If you find one licensed to sell multiple policies from multiple companies (independent agents) that person can often help you get the best insurance rates, too. Following is some information on some of the most common small business insurance policies:

Business Insurance Policy Type What Is Covered?
General Liability InsuranceWhat is covered under commercial general liability insurance? It steps in to pay claims when you lose a lawsuit with an injured customer, employee, or vendor. The injury could be physical, or it could be a financial loss based on advertising practices.
Workers Compensation InsuranceWhat is covered under workers compensation insurance? This type of insurance protects a business and its owner(s) from claims by employees who suffer a work-related injury, illness or disease. Workers comp typically provides the injured employee with benefits to cover medical expenses, a portion of his/her lost wages, rehabilitation costs if applicable, and permanent partial or permanent total disability.
Product Liability InsuranceWhat is covered under product liability insurance? I pays an injured party's settlement or lawsuit claim arising from a defective product. These are usually caused by design defects, manufacturing defects, or a failure to provide adequate warning or instructions as to how to safely use the product.
Commercial Property InsuranceWhat is covered under business property insurance? General liability policies don't cover damages to your business property. That's what commercial property insurance is for. It protects all of the physical parts of your business: your building, your inventory, and your equipment, giving you the funds you need to replace them in the event of a disaster. If you work from home, you might consider a Home Based Business Insurance policy instead.
Business Owners Policy (BOP)What is covered under a business owners policy (BOP)? This is a policy designed for small, low-risk businesses. It simplifies the basic insurance purchase process by combining general liability policies with business income and commercial property insurance.
Commercial Auto InsuranceWhat is covered under business auto insurance? This type of insurance covers automobiles being used for business purposes. This could include a fleet of business-only vehicles or a single company car. In some cases it might cover your car or your employee's car while they're being used for business. These policies have much higher limits, ensuring you can cover your costs if one of these vehicles gets into an accident.
Commercial Umbrella PoliciesWhat is covered under commercial umbrella insurance? This type of policy is a sort of "gap" insurance. It covers your liability in the event that a court verdict or settlement exceeds your general liability policy limits.
Liquor Liability InsuranceWhat is covered under liquor liability insurance? It covers bodily injury or property damage caused by an intoxicated person who was served liquor by the policy holder.
Professional Liability (Errors & Omissions)What is covered under professional liability insurance? This type of business insurance is also known as malpractice oe E&O. It covers the damages that can arise from major mistakes, especially in high-stakes professions where mistakes can be devastating.
Surety BondWhat is covered under surety bonds? Bonding is a contract where one party, the SURETY (who assures the obligee that the principal can perform the task), guarantees the performance of certain obligations of a second party, the PRINCIPAL (the contractor or business who will perform the contractual obligation), to a third party, the OBLIGEE (the project owner who is the recipient of an obligation).

Who Needs General Liability Insurance? - Virtually every business. A single lawsuit or settlement could bankrupt your business five times over. You might also need this policy to win business. Many companies and government agencies won't do business with your company until you can produce proof that you've obtained one of these policies.

Business Insurance Required by Law
Small Business Commercial Insurance

If you have any employees most states will require you to carry worker's compensation and unemployment insurance. Some states require you to insure yourself even if you are the only employee working in the business.

Your insurance agent can help you check applicable state laws so you can bring your business into compliance.

Other Types Of Small Business Insurance

There are dozens of other, more specialized forms of small business insurance capable of covering specific problems and risks. These forms of insurance include:

  • Business Interruption Insurance
  • Commercial Flood Insurance
  • Contractor's Insurance
  • Cyber Liability
  • Data Breach
  • Directors and Officers
  • Employment Practices Liability
  • Environmental or Pollution Liability
  • Management Liability
  • Sexual Misconduct Liability

Whether you need any or all of these policies will depend on the results of your risk assessment. For example, you probably don't need an environmental or pollution policy if you're running an IT company out of a leased office, but you would need data breach and cyber liability policies to fully protect your business.

Also learn about small business insurance requirements for general liability, business property, commercial auto & workers compensation including small business commercial insurance costs. Call us (855) 767-7828.

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

For manufacturers, having the proper coverage is very important. You will need Products/Completed Operations Liability Coverage to protect you against injuries or property damage cause my the products you make or sell.

Manufacturing is an extremely broad category that includes countless potential hazards and exposures in virtually all coverage areas. Because of this, every individual manufacturer is unique and a specific risk survey of every operation is advisable.

The basic insurance needs for every class of business or operation includes property coverage for buildings, machinery and equipment, as well as for raw stock and finished products.

Liability insurance for premises exposures is important but products liability insurance presents greater concerns so these exposures and coverage needs must be evaluated carefully.

In addition, protection for injuries to workers, environmental coverages and automobile insurance are priority items.

What does the insured does that could result in a covered loss? The insuring agreement only requires that the insured be legally obligated to pay damages for injury to others or damage to their property included within the products-completed operations hazard covered by the insurance.

Because of this, every product manufactured and completed operation exposure for each named insured must be determined, described and evaluated to be certain that each represents acceptable exposures, or are acceptable classes of business to the insurance company providing coverage.

Once the extent of all business activities and operations is determined, the process of identifying hazards begins. The first step in the process is completely listing and describing all current products being manufactured and projects being worked on.

The next step is obtaining the same information for discontinued products and completed projects for the past five to 10 years, depending on the products or projects involved. This should include an explanation of why the products were discontinued. If some completed projects were of a different type than those currently being worked on, an explanation is in order, including whether the insured may resume them in the future.

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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