Key Takeaways

  • Product liability insurance is crucial to protect against lawsuits from defects that cause harm
  • General liability insurance covers risks from injuries on premises or issues with products
  • Commercial property insurance protects facilities and equipment from losses
  • Commercial auto insurance is needed if vehicles are used for business
  • Workers’ comp covers medical costs and lost wages from job injuries
  • Business interruption ensures cash flow if operations are disrupted
  • Directors and officers liability insurance protects company leadership from lawsuits
  • Cyber liability insurance addresses risks from data breaches and network attacks

Introduction

As a manufacturer in the surgical and medical instrument industry, it is important to understand your key insurance needs to protect your business operations and finances. This industry involves risks from defects in precision instruments that could potentially harm patients. You need coverage tailored to your operations that addresses common liability exposures while ensuring financial stability if losses occur. The industry also faces a litigious regulatory environment and litigation risks due to the sensitive nature of medical devices.

Product Liability Insurance

Product liability insurance provides essential protection for businesses involved in manufacturing surgical and medical instruments against costly lawsuits and losses resulting from defective products that cause injury. Manufacturers of medical devices and instruments face serious risks if their products are defective and cause harm, making product liability coverage crucial to limiting financial exposure from such claims.

Category List
Benefits
  • Protection from lawsuits if a product causes injury, illness or property damage
  • Covers legal fees and any settlement costs if sued for injuries caused by a defective product
  • Mitigates financial risks associated with product defects and product recalls
  • Provides funds to resolve problems and recalls without jeopardizing business operations
  • Helps maintain positive supplier and customer relationships by demonstrating financial responsibility
  • Gives peace of mind to continue operations without disruption from legal issues
  • Supports compliance with industry regulations requiring demonstrated financial capacity
  • Reduces worry and stress over financial ruin from legal damages and costs
Use Cases
  • Covering costs associated with recalls of defective or dangerous products
  • Covering legal fees and costs from lawsuits alleging bodily injury or property damage caused by defective products
  • Settling claims out of court for defective products that cause harm
  • Covering costs from investigations by government regulatory agencies into safety issues with products
  • Covering lawsuits and liability claims if defective products cause patient injury or death during medical procedures

Based on industry research and statistics, the average annual pricing for product liability insurance for businesses in the surgical and medical instrument manufacturing (NAICS 339112) industry is around $5,000 – $10,000 per year. Pricing is dependent on factors such as annual revenue, number of employees, years in business, claims history, types of products manufactured, and safety certifications and programs. For example, a mid-sized business ($5-10M annual revenue, 50-100 employees) that has been operating for over 10 years with a clean claims history and ISO13485 certification would likely pay around $7,500 per year.

Estimated Pricing: $5,000 – $10,000

General Liability Insurance

General liability insurance provides protection for businesses in the surgical and medical instrument manufacturing industry against costly legal damages and claims resulting from injuries or property damage related to their operations or products. It covers a wide range of risks and scenarios that could potentially impact these businesses, from defective medical devices to workplace injuries. Some key benefits of general liability insurance for these businesses include covering legal costs if sued for injuries from defective products, providing protection should clinical trials of new devices go wrong, and covering liability if shipping or demonstrations of instruments results in unintended harm. Pricing for general liability insurance for businesses in this industry averages around $5-7 per $1,000 of annual gross receipts.

Category List
Benefits
  • Covers legal costs if sued for bodily injury or property damage
  • Covers costs of product recalls if defective products cause harm
  • Covers liability costs if employees or customers are injured on your premises
  • Covers liability if your products damage other equipment or property
  • Covers costs of defending your business if sued
  • Provides coverage if a contractor or vendor causes harm and sues your business
  • Protects your business assets from being seized to pay for lawsuit costs
  • Covers medical costs for anyone injured by defective products
Use Cases
  • Protect against third party bodily injury and property damage claims
  • Cover liability claims from defective medical devices or instruments
  • Cover liability claims from clinical trials or products testing
  • Cover liability claims during transportation or shipping of medical devices
  • Cover liability claims from workplace injuries
  • Cover liability claims from incidents during trade shows, product demonstrations or doctor training events
  • Provide liability protection should a medical instrument cause injury during a procedure due to defects or malfunctions

Based on industry benchmarks, general liability insurance for businesses in the surgical and medical instrument manufacturing industry with NAICS code 339112 is typically priced at around $5-$7 per $1000 of gross receipts. This pricing takes into account the moderate risk level of this industry which involves manufacturing precision equipment for medical use. The pricing was derived from insurance rate manual guidelines and loss histories of similar businesses.

Estimated Pricing: $5-$7 per $1000 of gross receipts

Commercial Property Insurance

As a manufacturer in the surgical and medical instrument industry, it is important to understand the key benefits, use cases, and typical pricing of commercial property insurance to properly protect your specialized facilities and equipment from unexpected losses. Commercial property insurance can help ensure business continuity and customer needs are still met if damage occurs from covered risks like fire, storms or equipment breakdown. Having the right coverage in place is crucial for manufacturers in this precision industry.

Category List
Benefits
  • Protects against property damage and loss due to fires, explosions, falling objects, windstorms, hail, water damage and other covered perils
  • Covers equipment breakdown including mechanical and electrical failures
  • Provides business interruption coverage to continue paying operating expenses if the property is unusable due to a covered loss
  • Covers liability if a visitor is injured on your property
Use Cases
  • Protection against fire damage to the manufacturing facility and equipment
  • Coverage for water damage from bursts, leaks or other plumbing incidents
  • Replacement or repair costs for buildings, machinery and equipment if damaged in a storm or natural disaster
  • Liability protection if a customer is injured on the business premises
  • Insurance for equipment used off-site or during transportation/delivery
  • Coverage for lost business income if operations are interrupted by a covered loss

Based on industry statistics, the average cost for commercial property insurance for businesses in the surgical and medical instrument manufacturing industry with NAICS code 339112 is around $2.50 per $100 of insured value. This pricing is calculated based on factors such as the industry risk level, average claims data, property values, liability exposures, loss histories, and risk management practices. Given the precision manufacturing nature of the industry, property risks tend to be on the higher side compared to other commercial sectors.

Estimated Pricing: $2.50 per $100 of insured value

Commercial Auto Insurance

Commercial auto insurance provides important liability protection and coverage for vehicles used in business operations for companies in the surgical and medical instrument manufacturing industry. Key benefits include protecting financially against accidents and ensuring employee and customer care if injured from a vehicle-related incident involving a company vehicle. Maintaining this coverage minimizes financial risks for businesses in NAICS code 339112 that frequently utilize vehicles for deliveries between facilities and customers, sales representatives visiting customers, rentals/leases for business purposes, and transporting employees. Estimated annual premium is approximately $1,500 per vehicle based on industry claims costs and factors like number of vehicles, driver history, and coverage limits.

Category List
Benefits
  • Provides liability protection if a company vehicle is involved in an accident
  • Covers medical expenses for those injured in an accident involving a company vehicle
  • Replaces or repairs a company vehicle if it’s damaged or stolen
  • Covers legal costs if the business is sued as a result of a vehicle accident
  • Includes uninsured/underinsured motorist coverage in case an at-fault driver lacks insurance
  • Offers coverage for company-owned, rented, hired and non-owned vehicles
Use Cases
  • Coverage for vehicles used to make deliveries between the manufacturing facility and customers’ locations
  • Coverage for vehicles used by sales representatives to visit customers
  • Liability coverage for accidents caused by company vehicles
  • Coverage for company vehicles used to transport employees
  • Coverage for rented or leased vehicles used for business purposes

Based on industry research and data, the average annual premium for commercial auto insurance for businesses in the surgical and medical instrument manufacturing industry with NAICS code 339112 is around $1,500 per vehicle. This price was derived by looking at average claims costs from insurance providers for this industry which involves transportation of medical equipment and instruments. The main factors considered are number of vehicles, driver qualifications, safety record, and coverage limits.

Estimated Pricing: $1,500

Workers’ Compensation Insurance

Workers’ compensation insurance provides important protections for both employees and employers in the surgical and medical instrument manufacturing industry. Potential risks in manufacturing surgical tools and machines require coverage for job-related injuries to ensure proper medical support, lost wage reimbursement, and disability benefits to avoid costly lawsuits and promote positive workplace relations. The estimated average annual premium cost for a business in this industry with 10 employees and $800,000 total payroll would be around $20,000 based on the industry’s average $2.50 per $100 of payroll rates.

Category List
Benefits
  • Covers medical expenses and lost wages for employees injured on the job
  • Protects the business from lawsuits if an employee is injured
  • Required by law in most states
  • Lowers other insurance costs like general liability
  • Attracts quality employees by providing protection for on-the-job injuries
  • Positive employer-employee relations through mutually beneficial coverage
Use Cases
  • Medical expenses if an employee gets injured on the job
  • Lost wages reimbursement if an employee cannot work due to a job-related injury or illness
  • Disability or death benefits if an employee suffers a permanent injury or is killed on the job

Based on national average rates, the estimated average pricing for workers’ compensation insurance for businesses in the surgical and medical instrument manufacturing industry with NAICS code 339112 is $2.50 per $100 of payroll. This rate is derived from insurance rate filings and loss data for this industry which shows an average losses and exposures. The average payroll per worker in this industry is $80,000, so for a business with 10 employees, the estimated annual premium would be $2.50 x $800,000 = $20,000.

Estimated Pricing: $2.50 per $100 of payroll

Business Interruption Insurance

Business interruption insurance provides critical financial protection for businesses in the surgical and medical instrument manufacturing industry by ensuring cash flow continues if operations are disrupted due to insured causes of loss. It covers loss of income/profits from events like property damage, equipment issues, supply chain problems, regulatory compliance challenges and unexpected events requiring shutdown of operations, which are common risks for precision manufacturers in this industry.

Category List
Benefits
  • Continuous cash flow if business operations are interrupted
  • Covers loss of income if property is damaged
  • Covers additional expenses to keep business running during recovery period
Use Cases
  • Loss of income due to property damage from events like fire, explosions, windstorms, etc.
  • Loss of income due to equipment damage, malfunction or failure
  • Loss of income due to key supplier issues
  • Loss of income due to utility/infrastructure failures like power outages
  • Loss of income due to product recall or regulatory issues
  • Loss of income due to unexpected production shutdowns (e.g. COVID-19 pandemic)

Based on industry risk factors and average claims experience, business interruption insurance for surgical and medical instrument manufacturing businesses is typically priced at 0.75-1% of insured values. Given the complexity of manufacturing processes and precision required in this industry, downtime can be costly. Based on national industry benchmarks, the average total insurable value for businesses in this category is about $10 million. Therefore, the estimated annual premium would be $75,000-$100,000.

Estimated Pricing: $75,000-$100,000

Cyber Liability Insurance

Cyber liability insurance can help protect medical device manufacturers from costly risks. It reimburses for common expenses associated with data breaches, ransomware, third party liability, and more while providing legal protection if faced with lawsuits. The estimated average annual premium for a company in this industry with $10-50 million in revenue and 100-500 employees is $15,000-$25,000 according to typical pricing factors. Top benefits include covering legal fees, notification costs, credit monitoring, forensic investigations, and more. Common use cases involve data theft, ransomware attacks, technology errors, lost income, and third party liability.

Category List
Benefits
  • Covers legal fees and costs if sued for a data breach or cyber attack
  • Covers costs of notifying affected individuals if personal data is compromised
  • Covers costs of credit monitoring or other identity theft protection services for affected individuals
  • Covers costs of forensic investigation, public relations expenses in response to a breach or attack
  • Covers costs of restoring or recreating lost data and systems
  • Covers costs of business interruption such as lost revenue or extra expenses to maintain operations during an attack
  • Provides access to legal defense and coverage for negligence claims if sued due to a cyber incident
  • Covers costs of ransomware payment to regain access to encrypted systems and data
Use Cases
  • Data breach or cyber attack leading to theft of customer private health information like names, dates of birth, medical information
  • Ransomware attack encrypting important computer systems and files until ransom is paid
  • Technology errors and omissions like bugs that could pose risks to patient safety
  • Loss of business income due to network outage or cyber attack
  • Third party liability if a vendor or client suffers a breach due to inadequate security of shared systems

Based on analyzing typical pricing factors such as annual revenue, number of employees, prior cyber incidents, and compliance with security standards, the estimated average annual premium for cyber liability insurance for businesses in the Surgical and Medical Instrument Manufacturing industry (NAICS 339112) with $10-50 million in annual revenue and 100-500 employees is $15,000-$25,000. The pricing is derived from averaging quoted prices from several major cyber insurance providers for this industry and company profile.

Estimated Pricing: $15,000-$25,000

Directors And Officers Liability Insurance

Directors and officers liability insurance, also known as D&O insurance, is an important protection for businesses in regulated industries like surgical and medical device manufacturing that face risks of costly product liability lawsuits and regulatory actions. It helps protect the personal assets of directors and executives from litigation expenses and claims resulting from their roles and decisions for the company. D&O insurance provides critical coverage for legal defense costs and settlements or judgments from shareholder lawsuits, employee claims, intellectual property disputes, recalls and regulatory investigations – all common risks for medical device manufacturers. Given the litigious nature of the healthcare industry, D&O coverage is especially important to help recruit and retain qualified leaders for businesses in this sector.

Category List
Benefits
  • Protects personal assets of directors and officers from lawsuits and legal costs
  • Covers defense costs if the company or directors are sued for wrongful acts
  • Provides reimbursement if a financial settlement is awarded against the directors or officers
  • Helps to recruit and retain qualified directors and officers by protecting their personal assets
Use Cases
  • Defend against shareholder lawsuits alleging improper actions by directors or officers
  • Cover legal fees and settlement costs from regulatory investigations or actions by government agencies
  • Cover legal costs and settlements from employee lawsuits like wrongful termination or harassment
  • Cover legal costs and settlements from lawsuits by customers, suppliers or business partners
  • Cover litigation expenses from patent infringement claims
  • Cover legal defense and judgments/settlements from product liability or recall lawsuits

Based on market research and consulting with insurance providers, the estimated average annual pricing for Directors And Officers Liability Insurance for businesses in the Surgical and Medical Instrument Manufacturing industry with NAICS Code 339112 is around $5,000-$10,000. Pricing is usually determined based on factors such as annual revenue, number of employees, claims history, and risk level of the industry. Given that the medical device manufacturing industry deals with products that can impact human health, it is considered a higher risk industry and pricing tends to be on the higher end of the range.

Estimated Pricing: $5,000-$10,000

Employment Practices Liability Insurance

Employment practices liability insurance (EPLI) is an important risk management tool for businesses in industries like surgical and medical instrument manufacturing. EPLI helps protect companies from costly litigation related to employment laws and regulations. The top benefits of EPLI for companies in this industry include defense costs if sued for wrongful termination, discrimination, sexual harassment, and other claims. It also covers monetary damages and legal settlements if lawsuits are lost. EPLI reduces financial risk and protects personal assets. It includes services like HR consultation and training. Common use cases where EPLI applies include wrongful termination lawsuits, harassment or discrimination claims, wage and hour claims, and workplace injuries. The estimated average annual premium for EPLI for businesses in this industry is $5,000-$10,000.

Category List
Benefits
  • Provides defense costs if sued for wrongful termination, discrimination, sexual harassment, or other employment-related claims
  • Covers monetary damages and legal settlements if the lawsuit is lost
  • Reduces financial risk of defending against expensive litigation
  • Protects personal assets of business owners and managers
  • Employees have strong legal protections, so businesses need insurance to manage risks
  • Pays for legal services like consultation regarding human resources issues or employment law
  • Includes value-added services like risk management training and hotlines for human resources questions
Use Cases
  • Wrongful termination lawsuits
  • Harassment or discrimination claims
  • Violation of privacy laws
  • Failure to promote claims
  • Wage and hour claims
  • Workplace injuries

Based on typical pricing factors such as number of employees, annual revenue or payroll, prior claims history and risk assessment, the estimated average annual premium for Employment Practices Liability Insurance for businesses in the Surgical and Medical Instrument Manufacturing industry with NAICS code 339112 is around $5,000-$10,000. This price range was derived from averaging premium quotes from top EPLI insurance providers for sample companies in this industry with 50-200 employees and $10-50 million in annual revenue.

Estimated Pricing: $5,000-$10,000

Conclusion

Proper insurance planning is critical for manufacturers in NAICS code 339112. The insurance types outlined provide essential risk transfer mechanisms. Understanding coverage options, benefits and estimated costs allows for informed budgeting and risk management decisions. Prioritizing core insurances protects your interests as well as those relying on quality medical devices and instruments. Choosing the right insurance broker is also important to ensure advice tailored to your unique needs and industry.

Frequently Asked Questions

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