Medical Devices Risk Management

Transcription

1 April 2017 SAMED General Member s Meeting / Novatec WS (RISK) Medical Devices Risk Management

2 What Product Liability is NOT Find an insurance broker who understands your industry, it s relevant regulatory changes and with a comprehensive understanding of your entire manufacturing & distribution processes Not General / Public Liability/Commercial Insurance Broad form commercial cover almost always exclude product liability. Commercial insurance only covers buildings combined, equipment and specified extensions such as Goods in Transit, Deterioration of stock, Business interruption etc. Not a means to cover fraud / crime or dishonesty Insurers do not cover the liability of perpetrators of crime, fraud or dishonesty against the acts they have committed Not Guaranteed by the original manufacturer First point of claim procedures in terms of liability will always start with the distributor of a product International Manufacturer policy wording and exclusions often does not correspond with SA jurisdiction SA might fall outside of the territorial limits of their product liability cover Sub sequential claims are often not covered by warranties / product guarantees Not necessarily Professional Liability Cover Any advise or instruction given by any employee / representative Any Errors or Omissions in professional instruction or advice by any staff member, including written instruction, protocol or product use instruction

3 Three major types of product liability claims: Manufacturing Defect Design Defect Marketing Defect Types of Product Liability What happens when there is a claim without product liability cover? Liability? The client facing entity will always be the first to be approached will you be prepared? How much will product liability cost my business? This varies according to product classification and level of establishment of the product / company Always will be less than any claims that may arise Annual premiums may be financed

4 How to use Risk Assessment and Supplier Risk Vetting to your advantage for insurance premium reduction Liability Insurance Costs Individual Company and Product Risk Assessment Use current changes in legislation to your advantage (Risk Assessment and Product Classification breakdowns) Reduce risk perception of the insurer by completing yearly Needs Analysis and Risk mitigation reports Product risk reduction evaluations from Trials / Development phase to Distribution and Established Product Provider phase could decrease premiums Supplier / Sub-Contracted Risk Vetting / Proof of Due Diligence Use SLAs (with built in Risk Vetting clauses with subcontractors and other subcontracted services to minimize overall risk 3. Proof of Due Diligence Ensure compliance with current quality control procedures when purchasing raw material again use SLAs with set requirements to minimize implication of negligence in case of a claim A B C D

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6 What other insurance risks should be considered? COMMERCIAL COVER Broad form commercial cover (with specified extensions such as Goods in Transit, Deterioration of stock, Business interruption, Accounts receivable to name a few) PROFESSIONAL LIABILITY COVER Any advice / instruction of company representative or the lack thereof MEDICAL MALPRACTICE LIABILITY 3. Many medical devices requires the initial consultation with / of a medical practitioner EMPLOYMENT PRACTICES, STATED BENEFITS, GPA, D&O All liability towards staff COID / Compensation Fund delays (cash flow impacted) Directors are very exposed to liability loss of income FIDELITY GUARANTEE Any losses due to fraud / criminal activities by an employee or company representative CLINICAL TRIAL / CONTROLLED STUDY Limited underwriters available for this type of cover, now available to SA Medical Devices companies

7 Proposal to Policy THE PROCESS

8 Proposal Documents General company information, brochures, procedures, compliance Full needs analysis is done by insurance agent (All insurance products identified to transfer risk) Risk assessment & Product classification All proposals forms to be signed off by director / appointed representative and dated Risk Presentation Comparative quotes via various insurance providers (FAIS Conflict of interest policy) Why Novatec prefers to work via UMAs? Different insurance products available from different underwriters (Medical Malpractice and Medical Device Liability very specialized fields) Quotation & Policy Inception Comparative quotes are presented & differences in terms and conditions, excesses are explained Insurance products are selected by the Insured Quote acceptance and policy inception instructions are given Retroactive Dates, Inception Dates and other important information is confirmed Policy schedule distributed to the Insured Full Record of Advice is done

9 The experts behind our expertise Current Underwriting Managers and Affiliates

10 Do you have any questions? Thank you for your time today. This is not what insurance is about! The real voyage of discovery is not in seeking new landscapes, but in having new eyes

11 Contact Us Telephone Chantalle ten Napel Wilson Mobile: Office: Location Regus Offices Southdowns, CnrNelmapius& John Vorster Drive, Centurion, Website