Medical Device Risk Management
Safety and quality are non-negotiable in the medical device industry. Risk management at early stage, Intellectual Property protection, design quality control, prioritizing, understanding and buying the insurance helps in managing the business risk as a medical device company. Medical device risk management for safety makes it easy to understand the risk associated and provides a solution. To originate a medical device from its idea to entrance in the market is a laborious job. Medical device companies work actively and mechanically to emerge and comfort in the market. The true challenge for medical device companies is to make devices that are safe and effective for human use. For this it has to undergo tremendous strategies right from design control, risk management and other regulatory requirements throughout its lifecycle from manufacturing till the product launch. Regulatory and safety compliance is non-negotiable for medical devices and its risk management is a crucial factor to ensure sustainable success of the device in the market.
The medical device risk management takes keen efforts to comply with regulatory and safety issues and the documentation throughout the device’s life cycle at every phase in order to analyze and solve the risk, but managing the business risk as a medical device company is one which is unpredictable and needs to be considered. The Horizon of risk management extends to the business risk management. Medical device risk management is the regulatory requirement while business risk management is a key to success.
- Invest your time to discover risk management and design control solutions with operon strategist. Adopt a new business process where we offer a range of facilities to suit your needs.
- Operon Strategist is ISO 13485 consultant helps to create the documents for ISO 13485 certification.
ISO 13485 Consultation for Medical Device
We have technical expertise for Medical Devices. We assist manufacturer to setup QMS and train employees
The real risk management is analysing, avoiding and resolving the threats accurately which are alarming to the business. The livelihood of a medical device company depends on the financial benefits of the company. The financial protection is necessary as accidental, unforeseen, and unpredictable shocks which can demolish the business. Therefore; the proper risk management throughout the lifecycle of the product would help avoid the business pitfalls.
THE NON-NEGOTIABLES TO BE FOCUSED ON BUSINESS RISK MANAGEMENT AS A MEDICAL DEVICE COMPANY
- Prioritizing the risk and threats to the business by applying the design control at early stage
- Business Insurance
- Intellectual Property Right protection
PRIORITIZING THE RISK AND THREATS TO THE BUSINESS BY APPLYING THE DESIGN CONTROL AT EARLY STAGE
Prioritization of the risk and threats can be done by appointing a dedicated risk management team which can implement the design control effectively, as a part of the quality system of the medical device so as to meet the safety and regulatory requirement which is the first step towards thriving product success. Design control is the integral part of the quality system which covers the entire lifecycle of a device. Design control is a connecting bridge between manufacturing and risk management which encourages and ensures safety and efficacy of the medical device.
BUSINESS INSURANCE
The business risk is well protected with insurance where it cannot be given the afterthought but the priority. The emerging unpredictable risk, global market competition, advanced technologies keep the makers in constant change where the insurance serves the purpose by protecting the business .Assessing the liabilities and legal regulations will help to determine the type insurance required for the business and help you protect the livelihood of the medical device business with insurance. The coverage includes Life insurance, Disability insurance, Professional insurance and Completed operations insurance. The insurance permits to transfer your risk to insurance companies
INTELLECTUAL PROPERTY RIGHT PROTECTION
Every innovation for product as well as idea needs intellectual protection. Medical device companies rely highly on IP protection. Medical Device Development needs years of time, effort and money to successfully launch and sustain the product in the market. The best way to safeguard the product is selecting the right IP for the product.
The IP rights that are applicable to the medical devices are as follows
- Patent
- Trademarks
- Trade secret
Patent
The patent legally protects and prevents others from making, imitating or using your invention. The patents that can be applicable to medical devices are both utility patents and design patents Utility patent can be sought to any new process, machine, manufacture, or composition of matter. The requirement to be fulfilled is that it should be novel, non-obvious and useful. E.g., utility patents protect the software and hardware design.
Design patent: Design patent protects the novel exquisiteness of the patented product. E.g., The design patent protects the user interface and the exterior configuration of the medical device. The utility patent term is 20 years from the filing date, while the term for a design patent is 14 years from the date of issue.
Trademark
Trademark is defined as a word, symbol, design, smell, or sound, or any combination that identifies the source of a product or service. This distinctive mark has greater scope of protection. Trademarks can be applied to the medical devices in a way the name of the device, or symbol or slogan is used with respect to the product which makes its identity. E.g., the brand name of the product needs immediate trademark protection.
Trade secrets
Under the trade secret the device\’s economic value is kept secret. Trade secrets consist of business plans, customer lists, marketing strategies and process-related inventions.E.g., the makers of medical devices prefer to keep the list of doctor and hospital clients as a trade secret.
MANAGING YOUR MEDICAL DEVICE BUSINESS RISK THROUGH RISK MANAGEMENT
The risk management involves the prior identification, understanding, controlling and preventing the failures that can lead to hazards associated with the safety and effectiveness of the medical device. Risk management is required by law and is the right thing to do. Risk management should not just be planned but should be the integral part of the organization, which would lead to the prevention, or mitigation of risks and threats. The scope of risk management should extend beyond the quality production and regulatory box to the business aspect.
CONCLUSION
Compliance for safety is the non-negotiable in a medical device company which requires extensive application of risk management where design control should be prioritized. The other non-negotiables include intellectual protection by applying for patents, trademarks and trade secrets which prevents copying of the innovation. Additionally, insurance to the medical device company which can protect your business. A fruitful business is built at the initial stages of the product lifecycle where risk management plays a key role.
REFERENCES:
- FDA: Design Control Guidance for Medical Device Manufacturers
- ISO 14971:2019: Medical devices Application of risk management to medical devices
- Gerald B. Halt, John C. Donch, Amber R. Stiles, Lisa Jenkins VanLuvanee Brandon R. Theiss. Dana L. Blue, FDA and Intellectual Property Strategies for Medical Device Technologies, Springer
- Guide to Understanding Business Insurance Products by A.M Best Company, 3 April 2007
