Medical Device Translation And Compliance

Any change to the design should be treated in the same way as the creation of the design. In such a case, all the necessary steps need to be followed, including reviews, verification, validation, approvals, and documentation. Once a product is released, any new change in the product design can affect all the users and badly reflect on the reputation of the manufacturer. So, the design changes are to be made at the earliest step and implemented before release.

Testing Strategies

In order to get market acceptability, every medical device must meet the functionality, usability, and reliability objectives. Apart from these, each device addresses a particular problem or condition, some of which are critical to life. Therefore, it is important to prove the effectiveness and safety of devices to the end users. This is achieved through iterative testing during verification and validation processes. These are driven by the regulatory environment and must follow international standards. The set of International Standards under ISO 10993 - "Biological evaluation of medical devices"- provides a reliable and globally accepted roadmap for the various tests and analyses related to medical devices.

The test strategy should be planned considering – (i) The device segment and product class (ii) Prescribed standards for the product as well as for testing, (iii) Capability of the testing labs and their accreditation status, (iv) The sequence of tests and the duration of each, (v) Total cost and the turn-out time of testing, and (vi) Final documentation for the regulatory requirement.

Being an iterative process, the testing is money-intensive and time-consuming. A strongly-defined testing/evaluation strategy helps to optimize cost as well as the test period to make the product market-ready on time. Also, the testing activity helps to comply with regulations as well as designing the highest quality product and manufacturing processes.

Verification and validation processes executed through lab tests, help to ensure that the device is aligned with the needs of targeted users and that it delivers the intended solution. Also, they ensure that all the requirements are met or not, and enhance the approval process.

Risk Management Procedures

Risk Management is the process of identifying, controlling, and preventing the failure that may cause hazards to users. It also mandates identifying associated risks. Upon reaching an unacceptable level of risk, it notifies developers to decrease at least up to an acceptable level.

Basically, the risk management of medical devices is enforced by the international compliance standard ISO 14971:2007 Medical Devices – “Application of Risk Management to Medical Devices”. Apart from this, risk management policies need to be incorporated across all the stages of medical device design and development. Evidently, it should be integrally linked with the design control process. Given the complexity of developing a medical device, risk management practices help ensure usability, safety, and regulatory compliance.

Figure 2 : The risk management process.

Figure 2 shows the modalities involved in the risk management process. The process starts with the identification of all hazards. Then select a specific one and measure the associated risks based on the consequences of hazards and the probability of risk. If the identified risk level is above the defined criteria, then it needs to be mitigated. The risk level depends on many parameters such as the device, technologies, or even the risk acceptability policy. Risk mitigation strategies could be implemented till the risk level becomes acceptable. Once the specific hazard becomes acceptable in terms of the risks, then the next hazard could be analysed.

Before finalizing a design in the medical device development, it is good practice to conduct a hazard analysis to get an idea about the standard hazards associated with the device. The ‘Primary Hazard Analysis’ can be done considering the following hazards :

(I) Raw materials and wastes: Toxicity, flammability, and reactivity of material.

(ii) Environmental factors: Sensitivity to temperature, humidity etc. Any environment pollution during the process.

(iii) Mechanical or electronic hazards : Whether the device (or its components) is likely to pose any health threat to the user, like electric shock or injury.

(iv) User device interface: Hazards associated with human factors like ineffective delivery, drug administration, incorrect or incomplete information, control of life-sustaining operations

When multiple hazards are identified, they can be prioritized according to the severity associated with them.

Practical Aspects of Medical Device Development

The Design Control Process described in the earlier section is mainly related to the compliance aspects of medical device development. Apart from that, a manufacturer may have to go through 5 distinct phases related to the product lifetime.

Phase 1: Device discovery and risk analysis
Phase 2: Formulation, concept, and feasibility
Phase 3: Design and development - verification and validation
Phase 4: Final validation and product launch preparation
Phase 5: Production, market introduction, and post-market follow-up