Feasibility

• Multidisciplinary analyses

Feasibility studies aim to give a comprehensive perspective on the following questions:

• Are there equivalent innovations on the market?
• What optimization routes are implementable?
• Intellectual Property (IP) and patent filing?
• Which markets are targeted? Why? When? How?

Considering the questions above:

• Which regulations have to be met?
• Are clinical trials needed?

Considering the questions above:

• How does this affect costs and funding?
• How to take this into consideration when crafting development plans?

Product adaptation

• Idea formation and conceptualization
• Optimization and molding plan for alignment
• Alignment of a technology, product or application to a new product
• Identification of specifications

Product adaptation aims to give a comprehensive evaluation on the following questions:

• Is it a new technology, product or application?
• What modifications are needed?
• Can it be formulated into an innovation or aligned with an existing product?
• Who will be using it? Consumer? Healthcare professional? Researcher? Someone else?
• Where it will be used? Environmental considerations? Cultural considerations? Genetic considerations? Other considerations?

Considering the questions above:

• What kind of human factors and usability testing is needed?
• How does this affect specifications? Standards & quality assurance? Design controls?

Risk management

• Risk management framework and planning
• Risk analysis and assessments
• Controlling and minimizing the risks
• Documentation and reporting of risk management

Risk management process of medical devices has been specified in ISO 14971
Risk control is a critical part of design and requirements verification and these tools can also be used to identify failure modes, critical device and user interactions besides risks.

Risk Management: Analysis, evaluation and control:

• Structure of ISO 14971
• Essential ISO/IEC standards
• Integration with Human Factors Engineering process ANSI/AAMI/IEC 62366-1:2015/A1:2020/ISO 14971:2019
• Risk analysis tools
• Implementation in Verification & Validation

Verification and validation

• Planning and development of verification testing
• Planning and development of validation testing
• Documentation and reports

Often understood as one thing, but essentially, they measure two different things:

• Verification: “Are we building the thing right?”
• Validation: “Are we building the right thing?”

Types of requirements specifications in medical device design and those tools that can be used in the verification and validation process to ensure that the medical device design captures requirements to obtain regulatory approval.

• Basic concepts and tools for requirement capture
• Design tactics
• Implementing Design of Experiments (DOE)
• Implementing Measurement System Analysis (MSA)
• ISO 13485:2016/FDA 21CFR part 820/ISO 9001:2015

Verification is defined in ISO 9000:2015 / 9001:2015 as means to demonstrate that specified requirements have been met.

However, regulatory requirements are too general to provide any real assistance on verification design, models or practices.

Verification goes hand in hand with medical device design to inspect each specified requirement:

• Verification test method design
• Risk-based verification models
• Verification quality practices
• Verification testing: Requirements, verification plan, protocols & logs

Where verification focuses on each and every requirement, validation ensures that the design captures requirements as a system as set in specifications for intended use.

Demonstrates the consistency and completeness of the design in its intended use:

• Design validation models
• Design controls
• Requirement specifications, functional specifications, design specifications
• Installation Qualifications (IQ), Operational Qualifications (OP), Performance Qualifications (PQ)
• DFV V-model and design tactics

Device and process validations should not be mixed with each other.

Compliance

• Ensuring compliance with regulations
• Managing regulations for planning monitoring
• Managing the monitoring process for planning
• Compliance with international standards (EU regulation, FDA regulation)
• Know-how of the local regulations and standards in Switzerland, Germany, Japan and China

From feasibility to verification & validation all actions should aim for:

• Demonstration of patient safety

Within these actions should be integrated procedures ensuring regulatory compliance:

• Conformity assessment routes
• QMS ISO 13485:2016/FDA 21CFR part 820/ISO 9001:2015
• Standard Operating Procedures (SOP)
• Corrective Action and Preventive Action (CAPA)
• Requirement traceability matrix
• Design History File (DHF) & Device Master Record (DMR)
• Document controls
• Clinical evaluation ISO 14155
• etc.

Commercialization

Commercialization via internationalization should be integrated into the development process as early on as possible.

• Commercialization strategies
• Business economics
• Business models
• Market entry strategies
• Partnerships & alliances 

Setting all above into international context:

• Internationalization
• Multinational innovation
• Intercultural R&D and knowledge management