Author: Yotam Portnoy

This post is dedicated to young startups and small companies currently facing numerous challenges, more than ever before. From our experience, we have, unfortunately, learned that during crises, there is often a tendency in young companies to neglect regulatory and quality issues. This is done to accelerate product development and meet investor timelines, under the belief that these matters can be addressed later. However, bypassing essential development stages and neglecting coherent documentation may lead to future difficulties, especially during regulatory submission.

Therefore, we have summarized a concise list of things you shouldn’t compromise on now, to ensure minimal investment when seeking regulatory approval later:

1. Intended use and Indications for use:

Define early on the official description that outlines the purpose for which the product is intended, including its medical function, conditions of use, types of diseases or medical conditions it addresses, and the intended user population. This definition is critical for the regulatory process as it determines the regulatory pathway, impacts clinical requirements guides the verification and validation testing of the product.

This task appears relatively simple, but in reality, it is not so. The Intended Use must be defined based on a deep understanding of the market and medical use, alongside regulatory expertise.

Additionally, it is crucial to consider medical reimbursement options, where alignment with both regulatory approval and reimbursement is necessary.

One common and crucial mistake among startup companies is attempting to define the regulatory classification and pathway of their device on their own, despite having no regulatory expertise, to save money. This can be a costly mistake that may result in significant expenses and time delays later when seeking regulatory approval. It is highly advised to invest the money and hire an expert to develop the regulatory strategy for you – defining the product classification, predicate device (for the US), main V&V tests, clinical aspects, and main QMS requirements for your product and of course the main stages for regulatory submission. The regulatory strategy shall be market-specific.

Another common mistake among startup companies or small firms is assuming that upon regulatory approval, they can immediately start selling the product. In reality, there indeed are companies that received FDA or CE approval but failed to penetrate the market because the product lacks medical reimbursement or an attractive sales channel.

2. Device description:

While it may seem self-explanatory, device description is a critical definition that sets the intentions and boundaries of product development. It must correspond with the intended use, and describe how the product will archive it. It’s important to specify what the product does, its features, design specifications, materials used, functional capabilities, operating principles, and any relevant performance characteristics. Additionally, it may include information on indications for use, contraindications, warnings, precautions, and instructions for use to ensure safe and effective use of the device in clinical settings.

The device description is not marketing material but more of an official statement of the company regarding its product. This will be used as the basis for regulatory submissions and labeling.

Marking materials will be based on the intended use and the device description as they are approved by the regulators. Therefore, it should be done carefully, and taking into account both marketing and regulatory aspects.

Unfortunately, we’ve seen more than once a startup that failed to define an accurate device description and as a result faced many inconsistencies and confusion, especially between what is presented to investors or in the marketing materials and what is permissible under regulation.

3. Risk management:

Besides being a mandatory requirement in most regulations, early-stage (during the planning of the design and development) risk management according to ISO 14971 allows for identifying potential hazards. This early identification enables to define the required verification and validation testing (including the necessity and the scope of pre-clinical and clinical trials) and make corrections and improvements to the product design before costly testing and validation begin.

For risk management to be beneficial in an early stage, more than the product’s design, EMC and SW should be considered. We suggested evaluating the risks of the manufacturing process and user-related form the beginning.

Manufacturing Process- when designing a device, the methods of its manufacturing should weigh into the design. Specially, if the product requires any special process or environmental conditions. For example, if you design a sterile finale product that has a built-in buttery, you will need to identify specific risks inherent in the sterilization of a buttery, and consider materials for the proper sterilization and design the product and its packaging to mitigate the identified risks.

In that matter, scaling up the manufacturing process might raise unexpected process risks, especially for products that require special technologies or specific knowledge. When identified early, the manufacturer might be able to avoid the pain of redesigning the product to scale up the manufacturing process.

User-related risks – once the intended user and environment are determined, risks related to user information perception, cognition, and actions should be identified. Then, when designing the product, you should consider possible controls for these risks.

Specifically, medical device reprocessing by the user may raise a lot of concerns and risks. Reprocessing of medical devices should be as simple and straightforward as possible for the user. When designing with such intention, you should be careful to identify who will conduct the reprocessing and what is their technical understanding (medical care professional? technician? layperson?). Equally important is to identify the environment for the reprocessing process. These considerations have a major effect on the required device’s durability, appearance, how its disassembled or connected, and more.

It important to understate that risk management is not a document but a continuous process that spans the entire product’s lifetime. The earlier it is initiated, the more accurate, comprehensive, and ultimately beneficial it will be.

4. Verification and Validation (V&V) planning:

Planning and conducting V&V activities early in the development phase, guided by risk analysis, are essential for regulatory compliance and product quality assurance. But, for young companies and startups, in ultimately important for budget planning.

Planning V&V early and documenting it systematically can help identify connections between processes, requirements, and tests, potentially saving on expensive laboratory trials later. Mapping required V&V tests also anchors budget management due to their high costs.

While planning the V&V tests, it is critical to conduct a thorough study of the applicable regulations, standards, and guidelines for your device.

5. Adherence to proper development stages and documentation:

Documenting milestones in product development, including version differences and actions taken for each version is crucial even for small teams. Clear documentation ensures consistency and facilitates a comprehensive understanding of project progress, particularly when managing tight deadlines and concurrent tasks.

It’s important to note that the above list outlines only the topics that are not recommended to be neglected even in difficult situations. This list is the bare minimum, and additional quality and regulatory requirements will be required depending on the market you intend to target. Of course, ideally, the development of the product should go hand in hand with quality and regulatory requirements.

In the rapidly evolving field of medical technology, achieving optimal usability remains a significant challenge. As we strive to create devices that are both technologically advanced and user-friendly, several key obstacles emerge. Understanding these challenges is crucial for medical device manufacturers and usability engineers to develop effective solutions.

1. Accommodating Diverse User Needs

The medical device landscape is unique in its wide range of users, from highly trained healthcare professionals to patients with varying levels of technical expertise and physical capabilities. This diversity presents a complex challenge:

• Healthcare Professionals: Devices must cater to specialists who require advanced functionalities without compromising efficiency.
• Patients: Home-use devices need to be simple enough for users who may have limited technical skills or physical limitations.
• Assistive Personnel: Often overlooked, this group includes various crucial roles that must be considered in the design process: Hospital Support Staff, Technicians, Home Caregivers, and Emergency Responders. Many of these users might interact with devices in high-stress situations, adding another layer of usability challenges.
• Cultural and Linguistic Factors: In a global market, devices must be intuitive across different cultures and languages.

2. Balancing Complexity and Simplicity

Modern medical devices often incorporate sophisticated technologies and multiple functions. The challenge lies in presenting these capabilities in a user-friendly manner:

• Feature Overload: Adding too many features can overwhelm users and increase the risk of errors.
• Oversimplification: Stripping down functionality to improve usability may limit the device’s effectiveness.
• Critical vs. Non-critical Functions: Determining which functions should be easily accessible and which can be nested in menus.

3. Seamless Integration with Existing Workflows

Healthcare environments are complex ecosystems with established procedures. New devices must fit into these existing workflows without causing disruption:

• Interoperability: Ensuring new devices can communicate effectively with existing systems.
• Training Requirements: Minimizing the learning curve for new devices to avoid workflow interruptions.
• Physical Integration: Considering how the device fits physically within the healthcare setting.
• Organizational Effects: Understanding and addressing the broader impacts on organizational structure, job roles, and processes. New devices may necessitate changes in staff responsibilities, and departmental interactions, or even create new roles, potentially leading to resistance or requiring careful change management.

4. Regulatory Compliance vs. Innovation

While not mentioned in the original paragraph, this is a significant challenge worth addressing:

• Stringent Regulations: Adhering to FDA and other regulatory guidelines can sometimes limit design choices.
• Documenting Usability: The need for extensive documentation of the usability engineering process can be resource-intensive.
• Balancing Innovation: Ensuring compliance while still pushing the boundaries of technological advancement.

5. Evolving Technology and User Expectations

As technology rapidly advances, user expectations for intuitive interfaces grow:

• Keeping Pace: Ensuring medical devices match the usability standards set by consumer electronics.
• Future-Proofing: Designing devices that can adapt to future technological advancements.
• Generational Differences: Catering to both tech-savvy younger generations and older users who may be less comfortable with technology.

6. Regulatory Compliance vs. Innovation

• Stringent Regulations: Adhering to FDA and other regulatory guidelines can sometimes limit design choices.
• Documenting Usability: The need for extensive documentation of the usability engineering process can be resource-intensive.
• Balancing Innovation: Ensuring compliance while still pushing the boundaries of technological advancement.
• Unbiased Summative Validation: Securing an independent, external team to perform summative validation can be challenging. This step is crucial for regulatory compliance and ensuring unbiased usability assessment, but finding qualified teams without conflicts of interest, managing confidentiality, and integrating their feedback into the development process can be complex and time-consuming.

This addition highlights the importance and challenges of unbiased external validation within the broader context of regulatory compliance and innovation.

7. Ensuring Unbiased Usability Validation

• External Team Requirements: Identifying and engaging qualified, independent usability experts who have no prior involvement with the device development.
• Confidentiality and Intellectual Property: Balancing the need for transparent evaluation with protecting proprietary information and innovations.
• Integrating Feedback: Effectively incorporating insights from external validation into the development process, especially when it conflicts with internal assumptions or preferences.
• Resource Allocation: Managing the additional time and budget required for thorough external validation without compromising other aspects of development.
• Regulatory Alignment: Ensuring that the external validation process meets all regulatory requirements while providing meaningful usability insights.

The medical device landscape is unique in its wide range of users, from highly trained healthcare professionals to patients with varying levels of technical expertise and physical capabilities. This diversity presents a complex challenge:

• Healthcare Professionals: Devices must cater to specialists who require advanced functionalities without compromising efficiency.
• Patients: Home-use devices need to be simple enough for users who may have limited technical skills or physical limitations.
• Assistive Personnel: Often overlooked, this group includes various crucial roles that must be considered in the design process: Hospital Support Staff (e.g., stretcher bearers, porters), Technicians, Home Caregivers, and Emergency Responders. Many of these users might interact with devices in high-stress situations, adding another layer of usability challenges.
• Cultural and Linguistic Factors: In a global market, devices must be intuitive across different cultures and languages.

8. Balancing Complexity and Simplicity

Modern medical devices often incorporate sophisticated technologies and multiple functions. The challenge lies in presenting these capabilities in a user-friendly manner:

• Feature Overload: Adding too many features can overwhelm users and increase the risk of errors.
• Oversimplification: Stripping down functionality to improve usability may limit the device’s effectiveness.
• Critical vs. Non-critical Functions: Determining which functions should be easily accessible and which can be nested in menus.

9. Seamless Integration with Existing Workflows

Healthcare environments are complex ecosystems with established procedures. New devices must fit into these existing workflows without causing disruption:

• Interoperability: Ensuring new devices can communicate effectively with existing systems.
• Training Requirements: Minimizing the learning curve for new devices to avoid workflow interruptions.
• Physical Integration: Considering how the device fits physically within the healthcare setting.

10. Regulatory Compliance vs. Innovation

• Stringent Regulations: Adhering to FDA and other regulatory guidelines can sometimes limit design choices.
• Documenting Usability: The need for extensive documentation of the usability engineering process can be resource-intensive.
• Balancing Innovation: Ensuring compliance while still pushing the boundaries of technological advancement.

11. Evolving Technology and User Expectations

As technology rapidly advances, user expectations for intuitive interfaces grow:

• Keeping Pace: Ensuring medical devices match the usability standards set by consumer electronics.
• Future-Proofing: Designing devices that can adapt to future technological advancements.
• Generational Differences: Catering to both tech-savvy younger generations and older users who may be less comfortable with technology.

Conclusion: Overcoming Challenges through Usability Engineering

While the challenges in achieving optimal usability for medical devices are significant, usability engineering and human-centered design approaches offer powerful tools to overcome them. These methodologies provide a structured framework for addressing the complex needs of diverse user groups, balancing functionality with simplicity, and integrating seamlessly into existing workflows.

By employing techniques such as user research, iterative design, and comprehensive usability testing, manufacturers can create devices that not only meet regulatory requirements but truly enhance the user experience. Involving end-users throughout the development process ensures that devices are intuitive and effective in real-world settings.

As the medical device industry continues to evolve, so too must our approaches to usability. By embracing these human-centered design principles, we can create devices that not only meet the technical demands of modern healthcare but also provide a seamless, safe, and satisfying experience for all users. This approach ultimately leads to improved patient outcomes, increased efficiency for healthcare providers, and a more robust, innovative medical device industry.

For more information about our Medical Device services visit:

When it comes to early-stage drug development, Phase 1 clinical trials are pivotal. These trials are designed to assess the safety, tolerability, and pharmacokinetics of new drugs or treatments. A critical decision for sponsors is where to conduct these trials. Here’s why performing Phase 1 clinical trials in dedicated Phase 1 units with a pool of patients offers significant advantages:

1. Expertise and Experience

Phase 1 units are specifically designed for early-phase trials. They are staffed with experts who are highly skilled in managing the complexities and nuances of these studies. From the initial dosing to monitoring adverse effects, their experience ensures meticulous handling of every aspect of the trial, contributing to more reliable and accurate results.

2. Enhanced Safety Monitoring

Safety is paramount in Phase 1 trials, and specialized units are equipped with advanced monitoring systems to track participants’ health in real-time. These facilities often have 24/7 medical staff and immediate access to emergency care, which enhances patient safety and allows for prompt intervention if needed.

3. Streamlined Operations

Dedicated Phase 1 units are optimized for efficiency. They are designed to handle the specific needs of early-phase trials, from patient recruitment to data collection. This specialization reduces the likelihood of operational delays and ensures that the trial progresses smoothly and on schedule.

4. Access to a Pool of Pre-Screened Patients

One of the biggest advantages of Phase 1 units is their access to a pool of pre-screened patients. These facilities often have a database of individuals who have previously expressed interest in participating in clinical trials and have been pre-screened for eligibility. This accelerates the recruitment process, helping to meet enrollment targets more efficiently.

5. Controlled Environment

Phase 1 units provide a controlled environment that minimizes external variables. This is crucial for obtaining clear, unbiased data on how a drug affects participants. The controlled setting helps ensure that the results are due to the drug itself rather than external factors, leading to more accurate and interpretable findings.

6. Regulatory Compliance

Specialized Phase 1 units are well-versed in the regulatory requirements for early-phase trials. They are familiar with the documentation, reporting standards, and ethical considerations needed to comply with regulatory agencies. This expertise reduces the risk of compliance issues and helps ensure that the trial meets all necessary legal and ethical standards.

7. Participant Comfort and Engagement

Phase 1 units are designed with participant comfort in mind. From private rooms to amenities and support services, these facilities prioritize the well-being of participants, which can improve their overall experience and adherence to the trial protocol.

In summary, conducting Phase 1 clinical trials in dedicated units with a pool of patients offers numerous benefits, including specialized expertise, enhanced safety monitoring, streamlined operations, efficient recruitment, a controlled environment, regulatory compliance, and improved participant comfort. For sponsors looking to navigate the complexities of early-phase drug development, these advantages can significantly impact the success and efficiency of their clinical trials.

For more information about our CRO services visit:

Medical devices have the potential to revolutionize healthcare, but this potential is not just in technical prowess but also in intuitive user interaction. The Food and Drug Administration (FDA) in the United States oversees a meticulous regulatory process for usability engineering, fostering the design of medical devices for safe and effective use in real-world environments.

Key Steps in the Regulatory Framework:

1. User Research and Task Analysis: This foundational stage involves understanding the device’s intended users, their expertise levels, and specific usage environments. Tasks users will perform are meticulously identified to pinpoint potential challenges
   and use errors.
2. Use-Related Risk Analysis (URRA): Potential use errors are evaluated to assess associated risks and hazardous situations that affect all potential end users. This stage helps prioritize areas for design improvements.
3. Deriving Use-Related Design Requirements: The usability engineer identifies user interface elements critical to caregiver and patient safety, deriving design requirements for the development team.
4. Formative Evaluations: Throughout development, iterative testing with representative users provides real-time feedback for continuous design refinement. The goal is to mitigate use-related risks to acceptable levels before finalizing the device.
5. Summative Testing: Once the design is finalized, summative testing formally validates its safety and effectiveness, serving as the final checkpoint before regulatory submission.

Benefits of a Robust Usability Engineering Process:

1. Enhanced Patient Safety: By minimizing use errors, the risk of patient harm is significantly reduced.
2. Reduced Training and Support Needs: Intuitive devices require less post-market effort in training and technical support.
3. Elevated User Satisfaction: Well-designed devices foster a more positive user experience for healthcare professionals and patients.
4. Streamlined Regulatory Approval: A comprehensive usability engineering program can expedite the regulatory approval process.
   

Conclusion:
The regulatory process for usability engineering plays a pivotal role in ensuring the safety and effectiveness of medical devices. By integrating usability considerations from the outset, manufacturers can create devices that are both technologically advanced and user-friendly, ultimately paving the way for improved healthcare outcomes.

For more information about our services to the Medical Device industry:

Incorporating usability in medical device development is a comprehensive, multifaceted process that spans the entire product lifecycle. At its core, it involves three key phases:

1. Early-stage user research and requirements gathering, where the needs and capabilities of end-users are thoroughly analyzed;
2. Iterative design and testing, where prototypes are developed and refined based on user feedback and usability evaluations;
3. Validation and post-market surveillance, ensuring the final product meets usability standards and continues to perform effectively in real-world settings. This holistic approach not only satisfies regulatory requirements but also significantly enhances the safety, efficacy, and user satisfaction of medical devices.

Medical devices are integral to modern healthcare, facilitating diagnosis, treatment, and patient monitoring. However, their effectiveness extends beyond technical capabilities. A critical, often underestimated factor is usability: the ease with which healthcare professionals and patients can interact with these devices.

Impact on Patient Outcomes:

Usability directly influences patient safety and treatment efficacy. Poor usability can lead to:

1. Increased Error Rates: Complex interfaces may contribute to misdiagnosis or incorrect treatment administration.
2. Suboptimal Treatment Delivery: Cumbersome devices may not be used to their full potential, hindering treatment effectiveness.
3. Elevated Costs: Unintuitive devices require more extensive training for healthcare professionals and at times extensive technical support.
4. Device Rejection: Both caregivers and patients may abandon difficult-to-use devices, leading to poorer health outcomes.

Regulatory Landscape:

Regulatory requirements worldwide mandate that medical devices undergo rigorous design, testing, and monitoring to ensure they are safe, effective, and user-friendly. Integrating human factors throughout the development process, conducting thorough usability testing, and documenting these activities are essential components. Post-market surveillance further monitors device usability in real-world settings to continually improve patient safety and device effectiveness.

The FDA’s Human Factors and Usability Engineering Guidance outlines expectations for incorporating human factors into device design and development. While not legally binding, this guidance reflects the FDA’s current perspective and serves as a valuable resource for manufacturers aiming for regulatory approval. Compliance with FDA recommendations is crucial as industry standards evolve, ensuring devices meet usability expectations and enhance patient care.

Under the EU MDR, similar stringent requirements are binding in Europe. Manufacturers must integrate usability engineering into the entire device lifecycle, perform systematic usability evaluations, and manage usability-related risks effectively.

ISO 62366 helps put these requirements into practice by providing a structured approach to Usability Engineering. The standard guides manufacturers in integrating usability considerations across the device lifecycle, including defining and evaluating user needs and risks.

Adhering to FDA guidance, MDR requirements, and ISO standards not only facilitates regulatory compliance but also demonstrates a commitment to producing safe, effective, and user-friendly medical devices that improve healthcare outcomes globally.

Conclusion:

Usability in medical devices is no longer peripheral; it’s a scientific imperative for ensuring patient safety, treatment efficacy, and regulatory compliance. Prioritizing user-centered design principles can foster improved patient outcomes and streamline regulatory approval processes.

For more information about our Medical Device services visit:

We are pleased to attend together with SE Pharma for the upcoming IPL Forum 2021- supply chain management conferences for the healthcare and food-tech industries!

The conference was held on 20.10.2021 at the Avenue Congress Center.

Gsap experts provide professional lectures:

The Annual Healthcare Industry Supply Chain Management Conference-IPL Forum 2021

Opening seat

9:20 – Implementing GDP in Israel – Regulatory Challenges and Key Insights from Audits:

Dr. Sigalit Arieli Portnoy, CEO

IPL Forum 2021

We are happy to share our range of services that we are providing to the digital health community to accelerate and promote startups- from concept stage to product approval.

You can find us also in the digital edition of” digital health” magazine in the “HAARETZ” newspaper: (page 16 )

https://www.haaretz.co.il/st/inter/Global/magazine/Haaretz/2021/01%20January/new%20Digital%20health/index.html#p=1