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Archive for category: News

Formative/Summative Usability Testing

Introduction to Formative and Summative Usability Testing for Medical Devices

Usability testing is an essential step in the design and development of any product, including medical devices. It is a process of evaluating a product by testing it with representative users to understand its usability, user-friendliness, and ease of use. There are two main types of usability testing: formative and summative.

Formative Usability Testing

Formative usability testing is conducted during the design and development process of a product, typically in the early stages. It is an iterative process that helps to identify any usability issues and make improvements to the design before the final product is released. Formative testing is typically less formal and less structured than summative testing and is used to evaluate the usability of a product and make changes as needed.
Source: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-human-factors-and-usability-engineering-risk-management-applications-including-medical-devices

Summative Usability Testing

Summative usability testing is conducted after the design and development process of a product, typically in the final stages. It is used to evaluate the overall usability of a product and to provide data on the product’s performance. Summative testing is typically more formal and more structured than formative testing, and the results are used to make final decisions about the product’s release.
Source: https://www.fda.gov/regulatory-information/search

Conclusion

Formative and summative usability testing are essential steps in the design and development of medical devices. Formative testing is conducted during the design and development process, and it helps to identify any usability issues and make improvements to the design before the final product is released. Summative testing is conducted after the design and development process, and it is used to evaluate the overall usability of a product and to provide data on the product’s performance.

Frequently Asked Questions:

Q: What is formative usability testing?

A: Formative usability testing is conducted during the design and development process of a product, typically in the early stages. It is an iterative process that helps to identify any usability issues and make improvements to the design before the final product is released.

Q: What is summative usability testing?

A: Summative usability testing is conducted after the design and development process of a product, typically in the final stages. It is used to evaluate the overall usability of a product and to provide data on the product’s performance.

Q: How does formative usability testing differ from summative usability testing?

A: Formative usability testing is conducted in the early stages of design and development, and it is an iterative process that helps to identify any usability issues and make improvements to the design before the final product is released. Summative usability testing is conducted in the final stages, and it is used to evaluate the overall usability of a product and to provide data on the product’s performance.

Q: How does usability testing help in the design and development of medical devices?

A: Usability testing helps in the design and development of medical devices by identifying usability issues, ensuring that the device is user-friendly, easy to use, and easy to understand, and providing data on the device’s performance. This helps to ensure that the final product meets the needs and expectations of the users and is safe to use.

January 15, 2023
http://improvita.com/wp-content/uploads/2019/06/improvita-logo-web.png 0 0 Improvita http://improvita.com/wp-content/uploads/2019/06/improvita-logo-web.png Improvita2023-01-15 23:08:212023-01-28 18:13:15Introduction to Formative and Summative Usability Testing for Medical Devices
Formative/Summative Usability Testing

The Best of Both Worlds: How to Combine Formative and Summative Usability Testing

Usability testing is an essential step in the design and development of any product, including medical devices. Formative usability testing and summative usability testing are two main types of usability testing that are used to evaluate the usability, user-friendliness, and ease of use of a product. In this article, we will discuss how to combine formative and summative usability testing to get the best of both worlds and how it can be beneficial in the design and development process of medical devices.

Formative Usability Testing

Formative usability testing is conducted during the design and development process of a product, typically in the early stages. It is an iterative process that helps to identify any usability issues and make improvements to the design before the final product is released. Formative testing is typically less formal and less structured than summative testing and is used to evaluate the usability of a product and make changes as needed.

Source: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-human-factors-and-usability-engineering-risk-management-applications-including-medical-devices

Summative Usability Testing

Summative usability testing is conducted after the design and development process of a product, typically in the final stages. It is used to evaluate the overall usability of a product and to provide data on the product’s performance. Summative testing is typically more formal and more structured than formative testing, and the results are used to make final decisions about the product’s release.

Combining Formative and Summative Usability Testing

Combining formative and summative usability testing can provide a more comprehensive evaluation of a product’s usability. Formative testing can be used to identify usability issues and make improvements during the design and development process, while summative testing can be used to evaluate the overall usability of the final product. By combining both types of testing, manufacturers can ensure that the final product meets the needs and expectations of the users, is easy to use and understand and is safe to use.

Best Practices

When combining formative and summative usability testing, it is important to follow the best practices. This includes involving representative users in both types of testing, conducting testing early in the design process, and incorporating feedback from users into the design. It is also important to comply with international standards such as IEC62366, which provides guidelines for the application of user-centered design principles in medical device design.

Frequently Asked Questions

Q: How can combining formative and summative usability testing benefit the design and development process of medical devices?

A: Combining formative and summative usability testing can provide a more comprehensive evaluation of a product’s usability. Formative testing can be used to identify usability issues and make improvements during the design and development process, while summative testing can be used to evaluate the overall usability of the final product.

Q: Is it necessary to involve representative users in both formative and summative usability testing?

A: Yes, involving representative users in both formative and summative usability testing is necessary to ensure that the product meets the needs and expectations of the users.

Q: What are the best practices when combining formative and summative usability testing?

A: Yes, involving representative users in both formative and summative usability testing is necessary to ensure that the product meets the needs and expectations of the users.

Q: What are the best practices when combining formative and summative usability testing?

A: The best practices include involving representative users in both types of testing, conducting testing early in the design process, and incorporating feedback from users into the design. It is also important to comply with international standards such as IEC62366.

Q: How can combining formative and summative usability testing help in ensuring the safety and effectiveness of medical devices?

A: Combining formative and summative usability testing can help in ensuring the safety and effectiveness of medical devices by identifying any usability issues early in the design process and making improvements before the final product is released. It also ensures that the final product meets the needs and expectations of the users and is easy to use and understand, which are critical factors in ensuring the safety and effectiveness of medical devices.

January 15, 2023
http://improvita.com/wp-content/uploads/2019/06/improvita-logo-web.png 0 0 Improvita http://improvita.com/wp-content/uploads/2019/06/improvita-logo-web.png Improvita2023-01-15 22:57:052023-01-28 17:15:59The Best of Both Worlds: How to Combine Formative and Summative Usability Testing
IEC62366 Consulting

Putting Users First: How IEC62366 Integrates User-Centered Design

The design of medical devices is critical to ensure their safety and effectiveness for patients and healthcare professionals. User-centered design (UCD) and IEC62366 are two important standards that manufacturers must adhere to during the design and development process. In this article, we will discuss the concepts of UCD and IEC62366 and their importance in ensuring the safety and effectiveness of medical devices.

User-centered Design (UCD)

User-centered design is a design approach that focuses on the needs, wants, and limitations of the end-users of a product. It involves involving users in the design process, observing their behavior and gathering feedback to ensure that the final product meets their needs. This approach is particularly important in medical device design as it helps to ensure that the device is user-friendly, easy to use, and easy to understand.

Source: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/user-centered-design-process-medical-devices

IEC62366

IEC62366 is an international standard developed by the International Electrotechnical Commission (IEC) that provides guidelines for the application of UCD principles in medical device design. It covers the entire product life cycle, from the initial concept to the end of the product’s life and it is intended to ensure the safety, effectiveness, and usability of medical devices.

Source: https://www.iec.ch/dyn/www/f?p=103:110:0::::FSP_PROJECT,FSP_ORG_ID:6469,2087

Applying UCD and IEC62366 in Medical Device Design

The best practices for applying UCD and IEC62366 in medical device design include:

  • Involving users in the design process: This includes conducting user research, gathering feedback, and observing user behavior to understand their needs, wants, and limitations.
  • Conducting usability testing: This includes testing the device with a representative sample of the intended user population to evaluate the device’s user-friendliness, ease of use, and understandability.
  • Incorporating design controls: This includes documenting the design process, testing, and results, and incorporating the feedback from users and testing into the final design.
  • Complying with international standards: This includes adhering to IEC62366 and other relevant international standards to ensure the safety, effectiveness, and usability of the device.

Source: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/

January 15, 2023
http://improvita.com/wp-content/uploads/2019/06/improvita-logo-web.png 0 0 Improvita http://improvita.com/wp-content/uploads/2019/06/improvita-logo-web.png Improvita2023-01-15 22:40:102023-01-28 18:12:37Putting Users First: How IEC62366 Integrates User-Centered Design
Human Factors

Human Factors Testing for Medical Devices

A medical device manufacturer uses the risk management process as part of their design controls to minimize and decrease any hazards connected with product use. However, anticipating usage faults before people start using the item can be difficult.

Difficulties are not necessarily tied to the item itself. Technology can be difficult to use at times, which can lead to human mistakes that cause injury. Human factors and usability engineering are very important for making sure that new products are safe and easy to use. This is because they examine how people interact with technology. Here’s an overview of human factors and usability testing for those in the medical device industry.

What is the human factor?

The human factor is how a user interacts with a medical device and the dangers that are created as a result of the human aspect. The FDA has suggested that sponsors plan and execute usability studies to identify and prevent or eliminate these hazards. The goal of these tests is to put their product through its paces in real-world scenarios, get user input, and make any required modifications to prevent patient adverse events and medication mistakes caused by use-related errors. This is commonly referred to as “human factors engineering.”

According to the Agency, it is critical to understand how people receive information from medical devices, how they comprehend that information and arrive at decisions, and how they use the device, its components, and its controls. It is also critical to comprehend how the gadget collects user input and then responds and offers feedback to the user on the consequences of their actions.

Importance of human factors testing

As healthcare and medication delivery systems become more complicated, regulatory authorities place a greater focus on guaranteeing their safety and efficacy through human factors testing and user research. Anyone utilizing a medical device, whether a clinician or a patient, should be able to do so without making mistakes that jeopardize the end user’s safety.

It is costly and time-consuming to have your gadget returned due to faulty testing, yet it happens very often. This problem is solved by conducting proper human factors testing at the outset. Human factors research looks at how a person interacts with a gadget in a simulated environment. The purpose of user testing and human factors in the medical device sector is to discover and eliminate any preventable mistakes that may occur by taking into account the product interface, environment, and user.

These simulated situations can attempt to mimic a nurse in a clinical environment, a surgeon inside an operating room, or a patient at home with connected medical equipment. Usability testing and human factors for medical and medication delivery devices are critical to ensuring that the product design is easily accepted by users and that it may be operated securely in real-world settings.

Benefits of human factors testing

Sponsors can create a medical gadget with a variety of useful features. On top of legal requirements and regulatory compliance, there are many benefits to human factors testing, also known as human factors engineering. They include:

  • Easier to interpret devices (interfaces, controls)
  • Easy-to-use and safer devices
  • More secure connections between device accessories and components (cartridges, tubing, leads, and power cords)
  • More powerful warning signals
  • Improved user comprehension of the device’s state and operation
  • Simpler controls, displays, device repair, and maintenance
  • Improved user comprehension of a patient’s present medical state
  • Reduced risk of usage mistakes 
  • Decreased user dependence on user manuals
  • Reduced likelihood of undesirable events
  • Reduced user retraining and training requirements 
  • Reduced likelihood of recalls

Special considerations in human factors testing

When doing human factors testing, medical device makers must take certain questions into consideration. These include:

Who are the device users?

Determine the product’s prospective consumers, including both intended and inadvertent users. Think about people who might use the product without realizing how dangerous it is or who are less able to protect themselves from the risks. A user’s ability to use medical equipment is determined by personal traits such as

  • Physical size, stamina, and strength
  • Physical dexterity, coordination, and flexibility
  • Sensory abilities (tactile sensitivity, hearing, vision)
  • Memory and other cognitive abilities
  • The health issue for which the equipment is utilized
  • Comorbidities (numerous ailments or diseases)
  • Literacy and linguistic abilities
  • General health condition
  • Mental and emotional condition
  • Level of health and education literacy in relation to the medical condition under consideration
  • General knowledge of comparable types of equipment

What environment will the device be used in?

Any project that wants to test and validate human aspects needs to model real-world situations. When a test requires participants to be trained in the appropriate use of a technology, consider imitating the real setting in which they will use it.

If the product or equipment will be used in a home kitchen or bathroom, the sterile, overly-bright light found in a hospital setting will not be an accurate representation of the genuine usage environment. Take into account all characteristics of the environment in which the product may be employed. A few examples are vibration, noise, temperature, and lighting.

What is the user interface?

The product-user interface includes all points of interactions between the product and the user throughout setup (unpacking, assembly), usage, disposal, and maintenance, such as:

  • Weight, shape, and size of the product
  • Displays, indicator lights, and visual and auditory alerts are examples of elements that offer information to the user
  • Product software components’ graphical user interfaces
  • The format in which information is delivered to the user, including feedback
  • Packaging and labeling, which may include training materials, operating instructions, and other information

Steps in human factors testing

A human factors validation study is an activity designed to demonstrate the safety and usability of a market-ready product in the presence of representative end users.
The three essential steps are:

Preparation and planning

Begin by collaborating with a business that focuses on medical device usability testing to keep your human factors validation research on track. Alternatively, consult with your company’s own human factors team. In either event, this is not a task for one of your marketers. It necessitates a highly specialized skill set as well as a testing method.

In addition to the human factors specialists, be sure to designate the correct core team of internal individuals to help with study preparation. We propose that at least one person from training, regulatory affairs, marketing, and engineering be included, as well as a point person to oversee the project.

Testing

Usability testing is something we’ve done at Improvita in a number of different locations and types of facilities. A specialized setting is sometimes required. Other times, you may need to take the tests to a place with a greater population of a particular surgeon. Whatever you do, make sure you leave enough time for orientation and setup.

Analysis and reporting

The human factors moderator is generally in charge of data analysis. If data was logged by a second observer, the two will discuss and compare notes. You can’t always rely on a single observer’s constant monitoring; that individual needs breaks. Having several sets of eyes on users is thus a smart practice. If there is a disagreement or the mission doesn’t go as planned, you can also use the opinions of other people to come to a more well-rounded conclusion.

FAQs

Why is human factors testing so difficult?

Usability testing as a scientific process is limited by its reliance on subjective, qualitative judgments.The data gathered during the testing procedure is heavily influenced by the experimenter’s experience, how the researcher interacts with the participants, and the individuals participating in the study. If testing is not carried out in accordance with recognized qualitative research guidelines, the procedure may yield incorrect results.

What is reliable human factors testing?

Reliable human factors testing is the kind of testing done to show that the product can be used by the expected or planned users without major mistakes or problems and in the expected or planned conditions of use. The testing should be extensive, sensitive enough to identify faults allowed by user interface design, and the results should be generally applicable to real-world consumer use.

Who has to do human factors testing?

With the purpose of minimizing usage-related hazards and risks and ensuring users can use the device effectively and safely, the best time to integrate human factors engineering is as soon as possible in the product development cycle to affect the user interface and product design to minimize use-related risks.

Improvita human factors and usability testing for medical devices

The incorrect use of medical equipment can cause significant damage or even death. Focusing on human factors during the development and design process can assist in identifying possible problems and lowering the risk of a product being used incorrectly before it is released to the public. Human-centered design is central to the Improvita method.

We provide a comprehensive range of medical device development and design services, including human factors. We provide products that are both safe and effective in the real world. Human factors testing is a vital investment when human lives are at stake. Feel free to reach out to us today!

December 21, 2022
http://improvita.com/wp-content/uploads/2019/06/improvita-logo-web.png 0 0 Improvita http://improvita.com/wp-content/uploads/2019/06/improvita-logo-web.png Improvita2022-12-21 22:36:572023-01-15 22:45:15Human Factors Testing for Medical Devices
News

Improvita Successfully Completes Human Factors Validation Program Supporting Beyond Air’s LungFit® PH FDA Approval

MADISON, Wis., Aug. 16, 2022 /PRNewswire/ — Improvita, Inc., a Madison-based company affiliated with Innovenn, Inc., that focuses on human factors testing, ethnographic field research, user interface testing, and user experience testing for medical devices, software as a medical device, and combination drug / medical device products, is celebrating the approval of Beyond Air’s LungFit® PH by the U.S. Food and Drug Administration (FDA). The LungFit® PH has been approved to treat term and near-term neonates with hypoxic respiratory failure (prescription use only).

Improvita and Beyond Air began their collaboration in 2021 to support the conduct of a human factors program, which resulted in the successful completion of the Human Factors Validation of the LungFit® PH.  Improvita provided full service human factors testing, including protocol writing, risk assessment, task analysis, participant recruitment, study execution, data analysis, and reporting of study results. In addition, Improvita provided support for the regulatory negotiations with the FDA. This cross-company collaboration led the team to successful performance of the FDA required Human Factor’s validation. The testing was synchronize with Beyond Air’s business initiatives and the final report was expedited and submitted to the FDA in the first half of 2022.  The product received FDA approval on June 28, 2022.

Improvita is beyond thrilled for Beyond Air’s LungFit® PH approval so that this product may have a positive impact on care for term and near-term neonates.

For more information, please visit www.improvita.com or email maryd@improvita.com.

About Beyond Air, Inc.
Beyond Air, Inc. is a medical device and biopharmaceutical company dedicated to harnessing the power of nitric oxide (NO) through its revolutionary NO Generator and Delivery System, LungFit®, that uses NO generated from ambient air to deliver precise amounts of NO to the lungs for the potential treatment of a variety of pulmonary diseases. For more information, visit www.beyondair.net.

Contact: Mary Dixon, Improvita Inc.
Phone: 608 620 9165
Email: 342615@email4pr.com

SOURCE Improvita, Inc.

https://www.prnewswire.com/news-releases/improvita-successfully-completes-human-factors-validation-program-supporting-beyond-airs-lungfit-ph-fda-approval-301606272.html?tc=eml_cleartime

August 16, 2022
http://improvita.com/wp-content/uploads/2019/06/improvita-logo-web.png 0 0 Deb Lovelace http://improvita.com/wp-content/uploads/2019/06/improvita-logo-web.png Deb Lovelace2022-08-16 19:45:172022-08-16 19:47:00Improvita Successfully Completes Human Factors Validation Program Supporting Beyond Air’s LungFit® PH FDA Approval
News

Improvita celebrates first anniversary with an innovative pivot in response to the global pandemic

Human Factors engineering (hfe) and testing on a medical device

Improving patient healthcare through Innovation

MADISON, Wisc., September 24, 2020 — One year ago, Innovenn, a leader in Digital Therapeutics, separated its human factors testing business under a new name: Improvita, which means ‘To Improve Life’. Improvita focuses on human factors testing, ethnographic research, user interface testing, and user experience testing for medical devices, software as a medical device, and combination drug / medical device products. With the launch of Improvita, a new and larger testing facility was opened September 2019 in Madison, Wisconsin.

For the first six months, Improvita ran successful human factors testing programs for multiple clients in the new facility. In March 2020, the Coronavirus global pandemic called for many companies to recalibrate; Improvita was no exception. Improvita continues to move forward, setting new standards in conducting scientifically rigorous human factors studies nationally as well as internationally. Mary E. Dixon, founder, president, and CEO of Innovenn and Improvita explains: “Improvita has developed procedures to protect the safety and well-being of all test participants and study administrators who attend on-site testing; we have also incorporated remote innovations, where appropriate, while maintaining the standards that allow us to continue this valuable work establishing the safety and efficacy of products in the hands for the users. The Improvita team has been able to respond with speed and innovation to an unimaginable worldwide industry circumstance.”

Necessity is the mother of innovation, and a sudden shift in how companies can come together to better the patient journey requires a quick pivot in priorities and energy. The Improvita team is always up to the challenge, going above and beyond to improve patient lives worldwide. We are thankful to celebrate this first year and excited to look at what the future years hold.

September 30, 2020
http://improvita.com/wp-content/uploads/2019/06/improvita-logo-web.png 0 0 Improvita http://improvita.com/wp-content/uploads/2019/06/improvita-logo-web.png Improvita2020-09-30 20:44:272020-09-30 20:44:27Improvita celebrates first anniversary with an innovative pivot in response to the global pandemic
News

A Message from Mary E. Dixon, CEO Innovenn / Improvita to the Medical and Scientific Community: COVID-19

To Our Clients, Partners, and the Greater Scientific and Medical Community,

In the wake of the COVID-19 pandemic, the Innovenn / Improvita team continues to be committed to providing the highest quality of service for our clients, promoting public health best practices, as well as aiding and empowering the greater medical/scientific community.

In order to do this, we have implemented procedures to ensure the continuity of our client’s business plans, and are dedicated to maintaining an innovative and adaptable workflow as we navigate this unprecedented time period.

COVID-19 has presented a host of unique needs within the healthcare sector, and the Innovenn / Improvita team is committed to doing our part to provide solutions. With a database of over 175 experts, our variety of expertise can be leveraged in numerous initiatives, whether it is scaling up manufacturing of ventilators/PPE or providing resources to ensure continuity of business. If you need experts who can lend a hand quickly, please reach out. Here is where we can help:

  • Regulatory Affairs
  • Statistical Expertise
  • Medical Device Engineering
  • Production Engineering
  • Safety Planning
  • Medical Device design and development
  • Process validation
  • IQ OQ PQ
  • Risk assessment
  • Technical Writing
  • Software Validation
  • Process Validation
  • Test Method Validation
  • Human Factors, UI, UX design and testing
  • Quality Engineering
  • Protocol Development and Execution

We would like to extend our deepest sympathies to anyone who has been impacted by loss during this difficult time, and pledge our commitment to going above-and-beyond for our clients and those on the front lines of healthcare in whatever way we can.

“Never lose hope. Storms make people stronger and never last forever.” – Roy T. Bennet

March 26, 2020
http://improvita.com/wp-content/uploads/2019/06/improvita-logo-web.png 0 0 Improvita http://improvita.com/wp-content/uploads/2019/06/improvita-logo-web.png Improvita2020-03-26 15:27:352020-03-26 15:50:04A Message from Mary E. Dixon, CEO Innovenn / Improvita to the Medical and Scientific Community: COVID-19

Recent Posts

  • Introduction to Formative and Summative Usability Testing for Medical Devices
  • The Best of Both Worlds: How to Combine Formative and Summative Usability Testing
  • Putting Users First: How IEC62366 Integrates User-Centered Design
  • Human Factors Testing for Medical Devices

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