Bold Insight’s Gavin Lew to highlight medical devices and human factors at Intellus Worldwide Summit

Bold Insight’s Gavin Lew to highlight medical devices and human factors at Intellus Worldwide Summit

*Gavin Lew, Managing Director of Bold Insight, will present at the 2019 Intellus Worldwide Summit Insights Evolution in Philadelphia, Pennsylvania on May 20, 2019. In his talk, Medical Devices & the Human Factors of Health, Lew will describe the regulatory environment for new product development involving medical device delivery. He will also detail how human factors research can be applied to advance product design and improve success.

“Because regulatory agencies, such as the FDA, now require human factors research on the design of a medical device to ensure safe and effective use, there is an opportunity for market research to support this effort during the early exploratory phase of a product lifecycle,” commented Lew.

With a deep expertise in medical device research, the Bold Insight team frequently presents at healthcare-related events and contributes to industry standards. Read our latest health news.

Connect with Gavin on Linked In and Twitter.

 

About Intellus Worldwide

Formed in 2018, Intellus Worldwide unified renowned industry associations The Pharmaceutical Business Intelligence and Research Group (PBIRG) and Pharmaceutical Marketing Research Group (PMRG) bringing together healthcare insights professionals and global pharmaceutical and medical device manufacturers and service providers. For more information about the event, visit https://www.intellus.org/Events-Webinars/Summit-2019

 

About Bold Insight

Bold Insight is user experience (UX) research agency based in Chicago. The team offers clients the expertise and professionalism of a large agency, with the imagination and agility of a startup. This dynamic offering results in responsiveness, sense of pride and ownership, and flexibility to exceed project expectations. Find out more at y9qch.hosts.cx or email hello@y9qch.hosts.cx to discuss your next project. *

 

Bold Insight awarded ISO 9001:2015 certification

Bold Insight awarded ISO 9001:2015 certification

Bold Insight, a user experience (UX) and human factors (HF) research agency, is proud to be awarded ISO 9001:2015 certification from NSF-ISR. Achieving certification is a demanding process that includes a rigorous audit to demonstrate Bold Insight’s conformance to quality assurance and information security standards, as well as, controlled processes that ensure excellence in the training and development of its researchers, participant recruitment, vendor management, and development and execution of research protocols. This globally-recognized certification represents Bold Insight’s commitment to quality and, ultimately, its customers.

“A certified quality system is the framework for ensuring excellence in service delivery for our customers,” said Bold Insight’s Quality Manager, Andrew Zawisza. “Operational excellence is necessary to achieve this certification and requires commitment from the entire organization. The Bold Insight team was eager to support this initiative. I’ve never seen a company achieve this so quickly, and with no identified nonconformances.”

Being ISO 9001:2015 certified is especially important when working in the medical device human factors space, and when working with large enterprises that have robust vendor management processes in place. These organizations find it easier to work with ISO-certified partners because the certification demonstrates a commitment to continuous improvement in the delivery of services for which they are seeking partnership.

Bold Insight Managing Director, Korey Johnson, added, “With the amount of research that we conduct in the medical device UX and HF space, it was never a question that we would obtain ISO 9001:2015 certification. Our investment in Bold Insight’s quality system is a demonstration to our customers of our commitment to provide them with the best possible experience when working with us as their research vendor. We are thrilled with how efficiently Andrew developed and implemented our quality system and look forward to using it to ensure we are constantly improving the services we provide for our customers.”

For more information about Bold Insight’s certification, reach out to hello@boldinsight.com.

About NSF-ISR

Manufacturers, regulators and consumers look to NSF International for the development of public health standards and certification programs that help protect the world’s food, water, consumer products and environment. Our mission is to protect and improve global human health. As an independent, accredited organization, our standards group facilitates the development of standards, and our service groups test and certify products and systems. We also provide auditing and risk management solutions for public health and the environment. Visit http://www.nsf.org for more information.

Bold Insight’s Korey Johnson co-presents human factors training to members of FDA’s DMEPA

Bold Insight’s Korey Johnson co-presents human factors training to members of FDA’s DMEPA

Representatives from the Human Factors and Ergonomics Society (HFES) provided a two-day training course on human factors science, user-centered design principles, and root cause analysis on September 25-26, 2018 at the Food and Drug Administration’s (FDA) White Oak Campus in Silver Spring, Maryland. This course was attended by representatives of the Division of Medication Error Prevention and Analysis (DMEPA) from the Center for Drug Evaluation and Research (CDER). Korey Johnson, Managing Director of Bold Insight, along with Dr. Anthony Andre, and Michael Wiklund were the three experts selected by HFES to provide this training course.

The training was intended to provide attendees with deeper knowledge of and appreciation for the scientific roots of human factors research and user-centered design. Training drew on seminal research and literature from the fields of psychology, engineering, and product design, and leveraged a wide range of practical examples of both good and bad application of human factors science.

“There are many reviewers within CDER tasked with assessing the extent to which submissions adequately support a decision indicating that a product can be used safely and effectively. Many of those reviewers have abundant experience assessing human factors and user-centered design related shortcomings. With this training we hoped to provide a bit more of the scientific underpinnings of our practice – on one hand to amplify instances where requests for additional research are warranted, and on the other hand to provide the scientific context for when that additional research may not be warranted,” said Johnson.

For more information about the Human Factors and Ergonomics Society (HFES), visit hfes.org.

Connect with Korey Johnson on Linked In, Twitter, or email.

Bold Insight is a user experience (UX) research agency based in Chicago. Our team offers clients the expertise and professionalism of a large agency, with the imagination and agility of a startup; specializing in medical device research, human factors validation, and large-scale global testing. https://boldinsight.com/human-factors

Bold Insight connects with human factors community at HFES 2018

Bold Insight connects with human factors community at HFES 2018

A leader in the medical device human factors industry, Bold Insight sponsored this year’s Human Factors and Ergonomics Society (HFES) International Annual Meeting to connect with HF/E colleagues and young professionals interested in pursuing a career in the space. The five-day event features panels, workshops, and networking to promote the evaluation and exchange of information among HF/E researchers, educators, and practitioners, along with opportunities for professional growth and collaboration.

“We are actively involved in mentoring students and those wanting more exposure in this exciting industry. HFES is a great opportunity to participate in programming focused on career development and mentoring,” said Korey Johnson, Managing Director of Bold Insight. Johnson will co-chair a session in the Health Care Track, Patient Experience and User-Centered Design on October 3. He also sat on the selection board of the Stanley H. Caplan User-Centered Product Design Award, an award that emphasizes innovative and user-centered approaches to human factors/ergonomics and industrial design, given during the conference.

The event is being held in Philadelphia, Pennsylvania on October 1-5, 2018. For more information about HFES and hosted events, visit hfes.org.

Connect with Korey Johnson on Linked In, Twitter, or email.

Bold Insight is user experience (UX) research agency based in Chicago. Our team offers clients the expertise and professionalism of a large agency, with the imagination and agility of a startup; specializing in medical device research, human factors validation, and large-scale global testing. http://Boldinsight.com/human-factors

Bold Insight to exhibit at Human Factors Excellence for Medical Device Design conference

Bold Insight to exhibit at Human Factors Excellence for Medical Device Design conference

Bold Insight will exhibit at the 4th Annual Human Factors Excellence for Medical Device Design on August 1-2, 2018 in Minneapolis, Minnesota. Bringing together human factors engineering and user experience (UX) professionals, the conference will highlight emerging trends in the field of human factors and usability as it relates to compliance, testing strategies, training, new technologies, and submission requirements. Bold Insight Managing Directors Korey Johnson and Gavin Lew will be on hand to showcase the latest approaches to medical device research.

“Every time I have attended this conference, I have enjoyed discussing extremely relevant topics with my clients and human factors colleagues,” said Johnson. “It’s important for the medical device industry and human factors and UX leaders to have a place to connect and collaborate to advance the safety, efficacy, and efficiency of medical devices. Lately, as digital therapeutics and connected devices become more ubiquitous, we take opportunities like this conference to discuss ecosystem-level considerations and best practices to ensure engaging and satisfying overall experiences as much as safe and effective use of a single component alone.”

Be sure to visit Bold Insight’s booth throughout the conference for special giveaways and lively discussion about the latest research technology, the FDA’s human factors engineering guidance, and the future of digital therapeutics.

 

About Bold Insight

Bold Insight is a UX and human factors research agency. From user research informing early product design to global human factors validation, we specialize in applying human factors engineering to all phases of product development. We have the expertise of a large agency, with the imagination and agility of a startup. Learn more

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