Our

Experience

Find Success With Agilis

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Our clients depend on our more than 15 years of focused experience, our intimate relationship with FDA and other regulatory agencies, and our diverse team that’s always ready to take on any challenge. Every day we assist to successfully navigate the human factors engineering design process.

Agilis Consulting Group was instrumental in helping our company develop and execute a successful human factors testing program that supports the safety claims for our product. They developed and executed the testing program that not only passed FDA scrutiny, but was on time and under budget!

Jill Schweiger, former Vice President Clinical Studies & Regulatory Affairs,
Flowonix Medical, Inc.

Rising to the Challenge and Achieving Positive Outcomes

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Some companies we have worked with include:

Abbott Laboratories Abbott Point of Care Alere
Amgen AstraZeneca Battelle Medical
Bayer Becton Dickinson & Company Celleration
Chattem ConTIPI DEKA
EMD Serono Enable Injections Exact Sciences
Flowonix GluMetrics HeartWare
Home Access Health Coporation Incline Therapeutics Intarcia
Intel Ipsen Johnson & Johnson
Kimberly Clark Medrad Medtronic
Merck Motorola NASA
NPS Pharmaceuticals Roche Sanofi
Sensys Medical Smith & Nephew Tandem Diabetes Care
Tyto Care Ulthera Underwriters Laboratories
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Smooth Sailing to FDA Clearance

The challenge…

An insulin pump manufacturer sought pre-market approval from FDA for two years. Each submission failed to satisfy the FDA’s concerns about deficiencies of the pump design. Our goal was to help the manufacturer achieve clearance by applying our expertise in human factors, user interface testing and risk mitigation in preparation for a 510(k) submission to FDA.

How we did it…

Leveraging our expertise in FDA requirements and regulations, we helped the manufacturer design a comprehensive human factors plan that satisfied the FDA. We shepherded the manufacturer through the human factors protocol, standing by every step of the way to help redesign when it was necessary to mitigate concerns exposed during user interface testing. At the conclusion of the process we assisted in conducting a summative study and generating a human factors report for inclusion in the 510k submission.

The result

Success! The FDA awarded pre-market approval to the pump manufacturer, and the device was cleared in 5 months.

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User Guides that are User Friendly

The challenge…

After the introduction of new FDA human factors regulations, a well-established, multi-national company realized it was not meeting standards for labeling and user guides. Two redesigns of the product user guides by another firm yielded poor results – failed human factors testing, users were unable to understand the user guides, and users had difficulty using the product while referencing the user guides. Our goal was to help the company create user guides that met the FDA human factors guidelines and successfully facilitated correct use of their product by the end users.

How we did it…

We worked with the company’s internal team to redesign the labeling and user guides. We utilized our proprietary, evidence-based methods to create a guide that both met the required human factors standards and also kept with the look and feel of the company’s brand image.

The result

Success! After working with Agilis for less than a month, the company performed a third customer test and the results improved over 90%.

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Growing From Startup to Success

The challenge…

A young, energetic startup team floundered in their attempt to develop a solid human factors plan that met with FDA approval. Our goal was to assist this company with developing a human factors plan that met with FDA guidelines to ultimately achieve FDA clearance.

How we did it…

Agilis provided the company expert FDA regulatory guidance and helped them to create a plan that the FDA accepted. We noticed other areas in which the startup would face hurdles, so we continued to partner with the team. We coached them through human factors testing, labeling and user guide design, and the planning and execution of a summative study.

The result

The startup received FDA clearance for its device in less than 6 months.

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Tailoring to Both Clinical and Home Health Care Users

The challenge…

A device manufacturer with otherwise excellent human factors acumen faced a labeling roadblock in the process toward FDA clearance. The information leaflet for their device that was initially intended for professional medical users and did not work for lay users. The manufacturer recognized the challenge of communicating product and medical information to lay users, as well as the added challenge of doing so for users between the ages of 7-55 years. Our goal was to help the company revise the information leaflet so that it was understood by lay users within the age range of the product users.

How we did it…

Agilis applied our proven evidence-based methods to help the company redesign and test a user friendly Patient Information Leaflet (PIL). The company was initially resistant to our methods, however this quickly faded upon testing of the PIL.

The result

Success! The performance measures showed that 100% of adult users rated the PIL as “effective” to “very effective,” and 95 % of the pediatric population felt that the PIL provided their adult caregiver with all of the information needed to use the device. And of course, the device was cleared by the FDA.

Human Factors Experts

The Agilis process prepares our clients to answer Regulatory’s most fundamental bottom line question: “Show us the body of evidence that provides a compelling, comprehensive and valid case that your device and IFU support safe and accurate user performance.”