human factors for drug-device combination products · of the recently published fda final rule (21...

May 19-20, 2014 • Courtyard Philadelphia Downtown • Philadelphia, PA

Human Factors for Drug-Device

Combination Products

Avoid Costly DelaysHear case studies and recommended practices from Abbvie, Eli Lilly and Company, Genentech, Janssen R&D, Hospira, and PATH on what they are doing to successfully interpret regulatory guidance

Effectively Navigate the Path to ComplianceLeading human factor study directors and practitioners provide regulatory and compliance perspectives, process safety solutions, and best practices to ensure regulatory success

Understand Human Factors Methodologies, Applications and Limitations Participate in 3 panel discussions covering pressing human factors issues in success criteria for formative/summative studies, human factors in clinical trials and CPC’s Response and Working with FDA

Achieve Regulatory Approvals and Maximize User Compliance, Customer Satisfaction and Product Success

Media Partners:

Premier Publication:

Ensure Your Drug-Device Combination Product is FDA Compliant

Hear Updates from Combination Product Coalition on Latest FDA Guidance Report

Keynote Presentation

Human Factors Insights from a Former CDRH RegulatorAnthony D. Watson Director Regulatory Affairs CMC Combination Products, Biogen Idec, and a former Director in the Office of Device Evaluation, CDRH, U.S. FDARead his Q&A Interview on page 7

www.IBCLifeSciences.com/HumanFactors



Understand Regulatory GuidelinesOverlooking the importance of human factors principles in your combination product can lead to increased development costs, delayed market launch, and adverse events. Reduce the risk of user errors and ensure patient safety by learning and networking with engineers, scientists and executives from around the world at the only conference focused on helping you successfully implement human factors engineering in your drug-device combination products.

Meet Regulatory Approvals by Successfully Implementing Human Factors Engineering

Showcase Your Research ➜ Present a PosterIf you have new results/data on topics relevant to this conference, we encourage you to submit a poster abstract for consideration. Any registered conference attendee may register to present a poster. The deadline to submit an abstract online is April 25, 2014. Full payment of conference registration and poster fees must be received by this date for the abstract to be included in the conference materials and a poster board assignment to be made (see the registration page for details on the poster fee). Posters should be PORTRAIT orientation, with maximum dimensions of 36 inches wide (3 feet) x 48 inches high (4 feet). Please note: Poster presentations may not be used as exhibit displays or for marketing purposes, and all posters are subject to approval by conference organizers. Only one poster presentation is allowed per registered attendee/author.

Highlight and Promote Your Company’s Expertise to the Drug-Device IndustryTake advantage of a unique and exclusive networking environment to help foster relationships and drive your business forward. A variety of opportunities are available to help you reach this specialized audience, including:

• Exhibit Space to Showcase your Company Products or Services and Generate Leads• Technology Workshops or Strategic Discussions to Demonstrate

Your Company’s Thought Leadership• Cocktail Reception or Luncheon Sponsorship to Promote

Networking and Brand Your Business• Badge & Lanyards, Tote Bags, or Other Specialty Branding ItemsTo learn more about sponsoring or exhibiting opportunities, contact Jennifer Thebodo at (508) 614-1672 or [email protected]

Bronze Sponsor:

Event Guide Sponsor:

Accelerate Your Drug-Device Product to MarketEnsure that your product meets regulatory compliance and is ready for market launch by hearing comprehensive updates from leading pharma and biotech companies. Don’t miss a must-attend presentation from the Combination Product Coalition on its recommendations to the latest FDA Draft Guidance. Access seven unique sessions that provide you the latest industry, technical and regulatory insights, as well as the chance to participate in panel discussions and networking opportunities with like-minded human factors engineers and professionals.

The FDA requires all drug-device products to properly define the user groups, conduct usability, formative and summative studies to ensure that proper consideration of user-interfaces are built into the device design to reduce risk of user errors and ensure patient safety.

The regulatory path can be challenging for drug-device developers, especially when it comes to interpreting and complying with the various human factors guidance documents from CDRH, CDER, and other centers and offices of the U.S. FDA.

Register Early for Best Savings ■ www.IBCLifeSciences.com/HumanFactors ■ 800-390-4078

7:00 Registration and Coffee

8:00 Chairman’s Opening Remarks Lee Leichter, RAC, MBA, President, P/L Biomedical

Applying and Complying with Regulatory Guidance and Recommended Practices

Keynote Presentation

8:15 Staring in the Mirror: Human Factors Insights from a Former CDRH Regulator A former FDA CDRH Director explains how he instills a combination products culture at Biogen Idec through the lens of human factors. The presenter will discuss how he uses concepts such as risk analyses, design controls, and systems concepts to help guide success for human factors studies.Anthony D. Watson, Director Regulatory Affairs CMC Combination Products, Biogen Idec, and a former Director in the Office of Device Evaluation, CDRH, U.S. FDA

8:45 Combination Product Coalition Response to FDA Requirements and Interactions on Drug Delivery Product Submission The CPC has developed, and provided to FDA, a document suggesting interpretations, positions and suggested guidance regarding the requirements, timing and interactions with the FDA on Drug Delivery Product submission. This was developed based on experiences shared by member companies. This presentation will summarize those areas that identified as needing improvement, change and/or consistency.Michael Gross, Ph.D., RAC, Principal Consultant, Chimera Consulting North America LLCDaniel G. Gottlieb, Attorney, Epstein, Becker and Green, and Representative for the Combination Products Coalition

9:15 Usability Testing of Drug Delivery Devices: What the Guidance Doesn’t Tell YouCurrent guidance on human factors testing of medical devices only goes so far, and provides limited detail of how to apply it to drug delivery devices. This presentation takes a practitioner’s viewpoint and discusses the key practical aspects of designing and running such studies. The presenter will also share his top tips for drug delivery human factors testing.Richard Featherstone, Human Factors Director, Medical Device Usability Ltd.

9:45 Panel Discussion CPC’s Response and Working with FDAModerator:Lee Leichter, RAC, MBA, President, P/L BiomedicalPanelists:Douglass Mead, Director of Regulatory Affairs-CMC, Medical Devices and Combination Products, Janssen Research & Development, LLCMichael Gross, Ph.D., RAC, Principal Consultant, Chimera Consulting North America LLCDaniel G. Gottlieb, Attorney, Epstein, Becker and Green, and Representative for the Combination Products CoalitionAnthony D. Watson, Director Regulatory Affairs CMC Combination Products, Biogen Idec, and a former Director in the Office of Device Evaluation, CDRH, U.S. FDA

10:15 Networking Refreshment Break in Poster and Exhibit Hall

Featured Presentation 10:45 Basics of Human Factors Engineering for

Drug Delivery Products This presentation will be a short introduction on the requirements and elements of a human factors program for drug delivery devices.Lee Leichter, RAC, MBA, President, P/L Biomedical

Human Factors and Design Controls 11:15 Combination Product User Testing and Human

Subjects ProtectionsThis presentation will describe Institutional Review Board (IRB) and human subject protections for combination product usability testing. It can be difficult to understand when regulations (typically associated with clinical trials) are relevant to human factors (HF) usability studies. Interpretation and application of the regulations can vary by organizational policy and IRB. The objective of this presentation is to help sponsors and HF investigators understand when Food and Drug Administration (FDA) and/or Department of Health and Human Services (DHHS) regulations require IRB review and approval prior to the start of a usability study. We will describe the relevant sections of the Code of Federal Regulations (CFR), identify resources, and offer suggestions for investigators and sponsors to better facilitate the IRB review process when it is appropriate. Rosalee Meyer, Ph.D., Cognitive Psychologist and Principal Investigator, Human Centric Design Group, Battelle

11:45 Integrating Human Factors Engineering into Design Controls for Combination ProductsCorrectly defining, integrating and documenting the scope and timing of HFE activities are fundamental to risk management, regulatory compliance, customer satisfaction and liability control. This presentation will illustrate the human factors engineering implications and opportunities of the recently published FDA final rule (21 CFR Part 4) on current good manufacturing practice (CGMP) requirements applicable to combination products. In particular, it will provide a roadmap for how best to define, integrate and document HFE methodologies throughout the required Design Controls (21 CFR 820.30) activities.Adam R. Shames, Founder & CEO, Core Human Factors, Inc.

12:15 Networking Luncheon in Poster and Exhibit Hall

1:25 Chairman’s RemarksLee Leichter, RAC, MBA, President, P/L Biomedical

1:30 Developing an ISO Standard for Drug Delivery Devices Appropriate for Patients with Visual ImpairmentThis talk will address the process by which an ISO standard is developed, as well as the philosophical approach used throughout the 11608 series of standards for “Needle-based Injection Systems for Medical Use,” of which this standard on “accessibility for persons with visual impairment” will be a part. Finally, it will share the breadth of expertise in the stakeholders involved, including regulators with Human Factors expertise, a renowned researcher focused on accessibility for persons with visual impairment, and a patient with visual impairment.Robert R. Nesbitt, CMfgE, Director, Advanced Development and Research, Delivery Device Research & Development (DDR&D), Eli Lilly and Company

Summative/Formative Study Strategies and Other Considerations

2:00 Scaling of Human Factors Engineering Efforts for Combination Products To help ensure the development of safe and effective combination products, the scale of human factors engineering (HFE) efforts should be based on the nature of the product and its intended context of use. This presentation will discuss methods by which appropriate HFE scaling decisions can be made in accordance with consensus standards, FDA guidance, and industry best practices.James Robert Kershner, MSc., Consultant Engineer, Human Factors/ Risk Management, Delivery Device R&D, Eli Lilly and Company

2:30 What You Don't Have to Do with Formative StudiesTackling human factors, as a regulatory requirement, is relatively new for pharmaceutical companies, so there is an understandable tendency to apply to human factors studies the logic of clinical trials, with which pharmaceutical companies have vast experience. However, this results in a great deal of unnecessary work, which translates into unnecessary time and cost—particularly for formative studies. The question, then, is: “What is necessary and appropriate in conducting formative studies?”, or, put another way: “What is not necessary and appropriate for formative human factors studies?”Steve Wilcox, Ph.D., Principle, Design Science

Monday, May 19, 2014 Employing Effective Human Factors Studies for Drug-Device Combination Products

Did You Know?53 Unique Companies from 6 Different Countries Attended Last Year’s Event


3:00 Panel Discussion: Success Criteria for Summative Studies• What tasks should be studied and validated during formative work? • Is there a reasonable success criteria for summative studies?• Is true patient risk as a success criteria for validations still the goal? • Should untrained user always be required in summative user validation studies?Moderator: Lee Leichter, RAC, MBA, President, P/L Biomedical Panelists: Ella Cozmi, Director, Human Factors Engineering, Hospira Richard Featherstone, Human Factors Director, Medical Device Usability Ltd.Edmond Israelski, Ph.D., CHFP, Director of Human Factors, AbbvieJames Robert Kershner, MSc., Consultant Engineer, Human Factors/ Risk Management, Delivery Device R&D, Eli Lilly and CompanyPeter Krulevitch, Ph.D., Engineering Director and Fellow, Janssen R&DSean Phillips, Founder, Rocket Strategic DesignMichael E. Wiklund, General Manager – Human Factors Engineering Life & Health, UL LLC, Wiklund R&DSteve Wilcox, Ph.D., Principle, Design Science


Summative/Formative Strategies and Other Considerations

4:00 Establishing In-Vitro Equivalence of Device Changes Made Throughout Development to Commercial for Nasal DeliveryAs development progresses, the device (in drug-device combination systems) used in early to late clinical studies undergoes refinements and a number of changes may occur as commercialization nears. Often, these changes and the effects are poorly evaluated and characterized. It is very important that these changes are fully evaluated with respect to performance of the device and the delivery of the drug to demonstrate equivalency. Equivalence may be established by in vitro means or by in vivo means depending on the dosage form and the mode of delivery and the type of drug. Opportunities to avoid costly in vivo human studies will be discussed.Gopi Vudathala, Ph.D., Regulatory and Quality, XCell Pharma Consulting LLC

4:30 Harmonizing Populations and Platforms Across Multiple DrugsThis presentation explore strategies and recommendations for cost and sample size reductions.Valerie Fenster, Senior Manager, Human Factors Engineering, Amgen

5:00 Panel Discussion Sponsored by:

Human Factor Studies and Clinical Trials• Real use studies – Human factors of studies or device robustness studies• Requirement for HF Studies before and after human clinical use• Is it possible to capture valid human factors data during a non-observed

clinical study?

Moderator: Lee Leichter, RAC, MBA, President, P/L Biomedical

Panelists:Valerie Fenster, Senior Manager, Human Factors Engineering, AmgenSuresh Gupta, Senior Consultant, Medical Technology Division, Cambridge ConsultantsGene Saxon, Program Officer, PATHGopi Vudathala, Ph.D., Regulatory and Quality, XCell Pharma Consulting LLCMichael E. Wiklund, General Manager – Human Factors Engineering Life & Health, UL LLC, Wiklund R&D

5:30 Close of Day One

7:30 Registration and Coffee

8:10 Chairman’s Opening Remarks Lee Leichter, RAC, MBA, President, P/L Biomedical

Scope and Timing of HF in Product Development

8:15 Use of Human Factors Studies to Justify Delivery Device Performance SpecificationsRegulators are often asking for performance specifications and acceptance criteria for delivery devices. For many properties, such as pre-filled syringe piston travel and break loose forces, or delivery device actuation forces, human factors studies can help to establish a justification of these specifications that is often required in eCDT Module 3.2.P.5.6. Examples of when human factors studies can be used to establish design inputs and acceptance criteria during the development process will be presented.Douglass Mead, Director Regulatory Affairs-CMC, Medical Devices and Combination Products, Janssen Research & Development, LLC

8:45 The Role of Human Factors in Developing Products for Low-Resource SettingsPATH envisions a world where innovation ensures a world where health is within reach for everyone. User centered design plays a central role in the realization of PATH’s vision. This talk highlights some of our experiences combining human factors evaluations with clinical studies, and the critical importance of eliciting and validating appropriate requirements throughout the design realization process.Gene Saxon, Technical Officer / Product Development Engineer, PATH

9:15 Leveraging of Human Factors to Architect the Ideal Use ExperienceHF practitioners are frequently asked to analyze and test existing design concepts, labeling and training materials. From a more strategic perspective, HF practitioners can use many of the same tools to prescriptively envision the ideal use experience. By understanding how target participants choose, learn, use, and dispose of analogous products, manufacturers can leverage contextually based findings to architect the use experience, as well as to draft, very early in the process, critical to success hazards and AFMEA documents. With the goal of utilizing scarce and costly resources more efficiently and effectively, this talk will present frameworks, methods and deliverables to help teams to lay the groundwork for successful program chartering, product development, and market launch.Sean Phillips, Founder, Rocket Strategic Design

9:45 Human Factors for Connected Health DevicesWhen a mobile medical app becomes part of a combination product, we are not only looking at a mobile application transformed into a regulated medical product, but also an intimate pairing of drug effectiveness and user experience. This complex and dynamic interaction necessitates that mobile usability embrace safety and efficacy in order to truly create the “patient experience.” This presentation includes our experiences in “connected health” to exemplify this new dynamic.Ashley Russell, MS, Senior Human Factors Engineer, Cambridge Consultants


Tuesday, May 20, 2014 Integration of HF into Product Development

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Human Factors Engineering Programs

11:30 Mining Post Market Human Factors Data: The Untapped Resource of Use Risk AssessmentUsability studies really begin when a product is marketed. However, obtaining useful post-market data can be expensive and time consuming. How can we go from MAUDE, AERS, and call-center complaint narratives to user-device interaction risk assessment and product improvement opportunities? This presentation will explore some recent methods in using systems query language methods to isolate human factors problems in post-market databases with recent case study examples..Robert North, Ph.D., Chief Scientist, Human Centered Strategies

12:00 Statistical Justification for Human Factors Studies: When is it Needed?This presentation will offer pros and cons for using quantitative methods and analyses for a variety of human factors process steps including user needs statements; conjoint analyses of feature desirability and feature utility; product requirements and their parameters; use error-focused risk analysis, including FMEA’s and FTA’s usability objectives or quantified usability goals; validation acceptance criteria such as AQL or RQL; statistically-powered sample sizes for comparing design alternatives in formative usability testing and the use of inferential statistics; and psychometric rating scales such as Likert scales, SUS, magnitude estimation, semantic differential scales, visual analog scales. Each area will be presented with examples that will illustrate the strengths and weakness of qualitative versus quantitative approaches.Edmond Israelski, Ph.D., CHFP, Director of Human Factors, Abbvie

12:30 Networking Luncheon in Poster and Exhibit Hall

1:40 Chairperson’s RemarksLee Leichter, RAC, MBA, President, P/L Biomedical

Case Studies: Integrating HF Studies Into Development Programs

1:45 Human Factors Testing and Design Evolution of a New Self-Injection DeviceSelfDose™ is a simple, manual device for self-injection of biologic drugs. Developed in a collaboration between Janssen and West Pharmaceutical Services, SelfDose™ was designed to meet the needs of patients, as well as reduce risk and complexity for pharmaceutical companies. This presentation covers the human factors studies that were conducted and the corresponding evolution of the device design to ensure proper function and mitigate use errors.Peter Krulevitch, Ph.D., Engineering Director and Fellow, Janssen R&D

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2:15 A Legacy Product Case Study: Demonstrating the Usability of a 510k-Cleared Nebulizer to Safely Administer PulmozymeGenentech manufactures and distributes Pulmozyme inhalation solution, a drug used in the management of cystic fibrosis. Recently, a development program began to add a third-party’s 510k cleared nebulizer to the list of approved nebulizers to administer the drug. One of the challenges in this program was establishing an appropriately scoped human factors program. As the sponsor, there is a desire to demonstrate that users can deliver pulmozyme safely. However, since the nebulizer is approved and distributed by a third party, there are limited choices for improving usability and use-safety of this device for our patients. This presentation will review the human factors program for this product as well as some of the challenges faced during development.Sherri Biondi, Associate Director, Genentech Inc.

2:45 Driving Adherence Through Human-Centered Device Design: Tools and Approaches to Uncover People’s Latent and Unmet NeedsThis presentation explores insights that inspire thoughtful design, with topics including:• How might we craft treatment experiences that fit seamlessly into people’s lives?• How might we make patients feel in control of some aspects of their treatment?• How might we strengthen patient-caregiver relationships through device design?This presentation explores insights that inspire thoughtful device design.Lucie Richter, Design Research & Strategy, Lucie Richter Consulting


4:00 Human Factors of Multisensory LearningThis presentation focuses on the use of multisensory learning for drug delivery training devices. By embedding multisensory learning technologies into a training device, the patient becomes quickly proficient in the use of the device, even if the device is not used for an extended period of time. Moreover, sensors can detect user errors to enhance the learning experience and improve safety. Embedded software offers error notification and correction, and helps prevent the error in the future. This presentation explains how multisensory training devices improve cognitive processing, retention in memory, and ease of retrieval relative to written instructions, videos, or quick reference cards.Paul van der Pol, Director, Research and Development, Noble, Inc.

4:30 Common Root Causes of Use ErrorsUsability testing enables manufacturers to determine whether a combination product is vulnerable to potentially harmful use errors. Data from thousands of test sessions suggest that many use errors involving combination products have a relatively small set of common, root causes. This presentation will discuss common root causes that impede a user’s ability to interact with the product safely and effectively. Maureen Mulcare, Managing Human Factors Specialist, Human Factors Engineering, UL (Underwriters Laboratories)

5:00 Close of Human Factors for Drug-Device Combination Products


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May 19-20, 2014 • Courtyard Philadelphia Downtown • Philadelphia, PA



Get the Latest Updates on Human Factors Engineering for Drug Delivery Productsn Avoid Costly Errors – Discover How to Integrate Human Factors Studies Into

Your Development Programs

n Achieve Compliant Human Factors Engineering – Learn About the Recent FDA Guidance Requests Regarding Human Factors

n Ensure Proper Device Function - Hear What Human Factors Studies Were Conducted for a New Self-Injection Device

n Understand Regulatory Expectations for Applying Human Factors Engineering

The ONLY Forum Dedicated to Establishing Effective HF Engineering and Achieving Compliance for

Drug-Device Combination Products

“All user errors/failures are not of equal importance and sometimes the 5% in error is far more telling than the 95%

that used the device perfectly.”QuynhNhu Nguyen, Lieutenant, US PHS, Biomedical Engineer/Combination Products

Human Factors Specialist, CDRH/FDA


Human Factors for Drug-Device Combination ProductsMay 19-20, 2014 • Courtyard Philadelphia Downtown • Philadelphia, PA

What is the most common mistake that drug-device product developers make during human factors testing?AW: There are probably two common mistakes. The first mistake is not conducting a thorough risk analysis and therefore missing important tasks that need to be tested during the study. The second mistake is failing to assess mitigations after implementing those mitigations. If a use error occurs that results in a mitigation, the sponsor needs to assess the effectiveness of that mitigation or provide a reasonable justification for not conducting the reassessment.

What is the biggest challenge to scaling a human factors program? AW: I believe the biggest challenge is finding the people with the applicable skillsets and then balancing their talents in your organization. For example, one member of your staff might be skilled at writing protocols whereas another member might be very talented at performing risk analyses. Other skill areas that people might highlight are: task analysis, simulation, study oversight, data analysis, and report-writing. During interviews, people tend to focus on whether or not the candidates have some HF experience. Of course this is appropriate. However, the specific skills should be actively assessed in the interview process as well. One additional consideration is that a HF group should be appropriately sized for the extent of combination product and medical device involvement of the company.

What advice can you offer for small drug-device companies who are beginning to incorporate human factors programs into their development efforts? AW: Start with good consultants who can provide evidence or examples of successful FDA interactions and understanding of global human factors requirements. Learn from the interactions so you can start thinking about your own human factors program. I recommend that you look to make your first hire someone who can lead a group of human factors experts. He or she does not have to be a HF expert but should understand the principles of HF well enough to ask critical questions during hiring or when interacting with consultants. Depending upon the size of your ambitions, this might be as far as you need to go. After successfully choosing your first person, try to remember that staying on top of human factors is a full-time job. Try your best to have a devoted person to human factors.

Exclusive Q&A Interview with IBC Life Sciences and Keynote Speaker Anthony Watson of Biogen Idec


human factors for drug-device combination products · of the recently published fda final rule (21...

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