News
Handbook on design available in 2009
July 21, 2008
Handbook of Human Factors
in Medical Device Design (CRC Press)
Edited by Matthew Weinger, Michael Wiklund,
and Daryle Gardner-Bonneau
Promoting the user-centric design of safe, effective, and usable medical devices, Handbook of Medical Devices Interface Design offers up-to-date information on general and specific design guidelines, each numbered and organized sequentially. A comprehensive guide, this book provides advice on fundamental topics, general human factors principles as well as the design of specific interface elements, specific types of devices, and devices for particular use environments. It includes expanded discussions of design issues, product design case studies, and supporting examples, tables, figures, illustrations. The text contains cross references that make finding information quick and easy.
Wiklund R&D's Michael Wiklund served as one of three handbook editors as well as a contributing author. He wrote the chapters on workstation design and software user interface design, co-wrote the chapter on general design principles with Matthew Weinger (Vanderbilt University), and co-wrote the chapter on mobility with Richard Stein (St. Jude Medical).
FDA’s Human Factors Team Leader Joins Wiklund R&D
July 15, 2008
Wiklund Research & Design is pleased to announce that Peter Carstensen has joined our consulting team.
Peter recently concluded a three-decade tenure with the U.S. Food & Drug Administration where he founded and led the agency’s human factors engineering team within the Center for Devices and Radiological Health.
While at FDA, Peter participated in numerous product design reviews, drove the development of multiple human factors standards and guidance documents, and advised domestic and international medical device manufacturers on how to incorporate human factors into their design processes en route to establishing a quality system.
Peter has served for years as convener of the International Electrotechnical Commission’s human factors engineering committee responsible for developing IEC 62366:2008, titled Medical Devices – Application of Usability Engineering to Medical Devices. He has also served on the Association for the Advancement of Medical Instrumentation’s human factors engineering committee that is presently developing an encyclopedic set of user interface design guidelines for medical devices (AAMI HE75-200X).
Peter’s multi-faceted role at WR&D will include helping medical technology developers fulfill U.S. and international regulatory requirements pertaining to human factors, prepare an appropriate design history file, and respond effectively to regulatory actions. He will also contribute to interface design evaluations and human factors program planning efforts.
Please contact us if you think Peter can help your organization meet its product safety and usability objectives, particularly as they pertain to regulatory reviews and approvals. Email: info@wiklundrd.com, Telephone: 978.371.2700.
Services:
- Help medical device manufacturers respond effectively to the FDA’s human factors related comments on 510k and PMA submittals.
- Assess the adequacy of manufacturers’ human factors program plans with regard to Quality System/Design Control Regulation and FDA-recognized standards.
- Management workshops on (1) human factors engineering approaches geared toward ensuring medical device safety, (2) working effectively with regulatory bodies, and (3) dealing effectively with adverse events involving human factors shortcomings in medical devices.
New office space
March 31, 2008
In March 2008, Wiklund Research & Design moved into a larger office space in the same studio-filled warehouse that has served as our company headquarters for the past three years.
Our new space has the same industrial style as the old one, including a ceiling of exposed beams and pipes. It gives us the room we have sought to grow the business and meet demand.
Book: Anesthesia Informatics
February 12, 2008
Michael Wiklund and Jonathan Kendler have contribute a chapter titled “Ensuring Usability” to Anesthesia Informatics, edited by Jerry Stonemetz and Keith Ruskin and pending publication by Springer. The chapter discusses the desirable human factors characteristics of anesthesia recordkeeping software applications, linking them to improved clinician efficiency and satisfaction.
Book description (from Amazon.com): “The ability to interface patient monitors directly to a computer, and generate a clinical record has existed for over 20 years. However, the acceptance of comprehensive electronic medical records in anesthesia has been slow to develop. Experts anticipate this reluctance is changing because of enhanced patient care through the use of detailed health information record systems. Anesthesia Informatics provides the health informatician and administrator with a comprehensive overview of this blossoming technology. With contributions from leaders in the field, this user friendly guide addresses how this technology has enhanced both the need for and the ability to collect and apply data in an acute care setting. It also offers invaluable insight on the business implications and the rationales required to make a purchase decision. Each section outlines need to know information to help the reader with the implementation and utilization of an Anesthesia Electronic Medical Record System. Useful case scenarios focus on the ideal components (anesthesia record, business rationale, communication, collaboration, and training) of a fully automated record keeping system.”
The book should be available by Summer 2008.
Product review for ID Magazine
January 8, 2008
International Design (ID) Magazine’s January/February 2008 issue includes Michael Wiklund’s latest product review, this time focusing on the Lifebridge B2T heart lung machine developed in Germany. In his review, Wiklund admires the 39-pound, $30,000 device’s portability and future potential to save lives at crime scenes, car accident sites, and gymnasiums, as well as enable patients receiving circulatory support to be transported within and between hospitals.
Article: Refined Touchpoints Drive Quality Perceptions
November 13, 2008
In the November 2007 issue of MD&DI magazine, WR&D’s Michael Wiklund discusses how refined touchpoints, such as control mechanisms, drive customers’ perceptions of product quality.
Wiklund writes, “Certainly the most important thing for a medical device is to perform its function properly. Ventilators have to pump gas into and out of a patient’s airway reliably. Patient monitors must receive signals from sensors with minimal artifacts. Endoscopes need to articulate and provide a clear image of the stomach lining. But these capabilities are givens in an industry in which devices require regulatory approval based on efficacy, even though they might require remarkable engineering efforts. So, adopting a human factors engineering mindset, let’s move on to the subject of making the interactive experience something special. We will approach this topic by way of the local appliance store.
Consider how the typical consumer shops for a kitchen appliance, such as an oven range. Of course, the consumer will ask the salesperson about the range’s fundamental capabilities, such as convective baking and self-cleaning. However, the customer will also judge the range’s look and feel by opening and closing the oven door, sliding the racks, and turning its burner controls. In performing these actions, the customer is essentially testing the product’s quality via the available information channels—eyes, ears, and hands. The consumer will assess several aspects. Does the oven door open and close smoothly, or in a jerky manner? Do the racks glide precisely while making a pleasing sound, or do they rack in their tracks and emit a metallic screech? Do the controls feel nice and turn precisely, or feel wobbly and plasticky? Depending on the quality of a selected range’s touchpoints, the consumer will make telling comments, such as “that’s awful” versus “I really like this one.” The effect on sales is obvious—people buy the range with a pleasing feel—the one with better touchpoints, consciously or unconsciously associating fine tactile and aural qualities with fine overall quality.
What bearing does such consumer behavior have on the design of medical devices, including capital equipment and disposables? Some clinicians report that they are insulated from buying decisions—that such decisions are made at a higher level, driven primarily by economic considerations and habit. However, a greater proportion of clinicians report having considerable influence on device selection, citing among their powers the ability to reject trial devices that “just do not work in their unit.” Therefore, a manufacturer’s efforts to produce devices with refined touchpoints should pay off, giving users a positive overall impression of their device initially and generating satisfaction over the long haul.”
The full text of the article is available online at Medical Device and Diagnostics Industry's Website
Wiklund leads product design panel
July 6, 2007
Michael Wiklund chaired a discussion panel at Living Rooms, a collaborative conference for industrial designers and human factors specialists that focused on home healthcare product design. The conference, which was co-sponsored by the Human Factors and Ergonomics Society and the Industrial Designers Society of America, was held in Washington DC on May 1-2.
Drawing on case studies, Wiklund and the participating panelists advocated close collaboration between human factors and industrial design specialists as a means to achieve breakthroughs in the design of safe and effective medical devices for the home. They recalled earlier days when the disciplines had less interaction and how the lack of communication served only to compromise design quality. Noting the accelerating convergence in the work of HF and ID specialists, the panelists recommended ways to ensure smooth collaboration on various types of projects and avoid turf battles.
Michael Wiklund presents keynote address at the 30th Canadian Medical and Biological Engineering Conference: Improving Medical Device Usability
July 2, 2007
Michael Wiklund presented the keynote address at the 30th Canadian Medical and Biological Engineering Conference: Improving Medical Device Usability (June 16-19, 2007, Toronto, Canada).
The conference was advertised as the premier event for biomedical engineering professionals in Canada. It focused on current research activities associated with improving the use-safety and usability of increasingly complex medical devices.
In his address, Mr. Wiklund shared lessons learned from his 20+ years of experience helping medical device manufacturers improve the usability and safety of their devices. He suggested that the medical industry had crossed the tipping point - referencing Malcolm Gladwell's best seller The Tipping Point - in terms of integrating human factors practices into the overall device development process. He attributed the progress to manufacturer's increased interest in device usability as a route toward commercial success, regulators' enforcement actions (e.g., embargoes, seizures, and recalls), and the release of IEC 60601-1-6, titled Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - collateral standard: usability.
The Art of Screen Design (2-Part Article)
April 12, 2007
In the March and April 2007 issues of MD&DI magazine, WR&D's Michael Wiklund and Jonathan Kendler explain how to make a software user interface visually appealing while remaining appropriate to its uses and use environment (See Part 1, Part 2). They also discuss how software user interfaces can be styled to reinforce a company's brand identity, describe a development process that allows for stylistic exploration and innovation, and provide advice on how to select a visual designer.
The authors state, "In the medical device domain, an embedded software application's visual appeal is subordinate to its safety, functionality, and usability. Nonetheless, screen aesthetics play an important role in how people react to a device. Refined looking screens can have a halo effect on quality perceptions, while primitive-looking screens can detract from the perception of quality. Therefore, device manufacturers usually have good cause to invest in software aesthetics (i.e., visual styling)."
The authors go on to state, "Undeniably, people prefer pleasing visuals to those that look disheveled, chaotic, or messy. Therefore, medical device sales can ride on software appearance if the end-users, and not just the budget managers, are involved in the decision to invest in appearance. Ideally a company that invests in screen aesthetics will have already taken steps to ensure that its software applications are functional, effective, and usable, thereby reflecting a total commitment to quality."
Wiklund to lead product design panel
April 11, 2007
Michael Wiklund will chair a discussion panel at Living Rooms, a collaborative conference for industrial designers and human factors specialists that will focus on home healthcare product design. The conference will be held in Washington DC on May 1-2.
Wiklund serves on MDEA jury
February 22, 2007
Michael Wiklund served on the jury of the 2007 Medical Design Excellence Awards competition (MDEA), run by Canon Communications, publisher of Medical Device & Diagnostic Industry (MD&DI). Now in its tenth year, the MDEA program is the premier competition for the medical technology community. An MDEA recognizes design achievements as well as the healthcare contributions of medical product manufacturers.
MDEA gold and silver awards will be formally presented during the Medical Design & Manufacturing East 2007 Conference and Exposition, in New York City on June 13, 2007. The winning products will be described in detail in the April issue of MD&DI.
In the photo to the right, Michael Wiklund shares the task of evaluating medical devices intended for use in hospitals with colleagues Ed Israelski (human factors program manager at Abbott Laboratories) and William Schneeberger (cardiothoracic surgeon at the University of Cincinnati Medical Center).
Wiklund Contributes to Book on Medical Device Accessibility and Usability
February 2, 2007
A new book titled Medical Instrumentation - Accessibility and Usability Considerations is now available through CRC Press. The edited volume includes a chapter written by WR&D's Michael Wiklund, titled Human Factors Standards for Medical Devices Promote Accessibility.
CRC Press states: ".the book first addresses the nature and extent of the problem by identifying access barriers, human factors, and policy issues focused on the existing infrastructure. The subsequent sections examine responses to the problem, beginning with tools for usability and accessibility analysis and principles of design for medical instrumentation. Building on this foundation, the third section focuses on recommendations for design guidelines while the fourth section explores emerging trends and future technologies for improving medical device usability. The final section outlines key challenges, knowledge gaps, and recommendations from accomplished experts in the field presented at the recent Workshop on Accessible Interfaces for Medical Instrumentation."
Visit CRC Press' website for more information.
Allison Yale quoted in Popular Mechanics
November 8, 2006
Popular Mechanics recently interviewed Allison Yale for "Inventing the Future," an article highlighting innovative science and engineering college programs. As a graduate of the Tufts University Human Factors program, Allison described the discipline as the "people person's engineering," referring to the program's focus on user-centered design. The article summarizes the unique, inter-disciplinary program and describes the field's rapid expansion into both the medical and technology industries.
Time Magazine names Moobella ice cream machine as one of the Best Inventions of 2006
November 8, 2006
Time has declared MooBella "The Mix Master," citing the manufacturer's automated ice cream making machines as one of the Best Inventions of 2006. Wiklund Research & Design designed the machine's user interface, which asks the walk-up customer to choose an ice cream flavor, mix-in, and ice cream grade, then produces the customized scoop from scratch within 30 seconds.
Time's citation states: "Most commercial ice cream machines dispense pre-frozen desserts. The MooBella makes its treats on the spot, storing milk, sugar and other natural ingredients in sterile, airtight containers (think Parmalat). Key in an order--your choice of flavor, premium or light--and it mixes, flash-freezes, aerates, then serves fresh ice cream, all in about 45 seconds. How does it taste? Our tester gave the coffee with M&M's (mix-ins are optional) an enthusiastic thumbs up, mumbling "excellent" and "really, really fresh" between mouthfuls."
Addressing Women's Needs in Surgical Instrument Design
November 4, 2006
In the November 2006 issue of MD&DI magazine, WR&D's Michael Wiklund and two co-authors (Jim Rudnick, and Jessica Liberatore of Ethicon, Inc.) address the topic of designing anthropometrically-suitable tools for female surgeons. They observe that as the number of women surgeons continues to rise, device manufacturers need to consider different design strategies to accommodate the requirements of this group of end-users. The authors state, "To date, women have had to cope with instruments designed for hands that are, in most cases, larger and stronger than theirs."
The article quotes Susan John, MD, a gynecologist practicing at Legacy Portland Hospitals (Portland, OR, who feels that women are frequently forced to make adjustments to ill-fitting instruments. She states, "Most surgical devices are designed with men in mind, which places women at a disadvantage," suggesting that women with small hands might opt out of a career in surgery because the tools of the trade were developed for larger hands.
The authors conclude, "Manufacturers should remember that half of the new doctors in the United States will be women in the not-too-distant future. In response, they must design products that will accommodate both ends of the user hand-size spectrum."
The full text of the article is available online at http://www.devicelink.com/mddi/archive/06/11/008.html
Michael Wiklund invited to present the keynote address at the 30th Canadian Medical and Biological Engineering Conference: Improving Medical Device Usability
September 13, 2006
Michael Wiklund has been invited to present the keynote address at the 30th Canadian Medical and Biological Engineering Conference: Improving Medical Device Usability (June 16-19, 2007, Toronto, Canada).
"The 30th Canadian Medical and Biological Engineering Conference (CMBEC30) will be the premier event for biomedical engineering professionals in Canada. It will offer a national forum for information exchange among researchers and practitioners working in biomedical engineering. The theme is 'Improving Medical Device Usability'. One of the main objectives of this conference is to improve communication and encourage collaboration among all healthcare professionals through the presentation and discussion of new research and current challenges" The plenary session will focus on current research activities relating to improving ease of use of increasingly complex devices, and the impact on patient safety of poorly designed medical devices." Reference: http://www.ficdat.ca/
In his keynote address, Mr. Wiklund's will share lessons learned from his 20+ years of experience helping medical device manufacturers improve the usability and safety of their devices. He will stress the importance of early and continued end-user involvement in the design process, discuss the impact of recently enacted regulations on the practice of medical device user interface design, and project the rate of return in an investment in usability.
Defining and Designing for Worst-Case Users
August 22, 2006
In the July 2006 issue of MD&DI magazine, WR&D's Michael Wiklund states "Although a medical device must tolerate electrical surges and fluid spills, it must also withstand the actions and inactions of unprepared, unfit, or impaired users. Disconcertingly, such users can be found in nearly every hospital job. An inexperienced technician who is a week removed from his previous job in an unrelated field would be one example of such a user. A 20-year veteran physician who has worked a particularly long day and lost the ability to concentrate would be another. Or such a user could be a layperson with multiple physical and mental impairments. Such individuals might unintentionally forget procedural steps, overlook critical indications, transpose numbers as they input settings, or press the wrong buttons. The consequences of these and other kinds of use error depend on the device's user-interface design characteristics and related safety features."
Wiklund lists the following user shortcomings as factors to consider in user interface design.
- Fatigue
- Lack of operational knowledge
- Divided attention
- Absentmindedness
- Physical and cognitive impairment
- Limited language and literacy skills
- Negative transfer of experience
He concludes, "Defining possible user shortcomings is the first step toward protecting against device errors that can cause patient injury and death, as well as property damage. The second step is to apply established human factors principles to accommodate user limitations and guard against use error. The third step is to provide a means for users to detect and recover from use errors. Following this approach, developers should be able to limit the number of adverse events related to use error."
The full text of the article is available online at http://www.devicelink.com/mddi/archive/06/07/012.html
Wiklund critiques modern office chair in June 2006 Issue of ID Magazine
July 7, 2006
In the June 2006 issue of ID magazine, WR&D's Michael Wiklund critiques the Vitra Headline task chair, designed by Italy's renowned Mario Bellini and his son Claudio. He advises readers that the Headline looks far better than it feels, noting that the chair's seat is excessively firm and lumbar support practically jams you in the back. On the positive side, he finds the chair has great upholstery that promises to keep you back and buttocks cool. The chair retails for $1730 (with armrests). Read the entire review titled "Lean On Me: Vitra's Latest Task Chair May be Better for the Brain Than the Body" at http://www.idonline.com/features/feature.asp?id=1550
Roundtable on Developing User Requirements for Global Products
March 28, 2006
The February 2006 issue of MD&DI magazine, WR&D's Michael Wiklund leads a "roundtable" discussion with other design experts on the demands that come with more globalization. The discussion highlights the importance of extending user research efforts to foreign markets where customers might have substantially different product needs and preferences than domestic customers. The discussion elucidates strategies for conducting the research on a limited budget and tight schedule. In the article, Michael cautions, "...you can get a black eye by spending too much time and money conducting international research. To outsiders, it looks like you've been on an all-expense-paid international junket while others slog it out back home." He goes on to emphasize the importance of conducting a properly scaled international research effort, which can lead to a breakthrough design solution. The full text of the article is available online at http://www.devicelink.com/mddi/archive/06/02/004.html.
Wiklund and Weinger Developing Workshop for Medical Industry's Global Harmonization Task Force 2006 Conference
December 23, 2005
Michael Wiklund is working closely with WR&D affiliate Dr. Matthew Weinger, a patient safety expert who practices anesthesia and teaches at Vanderbilt Medical School, to develop a human factors workshop for patient safety professionals. The workshop, which will cover the user-centered design process and usability testing, will be presented first at the Global Harmonization Task Force 2006 Conference, scheduled to take place in Lübeck, Germany in late June, 2006.
Dräger, an anesthesia delivery equipment manufacturer that is hosting the GHTF's 10th annual meeting, expects the event to draw upwards of 300 people. The conference theme is designing for patient safety in the context of a global regulatory model.
We have a main office and a nice size lab space in which we can conduct a wide range of user research activities.
Wiklund Research & Design has moved into new office space.err.relocated its world headquarters!
September 12, 2005
Our office building, which is situated on Nashoba Brook in West Concord Village, used to be a woolen mill. Today, it houses the Nashoba Brook Bakery and Café on the 1st floor and several creative enterprises on the 2nd floor. Our neighbors include architects, photographers, advertising designers, and artists.
We have a main office and a nice size lab space in which we can conduct a wide range of user research activities.
Michael Wiklund quoted in "The Silver Sheet"
August 11, 2005
Michael Wiklund's views on human factors in medical device development were cited extensively in "The Silver Sheet," a newsletter focused on medical device quality control (download the July 2005 issue - Volume 9, Number 7 - at http://www.thesilversheet.com/FDC/Monthly/silver/TOC.htm). In the article, titled FDA Focuses on Human Factors to Help Minimize Device Recalls, Michael is quoted to say, Generally speaking, in large corporations, the human factors effort is still very modest at best.[but] Companies know they absolutely have to [implement a human factors program]. The comprehensive article concludes with the final comment by Wiklund: "Human factors engineering is quite justified from a business case point of view. When you think about the folks who have experienced product liability claims and a big payout, I'm sure they'd like to retrospectively go back [and] make the investment in human factors."
Article: Return on Human Factors Investment
August 11, 2005
Michael Wiklund's latest article in Medical Device & Diagnostic Industry is available online at http://www.devicelink.com/mddi/archive/05/08/021.html. In the article, Michael asserts that while the cost of human factors programs may seem daunting, the savings realized from them more than justify their expense. He conservatively estimates that the return on investment could fall in the range of 10-to-1. The article outlines the various ways that an investment in a device's usability will generate savings during and after development, as well as boost sales revenue.
Michael Wiklund addresses AAMI conference
July 1, 2005
Michael Wiklund delivered a series of technical presentations at the Association for the Advancement of Medical Instrumentation's recent conference titled Human Factors, Ergonomics, and Patient Safety for Medical Devices, held in Washington, DC, June 28-30, 2005. His talks addressed the basic principles of human factors, usability testing of medical devices, and the costs and benefits of human factors in medical device development.
He also introduced several case studies on products (defibrillator, ultrasound scanner, sinus surgery tool, and blood chemistry analyzer) that reflect good human factors engineering. A well-produced videorecording along with the associated PowerPointT slides of all conference presentations are available on CD-ROM from AAMI (see http://www.aami.org/meetings/hf/cd.html). Prior to the conference, WR&D helped AAMI plan the conference and recruit speakers.
Keypoints from Michael Wiklund's Presentation at the AAMI's June 2005 Conference:
The human factors imperative. Human factors engineering is certain to help medical device manufacturers produce competitive product offerings, as well as meet FDA requirements and international standards. Significant benefits from a comprehensive human factors engineering program accrue to health care recipients (i.e., patients), direct providers (i.e., doctors, nurses, therapists, technicians), and institutions (clinics, hospitals, insurers).
Return on investment. An investment in the human factors engineering of medical products might yield a return on investment in the range of 10:1 or better. While manufacturers will incur substantial costs prior to market launch, the benefits will accrue for many years. Benefits to manufacturers include reduced learning tool development and production costs, reduced product liability exposure, reduced demand on customer support services, and increased sales. See http://www.wiklundrd.com/hf_roi.ppt
Usability testing. Usability testing may be the single most important step in meeting human factors process recommendations from regulatory bodies, such as FDA and TUV. Testing early and often is usually better than waiting to conduct a single, comprehensive test late in the development process. Test findings typically lead to design improvements that boost overall device safety and usability.
Product review in ID magazine
February 28, 2005
Read Michael Wiklund's human factors design critique titled, Brace Yourself: A Line of Joint Supports is the Prescription for Healing in Style, in the March/April 2005 issue of International Design. Also read his mini reviews of an innovative football helmet that protects against concussions and special pads that take the stress off a baseball catcher's knees. Get more info on ID magazine's web site.
Michael Wiklund to speak at AAMI conference
February 28, 2005
Michael Wiklund is scheduled to speak at the Association for the Advancement of Medical Instrumentation's upcoming conference titled Human Factors, Ergonomics, and Patient Safety for Medical Devices, to be held in Washington, DC, June 28-30, 2005. His talk will address the basic principles of human factors,usability testing of medical devices, the costs and benefits of human factors in medical device development, and introduce case studies on products that reflect good human factors engineering.
Michael Wiklund addresses MEK 2005 conference
February 28, 2005
Michael Wiklund spoke at MEK 2005 Congress on Medical Devices, Human Factors and Patient Safety, held in Muenster, Germany, March 17-18, 2005. His talk addressed the costs and benefits of human factors in medical device development. Download an adapted version of his presentation (PowerPoint file) .