Farm Blog

Selecting Ideation Methods for Medical Product Development

Group ideation sessions can provide an effective platform for creating novel and innovative ideas. With so much material and so many ideation methods available, however, one of the biggest challenges lies in selecting the most appropriate ideation method.

Two factors are critical when selecting an ideation method: one, correctly identifying the type of problem to be solved, and two, deciding on an appropriate degree of transcendence. See Figure 1 for a visual organization of the selection process.

Identifying the problem: The first step in selecting an ideation method is to understand the type of problem you are solving. For example, if the technology is already developed and your task is to design a more efficient process, you might consider starting with a method that has been proven to be effective for workflow problems. Identifying the right problem can be as challenging as developing a solution, so be sure you have a thorough understanding of what it is you are trying to solve before wasting valuable resources.

Degree of transcendence: Early in the development process, it helps to explore far reaching ideas, but this may not be the case in later phases of development. It’s important to know where you are in the development process, so that you can decide on an appropriate degree of transcendence. Transcendence is defined as the degree by which you deviate from existing ideas or solutions. There are a number of reasons transcendence might be inhibited in group ideation sessions, including cognitive challenges such as social anxiety. Fortunately, some ideation methods are better suited to tradition, while others are more geared towards transcendence. It is important to decide how far you want to push the ideas so that you set appropriate expectations and enable individuals to focus on the right problem.

Key attributes

The two criteria outlined above will not alone ensure successful ideation sessions. In addition, there are key attributes that must be considered before conducting any group ideation session.

Resources available: People are the most valuable resource in an ideation session, so it’s important to ensure you have the right people for the job. Most successful sessions involve an interdisciplinary team of individuals, including people with domain knowledge about the problem.

Degree of structure: Some ideations methods provide more guidelines and/or processes. Research has shown that individuals new to group ideation perform better using more structured methods. Inspiration card workshops, for example, outline three steps to developing ideas, including a period of divergent thinking and a period of convergent thinking.

Sources of inspiration: There are countless ways to introduce inspiration to an ideation session, many of which are described within the specific ideation methodologies. Sources of inspiration can be physical, literary, metaphorical, technology based, or purely imaginative. Sources of inspiration can greatly influence the direction of the session, so give thoughtful consideration to the inspiration you provide.

Good practices

Applied Imagination author Alex T. Osborn’s original four rules still apply: (1) go for quantity, (2) encourage unexpected ideas, (3) defer judgment, and (4) combine and improve ideas. The initial goal is divergence—to create a lot of ideas. You should evaluate ideas, using specific criteria, later in the process.

Provide breaks: Research has shown that brief breaks during an ideation session can lead to increased productivity throughout the session. Breaks allow participants to make novel connections or consider new ideas without actively considering the problem.

Create and enforce rules: It almost sounds counterintuitive, but studies have found that providing rules enhances productivity. The rules can be as simple as: (1) stay focused on the problem, (2) do not tell stories, and (3) do not criticize.

Getting stuck: It’s inevitable that at some point in the session the group will run out of ideas and/or energy to explain the ideas. Consider using quick, informal methods, such as Provocative Operation or Oblique Strategies, to reignite creative thinking.

Positive motivation and incentive: When team members are held accountable for delivering good ideas they make a deliberate effort to better understand the problem and contribute to the overall success of the team.

Concluding thoughts

Organizations can increase the likelihood of conducting successful ideation sessions by sharing experiences in an editable database. By documenting the elements of each session (including the process, people involved, and sources of inspiration used), organizations can develop a company-wide knowledge base highlighting successful ideation experiences. Finally, increased productivity during ideation sessions is not enough to ensure innovation. Ideation sessions must be combined with suitable decision making and down-selection tools to ensure creative ideas are appropriately implemented.

*This blog post was originally featured on Medical Device Summit's MEDesign blog.

User Research, Sustainability, Design + More: Top 5 blogs 2010-2011

Conducting User Research in the OR

Medical device manufacturers understand the need to conduct in-depth user research in the field (design ethnography) as part of the product requirements process, but little information exists on what to expect when conducting user research in the OR. Although every hospital is different, here is some practical advice from Farm’s experience…

http://www.farmpd.com/Farm-Blog/bid/75996/Conducting-User-Research-in-the-OR-What-You-Should-Know

Sustainable Product Design: One Powerful Principal

An individual perspective on a research study titled "Sustainability & Innovation Global Executive Study and Research Project." The bottom line: Companies who embrace sustainability are winning. A focus on one powerful, underlying principle that any company should consider…

http://www.farmpd.com/Farm-Blog/bid/62785/Sustainable-Product-Design-One-Powerful-Principle

Selecting Cities for User Research

How do you select cities for user research? You should select cities based on the type of research—is it generative field research to identify user needs or areas for innovation, or formative testing of prototypes in order to get design feedback? Select cities based on the type of research you’re doing…

http://www.farmpd.com/Farm-Blog/bid/49324/Selecting-Cities-for-User-Research

System Design for Auditory Perception

Auditory fatigue, or auditory desensitization, occurs in many working environments where auditory perceptual needs go unmet. Poor auditory environments challenge our ability to understand a situation, make appropriate decisions, and respond in a timely manner. Fortunately, these challenges can and should be addressed through appropriate auditory system design…

http://www.farmpd.com/Farm-Blog/bid/39048/System-Design-for-Auditory-Perception

Ideation Throughout Medical Product Development

A wide range of techniques have been developed to help product development teams produce novel ideas effectively and efficiently. Unfortunately, few design professionals are aware of these methods, and even fewer understand the elements of creativity to help make ideation sessions more productive…

http://www.farmpd.com/Farm-Blog/bid/64442/Ideation-Throughout-Medical-Product-Development

Five Promising Medical Device Mobile Apps

The medical device industry is likely on the cusp of a significant technology surge, one that merits close attention from device manufacturers, designers, and investors. Medical apps for mobile Apple and Android platforms continue to be developed at a rapid rate. But what’s new and noteworthy is that these apps are starting to evolve from information-only tools for consumers and clinicians – think calorie counters, clinical reference guides, or physical fitness support – to actual medical devices. Such apps are likely to change the future face of medicine.

The FDA stepped in with its July 2011 draft guidance on mobile medical applications. It carves out what the FDA calls a “small subset” of mobile medical apps that impact or may impact the performance or functionality of currently regulated medical devices, distinguishing them from ones that merely support healthcare decisions or tracking. Examples of mobile medical apps that the FDA considers subject to regulatory oversight are:

• Those used as an accessory to medical devices already regulated by the FDA, for example, an app that allows a clinician to make a diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or mobile tablet; and
• Those that transform mobile devices into regulated medical devices by using attachments, sensors, or other peripheral devices, for example, an app that turns a smartphone into an ECG machine to detect abnormal heart rhythms or to determine if a heart attack is occurring.

Happily, the FDA has already approved a few mobile medical devices, signaling its awareness of how important it is to not block the wave of future mobile medical devices. It’s not hard to understand why this wave is likely to break big. According to one study, 80% of physicians already routinely use some sort of smartphone during their workday. Another study predicts that by 2015, 30% of the world’s smartphone users will use mobile health apps, up from 5% today. So the sheer numbers involved are one driver of this trend. But equally significant is the potential that mobile medical devices have for improving the life of those with poor access to healthcare—for example, rural areas of the U.S. or third-world countries. Their ubiquity and portability will help bring medical care to places where expensive equipment would likely never go, improving access while lowering costs.

Let’s take a look at five promising mobile medical devices:

1. Mobile MIM – Approved by the FDA in February 2011, this app allows physicians to view medical images on their iPad, iPhone, and iPad touch. It facilitates medical diagnoses based on CT, MRI, and PET images. Its portability enables clinicians to “immediately view images and make diagnoses without having to be back at the workstation or wait for film,” notes William Maisel, M.D., chief scientist and FDA’s CDRH deputy director for science.
2. AirStrip OB, Cardiology, and Patient Monitoring – AirStrip Technologies offers FDA-approved platforms that allow patient-critical information to be accessed by physicians/nurses using smartphones or tablets. It permits mobile transmission of information, including ECGs, maternal/fetal waveforms, vital signs data, and peak ventilator pressures. Remote real-time viewing allows anytime, anywhere clinical decision-making.
3. Mobisante – Recently FDA-approved, Mobisante utilizes a peripheral attachment to convert a smartphone into a small, portable, and accurate ultrasound machine. The attachment costs $7,495, and while the images are not as crisp as top-quality ultrasound machines, those cost much more, according to Jason Wagner, MD, an ER physician who reviewed this device. These medical devices are targeted for physicians on field calls or in remote areas.
4. iPhone ECG – AliveCor, developer of the iPhone ECG, kicked up a real stir when its video demo went viral on the internet. It has developed a device that transforms any smartphone into a clinical-quality electrocardiogram (ECG) recorder. It is described as a single lead that attaches to the back of an iPhone and displays heart rate information via an app. This medical device has not yet received FDA approval, but the company recently announced that it raised $3 million in its first round of funding.
5. Handyscope – This iPhone peripheral converts the smartphone into a dermatoscope. It slides onto the phone and magnifies its camera up to 20x. A concurrent Handyscope app assists in diagnosis and clinical decision making. Not yet FDA approved, these medical devices could be invaluable tools for skin cancer screening in rural areas.

In the course of research for this blog, it’s clear that there are lots of other promising mobile medical devices out there that haven’t yet moved from idea to actuality; it’s even more abundantly clear that this is an incredibly rich field for innovation and one that the medical device industry should embrace.

Conducting User Research in the OR - What You Should Know

Medical device manufacturers are increasingly aware of the need to conduct in-depth user research in the field (design ethnography) as part of the product requirements process. We work at a product development consultancy and conduct many of these studies each year on behalf of our clients. Sometimes, the goal is to better understand a surgical procedure to uncover areas for innovation; other times we are observing the use of a particular device to identify opportunities for improvement.

We have found that little information exists on what to expect when conducting user research in the OR. Although every hospital is different, here is some practical advice from our recent experience.

Getting into the OR

The first hurdle to overcome is gaining access to the OR and its staff. Unless you work in an organization that has hospital affiliations, it may be difficult to locate surgeons who are willing to participate. In our experience, there are three common routes:

• The manufacturer identifies potential candidates through its sales force. If you work for a medical device manufacturer or are consulting for one this is typically the easiest route. Sales reps have on-going relationships with OR managers and surgeons, already have hospital access, are familiar with protocols, and know the hospital layout.
• The manufacturer provides a list of potential candidates. Sometimes our clients provide the names of surgeons they know, and we contact them directly. In some cases this works well, if the doctors have been contacted ahead of time and indicated interest, but if not, it is very similar to cold calling.
• Old-fashioned recruiting methods. This includes cold calling, advertising online, and sending out flyers. We have found that doctors respond well to email and faxes, and offering a monetary incentive is standard practice. We usually work through their assistants.

Credentials

Regardless of how you recruit the surgeon, you will still need to provide credentials proving that you are trained and immunized in order to enter the peri-operative area. Examples of training include: HIPAA, blood borne pathogens, and OR etiquette. Typical immunizations include: Hepatitis B, and TB, sometimes chicken pox and MMR.

Increasingly, hospitals to require OR visitors to be registered with a credentialing agency such as RepTrax or VendorMate. These require you to pay a fee and submit proof of your training and immunizations online. Bring your printed record of immunizations with you to the hospital as a backup just in case.

When You Arrive at the Hospital

If using one of the credentialing services, you’ll start by logging into the vendors’ kiosk and print out your badge, and then check in with the front desk of the surgical unit. You may also be asked to sign a visitor’s sheet and/or a HIPAA agreement for patient privacy.

Once checked in, you will need to change into OR attire. This includes scrub top, scrub pants, hat, and shoe covers, and mask. Your training in OR etiquette and bloodborne pathogen training comes in handy here. Avoid bringing valuables with you as there may not be a secure locker available.

Expect to wait around for a while. Sometimes surgeries don’t start at their appointed time for various reasons. Depending on the size of the operating room, hospital protocol, and surgical team preference, you may be allowed in the OR during set up or asked to wait outside. Ask what you are able to bring into the OR (for example, a camera bag or briefcase). In general, bring as little as possible and only what you absolutely need.

Taking Photos and Video

It’s critical to document field research with photos and/or video, but this is a bigger challenge in the OR than in other environments. It is best to obtain permission from the institution and surgical team ahead of time, and we’ve found that surgeons in teaching hospitals generally are more used to people taking photos and videos. Make sure you are trained in patient confidentiality and refrain from taking photos of the patient and/or identifying information. In most cases, the surgical team must obtain patient consent that day, so remind them ahead of time.

OR Etiquette

When you arrive in the OR, introduce yourself to the circulating nurse, offer your business card, sign in if necessary and explain why you’re there. Don’t assume that the circulating nurse and the rest of the OR staff know who you are or what you’re doing, because they may not have been told. Verify again that the surgeon and patient have given you permission to take photos and videos.

At the start of the case

• Know the roles of the OR personnel and act respectfully toward every member of the surgical team, regardless of his or her role.
• The safest bet is to stand up against the wall out of the way, and wait for instructions. The circulating nurse or surgeon will point out a good place to stand.
• If you have a briefcase or camera bag, tuck it out of the way in a corner or behind you near the wall.

Sterility

• If it's blue, don't touch it or reach over it. It's safe to assume that everything blue is sterile.
• Anything draped in clear plastic is also sterile (for example, the C-arm X-ray machine).
• Do not reach over or point over a sterile field for any reason.
• Never, under any circumstances, brush up against the surgical table, draped equipment, or anyone sterile.

During the procedure

• If you move around to get a better view, do it slowly and carefully. Be mindful of tubes and cables, and stay away from any sterile areas or equipment.
• If a lead apron is not available, step out of the room when X-rays are taken, or stand behind a non-sterile person who is wearing one.
• Never eat or drink while in the OR.
• If you’re new to observing surgeries, certain parts of the procedure may bother you. Simply look away or focus on something else.
• If you are ever asked to leave, for whatever reason, do so immediately and bring your things with you.

Interacting with OR staff

• Always ask if it's OK to ask questions about what physicians or staff members are doing.
• Don’t take offense if the surgeon doesn't talk to you during the procedure. He or she may offer commentary, but if not, save your questions for after the case.
• Don't ask anesthesiologists questions until after the patient is intubated, the tube is secured and connected to the circuit, and/or the anesthesiologist has sat down.
• OR staff will typically not talk to you during a case. They are trying to listen to what the surgeon says, and it's hard to hear a mumbling doctor when they’re talking and listening to someone else.

After the Case

We almost always schedule time to interview the surgeon and/or other OR team members after the case. Expect to wait in the staff or physician’s lounge for a while following, because there are lots of post-operative tasks to be done, such as transferring the patient to the recovery area, documenting the case, speaking with the patient’s family, etc. Use this time to review your notes and finalize your follow-up questions.

Be mindful of the physician’s time, and only ask the most important questions you need to. We typically have a set of pre-determined questions and then ask for clarification on what happened during the procedure. And of course, end the interview with a profound “thank you.”

Our final advice for conducting research in the OR is to be respectful, flexible, courteous, and professional. Always defer to the wishes of the OR staff, because the welfare of the patient and everyone’s safety are far more important than the data you’re collecting.

*This blog post was originally featured on Medical Device Summit's MEDesign blog.

Product Development Design Insights Video

At this year’s MD&M East Conference and Exposition in NYC, Medical Design Technology’s Editor-in-Chief Sean Fenske stopped by Farm’s booth to learn more about Hologic’s Selenia Dimensions (3-D) Digital Mammography Tomosynthesis System, winner of a 2011 Medical Design Excellence Award.

Tomosynthesis has been talked about for many years but didn’t become commercially viable to produce until Hologic introduced the Selenia Dimensions (3-D) Digital Mammography Tomosynthesis System. This is the first commercially available breast tomosynthesis system in the world based on years of research and development as well as input from users. Previous technologies took more than an hour of heavy-duty compression processing to get one image reconstructed, and now it takes a matter of seconds. The Selenia Dimensions system gives radiologists the ability to identify and characterize individual breast structures and reveal the inner architecture of the breast, free from the distortion typically caused by tissue shadowing or density.

During a tomosynthesis mammography scan, multiple low-dose images of the breast are acquired at different angles. These images are then used to produce a series of one-millimeter-thick slices that can be viewed as a three-dimensional reconstruction of the breast. Instead of viewing all tissue complexities on a traditional 2-D mammogram, the radiologist can now scroll through the layers of the breast. This allows the radiologist to see around features in the tissue and identify areas of concern that may have been hidden by overlapping tissue or dismiss normal areas that may have appeared suspicious on a 2-D digital mammogram. As a result, recalls may be reduced, unnecessary biopsies may be eliminated, and breast cancers may be identified earlier.

According to the American Cancer Society “Breast Cancer Facts and Figures 2009-2010,” one woman in eight in the U.S. is diagnosed with some form of breast cancer during her lifetime, making it the most commonly diagnosed cancer among American women. Breast cancer is responsible for over 40,000 deaths each year in the U.S., making 3-D digital mammography tomosynthesis the ideal choice for detecting breast cancer.

In this video interview, Hologic’s Nikos Gkanatsios provides insight into tomosynthesis technology and the development of the Selenia Dimensions system. Farm’s Darrin Manke discusses Farm’s involvement in the product development effort and how Farm assisted Hologic in the industrial design, human factors engineering, and user interface of the device.

Medical Product Development Using Finite Element Analysis

Finite Element Analysis (FEA), or computer simulation, is a powerful tool in the medical product development industry, but it is often misunderstood or misused. If you decide not to read much further, understand this one thing: FEA is a prototype reducing tool, not eliminating. Any one of the myriad of simulation programs can output very colorful and technical looking plots, but detailed experience and physical testing are critical to back them up. The only way to know for certain if you are right is to test it.

Simulation tools from SolidWorks, Pro/E, and even ANSYS have become both easier to use and more powerful. The development road to simulation is a pretty easy path to follow.

Hand Calculations

The most critical starting point is hand calculation. Whether it’s a free body diagram, energy conservation equations, or drop test G load estimations, everyone should work it out on paper first to get a feel for the order of magnitude inputs/outputs you are dealing with. Paper is cheap and good analysts need to develop their gut when scrutinizing results farther down the road.

Physical Testing

Nothing beats the real world when it comes to experience. You need to understand how hanging weights, heating up an enclosure with and without a fan, or the true shock inputs from a four-foot drop affects part design. There is a physical reason why you want larger rounds on bolt bosses. With strain gages and hanging weights, it takes minutes to actually see why. With the advent and popularity of desktop 3D printers, you can be up and testing white-sheet-of-paper concepts in hours. Remember that stress is a function of Force/Area, so the material will not affect the high-stress location, just the ultimate load.

Basic Linear Simulation

When looking to enter the computer world, there are many programs to choose from. I am not going to go into the depths of linear and non-linear analysis and what that means. If you want to analyze parts and keep them below the yield strength of the desired material, you are in the linear world. Most people tend to stick with programs that neatly integrate with their CAD package, so SolidWorks Simulation and Pro/E’s Mechanica are great places to start. Comparative studies at this level are your best friend for design optimization. If you have a tested and proven part, run it through simulation and iterate your design. Based on the results of the known good part, you will quickly see the percentage increase or decrease in strength as you change the design.

Complex Non-Linear Simulation

After you master the basics of simulation, prove your designs with testing, and know right away if a simulation result looks wrong, it’s time to step up to a more dynamic and flexible simulation program. The non-linear world examines complicated contact, fluid/gas flow, and materials (think rubber or compressible fluids). When given the opportunity (and budget), I always go for analyzing assemblies as opposed to individual parts. All too often when looking at individual parts, the assumed assembly constraints are compromised estimations. You can learn a ton from part-to-part interactions that may not react as you expected. In terms of computational fluid dynamics (CFD), we are continually shrinking packaging and power requirements. A great way to see if you need a fan is to analyze it; but to do that, you need the internal assembly to accurately model the air flow path. In terms of software, I can’t say enough about ANSYS. No other FEA package I have worked with has the solution monitoring functionality that ANSYS has. You have multiple tools and data monitoring features to predict if an analysis run is going to fail before it finishes, which can save hours from big runs.

Each of the steps above has its time and place whether you are just starting out or are a seasoned veteran. In the product development world, billable time is literally money. You always have time to do a quick hand calc., but you may not have time to fully analyze a ten-part assembly. Experience will dictate where you can simplify and expedite the process for usable data, or when you have to put your foot down and argue for analyzing the whole assembly. In closing, here are a couple tips I learned the hard way:

• Trust your gut. If it looks wrong, it probably is.
• Mesh density in high-stress areas for h-method solvers (vast majority except Pro/Mechanica, p-method) is absolutely critical to accurate answers.
• When physical testing, do not verify your analysis results on deflections only, unless that is the specific data you are after. FEA programs solve directly for displacements, but stresses are estimated based on equations directly related to element accuracy.
• Check your work with other people. Farm has a dedicated Stress Group to review even the simplest analysis run. It’s very easy to get lost in the minutia and lose the big picture.
• There is no such thing as a quick analysis. Take your time and do it right, including some kind of verification.

If you have any questions please feel free to contact me or leave a comment.

Ideation Throughout Medical Product Development

The concept of generating ideas within a group environment is nothing new to product development. Alex Osborn popularized the process and contributed a set of highly influential rules in 1953. Since then, a wide range of techniques have been developed to help product development teams develop novel ideas effectively and efficiently. Unfortunately, few design professionals are aware of these methods, and even fewer understand the elements of creativity to help make ideation sessions more productive. This blog will be one in a series of blogs where I’ll discuss the attributes of creative ideation within the context of medical product development. My goals are to provide insight that will help development teams select appropriate ideation methods and, just as importantly, modify existing methods to meet their unique needs.

To begin I’ll provide a brief overview of the literature on creativity and innovation from a cognitive and social psychology perspective to see how recent thinking might affect group ideation sessions. In subsequent blogs I’ll dive deeper into elements of creativity and innovation and introduce a framework for conceptualizing and selecting ideation methods. It is important for me to point out that my research and thoughts are focused on medical product development, which provides a unique set of challenges in the product development industry. With that noted, the core objective of any ideation session is to come up with many creative ideas, or ideas that will somehow add value to the individual or organization trying to solve a problem. It is my hope that by addressing this topic, readers will be able to conduct more successful ideation sessions.

Creativity and the Value of Generating Ideas

There is an assumption that more ideas lead to better ideas. Much of this derives from Linus Pauling’s ubiquitous quote, “The best way to get a good idea is to get lots of ideas,” (in Sharp, Rogers, & Preece, 2007, p. 417). There is, however, research to the contrary. Nevertheless, in medical product development, more ideas lead to better decision making, and the FDA likes to see a process for decision making.

Ideas alone are not inherently valuable. Creative ideas must be implemented; that is, they must be realized through some tangible, usable, and beneficial product or service. To clarify, “…creativity broadly refers to the generation of novel approaches or ideas; innovation refers to the application of ideas in a specific context,” (Biskjaer, Dalsgaard, & Halskov, 2010, p. 12). Creative ideas must lead to innovation.

Clearly, organizations would not exist without their ability to innovate—to generate new products, services, or experiences. There is an implied conflict, of course, because organizations must balance creativity with process optimization. One goal of group idea generation sessions, then, is to come up with creative ideas effectively and efficiently. Finally, creativity requires knowledge and a way to explore that knowledge. The process by which we explore that knowledge effectively, whether as an individual or a group of individuals, is the focus of applied group creativity. The exploration of knowledge starts with developing alternatives.

Forms of Creativity

According to the literature, there are a limited number of ways in which creative ideas are generated. This fact has important implications for the way in which ideation sessions should be conducted. For example, if the goal is to simply redesign an existing medical product, designers should select ideation methods that are more grounded in tradition. Developing a new product from scratch, however, might require a method focused on transcendence. I’ll define the important elements of ideation sessions for medical products in later blogs. Boden (2004) describes three general forms of creativity:

1. Unfamiliar combinations of familiar ideas. Similarly, Sharp, Rogers, and Preece discuss the value of the cross fertilization of ideas from different applications (2007).
2. Exploring conceptual spaces. This method suggests working within a structured style of thought to deliver ideas that have not been previously conceptualized. In general, product evolution occurs through use, observation, and drawing on knowledge from similar problems.
3. Transforming the space. One challenge is for people to overcome expectations of what’s possible. Transformation includes ideas that could not have been conceptualized using the existing conceptual framework. Many ideation sessions focused on the future try to transform the space (see, for example, Nathan, Klasnja, & Friedman, 2007).

The Creative Process

Most of the available research aligns with Osborn’s initial observation that creative ideation involves a series of cognitive processes which are not necessarily performed in sequence. Osborn refers to these processes as fact-finding, idea-finding, and solution-finding. (Osborn includes verification within the solution finding process.) These ideas align closely with more recent descriptions of cognitive tasks including preparation, incubation, illumination, and verification (Boden, 2004). In addition, there are numerous sub-tasks including, but not limited to, gathering and analyzing pertinent data, selecting ideas internally, idea production, evaluation, adoption, and decision-making. In most cases these cognitive processes do not align strategically with ideation sessions (Maiden, Robertson, & Gizikis, 2000), but some of the more structured ideation sessions have tried to map the steps in the process to the cognitive tasks outlined above (see, for example, Jungk and Müllert in Biskjaer, Dalsgaard, and Halskov, 2010). However, the research results are conflicting, and more research is necessary to see if ideation sessions are more productive when they align closely with cognitive theory.

Importantly, the creative process as we know it has informed several important best practices that should be considered during any ideation session. I’ll conclude this blog with a short list of best practices for ideation sessions. This list is preliminary. I invite readers to add best practices and ideas from their own experiences. The next blog in this series will discuss the value and specific challenges, both social and cognitive, of generating ideas within groups.

References

Biskjaer, M.M., Dalsgaard, P., & Halscov, K. (2010). Creativity Methods in Interaction Design. DESIRE '10 Proceedings of the 1st DESIRE Network Conference on Creativity and Innovation in Design 12-21.

Boden, M.A. (2004). The Creative Mind: Myths and Mechanisms (2nd ed.). New York, NY: Routledge.

Kelley, T. (2001). The Art of Innovation. New York, NY: Doubleday.

Maiden, N., Robertson, S., & Gizikis, A. (2004). Provoking creativity: Imagine what your requirements could be like. IEEE Software, 21(5). 1-13. doi: 10.1109/MS.2004.1331305

Nathan, L.P., Klasnja, P.V., Friedman, B. (2007). Value scenarios: A technique for envisioning systemic effects of new technologies. CHI '07 Extended Abstracts on Human Factors in Computing Systems (pp. 2585-2590). New York, NY. doi: 10.1145/1240866.1241046

Osborn, A.F. (1963). Applied Imagination: Principles and Procedures of Creative Problem-Solving (3rd ed.). United States of America: Charles Scribner’s Sons.

Sharp, H., Rogers, Y., & Preece, J. (2007). Interaction Design: Beyond Human-Computer Interaction (2nd ed.). West Sussex, England: John Wiley & Sons Ltd.

Sustainable Product Design: One Powerful Principle

A few months back, MIT Sloan, in collaboration with Boston Consulting Group (BCG), recently published the verbosely titled Sustainability & Innovation Global Executive Study and Research Project. It's a well-researched study—which is to say that it's a long read—and definitely worth reading.

I read it. It got me to thinking about the fallacy of ignoring what can't be measured, that sustainability needs to be a part of performance reviews (behind budget and schedule, certainly, but it deserves a spot), and so on. I found myself concluding that companies that embrace sustainability are winning (from both a financial and talent perspective), and poised to widen the gap.

I created notes that resulted in an exhaustive set of recommendations or methods for improving the sustainability of any company. And that is the problem...they are only methods.

Methods are weak and fleeting, so instead I decided to focus on principles. Scratch that, I will focus on one powerful, underlying principle that any company should consider.

Start small, start now.

It's how you train for a marathon; it's how you save for retirement; it's how you do almost anything. Yet hyperbolic headlines get traffic so that you are conditioned to think that you either have to "Make Your Company Sustainable to the Bone" or do nothing, and that is a dangerously false dichotomy.

Instead, look at your business for low-hanging fruit. For current products look at PVC alternatives (DEHP-free) or switch to a plastic that has a small percent of recycled content. If you are doing a redesign, consider architectures that encourage recyclability or re-use.

These small wins, like compounding interest, can snowball. They will make your products more attractive to buyers (see Kaiser Permanente's Sustainability Scorecard) and are an insurance policy against future legislative change. Feeling good about what you're doing is a byproduct, what drives sustainable product design is practicality.

In the sustainability game, the barrier to entry is less a barrier than a threshold. All you need to do is move in the right direction.

I highly suggest reading the report Sustainability & Innovation Global Executive Study and Research Project. Really interested? Use comments or contact us privately.

Human Factors and Usability to Improve Device Performance

A recent article featured in Orthopedic Design & Technology, titled “More Tools in the Toolbox,” by Mark Crawford, contributing writer, highlights key insights and interviews with suppliers of the surgical instrumentation industry and sheds light on manufacturing partners leveraging a creative network of product development to stay ahead of increasing OEM demands.

Farm’s Director of Business Development, Marc Dubreuil, discusses the importance that medical device manufacturers are placing on human factors and usability in an effort to improve device performance and safety and to reduce errors. Marc candidly talks about Farm’s usability process, Farm’s focus on user interaction, and the importance of user research when working with clients.

Infusion Device Safety – Update on Progress

Back in October 2010, I reported on attending the joint AAMI-FDA Infusion Device Summit, which took place at the FDA’s Rockville, MD campus. The summit brought together 330 diverse stakeholders: doctors and nurses, clinical/biomedical engineers, hospitals and other healthcare organizations, FDA officials, device manufacturers, product development firms (like Farm), academicians, safety organizations, and others.

The initial outcome of the summit was a list of the top 13 priorities for infusion device safety, which can be found at http://www.aami.org/news/2010/101410.press.infusion.priorities.html.

I had noted that these would be addressed in an upcoming action plan. I just received my copy in the mail titled, Infusing Patients Safely: Priority Issues From the AAMI/FDA Infusion Device Summit. AAMI announced in a press release the availability of the report, citing Farm as a source of bringing awareness to the upcoming publication.

Call to Action

After the summit, the AAMI Infusion Device Standards Committee organized the 13 top-priority issues into five clarion themes, and the new report is organized around these themes:

• Standardize systems and processes for reporting, aggregating, and analyzing infusion device incidents (covers four issues)
• Improve the integration of infusion devices with information systems and drug libraries (covers three issues)
• Mitigate use errors with infusion devices (covers three issues but is an overarching element)
• Improve management of multiple infusions (one issue)
• Reconcile challenges and differences in the use environments of infusion devices (two issues)

The report also includes material from the summit presentations and a bunch of expert perspectives solicited after the summit. The lead user profiles are particularly interesting because they present solutions that various hospitals and healthcare organizations have implemented to address infusion pump safety. I think it’s great that the medical community is now sharing lessons learned.

My favorite quote was from Dr. Matthew Weinger of Vanderbilt University: “We need to design safety features that make it easy for the user to do the right thing.” I remember writing that down in my notes when he was speaking. (Dr. Weinger is co-chair of AAMI’s Human Factors Committee, which I’ve been sitting in on.)

Where We Go From Here

Another development is the establishment of a Medical Device Safety Council focusing on infusion devices (Medical Device Safety Council/Infusion). This council is being established within the AAMI Foundation, which is a charitable and educational organization. This council will have an executive committee and a number of working groups with assignments based on the five clarion themes. You can see the assignment grid, with the names of the group leaders, at http://www.aami.org/infusionsummit/Documents/WorkingGroupsSummary.201101.pdf

Nearly one hundred summit participants (including me) signed up to participate on specific priority issues and will be invited to join the working groups. I’m particularly interested in mitigating use errors (of course!) and in the effects of the home use environment on infusion device safety, which is not only timely but relevant to several client projects Farm is involved in.

For more information on this topic, go to:

FDA’s infusion pump website: http://www.fda.gov/InfusionPumps

AAMI’s infusion pump web page: http://www.aami.org/hottopics/infusion%20pumps/index.html