The 2012 Symposium on Human Factors and Ergonomics in Health Care took place March 12-14 in Baltimore Maryland. There were nearly 400 human factors professionals, manufacturers, healthcare providers, policy makers, and other stakeholders there, including many of my friends and a number of Farm’s clients.
On the final day, Ron Kaye and Quynh Nhu Nguyen from the FDA’s Human Factors Group presented the Closing Plenary Session: FDA Human Factors Q&A. The chair and moderator was Anthony D. Andre, who organized the symposium. Previously during the conference, the audience had submitted questions for consideration, and the ones below were selected to be answered by the Agency. I’ve done my best to paraphrase based on my notes.
- Q)When do you expect the FDA draft human factors guidance document to be finalized?
- A)The guidance is expected to be finalized by the end of this year. The human factors team is going through 600 good comments and is making changes.
- Q)What is the average turnaround time on a validation protocol review?
- A)For devices where only CDRH is involved, a minimum of 30 days. For combination drug-device products where both CDRH and CDR are involved, it is estimated at 30-60 days.
- Q)What are the two most common or serious mistakes found in FDA submissions?
- A)No human factors done at all and no tangible link between risk priority and user tasks. “We have had a lot of success but there is still a lot to be done.” Now that the new guidance has been out there the FDA has found that companies are following it and practicing good process.
- Q)Do I have to have a perfect product with zero errors?
- A)The point is to find errors and fix them…The fact is some things just cannot be designed out of the device. If this is the case, the device still could be better than other products on the market, even if it’s not perfect. When a manufacturer claims that it is as safe as possible, sometimes the human factors team will meet with the medical officer and get his opinion. FDA reviewers take his input very seriously and try to make the best possible decision. The final and most difficult question is: Do the benefits outweigh the risks?
- Q)If the new product is clearly better and safer than the legacy (predicate) device, do you get “credit”?
- A)Reviewers look at each submission in isolation, and don’t compare. For example, if one device has 10 serious errors and another one has five, will the FDA accept the one with five? No. The question is: What are the problems and can they be fixed? For some products misuse can cause death, for others misuse might cause minor irritation. This doesn’t mean they will ignore the less risky product, but in reality, limited resources force the Agency to focus on the more dangerous products.
- Q)Can manufacturers request specific reviewers?
- A)Yes, you can include the request in a cover letter and send that along with your submission.
- Q)If there is an existing product on the market and you have made only one component change, do you have to revalidate with the same rigor?
- A)It depends on what the component was. If a case can be made, you can focus the validation testing on just that one component, but it depends on the risk associated with the component in question.
- Q)Are there categories of devices that do not require human factors testing?
- A)If there is no significant user interaction and the device is low risk then maybe. The FDA is working on a list of these devices, which will be published at some point.
- Q)What is the FDA’s approach regarding software and electronic medical records?
- A)This is not being decided by the human factors team; Dr. Patel in the Management Office is leading the effort. We have reviewed stand-alone software applications and evaluated whether or not critical actions are supported well by the UI. It can get complicated, however.
- Q) Do you have to test a kit that includes approved syringes for home use?
- A) It depends on risk analysis and justification for why not. The FDA takes into account user profiles (tremors). Do users have unique aspects affecting the use of syringes?
- Q)How is delay of therapy viewed?
- A)Depends on how long of a delay and clinical relevance of speed. For some products, like AEDs and infusion pumps, a delay is critical. You should evaluate what the delay means clinically.
- Q)For combination devices, should you incorporate anything learned from a Phase Three Clinical Study into your human factors studies?
- A) You should conduct your summative testing first, make changes, and then go into your Phase Three Clinical Study.
- Q)What if you are trying to get a combination device approved but there are ancillary steps like washing your hands or preparing the injection site and you know that patients don’t do it? It is out of the manufacturer’s control.
- A)In general, if these tasks are critical to safe use, you should look at them.
- Q)Can you test a device in phases, for example, test the basic tasks first and then have people use the device for a while and learn the more complex tasks during use, and test those later?
- A)Depends on the training that’s necessary to use the device safely and effectively. We would need to know more about the device you’re referring to in order to answer the question.
These were certainly some interesting questions, and I along with the rest of the audience really appreciated the Agency’s willingness to address them in a public forum. It was a perfect closing to the event.
The quality of a CAD database is directly correlated to its adaptability.
What do I mean by that? If you've designed a device (let's say an orthopedic brace) and want to change something fundamental to the design (e.g., the shape and size of the arm to fit in the brace), an adaptable database will dutifully read your request and update all subsequent surfaces and parts such that your design intent remains intact.
But while all high-quality traditional databases have some degree of flexibility, precious few of them are adaptable.
Consider, for example, the humble office chair. It has some surfaces that attempt to conform to your body, a few mechanisms to adjust height and tilt, several wheels at the base, spokes reaching out the wheels from the column in the center, and perhaps the armrests are adjustable as well. A traditional CAD database would have, by virtue of the techniques used in its development, a certain degree of flexibility. An adaptable database would take things a step further.
Warning: The sections on traditional databases may seem a slightly esoteric if you don't spend much time in CAD. For the big picture, skip ahead to The Value of Adaptable Databases.
Sticking with the chair example, a high-quality traditional database would allow you to adjust the range of motion of the tilt mechanisms, perhaps the number of wheels at the base, the length of the spokes attaching the wheels to the center column, and so on. Generally speaking, any feature of the chair that can be defined by a single number could be changed and updated. Some of the means used to reach such an end:
- Your CAD should be DRY (Don't Repeat Yourself)
- Surface Refs > Edge Refs > Point Refs
- Good dimensioning is as little dimensioning as possible (but not less
- 10 simple features > 1 complex feature
- and so on...
While these will take you a long way, adaptable databases, as mentioned before, go further.
By implementing additional techniques on top of traditional best practices, design intent is able to be so thoroughly baked into an adaptable database that its flexibility is no longer limited to a few discrete parameters. Instead, it's able to read user-specific scan data and adjust the height, length, width, and surface curvature such that the resulting database is now custom-fit to the user.
Consider the following techniques when building an adaptable database. The level of adaptability required will drive to what extent (if at all) such additional techniques will be implemented.
Splines are complex. While the descriptions of lines and arcs are so clear that it's difficult to remember not knowing them, a description of splines will quickly get you into calculus territory. It's no wonder that as you look around you are likely to see yourself surrounded by products constituted of lines and arcs instead of splines. The engineers of those products are telling you something: using splines is hard.
That said, splines are the lifeblood of an adaptable databases. This is especially true in databases that want to adapt to user anatomy: there aren't (m)any pure arcs anywhere on our bodies, and trying to force something is a path fraught with peril.
What is truly important?
When an FEA study reveals a weak spot, it's likely the problem can't be fixed by changing one parameter. In such a case, the traditional approach is to adjust several dimensions in the model to sufficiently mitigate the problem. This works for traditional models, but leaving such a critical area defined implicitly rather than explicitly puts your database at risk when it scales.
The adaptable approach is to rebuild the model such that the weak spot is explicitly defined; ensuring that it does not poke its head out again as the database begins to adapt.
Make it data-driven
In the age of big data we are limited not by the amount of data we have, but by our ability to leverage it; product development is no exception. Anthropometric data, use scenarios, FEA, cost of goods, etc. would all, in an ideal world, drive the CAD database. Instead of such an explicit relationship, information typically makes its way into the CAD database via a more circuitous path:
- Data is obtained
- CAD is adjusted to reflect new data
- Design is prototyped
- Prototype is tested
- Tests produce data
This continues until the test data indicates that the performance of the prototype is acceptable. It's a sound approach, but difficult to scale. Geometry that is explicitly driven by data rather than becoming an iterative approximation of it is bound to be more adaptable.
Once you have built a sufficiently adaptable model, you have the opportunity to take advantage of some high-end capabilities.
Top CAD programs provide the capability (either through additional off-the-shelf extensions or access to an application programming interface) to set up studies that can take a "generic" of your design, read in a 3D scan of an object (e.g., a part of a patient's anatomy), compute various analyses between the “generic” and the scan (e.g., distance between the two at a specific point), then adjust dimensions to optimize those parameters (e.g., minimize the aforementioned distance).
These extensions and APIs are the mechanisms that enable adapt-able databases to adapt.
The value of adaptable databases
You may have already guessed why most databases today aren't adaptable; it’s hard and the benefits aren't significant enough to make the effort worthwhile. Most companies with products of various sizes have relatively few variations (think S, M, L, XL). In this case, adaptability is superfluous.
But what if a competitor was able to offer thousands of sizes and able to clinically prove that his/her device, by virtue of its superior fit, was able to improve performance, patient compliance, and recovery time? What if the cost of such a device was nominally more expensive, but (for the reasons just mentioned) provided greater value?
In such a circumstance, the ability of your CAD model to adapt goes from being a nicety that smooths the ECO process and manufacturing tweaks to a full-blown competitive advantage.
Today, this is the case for high-end implants. Some companies are currently working on such an approach for prosthetics. Forward-looking organizations will keep tabs on this trend, and adapt accordingly.
*This blog post was originally featured on Medical Device Summit's MEDesign blog.
A process-based analysis to better understand why smart infusion pumps have become so problematic. Hint: Design alone is not to blame.
The use of smart infusion pumps has become ubiquitous in many U.S. and international clinical settings due to the tremendous patient benefits these devices offer. Briefly, infusion pumps are medical instruments that deliver medications to a patient’s body in a “controlled, precise, and automated manner” (FDA, 2010, p. 2). There are several key attributes that distinguish smart infusion pumps from their more traditional counterparts. The key benefits of smart infusion pumps include: (1) the ability to incorporate a large medication library into the device, (2) the ability to alert users of potential use errors, and (3) the ability to collect usage data, which can be used to improve work practices.
These benefits, however, do not eliminate use-related risks. Improper use of and/or malfunctioning smart infusion pumps can cause serious adverse health effects and even death. In fact, since 2005 more than 56,000 reports of adverse-related events have been reported and more than 87 product recalls have been conducted (FDA, 2010, p. 3). This is important to understand because 90 percent of hospital patients take advantage of infusion pumps during their stay in the hospital (Brady, 2010).
Are We Identifying the Right Problems?
The dichotomy is clear, but what is not clear is why smart infusion pumps have become so dangerous. Unfortunately, many stakeholders, including the FDA, have been quick to point out inadequacies in infusion pump designs as key obstacles to patient safety. While design flaws have been identified, the real problem is more complex and involves multiple systems and stakeholders. Design alone cannot solve the entire problem. It is important, therefore, that we use a detailed analysis of the infusion pump process to identify more pervasive issues.
Systemic Challenges to Smart Infusion Pump Design
The opportunity for error occurs across multiple steps of the infusion pump process, with many occurring both before and after actual use of the smart infusion pump. Therefore, the infusion pump process will be analyzed according to six key areas to better understand why certain problems have persisted. Key areas include: (1) policy, (2) prescribing and ordering, (3) medication storage, (4) medication preparation, (5) administering, and (6) monitoring.
Policy One of the biggest challenges to understanding the root cause of problems associated with infusion pump use is the lack of infusion pump standards. There is little agreement on what should be standardized, let alone what the standards should be. Many stakeholders believe consensus on infusion pump standards would lead to immediate, short-term benefits and safer infusion pump use. As a starting point, standards should include drug name, recommended minimum and maximum dosages, upper and lower administration rate limits, standardized concentrations, and dosing units. The standards should also address special cases, including certain patient populations and clinical conditions, medication administration techniques (i.e., IV push), and monitoring requirements (ASHP, 2008).
Despite the relative acceptance of these measures, there are still many challenges to overcome. For example, the culture of fear propagated by liability concerns has made it increasingly less likely that practitioners will share their drug libraries. Nothing short of a cultural shift will help overcome the secretive nature of this information, which would allow drug libraries to be more accurate and more comprehensive.
Prescribing and Ordering Current prescription and ordering practices do not dictate how IV medications are ordered. Practices differ amongst practitioners, geographical regions, and clinical settings. As a result, different medications often end up looking very similar, leading to confusion and increasing the likelihood of administering errors. This situation could be improved by decision support systems that reinforce best practices at the point-of-care, which smart infusion pumps are in a unique position to provide.
Medication Storage States often control professional regulations, including storage practices, which can lead to very different practices from one clinical setting to the next. Drug compounding, for example, often takes place in different locations, making it difficult to store “commercially available ready-to-administer infusions” in consistent locations, such as patient care areas (ASHP, 2008, p. 2370). Unfortunately, storage problems are not something that can be solved by the design of the infusion pump itself. Only standardized storage practices will lead to quicker response times and improved patient outcomes.
Medication Preparation Many IV medications come in forms that need to be manipulated by a person before being administered. Leaving the admixing to any practitioner, however, leaves the door open to human error. In addition, there is no recognized format for labeling admixtures (ASHP, 2008). These are both key causes for concern. Providing medications in ready-to-administer form would greatly reduce IV drug administering errors, and standardized labels with machine-readable bar codes would enable smart infusion pumps to verify the correct medication is being delivered to the right person.
Administering Administering the drug is one of the most difficult steps of the process because the hospital environment challenges the user’s ability to make appropriate decisions. In addition, many users will find workarounds for systems that unintentionally increase time delivering medication (Yang, Ng, Kankanhallia, & Yip, 2011). The perceived need for speed consistently outweighs safe practices in clinical settings (Koppel, Wetterneck, Telles, Karsh, 2008). It is not surprising, then, to discover that users override approximately 90 percent of all infusion pump alarms (Brady, 2010). Smart infusion pumps can and should be designed to promote safe administering practices while limiting the ability of users to practice unsafe workarounds.
Monitoring There is no national standard operating procedure for documenting and/or responding to suspected medication errors, leading to the pervasive inability to identify the root causes of problems. This may be the result of the punitive culture of the healthcare environment itself. As the ASHP pointed out, there is a general “fear of blame and punishment for reporting errors or raising safety concerns” (2008, p. 2373). Unfortunately, this has led to a surprising lack of data that could lead to a better understanding of smart infusion pump usage. One benefit of utilizing smart infusion pumps is the ability to capture and analyze usage data, which would help identify bad practices.
Drug libraries will never be complete and nor should they be. As a result, smart infusion pump systems cannot exist without regular library updates. Effective library updates and maintenance can be achieved through a committed interdisciplinary staff, including stakeholders that may not have been traditionally involved, such as information technology (ISMP, 2009). The updates should be closely monitored by regulated oversight.
Clearly, design alone is not to blame for the problems facing smart infusion pumps. New medicine and patient care options will continue to expand and smart infusion pumps need to keep pace with the advances in medicine. The problems that have been outlined, which are certainly not exhaustive, exist throughout the process and the environment of use. The future of safe smart infusion pump use depends wholly on improved practices throughout the process, including standardization of healthcare practices, an improved culture of trust and safety, and a collaborative effort that leads to consensus on safe practices.
*This article was originally featured in Consultant's Corner, a Qmed publication, on March 12, 2012.
American Society of Health-System Pharmacists (ASHP). (2008, July). Proceedings of a summit on preventing patient harm and death from i.v. medication errors. American Journal of Health System Pharmacy, 65, 2367-2379.
Brady, J.L. (2010). First, do no harm: making infusion pumps safer. Biomedical Instrumentation & Technology. 44(5), 372-380.
Koppel, R., Wetterneck, T., Telles, J.L., Karsh, B. (2008). Workarounds to barcode medication administration systems: Their occurrences, causes and threats to patient safety. Journal of the American Medical Informatics Association, 15(4), 408-423. DOI: 10.1197
Institute for Safe Medication Practices (ISMP). (2009). Proceedings from the ISMP summit on the use of smart infusion pumps: guidelines for safe implementation and use. Retrieved from: http://www.ismp.org/tools/guidelines/smartpumps/comments/printerVersion.pdf
U.S. Food and Drug Administration, Center for Devices and Radiological Health. (2010). White Paper: Infusion Pump Improvement Initiative. Retrieved from U.S. Food and Drug Administration website: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/GeneralHospitalDevicesandSupplies/InfusionPumps/ucm205424.htm
Yang, Z., Ng, B., Kankanhallia, A., & Yip, J.W. (2011). Workarounds in the use of IS in healthcare: A case studyof an electronic medication administration system. International Journal of Human-Computer Studies, 70(2012), 43–65. DOI: 10.1016/j.ijhcs.2011.08.002
The FDA’s position on validation testing requires that testing be conducted in actual or simulated environments. This focus has put the spotlight on the benefits of medical simulation centers. These centers have the ability to recreate sophisticated hospital environments and enable complex medical tasks to be performed in true-to-life scenarios, allowing manufacturers to determine whether a device is safe and effective before exercising it in a real clinical setting such as a clinical trial. Farm uses these facilities when appropriate to conduct summative testing for our clients.
Typically established as training centers for medical professionals, medical simulation centers are resource-rich environments that can be transformed into many types of hospital settings, such as operating rooms with a scrub-in area, labor and delivery suites, or acute care settings. We’ve found simulation centers typically have access to most of the necessary supplies and equipment used in an actual hospital setting, such as surgical gloves and dressings, crash or drug carts, syringes, IV poles, infusion pumps, ultrasound machines, and patient monitors—you name it. Specialized equipment, as well as the device being tested, can also be brought in.
Most medical simulation centers give researchers the ability to mock up the conditions of device use. For example, one can alter the height of the patient bed; enable alarms, overhead pages, and other medical device sounds; and vary lighting to match typical use conditions. The staff members who manage the simulation centers often have medical backgrounds and can provide their expertise and assistance in setting up realistic scenarios.
Simulation centers vary in their level of fidelity (or realism). When planning a usability validation test, researchers should consider the level of fidelity required based on the type of device, the environment in which it is used, and the level of impact environmental conditions could have on user interactions with the device. For example, it may be important to test a device designed for use in an emergency room setting in a high-fidelity simulated environment (such as the Center for Medical Simulation in Cambridge MA) in order to consider how frequent distractions influence the use of the device. According to ANSI/AAMI’s HE75:2009 guidance document, “ER staff, in particular, are regularly interrupted because of the unpredictable nature of their work environment…In one study, ER physicians were three times more likely to be interrupted than their primary-care peers working in medical offices and spent more time managing multiple patients simultaneously than primary-care physicians.”i High-fidelity labs may have more capabilities to recreate ER-like auditory distractions that typically occur, such as alarms, fans, and other sounds from the presence of multiple medical devices, staff and patient conversations, intercom pages, physical commotion, etc. In contrast, low-fidelity labs may be sufficient in cases where the physical and/or clinical environment is much less complex and much more controlled.
Since the primary focus of medical simulation centers is to educate medical professionals, many are equipped with high-fidelity video cameras and audio equipment. Students are recorded performing various procedures and the video is used as a teaching mechanism to improve their skills. Faculty can also use these videos to evaluate the abilities and techniques of students. For usability validation testing purposes, the audio and video capabilities allow stakeholders to observe sessions remotely or from a separate room and provide a record of each test session that may be reviewed later during data analysis.
In some cases staff members or actors (cohorts) play the role of patients, medical professionals, or relatives. These actors can be tasked with introducing realistic interruptions, adding stress or pressure to the medical scenario at hand. For example, they may act highly emotional, ask difficult questions, or interfere with a physician during an important step or procedure.
Mannequins are often used to stand in for patients during a usability test. High-end mannequins such as METI man and Blue Phantom trainers offer a plethora of capabilities, including adjustable internal bleeding levels, tissue that matches the real acoustic characteristics of human tissue and can be used with ultrasound, sensors that can detect the depth of nasal or oral intubation tubes, chest rise and lung sounds that can be synchronized with different breathing patterns, and pulse strength and blood pressure that can vary depending on ECG readings. We’ve seen adult female mannequins that can simulate childbirth and neonates that can produce various types of cries. The high-fidelity anatomy of these simulators, along with the ability to make them “speak” to medical professionals (a function operated by staff members from a control room), translates into an experience that very closely mimics genuine hospital scenarios.
In this ABC News video students at New York’s Simulation Center receive life-like lessons from high-tech mannequins:
As prescribed in the international standard IEC 62366:2007, “Usability validation may be performed in a laboratory setting, in a simulated use environment, or in the actual use environment.”ii Given all of their capabilities, medical simulation centers are worth considering for medical device validation tests. Be warned, however, that it isn't always the right solution for medical device usability testing. Their usefulness is a matter of applicability. Researchers must also consider whether patient behavior would significantly affect the outcome of the test, because if so, it may be necessary to evaluate the device in an actual clinical setting using real human patients.
Personally, I’m amazed at what one can accomplish in the simulation centers and eager to see what the next wave of technology innovation may bring!
i Association for Advancement of Medical Instrumentation, ANSI/AAMI HE75:2009
ii IEC/ISO International Standard 62366, Edition 1.0, 2007-10
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.
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.
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.
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.
Conducting User Research in the OR
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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:
- 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.
- 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.
- 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.
- 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.
- 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.
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.
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.
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.
- 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.
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.
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.
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.
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.