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Getting Engineers and Designers to 'Play Nice'

Here are three ways to help make it happen in medtech.

Tom KraMer, Kablooe Design

Rebecca 1917 BullyingThe stigma has been around for a long time. Engineers hate it when designers come up with concepts that can't function or be manufactured. Designers hate it when engineers ruin the design intent and make a square metal box to house all the components. Lots of time is spent throwing the concept over the wall to the other group and thinking that it is their problem now.

What can be done? There are a few best practices that give your designers and engineers common ground that allows them to work together to hit goals that they both share. 

Here are some to consider for your team:

1. Create a Senate Sub-Committee

Democrats and Republicans are in a constant struggle for power. How do they get anything done? They create sub-committees with people from both parties on board to make decisions. Apple does a similar thing with their product development team. They have an industrial design team, and they have engineering teams, but they also form a product development team with designers and engineers, and this team is tasked with some of the major responsibilities of the project.

Sharing responsibilities for decisions helps them to listen to and consider each other's needs on the project, allowing them each to weigh the respective importance of issues and make decisions that are best for the overall project.

See KraMer discuss best practices in product development at MD&M Minneapolis, September 21-22, 2016. Qmed readers get 20% off with promo code Qmed16.

2. More Broadening, Less Specializing

It is tempting to put each team member in a corner and make them only focus on one task that they do well. It is hard to pull a bunch of specialists together to make one cohesive item. Instead, consider giving your engineers some activities in the early design phases, such as involvement with ideation and industrial design reviews. Also give your designers responsibility for some of the design for manufacture and assembly tasks.

Letting them overlap in this way will surely drive conversation about important issues between the groups and lead to meaningful discussion and mutual understanding of needs.

3. Usability is King

Have them both involved in usability studies up front. I don't mean just have them read the usability report, but actually have both engineers and designers TAKE PART in the studies that lead to the customer and product requirements.

This firsthand knowledge of the user needs will give them what I call "a-priori" knowledge--the idea of knowing ahead of time what the device needs to be in order to be successful. Armed with this knowledge, both teams will often find common ground for design options, and actually support each other's activities knowing they are all driving towards a common goal.

Try to think of it as an archaic thing from the past for engineers and designers to not get along. In this day and age of rapid development and prototyping, things move fast and collaboration between departments has to take place on a regular basis efficiently. If they don't, your product and company will end up taking some lumps from the competition. 

Let team members from both groups be Leonardo DaVinci's and wear a couple of hats, and see how they begin to empathize with the goals and functions of the other group. You will be surprised how well they begin to work together when they have shared ownership of goals.

Tom KraMer is a UBM Medical Devices Group Advisory Board member and founder of Kablooe Design (Coon Rapids, MN). Tom is passionate about making medical device ideas become reality. 

[Image, from 1917 silent film "Rebecca," is public domain.]

5 Medical Technologies Fit for Football

5 Medical Technologies Fit for Football

Football is back. In honor of the NFL season opener, we're highlighting five in-development medical technologies that are trying to make the sport safer for players.

The start of football season is an American tradition, the unofficial start of fall. While the sport is as loved as always, there is growing attention about the potential medical dangers of tackles and takedowns.

NFL, in partnership with GE, Under Armour, and the U.S. Department of Commerce's National Institutes of Standards and Technology, has put a spotlight on efforts to address brain injuries with its Head Health Challenges. Numerous companies are striving to create solutions and technologies that prevent, detect, and treat concussions and traumatic brain injuries (TBI). 

Here are a few medical technologies that are focused on keeping football players' brains healthy so that they (and their fans) can keep enjoying the sport. 


Learn about "Tapping the Explosion of Offerings in Sensors" at the MD&M Minneapolis Conference, September 21-22.



How To Generate Usability Requirements and Conduct Usability Testing

How To Generate Usability Requirements and Conduct Usability Testing

What is the best way to approach the vital step of usability testing? An expert shows how device makers can understand user needs, generate usability requirements, and perform the necessary assessments.

Dean Hooper

In many organizations, iterative usability testing and sound product design has become a widespread concept to the point of being considered a tautology. The consumer product industry views it as a competitive advantage and regulated product makers are feeling pressure to comply with human factors principles during product development. Indeed, FDA, for one, is requiring many medical device producers to demonstrate product safety and usability characteristics in order to market their products. This is done through simulated use and traditional usability testing.

However, product development teams and managers remain concerned about the resources, both time and people, needed to include user-centered activities, as well as the best approach to assess error and its impact. Product managers want to know what to test, how many iterations to perform, and how to know when formative studies are finished. A concrete, agreed-upon definition of "finished" would allow for planning while making the results of usability testing understood and owned by the entire team.

 Hear Hooper speak about "The Latest Shifts in FDA Regulations on Usability and Designing for User Needs" at MD&M West in Anaheim, February 7-9.

The generation and testing of usability requirements provide the team with usability success (and failure) criteria for making a determination as to when the design is "good enough" and to ensure with confidence that potential errors have been investigated and evaluated.

Figure 1 summarizes the life cycle of usability requirements from initial user needs to final design inputs. The activities outlined in red are iterative in nature. As empirical usability data is collected, requirements may be refined and additional errors exposed for further evaluation. The mitigations resulting from the uFMEA are then translated to design inputs.

Figure 1. Flow of usability requirements through product development.

Through the use of a case study, this paper will begin with the definition and examples of usability needs and goals, description of activities used for the formation of use functions and testable requirements, how requirements drive testing scenarios, and, ultimately, how they define design controls for iterative testing and design decisions.


A conceptual blood pressure monitoring system was used as an example. A main component of the system is a smart phone app that allows the patient to monitor levels real time via a blood pressure gauge, detect hypo- or hypertensive conditions, record activity and related information, and send information to the clinic. 

User Needs

Just a (very) few words about user needs. In any one industry all products are designed to meet a (very) finite set of needs. These needs must be solution free and describe the intended goals of the end user. Given this definition I propose the following set of needs for all medical devices.

User Needs 1 through 4 relate to the clinical outcome itself.

     1. Don't hurt yourself, another, or the patient.

     2. Monitor and diagnose accurately.

     3. Maintain or improve the intended patient's condition.

     4. Determine efficacy and/or compliance of previously prescribed therapy.

User Needs 5 and 6 relate to personal needs given the specific malady.

     5. The treatment shall be discrete and not impose on patient privacy.

     6. The treatment shall be administered in a timely fashion to maximize the efficacy of the therapy.

Functional Analysis

The next step after solution-free needs are formalized is to determine what the user must do to meet those needs. These functions are usually defined with a solution in mind. Indeed, and as illustrated in Figure 1, the technology chosen may drive the formation of functions. For example, the decision to use a cellphone app will add a user responsibility to maintain and charge the cell phone battery as needed. In the case of a blood pressure monitoring smart phone app, the following functions were identified:

1) Battery Monitoring and Charging. In order for the system to function properly, battery power must be at an operating level. The battery must be charged from time to time depending on usage.

2) Application Set-up. The system software must be tailored for the needs of the individual patient. This is accomplished via software settings.

3) Log Events. While not crucial for the use of the system, the patient user may log significant events into the application.

Usability Requirements

Based on the functional analysis and the resulting set of user functions, a set of system usability requirements or goals are generated. These requirements must be stated so as to make them testable. For more on this, explore the US standard on usability requirement generation. In order to reach established usability goals, each requirement must be met by all adequately trained users on the first attempt with the aid of instructions for use, if necessary. Any observed error shall be subject to an analysis to determine the nature of design mitigations, if needed. This subsection contains the usability requirements subjected to verification. They are organized by their respective function. The appropriate user must be able to:

1) Battery Monitoring and Charging.

  • The appropriate user must be able to determine a current battery strength upon presentation.
  • The appropriate user must be able to recognize when the battery needs to be charged when presented with a battery depleted condition.
  • The appropriate user must be able to charge the battery from a depleted state.

2) Application Set-up. The system software must be tailored for the needs of the individual patient. 

  • The appropriate user must be able to locate and upload the app on a smart phone.
  • The appropriate user must be able to customize the app to indicate the presence or absence of a blood pressure gauge.
  • The appropriate user must be able to verify systolic and diastolic pressure times as prescribed during device set up.
  • The appropriate user must be able to enter corrected blood pressure values as prompted.

3) Log Events. The patient user must be able to enter relevant information concerning a specific pressure reading into the application. These events may be:

  • The appropriate user must be able to input stressor events as directed.
  • The appropriate user must be able to input exercise events as directed.
  • The appropriate user must be able to input overall health assessment as directed.

Task and Human Failure Analysis and Testing Scenarios

The identified usability requirements may then be used as use goals in a goal oriented hierarchical task analysis. Each goal is evaluated on the discrete tasks and sub-tasks required to achieve the goal. This exhaustive task analysis is then used as the foundation for a use error analysis. Figure 2 illustrates part of this analysis. Again this is an incomplete analysis for illustrative purposes. Here is a detailed description of a human failure assessment process. 

Figure 2. Partial Human Failure Analysis

Once task and human failure analyses are complete, the design team can formulate usability testing scenarios to verify the requirements. The tasks and sub-tasks may be used as a guide to evaluate testing performance if use difficulties do occur.

Usability vs Safety

Most industries such as mass consumer electronics would conduct a more formal requirements verification test as formative studies. Each requirement is transformed to a usability goal by adding success criteria. For example, such a criterion could be that 90 percent of test users successfully perform the task related the requirement. If this level is achieved, then the usability goal is reached and the design is formalized. If the goal is not met, the design is iterated and retested, if needed, until the usability goal is met.

In the case of regulated medical device development, the only criterion can be a 100% success rate. While requirements can drive scenario development and subsequent testing, any errors must be evaluated for cause and potential risk. That is, the requirement becomes less usability goal and more a guide for testing scenario generation and subsequent evaluation of user performance. However, both usability goal verification and use error testing can be conducted simultaneously.

Dean Hooper, principal at HE Consulting, provides user-centered design expertise to all phases of product development, from initial needs gathering to final product validation. He can be reached at [email protected]


5 Medical Technologies Fit for Football—X2 Biosystems

X2 Biosystems

X2 Biosystems, located in Silicon Valley and Seattle, has created the Head Trax system to measure the impact of repeated hits to the head.

The system includes the X-Patch Pro sensor, worn behind the ear; the X2 Sensor Data Management (SDM) app, which allows for collection and analysis of the sensor data; and the X2 Integrated Concussion Evaluation (ICE) app for testing neurocognitive performance before and after the high-contact activity.

X2's Sports Advisory Board is packed with football greats, like Terry Bradshaw and Ray Lewis. The company was recognized earlier this year with the 2016 Pioneer in Healthcare Technology Innovations Award by The Society for Brain Mapping Therapeutics. 


Continue on to "Olympians Love These Technologies"

[Image courtesy of X2 BIOSYSTEMS]  

Learn about "Tapping the Explosion of Offerings in Sensors" at the MD&M Minneapolis Conference, September 21-22.

5 Medical Technologies Fit for Football—Software for Sideline Imaging

Software for Sideline Imaging

Researchers at the University of Aberdeen in Scotland are focused on developing software that would walk someone through conducting the brain scan on a person with a potential TBI using portable ultrasound equipment. That software would also turn the brain scan into a 3-D brain model that could be transmitted to a remote expert for rapid diagnosis and advice. 

According to a university press release, the software is still in the earlier development stages but is being trialed on hospital patients.

The work is being funded by the Defence Science and Technology Laboratory's Centre for Defence Enterprise and it applications seem focused on military use, but it's not much of a leap to envision such software in use on the sidelines of a football field. Faster detection and treatment could have a meaningful impact on long-term clinical outcomes.



Learn about "Tapping the Explosion of Offerings in Sensors" at the MD&M Minneapolis Conference, September 21-22.

5 Medical Technologies Fit for Football—BlackBox Biometrics

BlackBox Biometrics

Rochester, NY-based BlackBox Biometrics has plenty of cred when it comes to military sensors. Its Blast Gauge System sensor, focused on TBI, has been used with the U.S. Army, Special Forces, FBI, and SWAT teams, according to information on the corporate website. 

The company has transferred that technology to sports with its Linx Impact Assessment System (IAS), a thin sensor that offers immediate evaluation of contact incidents. That impact data is available to players, coaches, and families via an app and can help inform decisions about whether further concussion testing is needed. 

The company underscores that concussions are not just a problem for professional athletes. A video on the Linx IAS website features young athletes and the company cites data that found that 40% of sport-related concussions are in children between 8 and 13 years old.


[Image courtesy of BLACKBOX BIOMETRICS]  

Learn about "Tapping the Explosion of Offerings in Sensors" at the MD&M Minneapolis Conference, September 21-22.

5 Medical Technologies Fit for Football—BrainScope


BrainScope, headquartered in Bethesda, MD, is working to find a way to determine which patients have concussions. 

BrainScope's Ahead 200 device (pictured above) received FDA 510(k) clearance in May 2015. The device takes an electroencephalograph (EEG) reading of a patient with mild TBI. With a smartphone and a custom sensor, the handheld system is used to assess damage to the brain. According to the corporate website, the Ahead 200, as well as its predecessor, the Ahead 100, are meant for development, not commercial, purposes. Its next-gen system is in the works.

The company was also one of the final winners in the Head Health Challenge I, sponsored by NFL and GE. Its TBI assessment technology was highlighted at the NFL Annual Meeting in March 2016.

BrainScope has also received millions in TBI research funding from the U.S. Department of Defense.


[Image courtesy of BRAINSCOPE]  

Learn about "Tapping the Explosion of Offerings in Sensors" at the MD&M Minneapolis Conference, September 21-22.

5 Medical Technologies Fit for Football—Quanterix


Lexington, MA-based Quanterix has developed the Simoa platform, which performs extremely sensitive automated detection and quantification of protein biomarkers. This includes blood biomarkers related to brain injury. 

Quanterix was recognized as one of six final winners in the Head Health Challenge I, sponsored by the NFL and GE, for its efforts to speed diagnosis of mild traumatic brain injuries. 

This summer, Quanterix announced a partnership with fellow winner Banyan Biomarkers that would add Banyan's UCH-L1 and GFAP assays for TBI biomarkers to its Simoa platform.


[Image courtesy of QUANTERIX]  

Learn about "Tapping the Explosion of Offerings in Sensors" at the MD&M Minneapolis Conference, September 21-22.

4. Financials

    Arrow  backLemonade Stand

Market volume estimates play into how you manufacture your device. Estimate it wrong, and you could be stuck with a manufacturing process that doesn't fit. "It plays into your business models," Murdeshwar says.

You need to figure out the right price for the device, or even how you are going to sell it.

And then there is the need to make sure the health providers can be reimbursed for the device after they buy it from you.

Reimbursement has become a huge issue, Murdeshwar says. No codes yet for the procedure you are proposing? It could add on years to your project. Says Murdeshwar: "It takes years to get a code, which is one of the main reasons that people don't come up with these crazily innovative devices, unless they know what's going to happen with reimbursement."

Find out about medical device design dos and don'ts>>

[Image courtesy of amy gizienski on Flickr, per Creative Commons 2.0 license]

3. Usability

    Arrow  backDesign

This is about persuading engineers to let designers into the product development process early. In the past, Murdeshwar has found this can be a difficult thing--something that makes the achievements of design-conscious companies such as Apple even more remarkable.

Engineers want to look at the solutions, plain and simple. But Murdeshwar finds, "When we implement this, we have to dumb it down. Any non-engineer has to be able to use it. ... There are many examples where you get these widgets--appliances, whatever--that are so complicated to use."

Murdeshwar finds device usability is achieved when you can say, "It's so easy to use, it's so usable, it's ergonomically designed, you want to hold it and go to bed."

Continue >>

[Image courtesy of Pixabay]