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You Don’t Get Harmony When Everyone Sings the Same Note
We live in a world of specialists. Nobody sings the same note, right?
Our corporations are filled with the special engineer of this or that. In the world of product development we might have human factors specialists, user experience specialists, manufacturing engineering specialists, and so on. We apparently have everyone singing a different note.
So why don’t we see the harmony that we should in product development? According to Northwestern University’s Kellogg School of Management, over 85% of all new product development efforts fail.
I think the answer could be that it doesn’t matter if everyone is singing the same note if they are all singing a different song. One note might sound great, but the rest of the song will be a disaster.
What does that mean for us in product development?
Making employees become specialists that just focus on one thing can make them lose sight of the “big picture” of the project. The key is to let your specialists not only experience the activities of the other disciplines, but actually let them take part in them. The more a mechanical engineer experiences design research, reimbursement strategies and brainstorming activities, the more he or she will understand the big picture and be able to make more informed creative and innovative design decisions.
Plus it will make their jobs more fun, and employees who enjoy their work are going to be much more innovative. Remember, the part of the brain that “gets” the humor in a joke is the same part of the brain responsible for problem solving. This means happy, pleasant thinking will help them be creative, and a fun job delivers on that promise.
So mix it up. Let the members of your R&D team take on tasks outside their normal discipline alongside those experts. The long term innovation benefits will be worth your while, and hopefully you will never hear, “that’s not in my job description” again.
What Goes Around Comes Around
Whatsoever a man soweth, that shall he also reap...
In 2009 I was invited to work on a device that would improve BPH (enlarged Prostate) surgery for patients and physicians. The long-standing procedure at the time left patients with a long, painful recovery and the prospect of wearing an adult diaper the rest of their life. The new device would have a quick recovery, be much quicker and easier to use, be nearly painless, and would restore the patient to normal life almost instantly.
I have always loved working on devices that are going to have a positive impact on people’s lives, and out of our 30 years of medtech development work, this was one of those golden opportunities.
At the time I was developing the technology, it never crossed my mind that someday I would be the recipient of its benefits.
Michael Hoey (founder of Francis Medical) came up with the idea of using steam to denature cell membranes and create lesions to reduce the size of the prostate. He thought of this while working on the carburetor of his race car… an ingenious concept. I was fascinated by this concept and gladly joined the team to develop the device.
In 2014 we tested several concepts with physicians at a conference in Florida (and the team taught me how NOT to wakeboard at that event). We took what we learned from the physicians and developed a final concept that went into clinical trials.
By 2018 the trials were over, sales had begun, and Boston Scientific acquired the device. It is now being widely used to perform this surgery in a much more painless, efficient and user-friendly way.
In 2021 I was diagnosed with BPH. I am so glad I got to know Mike and his team so well during the research for the project. Doing human factors work for his team was fun and full of memories that I will always retain. Providing the usability engineering and user centered design work for the device was rewarding both in the work itself, knowing your work will be helping others, and in getting to know so many talented team members to well.
When I got my diagnosis, I reached back out to Mike right away to find out who the best local urologist was who was using the rezum treatment. This Friday I go in to Minnesota Urology to get this procedure (rezum) performed on me.
I once heard the late Earl Bakken, inventor of the pacemaker, talk about how he never thought that the device he invented would one day be used to keep himself alive. I thought that was a nice “full-circle” delivery of good karma as a result of using his talents to help other people. This week, here I am thinking the same thing. Although this surgery is not about saving my life, It is definitely a major quality of life event that I now get to reap the benefits of. Like many things in life, if we focus on helping others, someday it could get paid forward back to us. It’s not our motivation for helping to improve other people’s lives, but sometimes it is an unexpected reward.
Shorten Your Medical Device Development Timeline Using These 3 Design Research Strategies
Is more design research putting the cart before the horse?
Design research can shorten the development process by making your FDA submission quicker and easier. Plus, you are making it more robust by doing the work now as opposed to later. Too many people wait until later in the process for this work and end up guessing on things or adding “filler” to their required usability data, which oftentimes the FDA can easily sniff out and flag. But by then it takes more time and money.
The point of design research is to provide the right information up front, so you can develop the best ideas early on. But nobody wants to spend the money to do it. It's a Catch-22. Frank Lloyd Wright said: "You can use an eraser on the drafting table or a sledgehammer on the construction site." The sledgehammer is a bit more expensive.
Design research actually minimizes project risk if you approach it correctly. What developers are ultimately trying to do with this research is understand what a user needs to do to be successful with the device. This helps create a thorough list of design criteria, but people seldom realize the immense value of this work. This criteria list can be leveraged to create design inputs, which is a necessary item for the eventual FDA submission. Also, if design research is documented correctly during the process, it becomes a robust formative study – another feather in the FDA hat. Here are some useful approaches for design research that will help drive success:
Read the full article HERE.
Designing Your Device So it Gets Reimbursed
It's not just an "old theory."
Kablooe's own Tom KraMer gave this speech at the 10x Medical Device Conference about designing your device for reimbursement five years ago. It seems like that's a good chunk of time to pass -- but in reality, the message is still relevant. Kablooe's team of designers and engineers use these practices every day in their projects.
https://www.youtube.com/watch?v=Oj20Fb4oNOI
IPS Joins Kablooe to Launch New Partnership
IPS and Kablooe are joining forces to give medical device companies comprehensive service offerings.
Hauppauge, NY and Minneapolis, MN – Feb. 02, 2021– Intelligent Product Solutions (IPS) and Kablooe Design, today announced the launch of a complete medical device design and engineering service, leveraging the expertise of these two award-winning product design firms. IPS and Kablooe, subsidiaries of Forward Industries (NASDAQ: FORD), have complementary services that help medical device companies successfully design, develop and launch new products.
With this complete medical device engineering and design offering, IPS/Kablooe services ensure speed to market of medical device products, successful user adoption and assurance of market advantage. The IPS/Kablooe combined services offering includes human factors engineering, verification and regulatory support along with upfront research and testing.
“Our combined expertise is unmatched in the industry and enables us to deliver the best-in-class medical device design services,” said Mitch Maiman, president of IPS. “Located in the heartland of medical device development, Kablooe has a strong reputation, expertise and track record in medical device design and we are thrilled to join with them to deliver this complete medical device design service.”
Tom KraMer, CEO of Kablooe commented, “With the extensive design and engineering service offerings available through this partnership, our clients are assured of an expert team from start to finish. We are agile, user centric, and flexible enough to always adapt our services to the needs of our clients, whether it is invention, feasibility, proof of concept, or design for production manufacturing. We now have the power to do it all.” Among its medical product design projects, IPS was awarded the GOOD DESIGN AWARD for its work on the AdhereTech Smart Pill Bottle, a personal medical device leveraging IOT technology to address medication adherence. The AdhereTech Smart Pill Bottle is currently used by leading pharmaceutical companies and pharmacies across the globe.
Kablooe’s many medical device design projects include the world class design and development of the Rezum® surgical system. Kablooe went from beginning to end with NxThera to get the Rezum® system into hospitals and clinics in the US and worldwide, leading to its acquisition by Boston Scientific. Nonin Medical has also regularly partnered with Kablooe, and most recently they worked together to create a patient monitoring solution that was easy to use and provided consistent measurements time after time in a rugged, reliable way for emergency responders.
CEO and Chairman of Forward Industries Terry Wise commented, “The integrated service offering combining the first-rate competencies of both Kablooe and IPS underpins our acquisition strategy. Forward’s ability to provide excellence in medical device design and engineering, a fast-growing sector, clearly positions the company for continued growth.”
About IPS
IPS, a subsidiary of Forward Industries (NASDAQ: FORD), is an award-winning global product design and development company that is headquartered in New York. IPS offers expert product design and engineering services, including Internet of Things (IoT) and wearable technology solutions. Its clients are among the leading brands in consumer electronics, medical devices, enterprise and security solution providers, and IoT-connected solutions, including AdhereTech, Google, Physio Control, Zebra Technologies, and charity: water. To learn more about IPS, visit http://www.intelligentproduct.solutions or contact info@ips-yes.com or @IPSdesigners.
About Kablooe
Kablooe, founded in 1991, is a leading product design and development company that is headquartered in Minneapolis, Minnesota. Kablooe offers expert product design and engineering service. Its clients are among the leading brands in consumer electronics and medical devices. To learn more about Kablooe, visit www.kablooe.com.
About Forward Industries
Incorporated in 1962, and headquartered in Long Island, New York, Forward Industries is a global design, manufacturing, sourcing and distribution group. The company has a 30-year plus track record of Far Eastern sourcing capability. Forward’s products can be viewed online at www.forwardindustries.com.
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For more media information, contact:
Lisa Hendrickson/LCH Communications
516-767-8390 lisa@lchcommunications.com
See original press release at GlobalNewswire.
How To Make A Better User Interface For Your Medical Device
Those of us who are in the design industry typically spend a lot of our time thinking about the person who is going to use our fabulous invention, and what the situation is like when they will be using it...
This is all part of our effort to ensure user-centered design principles are followed. When it comes to medical devices, these principles are more important than ever. If a user becomes confused about the function of a surgical tool during a surgery, the results could be disastrous.
This led us to think a bit about the factors that have contributed to the most successful user interfaces on medical devices that Kablooe has developed over its 30 years of medical device design. We identified a handful of principles that led to those success stories. Here are the most important practices we put in place when considering the design of medical device user interfaces.
1. Rethink What You’ve Been Taught About Creative Problem-Solving
Our “think like a designer and an engineer” mantra is a bit more philosophical than it is tactical, but extremely important nonetheless. This is not easy, however, especially in this day and age.
There is a lot of misinformation out there about how our brains work. Many of us were led to believe at some point that because of our personality, we had a stronger left or right neural network. Studies have shown that this is not true. According to the Institute for Brain Potential, the lobe of the brain that is responsible for art, beauty, and humor is also responsible for creative problem-solving — and that is the chief role of an engineer. Additionally, because of the neuroplasticity of the brain, we can use the left or right side equally as well, according to a University of Utah study. Because we know the brain is neuroplastic and that lobe can be exercised with these activities, it stands to reason that someone who is regularly exposed to art, music, and humor will be a better engineer.
However, these exercises are tragically absent from our academic lineup for engineers today. In most of academia today, we actually train people to not be creative. Most if this comes from our “linear” way of educating students. (See Sir Ken Robinson’s TED talk here.) When a student enters the academic world on an engineering path, they become pigeonholed as a person who either can’t, or doesn’t need to, possess the ability to participate in artistic activities.
Furthermore, in engineering academia, much emphasis is put on finding the “right answer,” and very little effort is focused on exploring many possibilities. I love the little cartoon that shows how a linear thinker would answer the task “Draw me a square” compared to the divergent thinker. You can see how using a non-linear method of thinking when considering possible solutions to a problem, and exploring many options, can lead to a host of possibilities that you can draw features from to form a final concept. This is how brilliant innovation is fueled and unexpected results are unearthed.
2. Take Advantage Of Creative Processes.
Here are a few ways to nurture creative problem-solving in your team:
- Have warm-up exercises before brainstorming and ideation. Exercising the part of the brain that is responsible for creative problem solving is extremely important when it comes to priming the brain for creative activity. Warm up exercises should include should include humor and problem solving, with some physical activity involved. The goal is to get the brain to release BDNF (brain derived neurotrophic factor) to stimulate creativity, and laughter initiates this response.
- Encourage a culture of fun, humor, and artistic appreciation. This keeps the BDNF flowing in the office all the time! Find ways to incorporate activities that promote these into your regular team calls and meetings. An example we like to use is to have a discussion topic at the start of a video call that requires everyone to respond and elicits humorous responses.
- When beginning to design a user interface, require your team to provide many solutions. It will force them to go deeper into that lobe to draw out more creative concepts. In the end, a combination of several concept solutions inevitably ends up being the best solution. This also assures that creative solutions are being discovered early in the development, which is much easier than trying to add innovative solutions later to a layout that everyone fell in love with at the start because it was the only option.
3. Incorporate Best Practices Into Your Routine.
There are a few things that have proven to be best practices over the years that maintain their creative prowess regardless of current trends or the passage of time.
The first is making sure that you understand what your users need to be successful with the device or system. This goes a bit deeper than just understanding your users in general, or getting some “voice of customer” data. It really means digging deep into
their world that encompasses your device or system and uncovering all their “little needs” that surround the “big need” that your device or system is attempting to solve in the first place. As Einstein once said, “If I had one hour to save the world, I would spend 55 minutes defining the problem, and only 5 minutes finding the solution.” In essence, he is saying that the most creative way to solve a design challenge is to intimately know your user. There are a host of methods in the design and human factors toolbox that can be used to do this.
Secondly, there are a number of design rules that should not be forgotten when developing a user interface, such as making sure there is a quick understanding of status, the ability to back out of a function, consistency across design elements, and, most importantly, affordance. Affordance is how well an interface or control makes it clear how it should be used. This seems simple, but it is often forgotten and sacrificed for the sake of space or detail.
Keep these things in mind while you are designing your next device user experience or interface, and you will be on your way to creating a “wow factor” that will have your user becoming your product evangelist.
Risk Mitigation For Homecare Devices
4 Tips For Anticipating The Unanticipated
Mitigating risk is one of the cornerstone activities of medical device design. The FDA’s goal is to only approve devices that are safe and effective, which means all risk would necessarily be removed from the use of the device. However, the definition of “safe” can be debated among developers because all risk can never be fully removed from any device. No matter how safe you make your device, if I want to poke myself in the eye with it, I can find a way if I really try.
With the surge in home healthcare these days, the topic of risk mitigation is becoming increasingly important, especially as it relates to home and remote healthcare devices. Designers now have to approach risk very differently than when devices were being designed solely for use by clinical personnel. This rise in home healthcare is driving the need for increased risk scrutiny for a few reasons.
First, the U.S. and many other countries are seeing a sharp rise in the number of seniors in their populations This means more people want to address their healthcare issues from a “healthy at home” standpoint, so the desire to address issues outside of the clinical environment is rising.
Pushing this desire to even higher levels is the pandemic. The psychological programming to alleviate boredom and seclusion by getting outside and being active is so pervasive that even folks who usually spent most of their pre-pandemic time inside are now finding a need to get outside… a very positive effect in the circumstances. This has also led people to want to monitor their health conditions while they are active and away from a clinical environment.
We have also seen an amazing convergence of clinical technology and consumer devices in the last decade. This has created a consumer appetite for healthcare items that users can obtain outside of the healthcare system, which can also produce risks due to the lack of clinical training with the device. Add to this the affordable care idea of penalizing hospitals for patients returning within 30 days of discharge, and you end up with a large number of people who have little or no clinical training interfacing with devices that affect their health outside of the clinical environment.
When we design devices for home or consumer use, there are many unique risk-related challenges we have to think about. Some of the most obvious are:
- How do we handle private medical information over digital networks?
- How do we prevent hacks into and breakdowns of devices over digital networks?
- How do we make sure the device is simple enough for a senior home user but sophisticated enough to provide quality data/services?
- How are we going to ensure sufficient manpower is available to screen data if we are generating more of it?
- If it is a constant use device, how can we ensure it is being used safely when care nurses are not with patients at all times?
- How can we get data to be useful across many information platforms?
- How can we make the use scenario well understood by seniors?
I would like to suggest four activities/mindsets that device developers can engage in while designing devices that can help mitigate the risks involved with failures in the seven areas above:
- Get a good understanding of what the end user really needs. We hear a lot about user needs, and the FDA mandates that we do verification testing to these needs. But understanding what the user really needs to be successful with the device can be a much deeper endeavor than most developers realize, including using ethnographies and other observational techniques to see what users actually do, rather than relying on what they merely say they do. Deep insights lead to strong innovations that reduce risk.
- Understand situational differences among demographics. A clinical device that a technician uses may have only one demographic, while a home-use device with the same function may have multiple demographics. Each of these users will live and operate in a different environment, using a different mindset, and will have different limitations and capabilities. Understanding these differences is the first step to solving the associated risk problems. Observational research with each of the different demographics is the key to this understanding.
- There is no replacement for the personal touch. In the quest to have technology solve our healthy at home needs, let’s not forget that so much more is learned about a patient through personal interaction. Whatever new technology you are developing, leave in the ability for a personal touch between caregiver and patient. You might get data from your device that tells you the patient has an elevated heart rate, but how will you know that it is due to worry over whether the patient’s dog will come back when she lets him out into the yard to go to the bathroom? What will your device do about that? Probably nothing. That takes a caring advocate in human form to help.
- Lastly, don’t design your device to randomly send data to some magic place in the cloud. That system is filled with people who have full-time jobs doing something else. And that system probably cannot afford to add more workers, especially the way hospitals are hurting financially right now. Make sure data gets sent to the appropriate people at appropriate times. Perhaps family members or other caregivers should be getting notifications first, before data gets sent to the doctor in the sky who has nothing better to do than wait around for data to come in from the millions of people using your device.
If you keep these things in mind at the inception of your project, and all throughout the development timeline, your homecare device should bear the honor of reducing risk and being safe and effective. I like to remember what I think of as the inverse rule, which claims that the more likely you are to need technology, the less likely you are to be savvy with it. I think of this when my elderly parents ask me for help with their email or when I ask my kids for help getting text on a video for my Instagram post.
This article originally appeared at Med Device Online.
Be Careful What You Wish For
I've heard a lot of stories about how the two world wars forced innovation to happen at a rapid pace in many areas...
No doubt some great things came out of this “rapid innovation.” I have often felt that great pressure produces the best results because it either yields a pile of rubble, or a diamond.
Many of the war stories I have heard had to do with food items. Mushed meat going into cans, chocolate being coated by a hard candy shell, etc. The driving force behind these innovations was the fact that we had to take something that was perishable (fresh fruit, vegetables, meats, grains, etc.) and preserve them for long periods of time so they could get shipped to soldiers overseas.
Factories became incentivized during wartime to change their processes. Food packaging, preservatives, chemicals, processing, bleaching, etc. all became tools to create packaged foods that had a sufficient shelf life.
When the war ended, factories more than likely felt the incentive to keep their investment in their new technologies and methods, and create markets that they could continue to sell their new wares into. Thus, we entered the age of processed food.
Arguably, before WW1, a survey of the average American diet would probably show a much higher percentage of fresh natural organic foods than would be shown today. I haven’t done it, but I bet if I gathered statistics on health and disease and made a chart, we would see a decline in health that somewhat mirrors the increase in processed foods. I doubt any one of you would disagree.
Think about the societal and environmental factors that went into the processed food movement - a global emergency, special laws, and mass propaganda (remember the “uncle sam wants you,” “defend your country,” “we can do it,” “loose lips sink ships,” etc.). At the time, all efforts were pushing for a good thing. However, without most of us recognizing what was going on, the processed food industry was creating a “new normal” for themselves.
The sobering thought here is that it never ended. This is now the standard operating procedure for most of the food industry as we know it, growing to be the large monster that we see today. The downside is that the long term health effects on our population have been very detrimental to our citizens over the years, and there are so many people now that have no memory of what is was like to cook with fresh food and ingredients.
We implemented emergency procedures that inadvertently became the new norm, and human health has suffered as a result.
When you use the term “new normal” - be careful what you wish for.
Forward Industries Acquires Kablooe Design
HAUPPAUGE, N.Y. and MINNEAPOLIS, Aug. 17, 2020 (GLOBE NEWSWIRE) -- Forward Industries (NASDAQ:FORD) today announced the acquisition of substantially all of the assets of Kablooe Design (Kablooe), an innovative leading medical and consumer design and development company based in Minneapolis, Minnesota for consideration comprising of cash, equity, assumed debt and contingent earn outs.
Kablooe is located in the US’s 3rd largest medical device development hub and its clients include leading brands in medical devices including Medtronic, Boston Scientific, Coloplast, Atricure, Cega Innovations and Rapid Diagnostek.
Commenting on the transaction, Terry Wise, CEO of Forward Industries remarked, “I am delighted and excited with the acquisition of Kablooe Design. Located in one of the heartlands of medical device development hubs, the company is an excellent strategic fit for the Forward Industries Group. Kablooe’s reputation, expertise and strong track record in being at the forefront of designing and developing innovative medical products is a perfect complement to the group as a whole and I am extremely confident it will afford cross fertilisation opportunities with our subsidiary, Intelligent Product Solutions. Strategically, Forward is well placed to grow and thrive in the future.”
Tom KraMer, CEO of Kablooe commented, “Forward Industries is an ideal partner for Kablooe because of its strength in medical products and we will continue delivering exceptional product design and development services. We remain committed to our team and to maintaining our offices in Minneapolis and, strengthened by the Forward Group, look forward to future growth.”
For more information on the terms of the transaction, please see the Form 8-K filed with the Securities and Exchange Commission on August 17, 2020.
About Forward Industries
Incorporated in 1962, and headquartered in Long Island, New York, Forward Industries is a global design, manufacturing, sourcing and distribution group. The company has a 30-year plus track record of Far Eastern sourcing capability. Forward’s products can be viewed online at www.forwardindustries.com.
About Kablooe
Kablooe, founded in 1991, is a leading product design and development company that is headquartered in Minneapolis, Minnesota. Kablooe offers expert product design and engineering service. Its clients are among the leading brands in consumer electronics and medical devices. To learn more about Kablooe, visit www.kablooe.com.
Cautionary Note Regarding Forward-Looking Statements
This press release includes forward-looking statements including statements regarding synergies, growth and opportunities from the acquisition. The words "believe," "may," "estimate," "continue," "anticipate," "intend," "should," "plan," "could," "target," "potential," "is likely," "will," "expect" and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. The results anticipated by any or all of these forward-looking statements might not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include our ability to successfully integrate Kablooe into Forward, changes affecting the business in which Kablooe operates, continued economic downturn from the COVID-19 pandemic and competition from third parties. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K. We undertake no obligation to publicly update or revise any forward-looking statements, whether as the result of new information, future events or otherwise.
For more media information, contact:
Anthony Camarda
(631) 547-3041
acamarda@forwardindustries.com