DeviceTalks Minnesota

DeviceTalks Minnesota

DeviceTalks is an educational forum bringing together engineering, product development and commercialization professionals to share the challenges and best practices of getting medical devices to the market. Join us on Sept. 9-10, 2019, as we explore the trends and technology that are shaping the future of the medical device industry. We hope to see you there!

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Agile vs. Design Thinking: Which is Better?

Car crash testI was recently at a conference that was ‘innovation central’ for medical devices

and had the privilege to see more new innovative technologies on the cusp of  greatness than I can mention in this short article.

I did notice however a tension between development philosophies with many of the projects. What it boils down to is two camps. There is the camp that sees the possibility for a new technology. They get fired up about testing it to see if it could work. Feasibility models are built, tests are run, and so on. These folks tend to be of a more scientific and academic background, but not always. The other camp is the group that is looking for a need to meet, and when the find one they qualify it out and begin to look for technologies that can create a device to meet the need.

To say that the first camp is practicing Agile, and the second camp is practicing Design Thinking is a far cry from accurate. However, a few major principles from each methodology do dominate each camp.

Agile is about testing things quickly, learning from that, and testing again. This means you have to make something. This is the thinking that is driving the folks in the first camp.

Design Thinking is all about meeting users needs and believing they will adopt your device solution into their lives. This is driving the folks in the second camp.

Both of those methodologies have good qualities that are very useful at the right times. But are some important things that should be applied in either scenario that will help ensure product success:

-User research should be done first. In design thinking it is all about discovering key stakeholders needs. But in Agile, there still needs to be a vetting process for the idea itself, and this process should include determining if the targeted user really needs or wants this device. Note this is very different from understanding that the user wants a solution to their problem. The user need exercise in agile could easily be ‘asking the 5 why’s” which will take you back to the core of the problem and make you think about other possible solutions to the problem, not just the one that you are itching to build and test now.

-Concepts can be tested in a lot of ways. Most people think in agile you have to build a working prototype to test concepts. This is not always true. There are a lot of things you can test with a sketch. Since a sketch takes a fraction of the time it takes to build a working prototype, think about all the concepts you can test for certain things with sketches compared to a prototype. This will help you eventually test prototypes that will be more ‘on target’. The point is to learn and improve, and both methods embrace that philosophy. Design Thinking embraces the idea of using low fidelity concepts to test early, and move to higher fidelity as you progress through learning. Agile believes in concepting the most important features first, them move into defining those of lesser importance.

-It's all about how you start. If you plan on learning about user needs from the start, and are focused on improving the concepts as you progress, you may find yourself using a hybrid methodology that is more robust.

Want to learn more about that kind of method? Kablooe’s D3 Process® (Design Driven Development®) is a process that uses thinking from both camps to develop products in a holistic framework that addresses user needs and develops solutions efficiently. Click here to learn more.

Design of medical devices conference

Design of Medical Devices conference

The University of Minnesota's Earl E. Bakken Medical Devices Center (part of the Institute for Engineering in Medicine), the College of Science and Engineering and the Department of Mechanical Engineering presents the 18th Annual Design of Medical Devices Conference, April 15, 16-18, 2019. The world's largest medical device conference will be held at the Graduate Minneapolis & McNamara Alumni Center, located on the University of Minnesota Twin Cities Campus.

Let's Face It: Medtech Development is Hard

As product developers, inventors, and engineers our human tendency is to chase what appear to be exciting ideas.

However, business dictates that we minimize idea-chasing and maximize real-world problem solving.

And problem identification is work. First we need to understand the problem, then uncover user needs, and finally define accurate product criteria to meet those needs.

Without this necessary upfront work, your ideas may be fun to think about but are likely off-target and not strategically focused enough to create meaningful design criteria.

Typical voice of customer data can be insufficient, in and of itself, to properly identify problems and get to foundational needs or “the need behind the needs.”

What makes it so hard? Think about the following:

  • Hidden problems aren’t always obvious, even to those who experience them every day. (Forest for the trees syndrome.)
  • Hidden problems often only reveal themselves over time. (Otherwise they are not hidden.)
  • There is a disconnect between the kind of problems the young and the old experience. (Solutions often are not connecting with user needs.)

That is why ethnographies are so important: Spend time with users, observe what they do, hear what they say, and ask them why—a lot.

This is how hidden problems are found. However, make sure you do not stop at this stage and jump right into idea creation.

Before you form a concept idea, make sure you do these two additional things:

  1. Create a large list of need statements. Most likely, you found one main problem that will be the focus of your product. Great. But if you were really paying attention during your research, then you will have also found many smaller problems surrounding it. These are all problems because they relate to the user’s needs. Make need statements out of all of them.
  2. Convert each need statement into design criteria. This new statement will describe what the product will need to accomplish in order to fulfill a specific user need. Being vague here is best. You don’t want to define the product and its features, you just want to describe what the product needs to accomplish.

Once this is done, you can start developing ideas that potentially fulfill the identified design criteria. Then you won’t merely be chasing ideas, you will be developing solutions with relevance to actual needs in the market.

If you need a process to guide you along the way, the Design Driven Development Process® can help you build relevant products that matter to the people that use them.

Now, chase that! 

Is Your Design Revolutionary or Evolutionary?

Your design may not be a breakthrough, but could it help you break free from some regulatory burden?

Not all new medtech designs are revolutionary, and that’s ok. Incremental advancements evolving from predicate devices—also known as evolutionary designs—could very well delight users and provide companies with a competitive edge.

Speakers at the upcoming MD&M Minneapolis conference will explore the potential of evolutionary design in the October 31 panel discussion, “Employing Evolutionary Design While Satisfying the Requirements for an FDA Compliant Process.”

MD+DI asked panel moderator Tom KraMer, president and CEO of Kablooe, a few questions about evolutionary design and what attendees can expect to learn. (KraMer has been a product innovator for more than 28 years and developed the D3 Process [Design Driven Development].) At the event he’ll be joined by John Cain, lead industrial designer for 3M; Mark Wehde, section head, Technology Development Division of Engineering, Mayo Clinic; Peter Madson, vice president/partner, Worrell; and Mike Bravo, director, preclinical strategy, NAMSA.)

MD+DI: What do you mean by “evolutionary design”?

KraMer: Revolutionary design is often thought of as the breakthrough, game-changing type of design that creates a new paradigm. This can be very difficult in 510k products because of the need for an equivalent device that precedes. Evolutionary design takes that next logical step up in function and meeting user needs, without the risk of creating a new world that users will have trouble adopting.

MD+DI: Why is evolutionary design important for today’s emerging medical devices and today’s healthcare needs?

KraMer: Building on the successes and knowledge base of the past is a great foundation for pushing the envelope to the next logical step. With evolutionary design, you can understand what users, buyers, and other stakeholders will tolerate and set your design goals there. With breakthrough designs, you are really forcing users to adopt or decline using it.

MD+DI: How does the approach help medtech professionals navigate the regulatory process?

KraMer: It can definitely help you stay in the 510k range and avoid costly PMAs. This isn't always the case, but it sure helps. It can also allow for more efficient testing, which can make regulatory submissions a bit easier.

MD+DI: Are there any design or development pitfalls that the process can help avoid?

KraMer: It can. Inherently, a design that evolves from a predicate will have a considerably defined direction. This can help the R&D team focus on a variety of feature and detail options. This can be a great tonic for the problem of focusing too early on a single solution and spending a large amount of time and money developing it before finding the need to pivot.

MD+DI: How does evolutionary design ensure human-centered design?

KraMer: It doesn't really. That is always up to the designers. If the predicate devices are poorly designed from a human-centered standpoint, the evolutionary design could easily be, too. It takes good designers to change this. The inverse is also true.

MD+DI: The panel discussion includes designers and engineers as well as a testing professional and an engineer from a healthcare system. Does evolutionary design ease collaboration among all these types of job functions or assist in any other way?

KraMer: It really can. When the focus is on smaller challenges, the team can go deeper into those areas, and that allows for collaboration and cross functional engagement. Time equals options.

MD+DI: What sort of discussion do you anticipate during the panel?

KraMer: I expect specific regulatory challenges to be surfaced and ideas for how they could have been avoided or turned a different outcome to be discussed. There might be some opposing viewpoints, but I'm sure they will all be valuable ideas from this group.

MD+DI: How will your session cover software and hardware development? Rapid prototyping?

KraMer: Software and hardware have their own verification and validation requirements, and I'm sure some of the differences and similarities will be explored. Rapid prototyping is a great tool to expedite design iterations and can help the evolutionary steps proceed in a tighter direction.

MD+DI: What do you hope that attendees will do differently after hearing the discussion?

KraMer: My hope is that they will take away some methods and tools for their teams back at the ranch to try that will help them more efficiently arrive at their solutions.

This topic was discussed October 31, 2018 at the MD&M Minneapolis panel discussion moderated by Tom KraMer titled, “Employing Evolutionary Design While Satisfying the Requirements for an FDA Compliant Process.”

Interview by Daphne Allen

Daphne Allen is editor-in-chief of MD+DI. She previously served as executive editor ofPharmaceutical & Medical Packaging News, which serves as the pharmaceutical and medical device channel of Packaging Digest. Daphne has covered medical device packaging, labeling, manufacturing, and regulatory issues as well as pharmaceutical packaging for more than 20 years. She is also a member of the Institute of Packaging Professionals's Medical Device Packaging Technical Committee. Follow her on Twitter at @daphneallen.

Kablooe Judges "Shark Tank" Event at Minnovate

Kablooe President, Tom KraMer, judged the University of Minnesota's #innovation talent last night at Minnovate's "shark tank" style event.

U of M student teams competed for cash prizes by unveiling their innovative device or system concepts that solved problems in one of three possible areas: #healthcare, sustainability, or IT.

Tom judged in the healthcare arena, awarding his kudos to a team that developed a device to detect concussions in autistic children.

It's always good to see that the innovative spirit is alive and well in #Minnesota, and the #Minnovate team is just one of many local groups that is keeping that spirit alive. Go Minnovate!

Find out more about Minnovate here:

Medtech Underground Appears

The Medtech Underground is alive and well in Minneapolis.

The "End of Summer" Soiree was in full swing at the Bakken Mansion in Minneapolis.

Kablooe President Tom KraMer was able to throw together some dapper attire and peruse the event with such medtech giants as Steve Anderson from Preceptis Medical, Danny Sachs with the University of Minnesota, and Darryl Barnes of the Mayo Clinic. The event was well attended, inspirational, and informational.

Bonnie Labosky delivered an inspiring keynote address sharing experiences of how to innovate in the face of tradition, while startups Preceptis Medical, Mobile ODT, Enclear, RXFunction, Sonex Health, and Medical Early Sign shared their stories. It's not often we can get that much medical device knowledge in one room, especially dressed that well in an old mansion! Kudos to the MedTech Underground for bringing this group to light!