MPR Associates Discuss Brainstorming in Medical Device Development and wearing “Six Hats”

Cameron Loper and Brian Scrivens of MPR Associates discuss brainstorming and how it can bring a medical device to market. MPR is a leading international design and engineering firm. Below, Loper and Scrivens discuss a “use case” which allows a company to ask, what does this device need to be able to do, who’s going to use it, what’s the environment going to be like? This helps them understand what needs to be accomplished.

 

 

Click below to hear audio interview and see full transcript below.

Brett Johnson:     Hello. This is Brett Johnson in New York City with OneMed Radio. Today, I’m with Cameron Loper and Brian Scrivens. They are product development engineers in the medical device and development field at MPR Associates. MPR is a leading international design and engineering firm. They work with the group that develops and brings new devices to market. Today, we’re going to talk about brainstorming and how it can accelerate bringing a device to market. Thanks for joining us today, gentlemen.

Brian Scrivens:     Hello. How are you?

Cameron Loper:   Glad to be here.

BJ:   So let’s talk about brainstorming. I mean one of the key things that you guys have focused on is your capacity to bring products to market faster and to compress the time. How does brainstorming help you do that

BS:     Well, Brett, actually brainstorming is a very powerful idea that’s typically used heavily in the beginning of a development process in order to make sure that we’re going to capture all the constellation of viable ideas out there for a product. To try to make sure that we’re really covering all the bases of possibilities that are available for further design and development.

CL:     I would add to that that’s right. There’s an infinite number of possibilities for giving a constraint for any product or problem and brainstorming is just a means, a structured means to generate ideas with minimum bias and as quickly as possible.

BS:   We also want to use this to shake up any preconceived ideas. Many times projects get started with the design is practically done in people’s minds and people go down that path without really exploring other possibilities. So brainstorming is a way to try to shake up that thinking and make sure that we’re starting fresh.

BJ:      So is brainstorming a process? I mean is there like a way that you brainstorm?

BS:    There’s a number of methodologies that are essentially plug-in components for brainstorming and that can be selected by a group depending on what they want to do. For instance, we typically start out thinking about something called a use case and that allows us to ask what does this device need to be able to do, who’s going to use it, what’s the environment going to be like. This helps us to understand what we’re trying to actually accomplish.

CL:   I think the use case is one of the most important ones. It gives a common understanding for everybody. By doing the mechanism or the tools of the use case, you define out the user needs and then you start to imagine the user experience. How are they going to interface with this product, what are all the interfaces with this product. Those can range from the start of the product such out of the box. You get this product and you’ve got to take it out of the box, what is that use case, what do you need to do. Of course, there’s the normal ones when they’re using the product no matter what type of product it may be, and then it can extend all the way to how do you dispose of the product. So they allow that common understanding and they allow a definition of how the product will be used and then that helps define later requirements around those different use cases.

BJ:     So are there like sort of management, information management tools you use? I mean like diagrams or systems. Can you talk about how you actually keep track of all this stuff?

BS:   Sure. The use case typically can be in a form of a process flow diagram, you know, like a block diagram people might be familiar with. It could be in the form of a table just describing different columns, one column being the steps, the other column being describing what the user is doing, and another column describing what the device is doing. Another tool we might use early in is a block diagram where a very high level diagramming out of the functional elements that we would imagine for a system.

CL:     I’ll add to that that products or systems are very complex in their nature especially when they’re undefined at the beginning. There’s typically some loose concept of how it will work, but it hasn’t been fleshed out. So going through that process of making an architectural or block diagram is very helpful for illustrating the different components of the system, how they interact, and it gives a visual picture to what at that point may have no definition.

BJ:  I saw you guys had talked in your outline about the whole idea of mind maps and the six hats and some other kinds of interesting sounding things. Do those relate to this block diagram as well?

BS:   Absolutely. I was just going to introduce those. Some of other tools that we would use and these could all be combined in a single brainstorming session or they could be used one at a time on different formats. But a mind map is essentially a graphical outline of ideas that people are brainstorming out around a topic. So it just helps to put out graphically what those ideas are that are new, the considerations, and then helps people to draw connections between two ideas that it may not be apparent that they are in fact related.

Six hats, a lot of times people get into a paradigm of they just blurt anything out in a brainstorming session. Six hats is a way of giving it direction. By that, I mean the six hats being emotions as for a red hat. A yellow hat would be if a moderator says well everybody put on the yellow hat, everybody is floating only positive ideas and they don’t really have a fear of being seen as ridiculous because they’ve been told that hey the moderator wants only positive ideas. So this is typically useful when combined with some other techniques such as mind mapping.

Another one that’s very interesting is random stimulus. On the right side, we might put down short word or a statement of how a goal might be accomplished and then on the left would be the idea of the problem to be solved and then in middle we’d insert a random word. Just having that in front of the group and then asking for solutions to the problem. Many times those words tend to key different ideas in people’s minds so it is remarkable how well this works.

BJ:    That’s interesting. It sounds fascinating. So is this typically all done like on a white board around a conference room or can you kind of set the stage of how you execute these creative ideas?

CL:    Well yeah, I think that’s a good question. First, we would typically start out with doing use cases and that’s usually an exercise that somebody can do on paper on their own and then bring that, share that with the group, but then that sets that stage. Then we will typically hold one to three brief sessions usually no more than an hour to run through all these other tools that Brian has mentioned. The key for this though is to have a good moderator and he or she is providing the value of keeping things moving, keeping the team going. Obviously using the six hats then they have other functions, there’s a person that will typically hold the pen and write things up on a board though that’s not required, by any means, you can have other people. The other key for a moderator is to have no bias. They have to allow for free flow of ideas because this is the creative part of the whole process and this where the ideas must flow and using everybody’s in built creativity to the extent possible is key.

BS:   What we’re looking for is new ideas and ways of thinking about a problem.

BJ:   Interesting. So in terms of the moderator then, is that someone that comes from within your team or do you get someone from outside that doesn’t really know much about the business of developing devices?

CL:      That’s a good question. I think it could go both ways, but we find that it’s better to have somebody within the team because while there are infinite ideas, there is some concept to start with and it helps to start focusing in over these sessions and during the sessions to a concept.

CL:       So somebody who understands it and can take that, can help guide that to more concrete. That’s the ultimate goal, right, is to come up with the concrete concept.

BJ:   Is there typically sort of a timeframe and number of periods of time over which these sessions, is this over a week, is this a month, is this over…? How many sessions do you typically use typically I guess?

BS:    Well you can’t it let it go too long because people get diverted with other demands. So we like to keep it in a week or two.

CL:    So if we’re talking about one to three brief sessions, we’re trying to keep any particular period of brainstorming within a week or a week and a half to have a session, process it, have another session.

BS:   But that’s a great point. Having a session, you have different types of people, right. So some people are out there, they’re vocal. Some people are reflective and they’re thinking about it and they need time. So we call it a gestation time where they’re taking it, processing it, they’re processing while they’re sleeping, while they’re in the shower, who knows, everybody is different. Then they’ll come back and they’ll have a fresh set of ideas and maybe more evolved ideas than the previous session. So it is valuable to have some spacing, a good couple of days between sessions.

BJ:   And these sessions are how long typically?

CL:   No more than an hour generally. We want to keep people energized, fresh and active and coffee is always served.

You know, it’s a very external and social process rather than being inwardly looking and how am I doing. We want people to be energized and participating.

BJ:  Is there a group size dynamic that makes sense or a time of the day that you tend to do these?

CL:    You know, mornings are good. I’d say no more than a dozen people, they can go that size and probably no less than four.

BJ:    I see. Okay. So now if you don’t do these brainstorming sessions, how does that affect or what’s the risk of not conducting a good brainstorming session?

BS:   I think our experience is that people tend to focus quickly on how to solve the problem. So you’ll see it in many, many meetings where you go and someone says we have this problem and rather than learning more about the problem and looking to be creative in looking at alternatives, people tend to focus on solutions and then very quickly focus on a solution. This is very much affected by culture and group dynamics and group think. In the NASA shuttle disaster, the challenge or a disaster, the O-ring failures, that’s held out as a classic example of people who get into one mindset and there can be no other alternative.

BJ:      So what happened in that situation?

BS:  Oh, what happened was that there were many signs that the temperature at the launch was below the specification of the O-rings for the motors, the rocket motors causing them to be brittle. People had a learned behavior to ignore the signs because the priority of the group was get the launch done. so, you know, as people look back on it, there was really a systemic behavior amongst the group to avoid addressing the issue.

CL:   People are always guilty or want to get to a solution and some people certainly want to get to a solution quicker. So this is your tools to hold off that process, their natural inclinations and take a creative step to open up the possibilities of solutions.

BS:   Right. If we don’t go through a systematic exploration of possibilities with brainstorming then we really run the risk that we’re going to chase a particular solution that’s not really optimal. In the worst case, this can mean years of time and millions of dollars wasted on an unsuccessful design approach. This happens more often than you would think.

BJ:  It’s fascinating. Do you see much of this in the medical device field? Have you seen cases where some great ideas or products just never got developed the way they could have been developed?

BS:  The success rate from an early stage design like this is at best about one in ten. This brainstorming is meant to make sure that a good product idea will survive the onslaught of challenges that it’s going to face through its development.

BJ:    Now it’s fascinating. So we are with Cameron Loper and Brian Scrivens who are with the product development engineers at MPR Associates which is an international design and engineering company focused in the medical device space. We’ve been talking about brainstorming and the power of brainstorming in bringing new products to market.

Gentlemen, you spoke earlier about concept devaluation and down selecting, can you tell us a little bit what that means?

BS:    Yeah, sure Brett. Well we just talked about brainstorming where really what we’re trying to is expand the list and the ideas that are out there for consideration. What we really need to do once we have those down in front of everyone is to have a process by which we can down select and apply some disciple to all those concepts that are available to us. So the main problem is how to be more effective at evaluating all these concepts in this case. So what this is about is a process for doing that, going through a systematic evaluation of the ideas that have been generated.

BJ:    How does that work? I mean do you just put it up on the wall and people vote?

BS:    Well some tools that are out there that we use often it’s not a comprehensive list by any means, but some that we find more useful are what we would call a decision matrix or P chart, people have heard it called that, a weighted scoring of user needs across the different concepts. So maybe in a column, you would arrange concept 1, concept 2, concept 3 to achieve a certain end and then down in rows you would say well I have user requirement 1, it must be no bigger than my hand. I have user requirement 2, 3. I go and I score each of those by how each of those concepts, by how well they answer the problem in that particular row. Is it in fact sized for my hand or is it too big or is it too small for instance. Well the one that was a well fit to my hand would receive the highest score.

The other thing that we do is apply a weight to each of these requirements. So we try to fit for the requirements that are the higher priority, the ones that are more meaningful to success. If I have a handheld device, well a very important factor for success is that it be in fact, it fit in my hand. So that might get a high score for weighting. Then through basically multiplying those two together, we then can come up with which concept has the highest score across those.

Some other tools are looking at some of the hazards associated with a concept. So we would look at how could this concept create a risk or a hazard for the user and that goes back to the use cases that we’ve talked about, the architectural layout that we talked about, the block diagram. We want to keep this at a very high level and just look at how those risks might come about.

Then, the third is simply concept bakeoff. A lot of times, you have two good ideas, you want to reduce the execution risk for a project, maybe you pursued two ideas at once and then you can have a defined endpoint at which you’re going to evaluate them further. So you want to do some design, maybe some prototyping and evaluate which one is the best.

CL:   As part of that evaluation you would define preferably upfront your metrics, what are you going to evaluate against. Certainly, there’s elements of one design versus another that you would want to evaluate and so at some point like Brian said, you have a milestone and then you get the team back together and do that analysis. Usually at that point, it’s pretty clear.

BJ: Is it common that you would have more than one idea that you would work on, is it two or is it three typically that you begin to move down the path with?

CL:     Typically 1, 2, 3, not very often at that stage. Here we try to go down with one because certainly it keeps the total cost of the project down, which is beneficial to everybody. Usually, the first set of tools are pretty effective at narrowing it down to one concept. It’s not always the case, there’s certainly sometimes competing designs. What I’ve found is through the creative conceptualization phase, the winning design usually becomes apparent and people recognize that. The winner is pretty clear.

BS:     If it’s not, you may go forward and actually prototype a couple of concepts and it’d have to do with the importance of making a launch date, the importance of budget and the importance of the technical risk that the team sees.

BJ:   Interesting. It sounds like you guys have got a great process that you put in place and I can see that it has a very big impact also on just having a more structured and appropriate approach to bringing new devices to market. So we thank you very much for your comments today.

CL:  All right. Thank you.

BS:  Thank you.

BJ:  So that is Cameron Loper and Brian Scrivens. They are medical device product development engineers for the firm MPR Associates, which is an international design and development company with a very strong practice in the medical device area. Thanks for joining as today. That’s again part of our Expert Series. Brett Johnson from OneMed Radio in New York. Good Day.

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