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Some of the world's leading medical device experts and companies.

Foreign.

Welcome back to the Global Medical Device Podcast.

My name is Etienne Nichols.

I'm the host for today's episode and today I want to talk about ISO 14971 risk management for medical devices.

Most of us are familiar with this standard and probably have those numbers memorized at some point.

But with us today is to talk about this is Edwin Bills who is a leading expert in medical device risk management, quality systems and regulatory affairs with over 35 years of experience.

He's an AS SQ Fellow and regulatory Affairs Certified professional and he helped develop ISO 14971 and ISOTR24971 standards.

Ed has co edited key publications, taught for Amy, AAMI and top universities, and now consults on FDA compliance and product safety.

He also advises medtech startups helping shape safer, more effective medical technologies.

And he's going to be opening for mdic.

He was just telling me a little bit earlier but, but Ed, how are you doing?

And what did I miss and get wrong?

Anything I should add or take away?

That's probably a little highlight, I know.

Yeah.

Well, and I wanted to mention your military service as well, but I saw, yeah, wherever you want to start.

What I'm curious is what pulled you into the world of medical devices and anything before that that you have drawn on.

I'd love to hear any of your experiences, honestly.

Well, actually you brought up the military and that's kind of where this all started.

Matter of fact, I got my, I was wearing, looking for something to wear today and I have my shirt on from Guam.

Oh wow.

And I, I spent quite a bit of time in Guam because I was, I'm, I, I'm a qualified submariner and I spent seven years in the submarine service and part of it was in Guam because I served on a missile sub and we operated out of there and went all over the Pacific and so I was electronics technician there and worked on something that today you call GPS.

But in 1965 we were using a Navy satellite transit satellite system for navigation and it was actually probably a little bit more capable than GPS is today.

Wow.

But it took two 19 inch wide, 6 foot tall cabinets to hold the electronics.

That was back in the early days when I started electronics in the Navy, I learned in tubes.

The first 24 weeks of our electronic school was tube theory and Then there was four weeks of this newfangled thing called transistors.

And.

And so I went.

My first submarine was a World War II diesel boat.

That's another story.

And we had serial number two of the SS radar system, which was a World War II radar.

So we had the second one installed on our ship.

And that was in the.

In the 60s.

So it was a fun gig.

I learned a lot and then went, like I say, to the missile boats and actually helped build one.

And that was really exciting because when I walked into our navigation center on the ship, when I reported aboard, it was bare steel.

There was nothing in it.

Wow.

There was cable running down the side, the electrical cables and everything.

And we brought in all the equipment, installed it, did the acceptance testing for the Navy.

And so I knew what was behind everything after it was installed.

And these new guys would come on board and they didn't know what was back there.

Oh, yeah, you knew down to the nuts and bolts, man.

That would be valuable experience.

It was.

It was amazing.

And that kind of helped me in medical device manufacturing.

Well, how did, how did that transition come about?

Because, I mean, that just seems like two different worlds.

It is.

But I took that electronics and started teaching electronics.

And I was doing it in a vocational school setting after I went to college and got my degrees and all that kind of stuff.

After the Navy, Navy college, then I started teaching.

And then this guy came in one day and he's friend of mine, he says, you know, our company needs somebody to teach electronic maintenance for our numerical control systems that we build and, and sell.

They were.

I was working for Cincinnati Mill, which was the machine tool builder for the world during World 2 and after.

And they had a division that made the controls for all the equipment.

So robots, the.

Oh, we even did composite machines.

We built the machines that built the B2 bomber.

We built the machines that built the B1 bomber.

Wow.

We had machines at McDonnell Douglas in St. Louis before Boeing bottom that had a 250 foot long bed for making wings bars for airplanes.

Yeah, I mean, there was.

It was an amazing world that I got to see and I got to be on aircraft plants and all different kinds of places.

So again, it expanded my manufacturing experience.

And then I was there and I. I lived in southeastern Indiana, and this plant was on the other side of Cincinnati and was 65 miles to work.

And I was sitting at home one day reading the newspaper people, I'm not sure they remember what a newspaper read, but there was an ad in the paper for a guy doing supplier Quality.

Well, I had.

While I was in the numerical control business, they.

My boss had come in one day and said, we want you to teach quality.

I said, frank, how do you spell that?

He said, we'll send you to school.

And so they sent me to school, all right, under some guy by the name of Joseph Duran, who was one of the Preem people.

Yeah, I was in Duran's class.

And really, he was.

He was 82 when he was teaching.

And we spent a week with him and part of the class, he took groups of about six, and we had a meal together, just a bunch of us right around the table with.

With the guru, you know, you bow down to.

But it was.

It was a great experience.

And then I got trained by a guy that worked on Six Sigma.

Motorola, invented that khaki boat for Motorola.

And then there was another guy, was a industrial engineer who.

I always forget his name.

Anyway, he.

He was really good.

He did the red X theory and a bunch of stuff, and he never wrote anything down.

He would go into a company and consult and help them, and.

And that was their job.

Huh.

So Khaki wrote the book about his information.

So this is kind of interesting to me because if you had that personal relationship with Joseph Duran, I would imagine that probably played a part when you were helping with ISO 14971, with the.

Didn't have the trilogy.

Quality planning, quality control, quality improvement, Pareto principle.

All of those things were his.

I have most of his books.

Yeah, yeah.

Okay.

And I did a presentation in one of these conferences on.

This is where this connection comes in.

When I was.

Was working at this company and they had me teaching quality.

Well, they used.

Duran had a 16 videotape series.

People may remember videotape vaguely.

Yeah.

And they were set up so that you were doing a development project and there would be a video, and you would watch the video and then you would figure out, how do we implement that on our project?

So we developed product following this model, which came from the quality planning and all that kind of stuff, the trilogy.

So we did it.

We implemented it there.

And so I was working with one of the guys who was from Purchasing, Fred Woods.

Fred and I ended up writing a paper on.

I don't think we called it vendor quality at that time.

So.

Can we stop a second?

Yeah, sure.

You want me to pause?

You mentioned the vendor quality.

Yes, we did a paper on vendor quality, which we presented at one of the Duran's quality conferences.

And so I'm sitting there doing that, and this newspaper thing came out And I looked in there and there was an ad for a guy doing supplier quality.

Oh, I can do that.

I just did the paper.

Yeah, yeah, I got my ASQ quality engineer certification at that point too.

But I was working in.

So I sent in my application and got hired.

And it was four stop signs and 12 miles from my house, which was a whole lot different than the 65 miles on the expressways and all that.

Life changing.

Yes.

So I took it, I accepted.

And then I walked in the door of this plant and I was there for a little while before I figured out we're doing medical devices.

And there's.

There was the 78 version of 820 at that point in place, which was just manufacturing quality, where they hadn't introduced the 96 version yet.

So design controls went, yeah, so I'm doing this supplier quality stuff.

And we had a lot of.

Of suppliers.

I got in 200 different plants in US, Japan, I know, Mexico.

I was in a bunch of places.

How did you.

I'm curious how with that many plants, was there any consistency or standardization across plants as far as their approach?

Well, no, these were our suppliers and we were getting steel, integrated circuits, hydraulic stuff.

I mean, it was across the board a lot of different materials.

And so I met all these different plants looking at things.

I went in a die casting plant once, and my habit from my Navy days, I walk in the door, look down at the floor, look up at the ceiling.

Okay.

You know, and the manufacturing plant, to get just a sense for their organization and all that, I looked up in the die casting plant and the floor with.

Had all kinds of dirt in it, stuff hanging and all that.

And, and these die casting machines, they would expel smoke and all, you know, it was a process.

And I told the guy, I said, you know, this is, this looks like this could be a problem.

And.

And the floor was not much better, but at least there was a lot of traffic on it.

So I went on and went on my business, went to other plants and I heard from this place, they said, you know what you told us about?

Yeah.

Said, well, one of our machines burped and it expelled some hot metal and all this dirt in the ceiling caught on fire and burned the roof off the plant.

Wow.

So I put that in memory and it probably wasn't another year.

I was in a different die casting plant.

Walked in, looked up at the ceiling, looked down at the floor.

I said, you guys need to benefit from my experience.

I said, last place that looked like this, they had a fire and Burned the roof off the building.

You need to clean this up now or we won't be doing business with you.

Yeah.

So.

And another problem that I encountered was when I went into this company, they had hired a new electric motor supplier and they, they made hospital beds.

So there's a lot of motors.

It was three or four motors on a bed.

Yeah.

So I'm looking at that and, and those motors.

We were having some problems, you know, and they said, yeah, we just, we just brought this supplier in because the other supplier was too expensive.

Oh no.

And so I worked with them and worked with them and trying to get improvements out of their processes and all this kind of stuff.

And finally I went to my boss and said, this ain't working.

He says, yeah, we got a lot of non conformances and returns and everything.

Don't.

We said we got way too many.

So we had to go back to the original supplier who was flawless.

That is so valuable.

That is so valuable.

Yeah.

So, you know, this kind of stuff is going on.

I'm learning more about regulations and things and, and finally I was the only supplier quality person there and.

And we had a new purchasing manager that came.

Well, he was moved from some other job and accounting and purchasing manager, but.

Okay, well, I'm not so sure about this, but he was brilliant.

He understood that.

First you got quality.

Second, you got delivery.

Third, you got price.

He said, that's how I'm measuring each of my purchasing agents.

Quality, delivery and price.

And the whole world changed at that.

Point because previously it sounded like price might have been first.

Oh yeah, yeah.

Typical.

A lot of companies purchasing.

Short sighted thing.

Yeah, yeah.

So Jerry turned everything around.

Jerry Kretzman, he's retired now, but he did a great job of changing the focus.

And we were doing a lot of stuff.

We were doing Kaizen projects.

And our first Kaizen project, the CEO of the company was on the floor underneath something doing some welding.

But he had been raised.

He was the second.

No.

Was he?

Yeah, he was second generation company ownership there.

And his, his dad had had him working in the factory floor with him is growing up so.

Doing everything.

Yeah, yeah, yeah.

So he could be.

He could do welding.

Yeah.

And I said we need to change this process because this isn't right over overhead welding from the floor.

We got to find some fixtures and change.

So the Kaizen projects did that.

We did a.

Did a whole bunch of really modern techniques back in.

That would have been, gosh, 19, but I went there in 78.

Yeah, well that's, you know, manufacturing So I was a manufacturing 88.

That's when I went.

They.

They're still.

You know, kaizen seems to be like a new thing.

If you go to a new manufacturing facility.

I mean, it's.

It's been around for a long time.

Kaizen, kata, kanban, all the Japanese terms that caught on.

So.

Well, we did process mapping on a wall in the factory.

Just meat paper, or we just painted the wall.

Yeah.

Wall white and put the whole process and all the movement that occurred.

Looking at how inefficient some of the things were, because we'd do an operation, then move the thing to.

To the warehouse and then bring it out of the warehouse and do the next step.

And then, you know, so movement, the amount of miles that a part moved in a plant was unbelievable.

Wow.

So now you started with the kaizen processes and some of the other Japanese methods.

Streamlining the processes, improving the flow, trying to.

To cut down on.

Just in time.

Right.

Those kinds of things.

Because we had.

Great.

Just in time.

But I'll tell you a story about jit.

We had a plastic injection molder supplier whose job was to deliver on Tuesday, every Tuesday, what we needed for the next week.

Well, on Saturday, this plant had a fire, and it was in a small town.

They had inadequate power, water supply.

The plant manager told the fire department to spray on the molds, keep the molds cool.

I can lose the rest of the plant, but I can't lose the molds.

Yeah.

On Sunday, they had the molds requalified.

On Monday, they were in a different plant producing parts.

On Tuesday, the truck arrived with a regular delivery.

Wow.

That's.

That's unheard of today.

I mean, I. I can't imagine.

That's incredible, but the power of ownership.

Right.

Right.

It was a.

A series of small injection molding companies that were owned by somebody at the top.

You know, he owned each of these individual plants, so he had the opportunity to move it to a different plant to meet his schedule.

Yeah.

And made it happen.

So it's interesting.

So I started my career in manufacturing, actually in steel.

Then I came to medical devices, got to work on neurosurgical and cranial fixation equipment.

Night and day world.

Completely different worlds.

Yeah.

And I can trace the value of that.

I mean, even pre.

Pre manufacturing engineer, I worked on a machine, and that was incredibly valuable.

Just working on the machine, with the rapport I had with the people on the floor to get that honest feedback on how things should move.

I could just imagine someone listening, saying, okay, yeah, I can recognize the benefit of all these manufacturing things, how does that play into risk management?

And so I'm curious what your take is.

I could, I could, I'm connecting some dots here, but I want to see what your take is.

Yeah, well, when you have problems in manufacturing, you know, you have a process that maybe is not quite as capable as you would like.

Maybe your CPK, use the term, is maybe 1.0 and, and it's churning out parts regularly that meet your requirements.

Right.

So the shipment comes and you open the box and you start sampling on incoming inspection.

And gosh, this stuff, it's not up to stuff.

We're gonna, we're gonna have to sort it and then sending the stuff that doesn't meet requirements back and tell them to rework it, you know, do a scar to use it.

Supplier directive, action request.

Yeah, we typically, you know, this is something, I'm glad you bring this up because this is something I mention every now and then with the medical device world.

We, when we talk about risk management, we're talking about just patient safety.

Typically most people outside of medical device world, you talk about, if you're in project management and you say we need to look at our risk management.

They're talking about scope, schedule, budget.

If it's safety related, you'll have some safety in there, but they're all covered.

Is that an issue?

And what are your thoughts?

Yes.

Top management's focus is what money.

Right.

Meeting their requirements.

Well, if you don't meet your quality requirements, if you have safety issues, what does that do?

That costs you money.

A typical recall of a FDA product is multi millions of dollars.

That goes direct to the bottom line.

And untold in reputational damage.

That was the next thing I was going to.

Yeah.

Because all this stuff is together and Duran talks about that cost of quality.

That's what one of the things that he and his quality handbook, which is sitting on the shelf behind me here, he has a whole chapter on cost of quality and the impact of failures and, and also the cost of, of doing inspection and testing versus the cost of doing repairs and then the, the failures in the field that really impact you a whole lot.

So all this stuff, if, if you want to think about cost of quality, it, you know, what is, what is the cost to the company of this?

You gotta, you gotta have safe and effective medical devices.

And where I was gonna go on the CPK thing.

Yeah.

Is if we're manufacturing medical devices, they should be made to a CPK of 2.0, not 1.0.

2.0.

Is six sigma.

Yeah, that 99.6 or whatever.

Yeah, we should be at least at that point.

And I used to have, from my, I had another class on statistics from a PhD who studied under Wheeler in, in Knoxville who happened to work at the bomb plant, worked at Oak Ridge.

He had some very interesting stories about going in and trying to improve processes and production, saying, no, we don't have time because we're only at 15% yield and we got to get products out the door.

And you know, and, and we don't have time to do this statistic stuff.

It's going to waste time.

15%, yeah.

And they had finally, you know, they were so upset about this and they said, okay, you got eight hours process for eight hours.

After eight hours they had the process running.

The statisticians came in and had it at 85%.

Wow.

Wow.

And they turned around and said, well, how much time do you need.

Man?

In two weeks they had it running at 99 point something.

Wow, that's impressive.

So there is that.

And they had an example of another company you may have heard of called Toyota.

Sure.

We have a control chart from Toyota that they handed out in class.

And the control chart was on the most important component on an automobile.

It was called a cigarette lighter.

Cigarette lighter production was running at 8.0 because they never had to stop the process.

They could keep it running all the time and it would just pump out product and it would meet our production needs just in time.

Yeah.

And we don't, you know, they, and, and I had a year chart and you could see all these Japanese notes on the thing pointing to places and you could see a change and all this along the way.

So they were constantly working on the process at 8.0 to improve it.

Wow.

Wow.

Yeah, that was Toyota before some of the new management came in and it's kind of slipped.

And that's actually something I was going to say is you don't hear about that kind of improvement very often.

Or at least maybe I'm just not here talking to the right people.

But 15% to 85% in eight hours.

I don't know if there's a resistance to change or what it is, but it seems like things move much slower in the medical device industry.

And what are, you know, how can we actually apply some, some faster moving improvements, would you say?

Well, take some of the tools that the Japanese did you, you've got experience with, with all the stuff that I did with Kaizen and those kinds of things, improve your processes.

But at the same Time use those statistical tools that are out there.

But there's an important consideration here.

When you get a statistician to help you improve your manufacturing processes, you want an, a statistician that is an industrial statistician.

Not some guy that comes from the college campus somewhere that, that does research.

You want somebody that does that and then when you get to the clinical trials, that person's not the right person to have.

You want a, a research statistician.

There's from the side.

So you gotta have the right person helping you at various points in the process.

That's a really good point because I could see the difference in, I mean just even in mechanical engineering, if you bring somebody out from the college who is purely theoretical and they have no manufacturing background, they may try to injection mold apart.

That has a, you know, a curve that you physically is impossible and just not recognize that.

Yeah, yeah, yeah.

Well, when I worked at Melikron we did injection molding machines, control.

So I, I know what you're talking about.

I'm sure you've seen some designs that were so fancy.

But one of the things, one of the things as a new employee they trained you to do.

From our division we got sent down to the main machine plant and we learned programming and we learned machine operation.

We, we had to turn parts, we had to machine parts and all that kind of stuff then go back up and make the controls that, that did those jobs.

Yeah.

So that was invaluable.

That's the way it ought to be.

Absolutely.

So I had seen all kinds of chips being made.

You have big, big piles.

Aircraft plant in was Nashville was Avco.

I think they had a big machine making a lot of titanium parts.

And the titanium chips were, were like hip deep on the floor.

But they came around and they got every chip off the floor.

Because of the price of titanium.

Yeah, yeah.

They had conveyor belts that ran under the machines that would extract them.

But then they would go clean up and, and bring all these.

Send them back to the smelter and re read.

Yeah.

Yes.

So go ahead.

Well, it's just so many experiences I got to have.

I got to watch a composite machine making parts that go into like the 787 is all composite.

The B2 I mentioned.

Yeah.

And was it the.

Was the F117, I think was a.

It was the first one we made.

But our composite machine, when we installed that at the Boeing plant, the guys that did the installation walked in the front door, they were blindfolded and led into the plant in the Middle of the plant.

And when they took their blindfolds off were curtains that went from the floor to the ceiling all the way around the machine that they were working on.

They wanted to go to the restroom, back to the blindfold, lead them out, lead them back in.

So it was that secret at that point.

Wow.

But, you know, Watson, composite.

But tape is about the width of a dollar bill.

We used to say the a dollar bill size of composite machines, composite materials worth more than a dollar.

Yeah.

So this was because it was one of the first using composite material.

And then you laid it in different directions because the strength was only longitudinally right then.

So you had to lay a stripe, stripe this way and then turn the machine and turn the machine and turn the machine.

The machine was 16 axes.

Wow.

Oh, man.

7 axis is the most I've ever worked with.

That's awesome.

We had 16 axis machines making composite stuff.

Wow.

I, you know, I never.

I've never seen.

I can't believe I've not looked that up to see how those made.

I used to do destructive testing on custom aircraft interiors, and we destroyed so much composite material.

This is, you know, as recent as 15 years ago, I guess.

So it's a little bit more recent, but.

Wow.

So anyway, all of these management.

Yeah, all of these different experiences led you to help and be on part of the committee that wrote ISO 14971.

So tell us a little bit about that.

Well, I was in the office as my supplier.

Quality hat on and couple desks away, was a quality engineer who was on the committee writing the third edition of IEC 60601.

The company was very interested in standards.

Yeah.

So Mike came in one day and he says, hey.

He says, we need somebody on the committee that has some kind of experience in decontamination.

And he said, you do that.

Because I was.

I was in charge of mattresses at one point.

That was part of my job.

Yeah, we made mattresses.

So getting lots of patients on and off mattresses, you gotta decontaminate.

Right.

Makes sense.

So the hospitals use all these chemicals that are really, really scary to get to kill all the.

All the bugs, you know.

So we had to make sure that when they put all these chemicals on the surface would survive, you know, and eat holes in it.

So I had learned about that, and I had done mattress testing, which is kind of interesting job, was getting on and off the mattress for eight hours.

I come home exhausted.

But no, I don't want to lay.

Down at any job, any.

Anyway, I got on the 601 committee on the third edition.

I was working there, and I got.

Let's see, I got transferred to a different facility now as the manager of quality and regulatory.

It was actually I got transferred to Charleston, South Carolina, and one of the.

One of the guys in purchasing that I'd worked with had.

Had gone to the.

The company owned another company that was in Charleston, and he had left this company and gone to the Charleston company.

And I've told my wife about him going to Charleston.

She says, you know, if anything ever would come up in Charleston, we ought to think about it.

Okay.

So I came home one day and said.

Cheryl said there was a job opening in Charleston because we just bought the plant down there.

It just merged the two companies.

Yeah.

And I went in and told my boss that I wanted it, and I think I got it.

And we're going to be moving.

That's a great town.

Such good food.

Such good food.

So anyway, went to Charleston.

I'm down there.

And my same boss that moved me to Charleston came in or called me one day and says, hey, our guy that was on the Risk Management Standards Committee quit.

He said, you're on it now.

Oh, subpoena.

So what's Risk management all about?

So I was running the.

The for the whole company now, not just one plant, but I'm doing risk management for everybody.

And we had a committee that was overseeing it.

We had our insurance agent, we had our internal insurance person.

We had our doctor.

We had an inside medical guy.

We had our product liability attorneys inside the company.

And then.

Oh, yeah, we also had some engineers and Humber guys that came in there.

Yeah.

And.

And we were doing.

We would bring in a product that was supposedly ready to go and look at the risk analyses and all the documentation.

And the rule was, you gave them that.

The committee, all the documentation two weeks before the session so they had a chance to look at the risk analysis and all the information.

So we're in there and we're looking at this bed.

Sounds simple enough, right.

This was one that was motorized so that a.

Instead of taking two or three people to move it through the hospital, you could do it with one set, a motor on it and some wheels on the bottom that were driven and all this kind of stuff.

So, okay, so let's test this thing out, see how it does what it does.

And we ended up taking it into this hallway that was right side, right outside our conference room that had an incline.

So the one person is there with me in the bed.

I was volunteered by the committee to Be in the bed and this guy's pushing the bed.

And they said, okay, now what happens if the, if the powered system fails?

So they had put a switch in and flipped off the power.

And now instead of going this way, the guy's going this way with the bed pushing him.

What's the risk of this happening?

We never looked at that.

Well, your bed's not ready to sell yet, so you need to go back to your risk management process and fix that problem.

Because we're not going to clear this product for marketing.

Because we had to say at the end of the process, you know, when you got to the overall residual risk evaluation, that was at the end of the process.

You've got a product, you say it's ready.

Let us look at the documentation and concur with you.

This is the case.

Well, here's one you missed.

So residual risk, that seems like one that companies probably struggle with.

And maybe that's an assumption on my part.

I'm curious if you have an opinion on one particular area that companies struggle with more than others.

But.

Well, the first one that they, they have is the use of fmea.

And you know about that failure mode effects analysis.

Yeah.

And they don't understand the proper use of tools.

They need to be using preliminary hazard analysis up front very early in the pro.

In fact, as soon as you have the intended uses and the patient population, the environmental use, those kinds of things identified, now you start risk management and human factors both there.

You now in ISO 1345 in clause 7, 3.3 C says the inputs, design inputs are the outputs of risk management.

Well, what does that mean?

That means risk management has to start before design input.

Yeah, yeah.

And where does, where does fmea?

Well, FMEA needs design outputs to be done.

That's way too late.

That's where you cost money and time like this, you know, this little.

The issue that we just talked about, you know, they didn't think about.

Yeah, the motor failure.

So that would have shown up hopefully at fmea, but it apparently didn't.

So you need to be thinking more.

Now another thing is that's overlooked all over the place.

Most of the product standards, the safety standards, identify hazards for you.

You can take that hazard and put it right in your risk analysis because the risk is deemed unacceptable if it shows up in a standard.

So now instead of trying to figure out what's the probability and the severity, you're past that point.

You're at unacceptable risk.

Okay.

Because it's there.

Yeah, yeah.

Then if you implement the solution that they advise you in the standard.

Now you, that's your risk control measure.

You put that in.

Okay, I'm, I'm doing a, a traceability matrix.

That's what I'm doing along.

No, I, I, I'm following the columns.

Yeah, yeah.

And then if you have a test in that standard that tells you whether that is acceptable or not, then that's the final step in your process that says that risk control measure is effective.

So now you're done.

Okay.

You don't have to do anymore.

Yeah.

So there's all those calculations and gyrations and everything that people go through to get to that point that can be bypassed.

That makes sense.

Now you're, you go ahead.

No, well, you mentioned the traceability matrix and that seems like a given in this conversation.

However, I am curious because of historical, you can go so far back that, you know, I wasn't, I wasn't there for so many of these things.

There had to be some risk management.

I mean you talk about being in a submarine in 50 something years ago.

There's a whole lot of risk management there.

Yeah.

I was in electronic school in the submarine service when the thresher was lost.

Wow.

And what was it, 225 people were died from that incident and they stopped production of submarines.

And that's how I got to the diesel boat.

I was, I was slated to go to a muscle boat but they, they had all of us in the, in the chain.

You know, we were headed down road because it, it took, I was in training for two years before I got to a boat.

And, and then we, we went that circuitous route while they redesigned the process.

There's a subsafe process is called, which is basically a quality system thing.

And what it does is it says anybody can report any defect anywhere along the line.

And if you don't, you're in trouble.

Yeah.

You know, because that's lives.

Yeah.

Well, I'll give you an example.

I did when we built this submarine, we took it out on the first sea trial.

The first sea trial, we took it all the way down to test depth.

Now The HULF is 3 1/2 inches thick of HY80 steel, which is high tensile strength.

Yeah.

Okay.

And it's a 32 foot diameter hull.

Okay.

Okay.

So we're inside and we had some guys that were, had some experience.

I was in relative, I was my first missile boat and they said, come on, we're going to go down the missile compartment and we're going to do this thing here.

So that's where one place you can go where you can go all the way across that 32 foot.

There's not stuff in the way.

So I said now tie this thing on this side and tie this string.

Carry it all the way across the other side and tie it there.

Get it as tight as you can.

Okay.

So we're, we're basically on the surface with this tight string across there.

I got the test depth that dropped 18 inches in the middle.

Wow.

Hull compression.

Was that it?

Yeah, because there's 0.44 pounds per square inch per foot of depth on the hull from the water weight.

Yeah.

Causes that.

So that's, that's the pressure was lost.

Something happened that the hull was crushed.

Yeah.

I used to do the algebra to get the, the I guess depth on the cotangent or whatever or 3218 inches.

That seems like a lot more than I would expect.

Wow.

Yeah.

So.

And, and not only the hull but every.

About every what it was about 18 inches.

There was basically an I beam around the inside of the hull.

Strength of the hull.

So we've got these, these I beams and then you know all the way around the circle to.

And, and the idea is of course if your pressure's on equal from all sides you all you have to do is, is resist that pressure and you know you're okay.

Yeah.

But the thresher didn't.

Well, later on when I'm on this boat on patrol at a Guam we got a message that says sub miss and it said the, the Scorpion was missing, overdue.

And then a little couple days later we got a sub sunk message that said the Scorpion was lost and they had not been through the sub save process.

They were built before it and they were, they were rotating all the submarines back through it to get them caught up and they didn't get there in time.

Yeah.

So there was another 99 loss.

So you know.

Yeah.

And I know there are lots of risk control measures and it seems like other industries have really figured out two things in particular that the medical device industry still seems to struggle with or at least consistently has issues with.

One of them is project management.

And that's maybe a whole nother animal.

I don't know if you want to talk about that or not.

But the risk management itself, that's the other thing.

And I don't know if you can mention.

Why is it just the different type with every devices so different?

I mean we're not building cars that there's a standard way of building something.

But I don't know, project management's really important.

I had an experience back in my numerical control days.

We had a project manager who we were designing a new control.

Okay.

It was a lot of electronics.

Right.

Much smaller and it was.

What was it?

That was for turning centers, I think.

And Lenny was assigned a project manager.

So he, he drew a part chart on an E size drawing.

He filled that whole thing up because this was before computerized project management.

Okay.

And over the, the three years of that project, Lenny wore out three electric erasers.

Thank that.

Because one of the things on that is you, you know, you run into problems.

Typical projects, things aren't going to be ready on time.

So what do we need to adjust so we can still meet our date?

Well, Lenny, in that three years missed the final date, the initial date that was established by three days.

Wow.

Wow.

Okay.

So just so people listening understand what that is.

PERT chart is the program evaluation and review technique chart which is used, it's a project management used to visualize tasks, their dependencies, timeline.

See the float.

Yeah.

Write a flowchart of the process and all the, the connections to different things.

And all the input.

Yeah.

All the estimated dates and what, how long it's going to take to do processes and all these kinds of things.

And, and what's interesting, PERT there, PERC was used to build Polaris submarines.

I see they had had a missile that was over here being built, a submarine over here being built.

And oh, by the way, we're going to cut this submarine in two and add 150 foot section of missile tubes and we're going to bring this missile and put in it and this is all going to fit together.

Yeah.

And we got all this navigation stuff we got to do.

And that was my part, you know, and nuclear power and so firing and everything else.

Yeah.

So Admiral Rayburn was the guy that led that project and it got done early.

Wow.

Yeah.

Yeah.

Project management, that is something the military and construction has figured out.

But medical device we're still working on.

Maybe not completely military hadn't been as good with it because when they buy new products, they don't do quite as efficient a job on that.

But that original design, that was an experience that they need to go back to and look at this and see what we can hear.

So if I go Back to either 1497 or 24971 are the things, particular sections that you feel like get particularly misinterpreted or ignored consistently.

Well, I talked about the FMEA thing.

Yeah.

Need to be using Other tools.

FMEA has a couple of problems with it.

One it doesn't cover.

It only covers failures.

It only covers single fault failures.

14, 9, 71 says all failures and it says normal condition.

When everything is working right, what kind of hazards can you have?

A scalpel when everything's working right, has a sharp edge and there's a hazard there.

Yeah.

Okay, so that's a very simple example, but that's true of all medical devices.

We have problems that we need to consider.

So FMEA doesn't cover that.

FMEA comes late in the process, as I said, design output.

So that's a tool that you can use as a check to make sure you didn't miss anything.

Yeah, but it still has gaps and holes in it.

Fault tree does multiple faults, you know, it pulls the whole thing together.

That's a nice tool that came in a software where that originated and, and then the PHA that I talked about, that's really good.

The questions in Annex A of 24 971, 37 questions there now asking you what's in this product?

What, what kind of risks do you envision from electricity?

Oh, electricity, yeah.

It's an electric product.

It's got a lithium ion battery in it.

Yeah.

Oh, well, I need to think about that.

You know, where the risk in that.

That's all stuff you can find at the beginning.

Yeah.

You know, so the standards, the questions on safety, you know, your concepts for design.

It doesn't.

FMEA doesn't talk about usability issues.

So you got your URA tool related risk analysis.

Yeah.

Which by the way, should be integrated with the traceability summary because a lot of that overlaps.

Yeah.

With user needs and, and so on.

Yeah.

The front end of the user needs and everything is real good.

But then it goes into your risk controls and all that.

Well, that's already in the traceability thing.

So there's a.

And that's why I have harped from the beginning we need software products for risk management.

Yeah.

It's a database application trying to track all this data and make sure it all works together.

So that that's a problem.

And I know Greenlight has a solution in that area and there's other ones out there as well.

But the idea, you know, of spending a lot of time on our good old spreadsheets, it's good for concept, but it's not good for some of the complex products that we have now.

Yeah, that was one of my biggest difficulties, I suppose, and I'm sure you've seen this as well.

But when I was, I used to be a project manager for a drug delivery combination product company.

So I, I was integrating the requirements from the drug company, multiple drug companies, to our single, you know, medical device.

Try to integrate all of the different requirements and tie those to our risk management.

All done in Excel.

It's a struggle.

I don't know how it's done these days, but that was one of the things that I realized.

You know, I saw engineers leaving the industry because of the documentation side of things.

I don't think that should be the case.

We're losing a lot of talent because we're not giving them the tools they need.

But maybe that's a different, different subject.

Well, the, the whole way we attack documentation is a, is a problem.

We wait to the end and go back and document reverse engineering.

Yeah.

And, and you mentioned combination products.

I'm on the combination products committee for risk management and currently 14971 is.

It was reaffirmed.

It's good for five more years.

24971.

Well, we've got two projects going on to expand 249711 is machine learning.

Now question on that.

I thought 34971 covers machine learning.

Well, it's a US and Britain document.

Okay.

We're now expanding to ISO.

Okay, gotcha.

So it is.

We're taking that base and expanding it to ISO.

So there will be 249712 when it's printed.

Eventually when we update 24971 it will roll into that so it'll get a little bit thicker.

And then there's another one on combination products by chance which has just started.

And that's going to be 24971 dash three.

Okay.

And that's coming from Amy's TIR 105 which I was on the committee to author that.

And we used the trace matrix from 14971 ideas to be the repository of all the risk from the drug and the device in one place.

Yeah.

And we also talk about interaction risks.

What if I put this, this drug in this plastic syringe?

What's going to happen?

Yeah.

What's chemical actions are going to be?

What are the risks of that?

That needs to be considered as well.

So we not only have the drug in the device, but the interaction.

So we have a system here that we're, we're developing and we need to do risk management from a system perspective for that.

And that's how they TRACE summary helps pull all that information in one place.

Love that.

That's good.

Is our IVDs, because it seems like that would be another area that deserves its own view.

I don't know if there's something coming up as well.

IVDs, there's a absolutely brilliant guidance in 24, 971 for IBDs.

Okay.

And they take an IVD and pull it.

You know, here's how you do it in 14971.

And the, the two people that wrote that, one of them still on the committee was at Abbott for 30 years, I think, and.

And she's.

She's great.

And the other guy retired.

He's in his mid-80s now, but he.

He was in IVDS forever too, so they did a fantastic job.

But it's also got some ideas that might apply to other areas worth looking.

At, no matter what you're in.

Absolutely.

Yeah.

Yeah.

So two more questions and then I'll.

I'll let everybody get back to their day.

If you've taught all over, from Amy to Virginia Tech and so on, what's one concept, or I guess that students or professionals struggle with the most when it comes to risk management?

Well, some of it is kind of basic.

If they're brand new to the industry, understanding the difference between harm hazards and hazardous situations and how that works, which is to me, I've been in it way too long.

Why did they have problems with that?

And, and we took the.

If you've seen the shark illustration of the different.

Well, anyway, we were at a standards committee meeting we used to meet in Sanibel in December was our standards meeting.

And the problem was by the time we got done with our meeting and got outside, it was dark.

So anyway, we were trying to come up with a way to explain the differences there.

And somebody said, well, you know, the shark swimming right out there, well, you can see them out the window there.

And the shark is certainly a hazard, but if I don't get in the water, no big deal.

No hazard.

Well, no, there's still a hazard there.

What you have there is a hazardous situation.

You have to get in the water and get exposed, you know, and the shark has to be somewhere nearby.

So there's your hazardous situation.

And then the harm is when you get bit.

So we were using that as a simple thing, and people kind of poo pooed that after a while.

I know another instructor, Amy, she uses coffee, you know, the hot coffee cup from McDonald's, like cardboard cup that spilled somebody's lap, you know.

Yeah.

And then, then we got to more, you know, got the cap on the thing, you know, all the different.

Now we got These kind of right ups have all kinds of protection built in and everything.

So that, that's just one way of explaining it.

But that's one in the beginning that people have trouble with and, and then trying to put all this stuff together in a, in a chain.

Now the trace summary to me is it helps a lot to see.

Well, now I got these things and then this risk is unacceptable.

Well, this one's okay.

This is acceptable.

I don't need to do anything for this one except in Europe because you have to do them all.

Yeah.

And then this one down here, this one's unacceptable.

So I need to have a risk control measure.

So now I gotta have a design input.

That's my risk control.

So risk control connects to design.

Develop now the risk control measure and then I decide what that's going to be.

I write a design output which is a specification for that requirement, which is a safety requirement.

And then I need to make sure that that actually shows up in the product.

Yeah, that I'm.

Oh, I, I missed it.

It didn't get in.

Don't want to find that at the end.

You want to make sure it's there.

So now you have design verification.

Does that, doesn't it?

It looks at things to see if everything, if the outputs are covering all the inputs.

And then the next thing, Well, I put this thing in here.

Does it work or not?

Well, is it effective?

I do design validation and maybe I can do some tests in verification that will show that.

But a lot of times it's invalidation, especially if it's a usability issue, because usability validation is done as part of design validation.

So we work together with the people doing usability a lot from the risk management side through the process and making sure that the hazards that they identify as issues get in as risk, then get implemented.

It inserted in the design and implemented and then validated by the usability validation at the end.

So we, we, you know, this is a team effort.

That's why I say, I always like to say risk management is a team effort, but so is the whole design process.

Absolutely, yeah.

And it should be.

Yeah, right there alongside the design.

Well, in the beginning is not just the design people.

In the beginning you need to have manufacturing in there because do they have to buy a new machine?

Well, that might take six months to a year to get that on board, you know, purchasing.

What kind of suppliers do they need to be searching for new things that you're going to use?

What kind of environment is this thing going into?

Medical environment?

Well, that's the medical people's expertise.

They can come in and tell you what kind of things you need to be considered there.

So there's, there's three people I came up with right away that need to be on that team at the beginning.

And then complaint people need to be on there because they need to understand what this product is going to be so they can prepare for doing complaint investigations at the end.

What's this product going to do?

Where's it going to work?

You know, all those aspects.

And then let's see what else.

Complaints.

Well, that's examples.

I mean, yeah, it's, it's a great example.

And to your point, people who are just doing this in a spreadsheet, that is a rough life.

You know, it really maintaining that traceability.

You talked about getting to that, that harm.

And what risk control measure do I have in place and is it still in place six months later?

Because if those are separate spreadsheets, you know, Greenlight actually does a really good job with their software with this.

Go ahead.

When manufacturing comes in and says we need to make a process improvement to reduce cost, so we're going to make a change to your design.

Okay, what's the impact of that change?

Yeah, so my process has to be resilient and to be able to manage change because it's going to happen.

There's no way around it.

Right.

Single mold injection.

You want to go through a multi cavity and you know, okay, the gates are here.

Why are they here?

That's a design output driven by a design input, which may be a risk control measure.

Absolutely.

Started with aluminum mold and now I'm going to switch to steel.

Yeah.

You know, what's, what's the impact there?

Yeah, your material.

What's the impact of using the aluminum mold that wears quicker?

Yeah.

Or in an anodization, you know, for whatever reason, going to a. Yeah, no, these are really good points.

And if you don't have that ability to trace from the design to previous risk mitigations, I mean, it's just a nightmare.

It really is.

And it's one of the reasons I think the medical device is not.

A lot of companies are not agile as they could be if they had the ability to go back and look and see.

Okay, this can change for these reasons.

Or if we stay within these parameters, we can move around.

Let me give you one more item that is really useful as our friends at the Food and Drug Administration have these wonderful databases out there.

You can put your product code in the total Product lifecycle database.

And it will come up and show you all the products that are built under that same product code and all the problems they have, all the failures and everything.

Failure codes.

It's a tremendous tool.

So when you're starting this new product, you put your product code in that database and then look up who your competitors are.

So you can tell marketing to go off and look at these different competitors and get some, you know, some dirt on them.

And then you look in there and see, well, these are the kinds of problems that we need to take into account when we design our product, because these failures have already occurred.

These are real.

There's your risk management beginnings.

Yeah, yeah, absolutely.

Yeah.

That's why I say pha.

The total product life cycle feeds into that, too.

Your complaints on your previous products that you've had that's similar or they use the same processes, even a different product, but it uses the same manufacturing process.

Oh, well, I guess there's some comparison there.

Yeah, that's a.

That's a really good point.

Yeah, that's a great tool to use, too.

I'm glad you brought that up.

I let us go over, but I could talk to you for a long time.

I mean, these are great stories.

This is what I. I live for.

This is the reason I do this podcast.

But I am going to have to.

I guess I'll have to shut us down, but hopefully our paths will cross before.

Before long.

Where can people go to find you to learn more and go ahead if you have any last words.

I'm on LinkedIn and I answer questions on LinkedIn.

When you hang up, I want to talk to you a second husband.

Yeah, absolutely.

Okay.

Well, thank you so much for being on the show, Ed.

And like I said, hopefully if.

If I don't, I'm not gonna be at mdic, but I hope it goes well.

And before too, maybe wraps.

We'll run into each other at some point, I'm sure.

Some point.

Yeah.

All right.

Okay, everybody who's been.

You've been listening.

We'll put some links in the show notes so that you can easily get a hold of Ed.

Obviously find him on LinkedIn and we will see you all next time.

Thank you so much for tuning in.

Take care.

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