Boston Scientific: New Rhythm Management Chief Says It’s A New Day For Quality

Full article reprinted from "The Gray Sheet" - July 28, 2008

Find out why the new president of Boston Scientific's cardiac rhythm management division, Fred Colen, says the company's shift to a statistics-grounded quality control system allows the firm to prevent product component problems that might previously have been missed.

New Rhythm Management Chief Says It’s A New Day For Quality At Boston Sci

The new president of Boston Scientific's cardiac rhythm management division, Fred Colen, says the company's shift to a statistics-grounded quality control system allows the firm to prevent product component problems that might previously have been missed.

It also opens up opportunities to develop products that might not have been manufacturable in the past, he says.

Colen, who has been with Boston Scientific since 1999 (see chart: "¹Fred Colen Bio"), joined the company's new CRM division as executive VP for operations and technology in 2006, just as the unit was acquired from Guidant.

At the time of the purchase, Guidant was struggling to regain the public's trust in its products following a series of well-publicized 2005 product recalls and to fix its quality system, which was the subject of an FDA warning letter that prevented any new product approvals.

After inheriting these issues along with the severely slumping market for CRM products, Boston Scientific CRM decided to focus on reforming its fundamental processes and let product development take a back seat.

With the Guidant warning letter restrictions now lifted, Boston Scientific has launched new lines of CRM product platforms, including the Livian cardiac resynchronization defibrillator (CRT-D), the Confient ICD and the Altrua pacemaker. These are the first products to be developed with its new quality system.

Last month, the company announced that the major overhaul of the former Guidant operations was complete. In conjunction with the announcement, Colen was appointed to head the business unit (²"The Gray Sheet" June 9, 2008, p. 8).

Colen recently discussed with "The Gray Sheet" the impact of the last two year's worth of manufacturing reforms.

"The Gray Sheet:" What were the goals of Boston Scientific executives in 2006 on the issue of improving quality?

Fred Colen: We took a pause in our new product development efforts in 2006. We consciously said 'Let's spend a lot of time and effort in building a new foundation for a higher quality level, then start building on that new foundation. This is costing us a lot of money, but for the most part it's building a new foundation and then once you have that you can leverage it over time.'

In the first of those two years since I've been [with the CRM division] we focused on the quality side, and we put a lot of the people and engineers who were working on the product development side into fortifying this new quality foundation. That was to the tune about 600 people and about $200 million.

That was a really focused effort to say, 'Let's get through this in the shortest period of time and when we've done that, we can go back and focus on product development,' which we've done. So those 600 people are not on the quality side anymore. They're doing their jobs on the development side, but with the new methodology in place and being able to leverage a lot of that quality foundation.

So the second year, as of Q2 of last year until this year, we've basically been refocusing on new products and the new pipeline based on that new foundation of quality and a new way of doing things. We now have a very rich product pipeline.

There are also upgrades within the quality structure and within the quality organization. For example, in supplier development, we had one guy doing basically all of the logistical work, all of the engineering work and all of the quality aspects of the supply side.

Today we have a separate director for logistics in the supply side, a separate director for engineering on the supply side, and a separate director for quality of the supply side and the quality director reports into the quality organization.

TGS: In practice, how have the company's manufacturing processes changed?

Colen: We looked at all of the manufacturing processes, in particular the capabilities of all the manufacturing processes, and driving up yield performance and therefore the quality of the manufacturing processes.

If we asked people in the industry, 'How do you know that a component or a manufacturing process or a device or a certain parameter of a device is acceptable?' The answer that we usually got is: 'Well, we do a certain amount of testing and we test the components.' Most of the test methodology is standardized. For example, shock and vibration testing, mechanical stability, electrical characteristics of parts, etc. - those test methodologies are pretty well established.

The area where it gets interesting is when you ask them, 'OK, how many devices or components do you test with that methodology?' And the answer we usually got in the industry at large is, 'We test 10 devices or 15 components and see if they work.' So the question we asked is, 'Why 10 or why 15? What is driving that quantity?' And basically the answer that we got industry-wide is 'That's engineering practice. That's what we've done all along. That's something that the whole industry has being doing for 40-plus years.' It's basically based on engineering know-how and experience over the years.

That is the piece that we've changed. I compare this to a clinical trial where we say, 'I have a hypothesis and I want to prove something.' The question one always asks is, 'If I want to prove or disprove the hypothesis with a certain confidence level, how many patients do I need to include in the clinical study?' It's a statistically-based approach and that is what we've now implemented in our organization.

So when we want to test a component or a device or a manufacturing process, we ask, 'What is the statistically driven sample size that we need to use to say this with a certain level of confidence?' And that determines the numbers.

TGS: How has this change impacted the volumes of quality control testing that needs to be performed?

Colen: Dramatically. For example, in the past we may have tested 10 devices for shock or vibration testing, but today that's more like 30 to 40, driven by the statistical analysis. In the past, we may have tested certain critical components 30 or 40 times, but that today could be 200 or 300 components or units. That gives us a much higher confidence level, which is statistically driven, about saying that these indeed work.

That is a groundbreaking and new approach in the industry. It is much more costly to do it that way, but it does give us higher confidence in the device and the components.

We also spent a lot of time thinking about how we work with our suppliers, and how we get these components in and how we control the whole process better. We have set up new procedures - a booklet full of information that we ship to all of our suppliers that says, 'Here are the ground rules of how we want to work together.'

For example, for any change that a supplier wants to make, however small he thinks it is and even if he thinks it doesn't impact the specifications of the component, he still needs to tell us about it and we will review and qualify that change with them.

TGS: Why didn't the industry adopt this statistical approach to testing earlier? Was it considered too expensive?

Colen: I don't think it was driven by expense. It was driven by the industry at large - not just at Guidant. It was just engineering practice. People thought, 'It's what we've always done. We've always tested 10 medical devices for shock and vibration and it always seemed to work so why change it?' It was based on that kind of thinking process. It was not driven by, 'I want to say this with confidence, so therefore, what should the sample size be?'

TGS: Have you learned anything from all of this additional testing that was a surprise or has significantly changed a manufacturing process?

Colen: There was some skepticism going into this. Some engineers thought, 'Why are we doing this? It's a lot more expensive, are we really going to learn something from this?'

But the organization learned very quickly that there is real value in it. We were able to see some variability in the components or devices and we could see that, while most would be OK, some were actually very close to what is called a cliff and that something wasn't quite right.

So when you do this more elaborate testing, you find where your sensitivities are and we've found, in the process of developing these new products, quite a few issues that we were able to mitigate up front. That has really been the value of doing it this way and this organization today is a real believer in this process and in this change.

TGS: Following the acquisition, was there anything in particular that you identified as an important deficiency in how Guidant operated that needed to be changed?

Colen: I wouldn't want to answer that black and white. The only thing that may fall close to this category was a need for [much] earlier engagement of the manufacturing people in the process of developing a new product. That's an area where we've drastically changed how we bring a new product into manufacture and into the market.

We are really working now as a cross-functional team and we emphasize that a lot. We are getting the manufacturing people engaged in the new product development process earlier and we are also spending a lot more money on that side as it relates to developing the manufacturing processes. That is probably the most dramatic change that we've implemented here.

I wouldn't want to call it a black and white picture, because also Guidant had cross-functional teams and was also engaging manufacturing, but just not quite to the level that we are now engaged in and not quite as early as we're doing now.

All of the things I'm talking about are industry-leading new activities. I don't want this to come across as saying that Guidant was bad, or their reliability wasn't good, and that this is now the way it should have always been. This is really the new industry-leading way of doing things and it should enable us - and that is yet to be proven over time - to make all our new devices top of the line.

TGS: Does the improvement in manufacturing quality allow you to manufacture products that perhaps you could not have before because it would have been too difficult to ensure consistent quality?

Colen: Yes, that is very true. I call those 'enabling manufacturing processes.' That enables you to bring a new product to market. If you have better manufacturing process with higher capabilities, you're also able to bring new products to market faster, because you stumble less in the manufacturing process, as well as enabling certain new features that you couldn't do before.

There are some examples of that particularly on the [ICD and pacemaker] lead side where we are able to provide a better product - thinner dimensions and things like that - that we couldn't do before. It's still very early on, but I think that we're going to see a lot more of that in terms of the benefits from improvements in the quality side that will enable much better new products and faster [development of] new products.

TGS: What is the next step in your quality improvement efforts?

Colen: One is never done. There is continuous improvement on the quality side. We still have room to make all of the manufacturing processes even more efficient, and with that [attain] even higher quality levels. Not that what we did yesterday was bad, but we can always do better. That needs to be the mindset of the organization.

We're also working on a whole host of new products, a whole host of new clinical science initiatives, new enabling therapies, new therapy expansions like optimization of heart failure devices. This industry is very exciting to work in because there are always so many new opportunities to think about providing better therapy for the patient or thinking about new therapies that weren't there yet.

- Reed Miller

Contents copyrighted © F-D-C Reports, Inc. 2008; protected by U.S. Copyright Law.

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