The MX Q&A: Damien Plisson, Dassault Systèmes

Described as holistic in its implementation, TPLC has been fostered recently by FDA as a strategic imperative for device manufacturers to improve product quality and time to market, says Damien Plisson, the medical device solution leader for the R&D division of Dassault Systèmes. Based in Vélizy-Villacoublay, France, with offices in Lowell, MA, and other cities around the world, the company specializes in product lifecycle management (PLM) enterprise systems, simulation, and CAD software for a spectrum of industries that includes life sciences, automotive, aerospace, and semiconductors.

Clients using Dassault’s PLM system include some of the largest medical device manufacturers in the world, Plisson says. Device manufacturers generate reams of paper records, but the PLM enterprise system of record-keeping allows manufacturers to support TPLC by leveraging records from each stage of the product’s developmental cycle, according to the company.

Dassault took part in a recent study indicating that device industry executives still need convincing, however.  Plisson was brought on board to move that process along, bringing expertise he developed over the years. He joined Dassault in March 2010 after holding the position of project leader working on the robotics for a vascular imaging system at GE Healthcare’s R&D division. He has also worked as a strategic consultant for the Boston Consulting group.

At GE for nearly five years, Plisson says he was the project’s architect and oversaw collaboration between a team of developers in India and their counterparts in the United States. His current job taps his product strategy background and “basically leverages my two previous experiences,” Plisson says. In this interview with MX the R&D executive discusses the background to TPLC, the challenge of executive buy-in, FDA’s role, and buildings full of paperwork.

MX: How would you describe the total product life cycle approach?

Damien Plisson: TPLC is a concept about having collaboration between the different people in the organization that are [working in] silos. It means improving efficiency and not having traditional development but having althea functions that work on the product…start working at the same time.

What are the origins of TPLC?

I don’t have the exact date when it started but the concept had been pushed by the CDRH [Centers for Devices and Radiological Health]. From my understanding the concept comes from studies on how to improve the efficiency of product development.

I understand that getting company executives on board is the main impediment to greater adoption of this concept in product development—having them buy into it.

You absolutely need to have the top executives buy into this approach because deploying TPLC needs to be done with strong support from the top. One of the main impediments is that the teams are used to working with less transparency than…is required. They work often in silos and adapting to TPLC means that they need to make important changes in the way they work.

I was thinking of an adoption that was maybe not as [apt] but it [involved] what Jack Welch did at GE when he pushed for Six Sigma. He said that all his top managers would have a percentage of their bonus that would be dependent on the adoption of Six Sigma teams. There needs to be a strong drive by executives to get this adoption.

What are some of the arguments one could make to a top executive? You’re possibly dealing with product development changes and departmental jurisdiction issues, for example. Or could someone argue that this is a just a marketing campaign to sell a software system?

If there is something to make this industry change it is the fact that they have maybe no choice to move. The regulators, namely FDA, are asking them to move in this direction. I just saw that in January of this year FDA has placed in their strategic priorities the full adoption of TPLC.

Okay, the regulators see the benefits of it. Do other regulatory bodies, say in Europe, see the benefits of this approach?

I’ve no precise quote about it, but there is strong harmonization among the different regulations. When you take the FDA regulation and the ISO regulation, it comes out to about 95% [overlap.] And in terms of companies willing to adopt TPLC…two-thirds of the large medical device companies are U.S. companies. And second, even if they are not based in the U.S. they are surely willing to sell in the U.S. because it is the largest market in the world.

Do you have a specific example of a company on record that has used this concept and improved its bottom line, its product, or its time to market, for instance?

I won’t be able to give you specifics, because we don’t have the rights to disclose it. [But] Medtronic …participated in a Webcast that was done last December to pitch the importance of adopting TPLC.

How widespread is the use of this concept in the device industry?

I can answer in the adoption of our PLM…because the concepts are very, very close. We have 4 of the top 6 and 15 of the top 20 [device companies using it.]

Is it used more widely in some countries or regions of the U.S.? Or does that matter, and it’s a case of just company by company?

It is a company-wide—or actually—a division inside a company.

Is PLM or TPLC used among any particular device segment more than any other?

I would say that the adoption starts with the Class III and Class II devices just because of the fact that the quality issues are so important. They have been exposed to regulatory issues before, and one of the answers FDA gave is…it is the right time to employ such an approach.

Can you elaborate on the interaction of this concept and regulatory requirements? FDA is, what, strongly suggesting that companies should transition to this concept?

It is strong advice. FDA through the CDRH is pushing the definition of the concept of TPLC, which is asking about the collaboration at each stage of the [product] life cycle between more teams in the company. In this concept there is also the notion of readily available information that is fully transparent. The decision making is enhanced through this dynamic collaboration.

In terms of process…in the typical ecosystem of a company…you have a dedicated team that is a quality, safety, and regulatory team that [interacts] with the regulators.…. But these people get their information and they need it from everyone else in the company. … Regarding the implementation of TPLC I will take the example not from new product development but from the quality management. I did a survey on the warning letters issued by FDA. The two main [problems] are on the warning letters on the CAPA process and on the complaint process. Using this approach when one has a complaint, typically it is a hotline that receives the call. They fill out a form, giving as exact information as they can about [the nature of] the issue…. And then immediately the regulatory people get this information and can start working on the analysis and push any request they have to other teams or even get direct access to product information to validate whatever product is responsible for it and what is the need for immediate action.

This sounds like a much more fluid product development approach than the “silo” one you were describing earlier.

Yes, one of the main benefits of this approach is a reduction of the cycle time. You asked me about the bottom line, [and] looking at the new product development, it adds to our [ability] to develop the new product. And also when you dive into the engineering…by having people work on mock-ups, on simulation…they [learn] the design, and [this] helps to reduce cycle time and the rework that is done at the end. [It’s] a collaboration between the engineers and the marketing team so that the marketing team can show it to a hospital to validate the concept.

A 2009 study involving Dassault Systèmes and other companies says that most device manufacturers still use sequential product development and “have along way to go”—that’s a quote from the summary—toward adopting TPLC. This seems to show that manufacturers are still not sold on the idea. How long does it take for a company to do this?

I would say that it depends on the fact that the top executives are willing to do it whether or not most of the time they get the strong issues that push them to go in this direction.

Such as?

Most of the time it’s the deployment [issues] from the quality side. The deployment of the collaborative approach that is pulled by quality teams, and…after that it evolves and grows through the whole company. But in terms of up-to-date deployment I would say that even the utilization of the assets is not something that is done everywhere.

Last December I was in a meeting with a VP of quality and he told me to look through the window to a new building that had just been built and he told me it was a building just built to store all the paper files. So you can imagine that there’s some work to do for each company to [institute TPLC practices.]

Where is this company? The U.S.? Europe?

It is in Europe, but it has offices in the U.S., too.

Reading about TPLC, I noted mention of an increase in the introduction of new medical devices, the point being that growth in the market would benefit.

There is an increase in competition in this market. But at the same time there is a tendency to have a decreasing [number of] approved [products] because FDA is…becoming more and more adverse to risk. This is one of the [issues involving] the U.S. versus Europe regarding innovation.

I think you may have read lots of papers, especially by people from the industry, lobbying against the increasing length of the FDA approval procedure [and] the increasing time of the PMA [process.]

I’ve read that investment in better design control and supplier quality would improve product quality, and those are the two top improvements that could be used as the main argument for adopting this approach.

It is. These two are the top ones for…quality issues…. But doing it right the first time is the best thing to do. [As far as] adopting it for design control, FDA is asking companies to make a DHF—a design historical file—to store all the evidence [of what] they have done right, that they have followed the procedures, which is to give transparency in the design. Having an organization and a system that does it for companies themselves without adding overhead is very helpful.

How many years do you think it will take before the industry heeds FDA’s guidance and this integrated approach penetrates further into device development?

I would think if we take the example of auto and aero, it will be something like five to 10 years. I think it will be faster because there is a good example between automotive and aerospace. With the FAA regulations the benefit is not directly on human health. Their requests are not that far from the requests of FDA. In addition, the tendency to work with scattered R&D sites is something that is happening for medium to large medical devices.

I imagine that within companies there would be interdepartmental differences to overcome or even turf battles. Is that one of the reason it may be difficult to implement?

What TPLC as a concept is about is to avoid this by bringing transparencies [into the development process.] This is why to avoid this [problem] we need a visionary leader…to guide the company and to [prevent] these turf battles.

Finally, does the healthcare reform focus on cost containment help the argument for adopting this idea?

Yes, it does, because cost containment means they need to reduce their R&D costs as well. And the TPLC approach will help to reduce the cycle times to get it right the first time and reduce the R&D costs.