Product development in manufacturing

Lynn Ihlenfeldt, Vice President of Product Development at Minnetronix, a company that develops and manufactures software and electronic-based medical devices, shares her manufacturing and product development experiences with EHM.

Product development is the process that takes us from ideas, or early prototypes, into a manufacturable unit that can be reliably duplicated in manufacturing in the volumes required. In addition to creating quality medical devices, manufacturing also includes ensuring that the design has been proven to meet its design inputs, that it delivers the therapy or the function that it is supposed to, that it has been approved to the appropriate level by regulatory authorities, the FDA for example, and that it has an effective documentation trail to support all these activities and more. In effect, in today’s competitive environment, it is imperative for companies either to have a stellar product development process, or to partner with someone who does.

Several significant facets are necessary for a well-tuned, cost-effective development team. These include:

• Compliant, well-known development processes - development continues to change over the years as new processes and improvements to existing processes, like user interfaces, are developed. A team that doesn’t practice its development year in and year out will have a difficult time catching up.
• Technologically up-to-date team - technology also continues to change, and you need to keep your engineers up to date on the latest technologies so they can create up-to-date medical devices.
• Regulatory savvy on your team - to make sure that the devices make it through the regulatory processes without any hitches, your team needs to keep in step with regulatory changes.

These are facets that are difficult to keep up with for a team that doesn’t do medical device development everyday.

In addition, product life cycles are shrinking¬¬–across industries and around the world– and ours are no different. Companies no longer have the luxury of time to recreate or “tune” development processes before each new product development.

Meeting schedules

There are four keys issues needed to balance the design requirements with a schedule of expected deliverables. The first is that you have well-written, realistic design requirements. That means that the technical requirements really say what the design has to do, and there is a coherency between the schedule, the budget the unit cost targets, and the technical requirements for the project.

The second is that there is a universal understanding of the priorities of the design. It is easy to make simple designs quickly and it is a little harder to make very complex designs quickly. Having that trade-off well understood and agreed upon by all the team members is very important.

The third key is a highly skilled, cross-functional team. You must have support available when you need it from every function that will contribute to that design.

Finally, issues arise in every single design effort. Some issues are big and some are small, but to be able to meet cost and schedule requirements and create the device that you want, you need a team that is flexible and committed to addressing issues in a timely manner.

Close-knit relationship

Medical products change as they go through their lifecycle due to several factors, from purely technical reasons like component obsolescence (people can no longer get the components that they use to make their device), or factors like user preference (for example, the industry is moving toward a particular input device or toward a particular way of interacting with a device). Sometimes there are advancements in therapies or advances in regulatory requirements that need to be incorporated into a device during its life. In a regulated environment like ours, these changes need to be tightly controlled, to ensure that the original regulatory approvals are not compromised, and that the new and improved device goes through the proper verification, validation, and regulatory approval. This would be an incredibly difficult task without a well-coordinated effort between the design, quality engineering, regulatory, and manufacturing functions.

Project transfer

Transferring a device from a laboratory – which perhaps has made a handful of prototypes – to a production facility is a process involving a lot of people and a lot of steps. There is information and documentation about how to properly build and test a unit, supply-chain information about suppliers and lead times, and a myriad of other issues such as service support – who’s going to do it, how is it going to work, is it field supported, what kind of activities need to happen when units come back from the field – issues like that.

The keys to a smooth transfer are:

1. A mechanism to address and resolve issues as they arise. Recognize up front that there is no such thing as a perfect transfer. There are hundreds of things that can go wrong in a complicated move from design to manufacturing. It’s a very good bet that at least a couple of those things are going to happen, so having an active mechanism for addressing and resolving issues as they arise is critical to every transfer.
2. A good understanding of both design and manufacturing. Team members who understand both design and manufacturing can be very helpful in sorting out any conflicts or misunderstandings that may occur.
3. A leader–that is, one person–in charge. It may not be the same person throughout the process. For example, early in product transfer it may make sense for a laboratory manager or senior engineer to drive the transfer process, but as the knowledge base develops within the manufacturing organization, it may make sense to pass that leadership to manufacturing. But having everybody on the team, design, manufacturing, quality and supply chain people, reporting to or at least deferring to one leader is critical to make sure the process runs smoothly. When working with external supply teams, it is extremely important to document plans and agreements in writing, to ensure that everyone has the same understanding. This is especially important if you are working with an offshore team, or a new partner, who may have a different expertise level and different transfer methodologies and expectations.

Managing risk

You need to be proactive and be early, and by that I mean it is very difficult to manage a risk once it has materialized into a problem. The easiest way to control risk is to design it out, starting from the beginning of device conceptualization. This takes a knowledgeable cross-functional team to consider every possible risk, from the obvious hazards of the device, be it blood handling, drug delivery, or diagnosis, to the more subtle hazards that can be created by a poorly designed user interface, for instance. The ISO 14971 standard has a nice approach to encourage addressing risk throughout a product’s life cycle.

Future

I see a couple of things happening in the future. One is that there is an overall trend affecting not just the healthcare industry, but hitting a lot of industries – the green trend. This is evidenced in our particular area by the RoHS and WEEE directives, which are significant for many devices, especially those with electronics. Although currently exempted from those regulations, device manufacturers are facing unprecedented parts availability issues and other effects such as significantly lengthened lead times for printed circuit board assemblies, the introduction of process changes and resultant increases in unit costs.

Q&A: Dhuanne Dodrill, President of Rollprint Packaging Products

Q. Rollprint is a flexible materials provider; can you explain what that means?

A. We make flexible packaging materials that are used for the primary packaging of medical devices and pharmaceutical products. Most of these packaging materials are multi-layered composite structures. The layers chosen to build a packaging material that will provide all the properties needed to protect the medical device or pharmaceutical product enable the fabrication of the package and allow controlled aseptic access to the product. Each layer provides different functionality, for example, durability, barrier, dimensional stability and aesthetics.

Q. Over the past 12 months, which technological advancements have been the most significant to medical device manufacturing?

A. In terms of packaging one of the biggest impacts on the requirements for packaging materials are the combination products that are being introduced. The device/drug combination products have really driven some of the new needs in packaging materials, specifically barrier packaging. Where a device previously needed a sterile barrier it may now also need a barrier to oxygen and/or moisture in order to ensure that the drug maintains it’s efficacy. This has created new and interesting challenges.

Q. What does it take to satisfy design requirements whilst also meeting cost and schedule expectations?

A. The key is communication, and it needs to start at the beginning of the development process. So often in the design of new devices, packaging it is an after thought. The device is developed and ready to launch and then someone realizes that they need to put it in something. Then, compromises have to be made in order to launch the product in time. From a packaging perspective we need to be involved from the very beginning. The benefits are two-fold. First, by getting all the parties involved early (material manufacturer, packaging, equipment manufacturer, device design team, and end-user input) a package that enhances the product’s functionality and can be readily manufactured can be designed. Secondly, in many instances, the conventional wisdom as to the cheapest and the most economical packaging material isn’t accurate. Getting the packaging material manufacturer involved in the beginning is extremely important if you want to end up with the best packaging material and the best package in the end.

Q. Do you experience this late stage packaging involvement often?

A. Yes! Unfortunately it is not unusual for packaging to be a bit of an after thought, and therefore a lot of opportunities to provide a truly outstanding and economical package are lost.

Q. Are you seeing any changes in the healthcare industry at the moment, in terms of packaging? How do you expect the sector to change over the next few years?

A. Packaging, as well as the entire healthcare industry, is much more cost focused and cost driven. One area that is affecting our industry, particularly with commodity products is manufacturing coming out of China. There are very low cost materials available in China and it is certainly changing the world for us.

As a result, we have expanded our manufacturing operations into South East Asia and, in the West we have been concentrating on using our technology to improve performance and develop better materials to help our customers reduce risk and cost.

“There are very low cost materials available in China and it is certainly changing the world for us” – Dhuanne Dodrill

“You need to be proactive and be early, and by that I mean it is very difficult to manage a risk once it has materialized into a problem” – Lynn Ihlenfeldt

“Companies no longer have the luxury of time to recreate or “tune” development