Greater product yield, potency, and purity are the goals of today’s IVD manufacturing and processing technologies.
Doing more with less is a goal of manufacturing across all industries, including companies making IVDs. Manufacturers want to make high-quality products in large volumes but with simpler, more-streamlined machinery, and with less waste.
To learn more about the current state of manufacturing and processing technologies in the IVD industry, Richard Park spoke with Sharon Bracken, Divisional Vice President, Global Operations, Diagnostics at Abbott.
IVD Technology: What have been the most significant advances in IVD manufacturing and processing technologies during the past few years?
Sharon Bracken: We have seen a variety of processes continuing to develop that are focused on providing greater product yield, product with higher potency and purity, and, in general, manufacturing equipment that has a smaller footprint and less waste associated with it.
Another area in which we’ve seen an ongoing trend is the manufacturing equipment itself. Instead of having equipment with a lot of pumps and moving parts or complex manufacturing equipment, we’ve seen movement to more simple manufacturing equipment that achieves the same high-quality products. And these machines achieve this with fewer steps, fewer moving parts, and less opportunity to break down during the process.
We also have standard in-line mistake proofing, looking at modular-type filling where more filling capacity can be added onto the same type of line.
Finally, we have seen flexible manufacturing become more of a requirement, especially when offering a large number of products. Some might be lower volume; some might be higher volume. Some may have different packaging.
Having manufacturing equipment that is more flexible provides the opportunity to adjust to any changes in customer demand and any changes in the actual product format. It’s designed for flexibility.
What environmental efforts have you put into your manufacturing and processing technologies?
Abbott works diligently to reduce our global environmental impact-from the sourcing of raw materials to the manufacture and distribution of our products to the use and disposal of our products by consumers and healthcare providers. The majority of our factories have what we call “zero landfill waste.” They have identified, through evaluation of their potential waste streams and manufacturing processes, where waste is yielded. Based on these evaluations, the facilities ask themselves, “Is there an opportunity for the potential waste to be prevented or eliminated? Can it be applied to other uses? Can it be used as something altogether different, such as fuel?”
We have active programs to evaluate our waste streams in all areas and reduce them. Then we put into place aggressive goals and metrics to ensure that we achieve those results.
We also reward the organization and the parts of our groups that are able to identify the best opportunities for waste reduction.
How do you make manufacturing simpler and more flexible?
I’ll give you one example. We had a piece of equipment that had multiple moving parts, and it would yield vials of material. We were able to complete the same process using magnets, therefore eliminating all the moving parts in favor of a one-step process. It became much easier to maintain, generated less waste, and made predicting the results easier.
What sort of expertise do you turn to for reducing waste and making manufacturing simpler and more flexible? Do you have that sort of expertise in house already at Abbott?
Finding the right skill set is important to us, and great ideas come both internally and externally. Engaging people from within Abbott to help identify solutions is important. An example we have seen focuses on reducing waste in landfills. Internally, people can rally around the cause and work with each other to identify ideas. These ideas come from people at all levels of the organization. In fact, we’ve seen some of the new hires who have come directly from the universities bring new ideas they have seen before. Additionally, we’ve had success finding solutions from other industries or other external organizations.
In short, it’s a good combination to be open to good ideas from all areas.
In terms of sheer technical complexity, what are the most troublesome and challenging areas involved in manufacturing IVD products today?
Having worked in other industries, I can say that IVD products, in general, have a bill of material—or a list of the compositions of the products—that presents some indicators of complexity. So if there are more components or more materials on a bill of material, it usually means there are more process steps. The simpler the bill of material and the sourcing availability of the material, the simpler in general the manufacturing can be.
Sometimes we deal with a certain raw material, and the characteristics and sourcing of that raw material must be completely understood, or it could also drive complexity. These are not necessarily new challenges; rather, they are ongoing factors driving complexity.
Are there different and unique challenges for the chemistry and instrumentation sides of IVD manufacturing, which are two major areas Abbott is heavily involved in?
Yes. First, I would mention two key factors that drive the differences: the pace at which these products are provided, and the duration of time these products are on the market.
An instrument could be designed, and it could be in the field for 10, 20, or sometimes even 30 years. These systems
|Sharon Bracken is Divisional Vice President, Global Operations, Diagnostics at Abbott. Prior to joining Abbott in 2005, Bracken held various senior posts with Johnson & Johnson, L’Oreal, Metrologic, and Ingersoll-Rand in supply chain, operations, engineering, and new product and process development. She can be reached via Darcy Ross at email@example.com.
must be supported that entire time.
On the chemistry product side, the life cycle moves more rapidly. And for the chemistry product on the market, the customer population changes, the government requirements could change, and the dating on that product gives it a finite life. Each lot of production is distributed to customers more frequently than the shipment of instruments to customers. These characteristics are what drive the difference.
In terms of distribution, there are also some unique requirements on temperature for the chemistry products. Some of them require temperature control when they ship. They’re not as sensitive to movement as instruments are. Instruments can’t be bumped around when they are shipped; so, they require special shipping conditions.
In addition, the instrument has to be ready for installation. The chemistry is different: it’s used, and then it is ultimately disposed.
Another point on the manufacturing side is that certain manufacturing batch sizes need to be validated with chemistry products. Demand for these products needs to be understood so that it is possible to validate to the right size.
On the instrument side, instruments are made of a large number of components. Putting it together is one thing, but the challenge is really sourcing all the parts that go into that instrument-making sure they all arrive on time and are assessed to quality requirements. Then it’s assembled, and usually it’s out there for years. In short, all the products come together to meet the customers’ needs.
Regulatory requirements and international standards are intended to keep IVD companies from designing or producing bad products. In what ways do those requirements help to make technically complex manufacturing processes simpler for IVD companies?
The designing part is the key. By focusing on high-quality design that’s compliant and by investing that time up front, it prevents the downstream issues.
For us, communicating with the regulatory agencies in all the areas that we do business, and understanding these agencies’ requirements, is important. The design aspect is one way that it helps. Regulatory standards also help us in our supplier selection process. And if these suppliers have regulatory experience, as well as a successful regulatory track record, it gives us confidence in selecting them and in doing business with them because there are common industry requirements we must understand and fulfill together.
You made an interesting point about investing time up front on the design of the products. Is it safe to assume that when it comes to manufacturing and processing issues, that is something that must be taken into consideration even as early as the initial design phases in the product development cycle?
I think it’s very important to learn from the past. It’s an evolution. If a platform or product was launched 20 or 30 years ago, it’s important to assess whether there were any manufacturing issues, such as part shortages.
Then, based on that assessment, the manufacturer rolls that information into either the design process or a new product design, and by doing this, continuous improvement is ensured.
You mentioned about partnering with suppliers and making sure they are compliant. In what way do IVD companies partner with suppliers regarding their manufacturing and processing technologies?
It is important for Abbott to work with our suppliers as an extension of our supply chain because what we provide is our responsibility. So we have people with experience in our internal manufacturing who know the standards to which we hold ourselves. And we partner with our suppliers and our third-party manufacturers to perform evaluations, identify best practices, and identify ways to improve quality continually. We partner with them in that regard.
It is not merely selecting a supplier, providing a purchase order, and waiting for the shipped product. We need to understand how the supplier manufactures. We can work together on where we source raw material, and at the end of the day it is transparent, and we all win by having a high-quality product.
What was your experience and reaction when you were first confronted with meeting FDA and other regulatory requirements?
I’ve worked in some other industries, and we had regulators and their requirements, so I didn’t see much of a difference in the IVD industry. We are all here to do the same thing-develop products to improve healthcare. From a manufacturing standpoint, it’s not just about making the product. It’s about ensuring that all the processes that support quality and compliance are in lockstep with one another.
Are such regulatory requirements equally useful when dealing with manufacturing such products as next-generation IVD tests and molecular diagnostics?
Yes. Regardless of the life cycle, regulatory requirements must be considered the same way. I couldn’t distinguish between a next-gen and molecular versus something that we’ve had on the market for 20 to 30 years because the desire to have a safe, effective product on the market is the ultimate result, regardless of where the product is in its life cycle.
Based on your experience with FDA and other regulatory bodies, do you have any advice for dealing with FDA and complying with regulatory requirements from a manufacturing and processing standpoint?
My advice is that everyone in the manufacturing organization needs to be engaged and committed to provide a safe and effective product, and it can’t be the purpose of only one function in a company.
How can IVD manufacturers streamline their compliance activities for FDA and for international regulatory bodies?
It’s important to understand what those requirements are because there are some common themes that exist.
There are certain requirements that countries may share in their regulations and that certain organizations share, and there are other requirements that are not shared.
If an organization understands them all, the requirements could potentially be grouped, and then it might be possible to say, “Here are some standard requirements that are pertinent,” rather than duplicating efforts for separate countries with similar requirements.
And then if an organization understands which requirements are unique and the length of time it would take to potentially get approval, that would be important to understand to ensure appropriate planning to get all those requirements met. The key is awareness, and understanding how to apply them.
How does Abbott coordinate all of its various manufacturing facilities around the world and the various regulatory requirements and international standards with which it must comply?
The challenges are making sure that an organization has the right representation for all the sites-treating the company as a global organization with no one site functioning as an island.
From a bottom-up standpoint, when we design our manufacturing processes, we design them with certain requirements. When we run those manufacturing processes, we run them to certain requirements. We have a process within which we look at the latest developments on the regulatory front and roll back any changes, make an assessment, and see if we need to adjust any of those internal requirements.
I’d like to follow up on a point that you made earlier about outside skill sets. You said that you’ve tapped into skill sets from other industries and external organizations. Please elaborate on that a little more.
We benchmark our processes across continents. For instance, we have a manufacturing site in Germany, and we share knowledge with a manufacturing site in Ireland.
For companies that are in proximity of us-either in the same industry or in different industries – we reach out to them either through professional business associations or directly, depending on the relationship, and collaborate on a benchmarking activity, as an example.
Abbott is a huge global conglomerate with many divisions outside of its IVD division. Have you tapped into any of the skill sets of your sister divisions?
Yes. We have a number of formal and informal connections at Abbott.
We have internal councils. We have an operations council. We have quality councils. These are the formal channels through which we agree on things together or work on challenges together.
And then we have the informal channels. For instance, we have individuals who used to work in other divisions.
We share, or we’ll say, “Would you reach out to another division and find out how they manage their commodity planning?” as an example. We do a variety of things.
What role does an IVD company’s organizational structure play in making the manufacture of a product easier or more complicated?
With a highly technical product, in my experience, if highly complex organization is overlaid on top of that, then decision-making becomes difficult.
For Abbott, we find that having an organization with clear rules and responsibilities, effective functional structure, and, quite frankly, individual skill sets – even individuals in leadership roles – can understand the detail of their organization but can also see the big picture. All of this helps us to be successful.
Is organizational structure and the role it plays in manufacturing and processing more challenging in a huge company the size of an Abbott as opposed to a much smaller IVD company that may not have as much bureaucracy or red tape?
I’ve been fortunate to work in both environments, and I’ve seen it succeed and fail in both environments.
Do IVD manufacturers outsource any of their manufacturing and processing activities? What is the business rationale for a company’s decisions in this regard?
Yes. I would say that each company likely has its own rationale, its own challenges, and its own philosophies on how to manage outsourcing. Abbott focuses on our core technologies and on identifying strong partners so that we can strike the balance of bringing innovative products to market that meet our customer needs effectively while also ensuring that we are leveraging our core competencies and delivering the quality, cost, and compliance that we need. It’s a balance and something that we evaluate.
What sort of activities would an IVD manufacturer be inclined to outsource to an outside partner or supplier?
Each individual process could be evaluated in manufacturing; so I really think it depends on how an organization chooses to run its manufacturing strategy.
What about manufacturing cutting-edge products, next-generation IVD tests, and molecular diagnostics? Certainly those pose unique challenges from a manufacturing standpoint. Is that something that an IVD company would be inclined to outsource to an outside company?
I think there is no one quick, easy answer to this question – each case, each product, and each technology must be considered individually. They do pose unique challenges, and these need to be balanced with where the product is in its development and what constitutes a given company’s philosophy.
What future trends and challenges will emerge for IVD manufacturers in the area of manufacturing and processing technologies during the next few years?
The first area, in terms of trends, is to make sure that we have the right talent pipeline and the right balance of innovation and global perspective to help make sure that we develop the right technologies in the first place. As an example, having the right people on board who have worked in R&D or have worked in Quality, is important when developing a company’s future manufacturingtechnology.
The other area is expanding business continuity planning to make sure that business has supply-chain robustness through all areas of its network, and that’s something that is important to refresh and evaluate on an ongoing basis.
Is the supplier base healthy? Does it have good business continuity plans? Is the distribution network healthy? Is there good alternative means of distribution should there be an interruption in the supply chain? It is something that we have to continue to challenge ourselves on and evaluate.
How do you ensure you have the right talent pipeline working at your company?
We have a dedicated employee base. We have excellent collaboration internally. When I talk about pipeline, I’m talking about making sure that we have individuals with experience around the globe who can help us when we’re developing manufacturing technology so that we don’t just keep going to the same solution. We can constantly identify new solutions.
We challenge ourselves not to settle for the status quo and not continue to do things the way we’ve always done them. In order to do that, we need people who have that perspective. We constantly strive for an innovative outlook.
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