IN PERSON
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Pete Rowden is the vice president of operations at Hologic Inc. (Marlborough, MA). Hologic is a diversified medical technologies company specializing in imaging systems, diagnostics, and interventional devices serving the healthcare needs of women. Rowden has over 20 years of experience in the medical device industry focused on manufacturing operations, supply-chain management, and facility requirements. He can be reached at pete.rowden |
As the molecular diagnostic market continues to grow and shift consumer needs, IVD manufacturers race to modify old facilities and adopt new standard processes to meet demand. However, the effort to attain the most innovative and reliable technology is challenged by budgetary concerns, domestic and international regulatory requirements, and supply-chain capabilities. In order to increase manufacturing efficiency, IVD companies must develop strategies that demonstrate accuracy, flexibility, and a commitment to standardizing processing technologies.
To learn more about how IVD manufacturing and processing technology is adapting to new market changes, IVD Technology editor Richard Park spoke with Pete Rowden, vice president of operations at Hologic Inc. (Marlborough, MA). In this interview, Rowden discusses modifying domestic standards to fulfill international requirements, cultivating strong supplier partnerships, and the advantages and disadvantages of automation. He also talks about the importance of corporate flexibility, managing global manufacturing operations, and adjusting to the demands of proprietary and custom product lines.
IVD Technology: What have been the most significant advances and the latest trends in the area of IVD manufacturing and processing technologies during the past few years?
Pete Rowden: More automation has come into play for IVD processing technology during the past few years. As manufacturers, we need to make sure the appropriate automation maintains the level of consistency necessary to create a quality product, and automation definitely has an advantage over human inspection and verification.
Another significant advance in IVD technology has been the development of a supply chain that is responsive to medical device needs and requirements necessary to maintain end-product quality levels. IVD manufacturing is different than other industries in terms of accountability and consistency. Companies often include certain core technologies because they are proprietary or the custom end-product requires specific suppliers. When a company’s product exceeds its suppliers’ capabilities, manufacturers have to find a supplier that will give their product the right attention.
How does automation fit into the manufacturing and processing technologies of IVDs?
As product volumes and markets increase, the human element becomes more expensive than the automation. Automation offers more reliability and consistency. IVD manufacturers mitigate risk with automation, which, in turn, becomes more cost-effective over time. For example, as Hologic grew and became the standard of care in the cervical cancer Pap smear market, we purchased a company in 2000 that initially was a part of our supply chain. Unfortunately, the company didn’t have the capital equipment funds to scale with us, and Hologic expressed an interest in controlling the cost of custom formulation. It made sense for us to continue supplying our needs from that location, so we bought the factory and, operating with the current workforce, focused the output to our requirements.
What are some of the general problems and issues automation may present? How do you monitor and address such problems and issues?
Calibration and preventative maintenance programs are included in the manufacturing process, but there is also a need to modify specifications when verifying that equipment is performing to expectations with a level of consistency that adds value to the process. Additionally, if there is a shift in the process, IVD manufacturers must conduct modifications such as in-line checks and verifications. If a vial with a stamped date code is kicked out, manufacturers usually perform a manual verification. So even though we have automated quality control systems in place, manual intervention also ensures that the automated quality control processes are operating accordingly.
Building Supplier Partnerships
How do IVD companies find the right suppliers that can meet their needs and contribute to the supply chain so that manufacturing and processing technologies continue to run smoothly?
Hologic has supplier-quality engineers, who understand the cost profile of the supply companies and visit each site facility. For example, if the product is in the early stages of development, we often will choose to work with a molding house or any type of supplier that has the capability to help us perfect the design. If the design is in the final stages of development, we give that supplier the opportunity to price the product or move it to a supplier that specializes in molding and replication.
Manufacturers must ensure the appropriate cost for the product throughout its life cycle. The product life cycle allows companies to examine their needs in regard to infrastructure and in-house design capability. IVD companies can create supplier agreements with smaller companies where manufacturers can monitor the dwell time and recoup their investment in design modifications or enhancements. It’s a win-win situation for both parties that allows IVD manufacturers to operate successfully in a competitive marketplace without compromising any compliance requirements or end-product deliverables to their customers.
How does an IVD company maintain a relationship with its supplier companies? How do you find a supplier that will continue to grow with you into the future?
Hologic holds a quarterly business meeting with all of our key suppliers to discuss the company’s objectives in consistency, design, and cost reduction. We have supplier agreements with our major suppliers that explains our expectations in detail, as well as a general exit strategy should the partnership not pan out the way we would like.
In terms of technical complexity, what are the most troublesome areas involved in manufacturing IVD products today?
One of the more difficult areas in manufacturing IVD products has been educating suppliers at a level necessary to ensure the delivery of consistent high-quality material. IVD manufacturers have a responsibility to their partnering suppliers to create a profitable business for them also. A lot of that relationship is based on understanding the product technology. If the sole source involves unique technology, companies need to have a plan B. There’s a lot of pressure to release a product in the marketplace according to a specific time window; then the issue becomes making sure the product is consistently available year after year when customers become dependent on it. Companies also need to conduct a final test and verification to confirm that there hasn’t been a supply chain shift that may affect your product.
Meeting Manufacturing Challenges
What are the more challenging areas companies have to address in terms of manufacturing IVD products in-house?
The most important elements in manufacturing IVD products is people and process. Companies must have the most efficient, cost-effective process that communicates correctly. Every day, I receive dashboards with information about every aspect of our daily product cycle. The dashboards make it clear when processes are successful and when processes aren’t working as well as we’d like.
Also, manufacturers need to encourage their staff to be passionate about what needs to be improved, then manufacturing engineers can be more effective with the most recent data available. It’s often called a global operation strategy, and Hologic’s global operation strategy is to ensure that we manufacture our products with the best quality where it’s most cost-effective for our business.
What sort of challenges do IVD companies face with global manufacturing operations in terms of coordinating processing technologies?
When Hologic decided to take a closer look at building a new facility in Ireland, there were a lot of different tax issues to consider, in addition to the number of medical device companies already located throughout Ireland. After closer inspection, we decided that the perceived tax challenges weren’t beneficial compared to what we had already established in Costa Rica through another acquisition.
We also looked at capital costs and transportation expenses for opening a facility in Ireland versus the current platform already in place in our Londonderry, NH, office. If transportation is inexpensive in regard to providing our products to a larger European market, then there wasn’t a real necessity to build a new platform there. Additionally, it would increase our sales by manufacturing locally.
What special difficulties are presented by manufacturing tests for cervical cancer?
The product formulations for cervical cancer tests involves additional regulatory requirements from several agencies including, but not limited to, the Environmental Protection Agency (EPA), the Department of Transportation (DOT), the National Fire Protection Association (NFPA), and the Alcohol and Tobacco Tax and Trade Bureau (TTB). EPA and DOT are extensively involved because of the use of certain methanol calculations. These organizations have to be involved to make sure that facilities meet specific limitations, and many of them perform drop-in code inspections like FDA.
We also have an environmental and health and safety staff on board who conduct internal audits of all our locations. Additionally, an independent organization outside of our group conducts another audit in the same locations. This system of checks and balances helps us identify any changing regulatory requirements that may be coming our way and gives us time to make the necessary modifications.
Manufacturing IVDs for cervical cancer goes far beyond meeting FDA requirements. Of course, companies always have to eliminate any possible exposure for their employees. You never want an employee to be in harm’s way, so it’s important to monitor and verify any possible exposure to harmful elements, whether they’re noise or vapors.
For example, due to a recent sprinkler system law in Massachusetts, our distribution center underwent some extensive modifications in which the warehouse was adapted to only house the large volumes of methanol in two compartments across the 37,000-sq-ft space, with firewalls in between them. Once the changes were complete, the Massachusetts state fire marshal needed to approve and sign off on the modification.
Evolving with Regulatory Agencies
What was your experience when complying with FDA and other regulatory requirements regarding manufacturing and processing technologies?
Essentially, FDA and other agencies provide guidelines that are not specific to one individual company, but rather generic to all IVD manufacturers. It’s up to the companies to interpret and incorporate the procedures into their manufacturing process. It’s also important to present such procedure modifications to the agencies for their review. It’s the manufacturers’ responsibility to communicate how they’ve adapted their facility to the regulatory requirements and why.
The auditors often arrive with subjective views on the process that will be scrutinized based on their past experiences. IVD manufacturers need to develop good relationships with FDA and regulatory agencies because the last thing companies want to do is fail to adapt necessary procedures issued by regulatory agencies. Hologic has done well with FDA audits, and FDA auditors have understood our company’s interpretation of the requirements and didn’t demand an explanation or response regarding our manufacturing process.
In what ways do regulatory requirements and international standards help to make technically complex processes simpler for IVD manufacturers?
Many regulatory standards help agencies measure every company consistently. Their goal is to give everyone a better understanding as well as a system of checks and balances. A good verification process helps manufacturers meet customers’ expectations with appropriate validations of process controls.
There are different risk profiles for international products versus domestic products regarding new technology. Although manufacturers need to ensure that products are designed appropriately, they also need to ensure that end-users will use them correctly. From a design or manufacturing perspective, companies have to communicate with their customer base regarding the complexity of their products and whether they meet the needs of their audience.
There are numerous examples of a lack of information between the manufacturer and the customer that have delayed or curtailed the success of a new product on the market. Companies certainly can’t anticipate the previous experience and knowledge of every potential customer, but IVD manufacturers should conduct a final in-house verification test before sending a product to commercialization.
How can IVD manufacturers streamline their compliance activities for FDA and international standards to eliminate redundancies in their manufacturing and processing technologies?
In both the U.S. and international markets, regulatory requirements must be accounted for when developing and manufacturing products for each region. IVD companies have to be mindful that what may be appropriate for domestic customers may not be appropriate for international customers. To some extent, a lot of the international standards for product compliance are based on labeling. For example, some symbols for an international label that are mandatory are considered optional in the United States. Also, it was a common practice to release products into an international market with labels written only in English. Now, many companies have switched to releasing their products in multiple languages for international markets.
How does an IVD company make sure its manufacturing and processing technologies comply with FDA standards and requirements?
Hologic has an internal regulatory group that reviews all new FDA guidelines and determines whether our company needs to make any modifications to meet those guidelines. FDA will often introduce new or updated standards with very generic guidelines, so every company has to decide how to interpret the spirit of the FDA standards and determine what’s the most cost-effective way to implement them. So our internal regulatory group interprets the spirit of the FDA change and the impact it may have on our business.
Anticipating Change
What role does a company’s organizational structure play in making an IVD manufacturer’s product line easier or more complicated?
As a company grows, its market and the product line change. So it needs to add supporting resources that will grow with the company’s business model and develop cross-functional relationships to continue success in its chosen market. When Hologic began manufacturing IVDs, we did not have our own environmental or health and safety staff. We acquired those departments as the business grew, developing their functions internally at several office locations to meet the business requirements.
Over time, smaller companies begin dedicating resources because the business warrants that level of focus. Such companies require a tremendous amount of communication between groups that needs to be open and constructive in order to develop roles and objectives that can help the company thrive and prosper in this space. Manufacturers want to grow their processes with the right people at the right time as the business warrants. It’s important to assemble the best team to work through processing and product management issues every day.
How do shifts and changes in market needs and customer demand affect manufacturing and processing technologies? How do companies address such changes?
One example of how changes in market needs affect processing technologies is when the marketplace warranted different labeling, and Hologic needed to have the ability to put all these markings on a limited label space. We also needed to have the ability to use different labels, one for domestic products and one for international products. This meant that our company required automated equipment that was flexible enough to adapt and take on additional automation as necessary. Many companies attempt to address changes in product needs by trying to plan for the future while leaving themselves enough space to tackle any unexpected market shifts in the current business model.
How exactly does an IVD company predict market shifts and plan for the future?
Flexibility is certainly important, but IVD manufacturers also need to have the capital available to invest in the automated lines before they are truly needed. Obviously, companies are limited to 168 hours in a week, but a redundant automated line can help manage any spikes in demand or requirements that weren’t anticipated. A certain amount of risk and capital expenditures has to be approved in order to plan for the future. Manufacturers have to convince their board of directors to invest money and development for enough capacity to commit the necessary resources if they hope to have any flexibility in the market.
Do IVD manufacturers outsource product development or manufacturing activities? If so, what would be the business rationale for a company’s decision to do so?
Absolutely. We outsource some of our manufacturing, but it often depends on how we can manufacture a specific product using the most cost-effective process available. Some custom or proprietary manufacturing will remain in-house, because the company is going to give the product the attention that perhaps their supply base can’t.
As for product development, some IVD manufacturers choose to outsource their platforms based on the skill sets that they wish to invest in-house. Some skill sets are not fully needed all the time, so outsourcing provides an opportunity to focus their resources in-house when it’s financially beneficial. IVD companies simply need to work with their outsourcing counterparts to ensure that their methods are a true extension of the manufacturer’s process in terms of expectations, consistency, and deliverables.
