Learn about our capabilities and offerings as a CDMO
We sat down with Bill Croisetiere (VP, Integrated Supply Chain), Chris Vigneau (VP, Manufacturing Solutions) to discuss our unique approach to manufacturing as a CDMO. Being both horizontally and vertically integrated is one of many aspects that sets Veranex apart from the rest of the industry, making us more flexible, agile, and experienced in finding solutions that fit a wide variety of needs. Read on to gain a better understanding of how we support clients throughout the development process.
Bill Croisetiere
VP of Integrated Supply Chain
Chris Vigneau
VP, Manufacturing Solutions
How does Veranex manage a design change or DFM improvement?
Chris: We start with the client’s needs first since, ultimately, that’s what really matters. Then we look for the most efficient way forward to manage a change through our validated processes. Due to the nature of how we’re set up, we’re afforded the gift of having multiple ways to get to the same result, so for any change that we need to implement, we follow along one of many potential pathways, guided by the client’s needs.
Bill: We have in-house capabilities to engage our Design, Engineering, and DFM teams to evaluate a change request based on the client’s requirements. Then we deliver them options for best execution and manage it internally to release that to production based on the client’s timeline and requirements to meet their demand.
How does Veranex identify opportunities for improvement in a client’s product?
Bill: By using the strength of our QMS and our ability to capture relevant data in the manufacturing process. We leverage that type of information and analyze it with our design teams internally to help identify areas between quality and design that might be relevant opportunities for improvement in a client’s product.
How could Veranex manufacturing help my company with regulatory approval and the road to commercialization?
Chris: So, this is one of our niches — our ability to do low volume. We have turnkey capabilities and capacity that we reserve specifically for programs that are trying to get to market. The way that we’re set up is that our product development programs don’t have to wait in line behind the capacity consumed for commercial production. And so, we’re intentionally focused on the criticality of our clients’ timelines. It’s huge for all the documentation, all of the infrastructure, and all of the people. Basically, whenever your program is ready to build, you can go ahead and build it and it’s not an additional two or three months because you’re waiting on when it’s convenient for the production team to support you.
Bill: We also have regulatory support in-house to help drive a submission and approval path and its execution. It goes right back to the vertical integration and horizontal integration of a CDMO — that’s our value.
We have the knowledge and understanding of impacts to filings or design changes that could occur based on conversations we’re having with the client about changes or about their next iteration of a product. We have the in-house knowledge to be able to talk with the client about what they might be able to reuse from documentation or execution or testing that was done in an earlier phase for an existing product. We can assist in getting a new product to submission without having to re-do that effort and spend the money and time on the next generation product that you might want to develop. That’s all available in-house, under one roof. Essentially, all of Veranex is available to support whatever the client’s needs are.
How often is it that you see a manufacturing request while the client is contemplating the next generation product?
Bill: Generally annually, depending on the market segment an organization is in. The client is likely getting feedback or wants an organization such as Veranex to help them get voice-of-customer information to gain a better understanding of how their product is being received and evaluate potential changes. If we’re talking about a next-gen product, all of that starts with feedback being gathered around the current product that they’re offering. And it wouldn’t be unlikely to occur every three to five years.
Chris: From a product risk profile standpoint, all these little changes can add up, so you must ensure you’re keeping the appropriate perspective. We cannot put ourselves or our clients in a risky situation because you could implement a change and then suddenly, when you were trying to improve something, you’re now facing a continuity issue.
What else can you do with your group that isn’t production?
Chris: We can do acquisition due diligence support, COGS and should-cost analysis, supply chain development, procedure writing, SOPs for how material should and shouldn’t flow, supplier audits, and supply chain management.
Because we’re horizontally integrated, we can support a client’s program with multiple options, whether that’s a domestic supplier, or foreign supplier, a fast prototype or one that takes a bit more time. When we present multiple pathways to the client, it helps in decision-making along the way.
Bill: I’d add that, because we’re not specific to orthopedics, or needle manufacturing for example, it means we’re open to and have experience with so many different opportunities in a wide variety of areas within healthcare-regulated industries.
What’s your approach when a client brings an opportunity to be quoted for commercial manufacturing?
Bill: We take the time to understand the client’s requirements to create a robust execution strategy. So, we look at where the client is at, and give them a good, firm assessment of what efforts they have in front of them, including potential obstacles. That gives us a pathway for their product to market. If we identify something that isn’t of value in obtaining the client’s goal, we’d have a conversation about it so the client can make a good decision in terms of where to focus their dollars and resources.
Chris: Sometimes this gets uncomfortable. A lot of people don’t want to hear, “Hey, you didn’t consider this,” or, “Surprise! This product is going to cost a lot more than you thought because of a decision you made six months ago,” but we’re committed to avoiding leading the client down dead ends. Another benefit is that our process lends itself to helping clients — it’s inherent to the way we do business to minimize the surprise factor. Even if you have experience, it’s not a guarantee that you know how to do everything. Our process pressure tests your product to uncover issues. It’s a lot better to figure that all out now versus later.
How does Veranex’s approach to Quality Management bring value to the client?
Bill: Our QMS is robust, yet flexible. It’s designed to work with the client’s requirements. We can improve design for clients by utilizing quality data that we have vertically and horizontally across our business and within our design team. We’re scalable because we have everyone under one roof — we understand the data and apply it to the right areas. This leads to efficiency improvements.
Chris: I’d just add that we meet our clients wherever they are. Whether they’re commercially producing now or pre-commercial, we can receive programs wherever they are across the development continuum.