Medical device companies are under intense pressure to develop programs that get their products on the market fast.
For the leaders in charge of the small or mid-sized firms that don’t have in-depth manufacturing engineering or manufacturing expertise in-house, that pressure manifests in the questions they repeat as they lay awake at night.
Does my contract manufacturer know enough to help me through the process? Can they scale up on my timeline? How can I know I won’t get burned when it’s time to ramp up?
The answers to those questions depends on who you have in your corner and the depth of guidance they can provide as you take your program out of the lab and onto the market.
As you read, you’ll see that the art of scaling up is about knowing what to plan ahead for.
How to think about process validation
A critical area of advance planning necessary for successful scale-up is settling on a consistent way to verify the repeatability and reliability of medical device manufacturing and packaging.
What do we mean by consistent?
When programs are in development, it’s common for prototypes or trial runs to be inspected after assembly and packaging. Human inspectors can easily manage a pace of a few hundred units a day.
Obviously, the situation changes at high volume. For one thing, when you’ve ramped up to tens of thousands of units daily, human inspection is infeasible. For another, medical device and packaging inspection is often destructive.
So, contract manufacturers instead rely on well-controlled processes to stand in when final inspection either is unrealistic or destructive. In other words, they master the art of working backwards. It requires:
- A deep technical understanding of which process parameters and equipment settings cause variability you would ordinarily inspect for
- Implementing controls that eliminate that variability
- Demonstrating via testing that those controls are adequate and can be maintained
Consider the nuance within that final point above and you’ll see why the validation process can be such a headache. The process you validate must be effective now and later. It has to work as well today as it does under the rigors of manufacturing at high volume.
Case in point: J-Pac is currently working with a customer that developed a nasal swab test for detecting COVID-19 among other respiratory conditions. While the customer supported some packaging and sterilization capabilities in-house, they lacked the specific equipment required to package and sterilize this novel product in a way that could be validated. On top of developing a valid packaging and sterilization process, J-Pac committed to investing in additional equipment and owns raw material sourcing to continue packaging and sterilizing the customer’s products through ramp-up to full production.
Supply chain management and bottleneck planning are essential
Of vital importance to any program is marshalling resources and organizing the complex network of suppliers needed to successfully scale up medical device manufacturing.
Some companies try to manage this aspect of their programs on their own to save time and money. Unless they have a seasoned logistics pro on staff, this often comes back to bite them.
If you’ve had the rug pulled out from under you because your supply chain wasn’t as robust as you thought it was, you know the feeling.
It’s better to lean on your outsourcing partner for supply chain management because they’re trained to ask: Where will this process break down? What are the bottlenecks? How can we prevent them before they even emerge? Consider what such a partnership can achieve for you:
First, the right outsourcing partner has connections to a much wider supplier network than you. When they leverage it, it gives you a head start in sourcing materials that match your exact product specifications.
Second, they’re keenly aware of how your supply chain needs will change as your program ramps up. They vet suppliers with one eye on the present and the other on the future. You need suppliers who can keep you stocked today and tomorrow. The ideal outsourcing partner usually knows which suppliers are better able to adjust their capacity according to changes in demand (and can get them to commit to that flexibility under the terms of supplier contracts).
Third, if you engage them early enough, your outsourcing partner’s advance supply chain planning might even drive changes to your design or manufacturing process that generate cost and time savings.
In our view, supply chain management is not an expense anyone should try to avoid. It’s one of the most important risk management plays you can make.
Good process design flattens ramp-up costs
By the time a medical device is approved for commercial production, your manufacturing process is set in stone and must remain intact even as production volumes ramp from hundreds or thousands to millions.
But developing a process that can sustain exponential increases in volume over time is only part of the story. Even a process that “works” is no good if the cost to run it rises on the same curve as volume. We’ve seen many companies wrestle with a bad process that forced them to plow would-be profits back into frequent capital expenditures.
The alternative — halting a program to re-validate a better process — is even worse.
The ideal outsourcing partner should understand your product and program well enough to develop processes that make the most efficient use of capital equipment expenses. This does not mean we want to skimp on equipment. Rather, it means that we bring equipment online within a process designed to harness its most efficient future use.
That means we need to break apart the steps in a manufacturing process and then add discrete equipment to those steps. It might appear counterintuitive or clunky early on, but it’s designed so that a linear addition of manpower to existing infrastructure drives an exponential increase in volume. In our experience, this is the most effective way to scale a program that breaks through to profitability quickly.
Walking that example backward in time, you can see from another angle the importance of planning ahead during the validation stage. Your success hinges not merely on having a validated process, but on validating the right process.
Case in point: We’re currently helping a new-entrant customer commercialize a device designed to simplify laparoscopic surgery. Our work so far has focused on developing a packaging and sterilization process which is currently under review by the FDA and European regulators. As a young company, the customer approached suppliers in search of one who would take them seriously and guide them through a complex process. In digging into the process and making helpful suggestions during process design development, J-Pac shortened the customer’s project timeline by three to four months.
Chart a course for your competitive edge
Medical device company leaders pour countless hours into developing products that advance the healing art. They need guidance from technical experts to execute the science of getting those products to market.
J-Pac Medical is committed to breaking down the barriers and providing the close support you need to secure profitability and maintain the competitive edge.
If your program is approaching a critical stage, now’s the time to contact us.