By Sean Fenske, Editor-in-Chief

The start of a new medical device project can be overwhelming. Many factors and considerations should be addressed at the start, but with so many decisions to be made, many elect to push some later stages further down the road. They leave answers for tasks like packaging, sterilization, and assembly to be determined after the product is designed. Unfortunately, this leads to increased costs and delays in getting to market.

Almost every manufacturing partner or supplier will tell you they should be brought in early. Decisions made alongside them prior to design freeze can help eliminate costly revisions or delays later in production. Even establishing a preliminary direction for these segments can significantly enhance success while keeping expenses under control. Finding the right partner to help enable this, however, isn’t always easy.

Fortunately, Douglas Constable, CEO of Life Science Outsourcing Inc., has addressed these concerns in the following Q&A. He shares insights on why it’s important to make decisions about packaging, sterilization, and assembly earlier in development. He also speaks to the impact of scale, meeting compliance requirements, the potential challenges of a handoff between companies, and the difference in the impact on start-ups vs. mature organizations.

Sean Fenske: Ideally, when do you want to make decisions about a product and the later stages in development and manufacturing, such as assembly, packaging, and sterilization?

Douglas Constable: Ideally, these decisions start earlier than most teams expect. Assembly, packaging, and sterilization are often treated as downstream steps, but they influence each other and the overall manufacturing flow long before commercial production begins.

In early development, the goal is not to lock in final processes; it is to understand how the product is likely to scale. That means asking practical questions early. How will this be assembled at higher volumes? What packaging format supports both sterilization and distribution? Which sterilization methods remain viable as volumes increase?

When those conversations happen early, teams gain flexibility. They can design processes that evolve rather than break as demand grows. When they happen late, changes tend to be reactive. That often leads to revalidation, delays, and added cost.

The most successful programs treat these decisions as part of a continuous process. Early alignment creates fewer surprises later and allows the product to move from development to commercial production with greater confidence and predictability.

This is where working with a partner like LSO adds value—by helping teams think through assembly, packaging, and sterilization together early, even when final volumes and designs are still evolving.

Fenske: What is the downside of making changes to these areas later in the development/manufacturing process?

Constable: The downside is that late changes almost always cost more and take longer than expected. By the time a product reaches later stages of development or manufacturing, assembly methods, packaging design, and sterilization are already connected through validation and regulatory commitments.

A manufacturing partner like LSO that evaluates assembly, packaging, and sterilization together helps reduce this risk by identifying dependencies early and managing change before it becomes disruptive. Looking at assembly, packaging, and sterilization as a single workflow makes it easier to identify constraints before they become problems and to plan for how the product will scale.

When changes are introduced late, they often trigger a chain reaction. A packaging update can require sterilization revalidation. A change in assembly flow can affect packaging configuration or kitting. Experience across all three areas allows these dependencies to be anticipated and managed, rather than discovered under deadline pressure.

The benefit is predictability. Early alignment supports stable timelines, reduces rework, and allows production to scale with fewer disruptions as demand increases.

Fenske: As development progresses, how can scale affect earlier decisions made for these areas?

Constable: As development progresses and scale increases, earlier decisions are no longer theoretical. They are tested by volume, throughput, and real-world constraints. Assembly processes must maintain consistency. Packaging must support higher output without introducing new risk. Sterilization must remain reliable as demand grows.

In many cases, those early decisions were made without full visibility into what scale would require. At that point, OEMs and startups can rely on the expertise of an experienced manufacturing partner to determine which decisions still hold, which need to evolve, and how to manage that transition in a controlled way.

As scale increases, small inefficiencies become more costly. Manual steps may need to be rethought. Packaging configurations may need to change to maintain throughput or sterilization compatibility. A capable partner helps manage these transitions by understanding how changes in one area affect the others and by sequencing adjustments to limit disruption.

The value is not simply in having made the right decision early. It is in having the capability to adapt decisions as scale increases while maintaining control of quality, compliance, and timelines.

Fenske: How do you ensure compliance requirements are met for these end-stage tasks before the actual product is finished being designed?

Constable: Compliance at later stages does not require a finished product, but it does require early structure and experienced guidance. Assembly, packaging, and sterilization each carry regulatory expectations that can be addressed while the design is still in progress.

For companies preparing to commercialize or scale, an experienced manufacturing partner, like LSO, helps translate evolving designs into compliant manufacturing assumptions. That includes defining likely assembly environments, packaging formats, and sterilization approaches early enough to align with quality system requirements, even as the product continues to mature.

Rather than waiting for a final design, compliance is built progressively. Process concepts are documented, risks are assessed, and regulatory constraints are identified upfront. This allows design teams to move forward with clearer boundaries and fewer late-stage surprises. As volumes increase or timelines tighten, those early frameworks become critical.

As the product reaches final design and validation, much of the compliance groundwork is already in place. Validation becomes a confirmation of established processes rather than a last-minute exercise. This approach helps companies move from development to commercial production with greater confidence, fewer delays, and a clearer path to scale.

Fenske: How can assembly, packaging, and sterilization decisions be affected by a handoff between vendors?

Constable: Handoffs between vendors introduce risk because assembly, packaging, and sterilization are tightly connected, even when they are managed separately. Each transition increases the chance of misalignment in assumptions, documentation, and process ownership.

When work is split across multiple suppliers, context is often lost. Assembly decisions may not translate cleanly into packaging requirements. Packaging choices may introduce constraints during sterilization. These challenges become more pronounced as scale increases, when higher volumes reduce tolerance for variation and timelines leave less room to resolve issues after the fact.

An integrated manufacturing model helps reduce that risk by keeping these activities connected. When assembly, packaging, package testing, and sterilization are managed within the same manufacturing partner, decisions are made with the full manufacturing flow in mind. In-house capabilities such as steam sterilization, small-lot EtO, and package testing allow issues to be identified and addressed early, often before they impact schedules or compliance.

Equally important is having technical expertise embedded in the process. Access to in-house microbiologists, validation engineers, and quality engineers allows changes to be evaluated quickly and consistently, without extended handoffs or external interpretation. As programs scale, this continuity supports clearer accountability, fewer surprises, and more predictable outcomes.

Fenske: Do the answers to any of these aspects change when dealing with a startup company versus a more established medical device manufacturer? Does the type of company impact any of these decisions?

Constable: The fundamentals don’t change. Assembly, packaging, and sterilization decisions are driven by product requirements, regulatory expectations, and risk, regardless of company size. What does change is the context in which those decisions are made.

Early-stage companies are often balancing speed, limited resources, and evolving designs. Decisions are made with less certainty about final volumes or long-term manufacturing strategy. In those cases, flexibility matters, and the focus is often on building a path to commercialization that does not create unnecessary constraints later.

More established manufacturers typically face a different challenge. Volumes are higher, timelines are less forgiving, and there is often an existing product portfolio to manage alongside new development. Decisions tend to prioritize consistency, predictability, and alignment with established quality systems.

This is where LSO’s model is particularly effective. Our teams support both startups and established OEMs by combining in-house assembly, packaging, package testing, and sterilization with deep technical expertise. Access to qualified microbiologists, validation engineers, and quality engineers allows decisions to be evaluated in real time and adjusted as programs evolve, rather than being revisited late under pressure.

For startups, that support helps create a clear and compliant path to commercialization without locking them into decisions that limit future scale. For established OEMs, it provides the structure, consistency, and predictability required to manage growth and complexity across multiple products.

In both cases, the type of company shapes how decisions are applied, not the standards behind them. LSO’s role is to apply those standards with the right balance of flexibility and control, so programs can move forward with confidence as they mature and scale.

Fenske: Do you have any additional comments you’d like to share based on any of the topics we discussed or something you’d like to tell medical device manufacturers?

Constable: One of the most important things for medical device manufacturers to recognize is that assembly, packaging, and sterilization are not isolated steps. They are connected decisions that evolve over time and become more consequential as programs move toward commercialization and scale.

What we see consistently is that early decisions matter, but they are rarely perfect. Even well-informed choices are made with limited visibility into how a product will ultimately scale. As programs mature, pressure, complexity, and constraint increase, and this is where the experience of a capable manufacturing partner becomes essential to adapt those decisions without losing control.

LSO’s role is to help manufacturers navigate that evolution. By combining in-house capabilities across assembly, packaging, package testing, and sterilization with experienced production teams and qualified technical staff, including trained assembly operators, microbiologists, validation engineers, and quality engineers, we help clients manage change without losing control of compliance, quality, or timelines.

For companies preparing to commercialize and for those managing growth across established product lines, the goal is the same. Build manufacturing processes that can evolve without repeated handoffs or disruption as volumes increase. When assembly, packaging, and sterilization are aligned within a high-scale production environment, manufacturing becomes an enabler rather than a constraint. LSO is built to serve as a long-term manufacturing partner, supporting products from early commercialization through sustained, high-volume production with consistency, control, and reliability. As your needs grow, LSO grows with you.

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