By Sean Fenske, Editor-in-Chief

Companies have many great ideas for new medical device innovations, but many times, they are not experts in bringing those concepts from the napkin sketch to the doctor’s office or surgical arena. Whether just starting out with its first product or introducing a new solution to its portfolio, an organization can lack the experience in the necessary steps of the journey. Such a situation can result in costly delays or ultimately, a failure to launch.

With this in mind, working with partners to help ease the pathway to market can be critical. These companies can offer assistance in testing, packaging, sterilization, regulatory, and more. But managing multiple firms that are handling different aspects of the development process can be burdensome and introduce risk. Working with a single entity that can assist startups through established organizations brings significant benefits.

To share his own thoughts on the advantages of working with a company that provides expertise on important facets of product development, John Nino, CEO of Life Science Outsourcing (LSO), responded to several questions. In the following Q&A, he speaks to the ways in which a company can support small to large medtech OEMs in packaging, validations, sterilization, and regulatory.

Sean Fenske: When it comes to medical device development, what are some of the more common regulatory-related challenges companies encounter? How does Life Science Outsourcing help overcome these issues?

John Nino: One of the biggest regulatory challenges we see is that teams often treat compliance as a checkpoint rather than a driver of design. Take sterilization: the decision between EtO, radiation, or steam is not just about what works in the lab. It dictates your material selection, your packaging format, and how your process validations will be structured. If that choice is made late, it usually forces redesigns, new testing, and schedule resets that can add months and significant cost.

Another common issue is documentation discipline. Engineers naturally focus on how the product performs, while regulators are focused on whether every requirement is fully traceable and repeatable. When those perspectives are not aligned, the gaps show up during audits or reviews, and they can stall approvals.

What we do at Life Science Outsourcing is help companies integrate those regulatory expectations into the development plan from the very beginning. That might mean structuring packaging validation around ISO 11607 while the design is still evolving, or running sterilization feasibility work in parallel with design verification so you do not lose momentum later. For executives, that translates into fewer surprises and a clearer line of sight to market entry. For engineers, it means designing with the right constraints in place instead of being forced into changes after the fact.

Fenske: When it comes to manufacturing, what challenges do both small and large medtech OEMs face? How does LSO help them navigate through them?

Nino: Whether you are a startup or a global OEM, the manufacturing challenges often rhyme, just at different scales. Smaller companies struggle with infrastructure. They may have an excellent design but lack the cleanroom space, quality systems, or validated processes to make it at commercial volumes. That gap creates delays because they are forced to either build internal capabilities or piece together multiple suppliers.

Larger companies face a different version of the same problem. They usually have the infrastructure, but the complexity of their global supply chains can slow down decision-making. Adding a new product line means coordinating regulatory, quality, operations, and finance across several regions, and that bureaucracy can be just as limiting as a startup’s resource constraints.

What LSO brings to the table is a way to compress those timelines. For small companies, we provide the infrastructure they cannot justify building themselves: ISO-certified cleanrooms, sterilization, packaging validation, and a mature quality system that is already inspected and approved. That lets them focus on the device rather than on building an entire operation from scratch.

For larger OEMs, we provide flexibility and speed. They can use us to scale a program quickly without waiting for their internal systems to reallocate resources or expand capacity. We act as an extension of their operations, with the ability to pivot faster than a large organization typically can. In both cases, the value is not just capacity, but the ability to move from concept to market without losing time to structural bottlenecks.

Fenske: Where are you seeing the roadblocks for companies in terms of logistical issues and share how LSO is helping ease them?

Nino: Logistics has become one of the most underestimated challenges in medtech. For smaller companies, it is often about not realizing how much coordination is required once a device leaves the production floor. Packaging, sterilization, distribution, and inventory control all have regulatory and quality implications, and if those are managed in silos, you can lose both time and traceability.

For larger organizations, the roadblocks usually come from global complexity. Moving product across regions with different regulatory frameworks, customs requirements, and sterilization standards can create delays that no amount of manufacturing efficiency can overcome. We have seen cases where a product was ready for launch, but the logistics chain added months because critical validations or transit studies were not aligned with the target market.

At LSO, we reduce that friction by integrating services that are often handled by multiple vendors. For example, we can coordinate sterilization, packaging validation, and distribution under one quality system. That means fewer handoffs, fewer chances for documentation gaps, and a clearer chain of custody from production to the end customer. For operational leaders, it translates into predictable lead times and reduced risk. For engineers, it ensures the product is handled and documented in a way that supports compliance in every market where it will be sold.

Fenske: Can you share some real-world examples of these issues to help illustrate the problem and solution?

Nino: A good example comes from the cardiovascular space. We worked with an early-stage company developing a minimally invasive heart valve replacement system. They had groundbreaking technology but needed an FDA-registered and ISO-certified partner to handle assembly and packaging. We stepped in to support process development, raw material inspection, ultrasonic cleaning, and packaging design. The result was not only a smooth path through validation but a product that went on to achieve clinical success and ultimately led to the company’s acquisition by a multinational. That shows how addressing both regulatory and manufacturing challenges early can protect the value of the innovation itself.

Another example is a startup in the breast biopsy market. They had no internal manufacturing capability, so every operational roadblock from cleanroom access to packaging validation stood in the way of getting their device to patients. By acting as a single source for manufacturing, sterilization, and packaging validation, we helped them streamline their launch. Once they gained market traction, they were able to scale into their own facility, but those first years were only possible because they had a partner to provide the infrastructure.

What these examples highlight is that the roadblocks are often less about the science of the device and more about execution. When a company is forced to juggle multiple vendors for critical processes, every handoff adds risk. By simplifying that chain and keeping compliance front and center, we help companies keep their focus on the clinical impact rather than logistical setbacks.

Fenske: Where else are you most often seeing companies struggle during the medical device development lifecycle? How does LSO help?

Nino: One area where companies often struggle is the transition that happens right after design freeze. A prototype can perform well in the lab, but that does not guarantee it will translate into a process that is validated, scalable, and compliant. The gaps usually show up in areas like tolerance control, assembly methods, or the way components interact during sterilization and packaging. That is where timelines can slip, because the product may need adjustments in order to meet regulatory expectations for consistency and repeatability.

Packaging and distribution testing is another frequent challenge. By the time companies reach this stage, the device design is locked, and they discover the packaging system is not sufficient to protect the product through sterilization or distribution. That can mean going back to address packaging performance, which is both costly and time-consuming.

This is where LSO comes in. Once a design is frozen, we apply our expertise in packaging, sterilization, and manufacturing support to accelerate time to market. By validating packaging systems, coordinating sterilization, and ensuring manufacturing readiness, we help turn a finished design into a commercially viable product without unnecessary delays.

Fenske: While regulatory, manufacturing, and logistics are complex and issues are understandable, where do companies get caught off-guard when they face challenges? What surprises them?

Nino: What surprises companies most is not the complexity itself but how interconnected every decision is. They may plan carefully around regulatory requirements or invest in manufacturing scale-up, but then discover that something as basic as packaging design adds months to the schedule. Creating a custom packaging system that can withstand sterilization and distribution is not quick, and many teams underestimate that. That is why we developed pre-validated packaging options, which can remove months of work and testing from the path to market.

Another area that catches teams off guard is the time required to build infrastructure. Cleanrooms, quality systems, and validated processes are not things you can stand up overnight. Even large organizations with resources in place often find their internal capacity tied up with other priorities, which can stall a new product launch.

Documentation discipline is another recurring surprise. A company can have a strong design and solid processes, but if the records do not meet regulatory expectations for completeness and traceability, progress grinds to a halt.

The good news is that these surprises are preventable. By anticipating the timelines for packaging, infrastructure, and compliance up front, companies can make informed decisions and avoid the stop-start cycle. Our role is to help them see around those corners, align critical steps with regulatory expectations, and keep momentum toward market entry.

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?

Nino: If there is one takeaway, it is that the obstacles companies face are real, but they are not insurmountable. Regulatory hurdles, manufacturing bottlenecks, and logistical complexities are all part of the medtech landscape. What determines success is how early and how clearly those challenges are recognized. Too often, companies assume the biggest risks are purely technical, when in fact the risks usually come from how all the supporting elements connect, such as packaging, sterilization, supply chain, and compliance.

My message to medical device manufacturers is to treat those areas with the same focus and rigor as the device design itself. Doing so not only reduces surprises but also preserves the value of the innovation by keeping programs on track. Our industry is full of breakthrough ideas that can improve or even save lives. The faster and more reliably we can move those ideas from concept to patients, the better the entire ecosystem will be.

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