With regard to developing and manufacturing a medical device with the added challenges of the regulatory environment, coming up with a good idea may seem like the easy part. There are a number of obstacles to success that can appear too overwhelming to overcome, especially to a startup company not intimately familiar with the environment. It can lead to wasted investment dollars and failure before a product even hits the market.
Fortunately, there is a well-established community of service providers ready and able to assist with every single step of a development and manufacturing process. Sometimes, however, it can be difficult for a startup to identify the right fit. What does one do if they just need cleanroom space? What about assistance with sterilization? Where should they turn for packaging answers? What if they require multiple solutions?
Addressing many of these questions and more is John Nino, CEO of Life Science Outsourcing. In the following Q&A, he provides a comprehensive look at how his company enables startups to succeed in their development and manufacturing stages and also covers the extensive level of support his firm is ready to provide.
Sean Fenske: Why is it important to your company to support the development of startup medtech firms instead of exclusively focusing on more established companies?
John Nino: Our mission at Life Science Outsourcing (LSO) is to nurture innovation, support development, and be a key part of the process that brings life-changing medical devices to market. We believe one of the most important ways to accomplish this is by partnering with start-ups at their earliest stages of development.
Startup medtech firms are the lifeblood of the medical device industry. They drive innovation, creating solutions to healthcare problems that can change lives and transform the medical landscape. By supporting these startups, we're investing in the future of healthcare, helping to create devices that could potentially revolutionize treatments and patient care.
We firmly believe in the value of being trusted partners from the inception of a device. By doing so, we can align our expertise with their vision from the start, ensuring the highest levels of efficiency, agility, and regulatory compliance. Our deep involvement from the beginning stages enables us to expedite their market entry, with the understanding that getting to market quickly can be the difference between success and failure for a startup.
At LSO, we have a rich history of supporting start-ups. Since our establishment in 1997, we've worked with over 850 startups, aiding in over $4 billion in acquisitions. This track record highlights our commitment to, and expertise in, helping small firms successfully bring their products to market.
Moreover, we see our work with start-ups as complementary to our relationships with more established companies. All our clients, regardless of size, receive the same commitment to quality, the same expertise, and the same dedication. This balanced approach helps us stay innovative, knowledgeable, and capable of addressing a broad spectrum of outsourcing needs. It keeps us versatile, adaptable, and always ready to support the development and launch of the next game-changing medical device.
Our dedication to supporting startups is a reflection of our belief in innovation, our commitment to partnership, and our desire to play a critical role in advancing global healthcare solutions. We are not only a performance-driven CMO; we're a partner in our client’s journey to improve lives.
Fenske: What capabilities/offerings are a startup able to take advantage of when they rent space from LSO?
Nino: Startups that rent space from Life Science Outsourcing are able to leverage an extensive range of capabilities that streamline the process of medical device development, allowing them to focus on their core competencies while we handle the manufacturing intricacies.
Classified Cleanrooms: Our facilities are equipped with CEPA-certified Class 5, 6, 7, and 8 cleanrooms, including a Class 7 dry room. We have dedicated spaces for low-humidity manufacturing and solvent scouring, which are essential for handling bioabsorbable polymers. Clients can closely observe product assembly from outside and inside these rooms, ensuring transparency and quality assurance.
Product Engineering and Prototyping: We offer on-site, quick-turn prototyping and product engineering within our in-house laboratory spaces. Our team works diligently to develop the validated processes a company’s product requires for market launch.
Experienced Staff: Startups have direct access to our highly skilled operators and support staff who can lend their expertise to ensure their product is assembled to the highest standards.
Comprehensive In-House Sterilization: Our facilities house comprehensive in-house EtO and steam sterilization capabilities, ensuring a faster time to market and reduced costs. We offer quick-turn, single lot release EtO sterilization in our 3M chambers and further streamline the process with our in-house testing of biological indicator sterility.
Commitment to Quality: As an FDA-registered and ISO 13485-certified organization, quality is our utmost priority. We maintain these certifications and undergo annual ISO 13485 surveillance audits and full quality management system (QMS) certifications for all our facilities. We also offer lot traceability, controlled labeling processes, and lot release including sterilization release.
Our commitment to startups extends beyond just providing space; we aim to be a comprehensive partner in their growth journey. Our wide array of offerings and established quality processes help startups overcome barriers and expedite their path to market, without compromising on quality or regulatory compliance.
Fenske: How does this offering differ from a startup simply working with a development/manufacturing outsourcing partner?
Nino: At LSO, our incubator service provides more than just the physical resources often found in traditional incubators. While most incubators provide access to labs, researchers, testing equipment, and office space, they usually specialize in meeting short-term objectives. The LSO difference lies in our comprehensive, long-term partnership approach and the end-to-end solutions we offer to our clients.
Our extensive services stretch beyond standard offerings, providing access to in-house sterilization and validation services, medical package testing, and highly-skilled operators and experts like our on-staff microbiologists. These in-house capabilities streamline the development process and increase efficiency, thereby reducing time to market.
Unlike some outsourcing partners who might only provide support at specific stages, LSO is committed to the long-term success of the startups we work with. We are with them from their initial R&D builds all the way through to commercialization. Our approach includes hands-on support during regulatory audits and beyond, ensuring the company can smoothly navigate the intricate medical device industry's regulatory landscape.
Moreover, while many development/manufacturing outsourcing partners may treat their work as a series of transactions, LSO aims to build a meaningful, long-term relationship with every startup we support. We see ourselves as an integral part of the team, committed to the startup’s success every step of the way.
In essence, our Medical Device Incubator Service differs from traditional incubators and outsourcing partners through our comprehensive capabilities, long-term commitment, and partnership mindset.
Fenske: Is the space exclusive to them for a set period of time? How do you keep multiple startups separate from each other and ensure intellectual property (IP) is protected for each client?
Nino: We understand the unique needs and concerns of startup medical device companies, particularly when it comes to scalability, flexibility, and IP protection. We address these issues in several ways.
We offer flexible arrangements to our clients, accommodating both short- and long-term needs. While the physical space in our facility is not exclusive to a single startup for a set period of time, we carefully manage the scheduling and usage of our facilities to ensure each client's needs are met and there is no overlap that could lead to concerns about privacy or IP protection.
Protection of our client's IP is a priority for us. We have stringent non-disclosure agreements in place to protect confidential information. We implement individual line clearances and use our large cleanrooms to keep projects physically separate and protected. This helps ensure no IP is inadvertently shared or exposed.
In addition to our physical measures, we are NIST 800-171 compliant, which means we follow stringent cybersecurity practices to protect electronic IP. Our facility also employs a robust security and surveillance system, along with access control mechanisms, to prevent unauthorized access to sensitive areas.
Our Quality and Operations staff have decades of experience working with both large and small original equipment manufacturers (OEMs). They are highly committed to protecting our clients' assets and ensuring all protocols and practices for IP protection are strictly adhered to.
We believe these measures, combined with our commitment to transparency and communication, provide a secure, supportive environment for startups to develop and manufacture their products without the added stress of potential IP issues.
Fenske: Are there any services included with the use of the space? Can the arrangement be a hybrid situation where they rent development space and also leverage services offered by LSO?
Nino: Absolutely, the flexibility of our services is one of the key advantages of working with Life Science Outsourcing. When a startup rents development space from us, they don't just get access to top-tier cleanrooms and facilities; they also have the option to leverage our extensive range of services and offerings.
Our comprehensive, end-to-end service offerings are designed to accelerate time to market and reduce costs. This includes assembly, kitting, packaging, and quick-turn sterilization—all performed under one roof for seamless integration and efficiency. This holistic approach helps startups streamline their development and manufacturing processes, enabling them to focus on innovation and growth.
We also offer access to pre-validated packaging solutions and validation services, eliminating the need for startups to source these services separately. By providing these additional services, we reinforce our commitment to the success of our clients and our goal of being a true partner that delivers end-to-end solutions for medical device OEMs.
So, yes, a hybrid arrangement is definitely possible and even encouraged. We tailor our services to meet the specific needs of each startup, allowing them to utilize our space and services in a way that best supports their business objectives. At LSO, we're not just a service provider—we're a strategic partner dedicated to supporting startups at every stage of their journey.
Fenske: Where do startups most often need guidance or recommendations for how to proceed and/or develop a device? For example, are they often overwhelmed by the regulatory process and guidelines?
Nino: Startups in the medtech sector often face significant challenges in areas beyond their primary focus of product development. While the ingenuity and efficiency of their device is certainly crucial, it's equally important to have an efficient QMS, establish traceability, manage supply chains effectively, and devise appropriate packaging strategies. LSO not only provides guidance in these challenging areas but also excels at tackling them head-on.
Startups often underestimate the importance of a well-structured QMS. At LSO, we provide guidance on developing a robust QMS that meets FDA and ISO 13485 requirements, an essential aspect for medical device manufacturers to ensure product safety and effectiveness.
Tracking each component of a medical device from raw material to the finished product can be an overwhelming task. We guide startups through this process and ensure complete traceability through our ERP system, from suppliers' raw material lot numbers to the final assembled product.
Also, efficient supply chain management is essential for maintaining production timelines and cost-effectiveness. Startups often need assistance in this area, and we provide expertise to help them establish reliable, efficient supply chains.
The packaging of a medical device plays a crucial role in maintaining its integrity and ensuring safe delivery to the end user. Startups often need guidance on developing a packaging strategy that is both effective and compliant with regulatory standards. With a wealth of experience in the medical device industry, we excel at creating effective, compliant packaging solutions that ensure the safety and integrity of our clients' products.
In addition, compliance with FDA regulations and ISO standards can be a complex, daunting task for startups. LSO provides invaluable support here, guiding startups through the regulatory landscape with our extensive knowledge and expertise. Our commitment to maintaining our FDA registration, ISO 13485 certification, and a range of other certifications exemplifies our dedication to superior quality management and risk mitigation. Our team's regulatory expertise is unparalleled.
Essentially, startups often need guidance in areas they might not initially consider. By partnering with LSO, startups can leverage our commitment to quality, our regulatory expertise, and our full suite of service offerings, giving them the support they need to navigate these challenges and accelerate their path to market.
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: I would like to reiterate that at Life Science Outsourcing, we are more than just a contract manufacturer. We pride ourselves on being a strategic partner to both emerging startups and established medical device companies. Our core philosophy revolves around providing integrated, end-to-end solutions tailored to each client's specific needs.
Navigating the path from device conception to market launch can be a daunting journey. It's not just about manufacturing a device; it's about meeting stringent regulatory standards, establishing efficient supply chains, ensuring full traceability, creating safe and effective packaging, and above all, maintaining the highest standards of quality.
While startups might have brilliant device ideas, the journey from the laboratory to the market is filled with challenges that can be overwhelming. That's where we step in. With over two decades of experience in the medtech industry, we have the expertise, resources, and dedication to guide startups through these complexities, helping them bring their innovations to market swiftly and efficiently.
To established medical device manufacturers, we provide the reassurance of working with a partner who understands your needs and challenges. We provide agility and flexibility to ensure smooth, efficient manufacturing processes while maintaining the highest standards of quality and regulatory compliance.
Whether you're an ambitious startup or an established company looking to expand or streamline your operations, Life Science Outsourcing is your trusted partner for success. We're here to support you at every stage of your journey, helping you bring life-changing medical innovations to the market. We're not just your contract manufacturer; we're your partner in making a positive impact in medtech.
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