Medical device innovators faced historic new challenges in recent years—challenges that carried over into labor shortages, supply chain and production delays, and shrinking resources. Yet, for long-term success, they must overcome those challenges and at the same time streamline efficiencies and achieve a meaningful cost reduction for continued innovation development and progress.
It seems that today’s market requires device companies to accomplish more with less, to be faster, and to get the job done with fewer resources. Meanwhile, it has become increasingly difficult to utilize multiple vendors to accomplish everything. As OEMs struggled to meet all the criteria, end-to-end outsourced service providers became the go-to solution that could do more without the need for piecemealing regulated services across increasingly disconnected channels.
While most incubators offer labs, research personnel, testing tools, and office space, their focus is primarily on short-term goals. In stark contrast, there are a few forward-thinking CMOs that recognize the value of long-lasting partnerships and they provide comprehensive solutions tailored to their client's needs. For startups, the chance to tap into such facilities isn’t just about physical resources; it's an opportunity to absorb invaluable expertise and mentorship, setting them on a trajectory for sustained success in the competitive medical landscape.
Resolving labor shortages and availability costs is easier than ever when your team can work with integrated services from one end-to-end solutions vendor who can easily pivot into new strategies and solutions that not only help you, but ultimately benefit the entire medical device industry. They can offer comprehensive medical device services that easily address regulatory needs within tight timelines, stay on top of all regulatory requirements, and offer a high-quality path to production to ease supply chain and labor burdens.
An effective end-to-end outsourced partner should offer the following services to ensure your current and future growth needs can and will be met.
Early planning can alleviate the limited availability of materials, as can agile solutions like pre-validated packaging. With one outsourced vendor managing this process, you’re more likely to reap the benefits of such strategic approaches to meet your production goals and substantially reduce your time to market. Verify that they can offer timely and cost-effective logistics as well as supply chain management services, and domestic and international solutions.
OEMs face many packaging and testing hurdles that can become convoluted and much more difficult when managing multiple vendor partners—especially when other outsourced services are needed as well. Finding an outsourced partner with established expertise in the medical device space benefits you in multiple ways, such as the ability to address regulatory needs in tight timelines, capability to pivot to a new strategy with pre-validated packaging options, and staying up to date with regulatory requirements. These will support your entire continuum of medical package testing needs and supply chain management with timely and cost-effective logistics from warehousing and inventory to packaging and delivery.
Pre-validated packaging is one asset when working with an end-to-end solutions vendor. Such packaging reduces risk while increasing the leverage of associated lead times and to production and to market, ultimately solving labor availability issues across account management and even manufacturing. It can also eliminate design qualification or stability testing processes, exponentially increasing efficiency and speed to market.
An outsourcing partner with a wide array of services can also take on your sterilization and validation needs. As a decontamination service provider, they may offer a wide range of options, such as ethylene oxide (EtO), gamma or e-beam, steam sterilization, and dry heat sterilization. Look for in-house expertise, such as on-staff validation engineers and microbiologists. They will likely have facility sterilizer equipment, in-house BI testing, supply chain simplification, and a long history of validation work. They should have knowledge and capabilities to select the ideal sterilization methodology for your device and be backed by a quality assurance system. This will give you confidence in the proper sterility level for your devices and ensure that protocols and documentation is an effective and compliant process.
An effective, broad services outsourcing partner should have extensive reach across the U.S. and even globally to meet your current or future demands. By providing services across a larger geographical area, they can support your medical device or diagnostic organization with their accelerated development and manufacturing capabilities, allowing you to start up, speed up, and scale up.
The right outsourcing partners can make delivering your medical or diagnostic device to market easier and more convenient, but in the end, they can also save your supply chain and eliminate risks from using several outsourced options. Utilizing many vendors can result in painful conclusions such as communication roadblocks, improper documentation, uncertain regulatory outcomes, and limited in-house capabilities. These will all impact your bottom line in a negative way. But identifying the right end-to-end outsourced partner can help build strong business relationships established on trust and expertise, allow for future growth, and deliver your much-needed device to market where it can do the job it was created for.
As the VP of Sales & Marketing at LSO, Yiorgos has vast leadership experience from various sectors. His background spans clinical and commercial sectors, making him a pivotal force in advancing LSO's integrated services, including assembly, kitting, packaging, and sterilization. He started in cardiovascular care, has published works, and is an active reviewer for the American Journal of Cardiology.
In the commercial arena, he's worked with Medtronic, Boston Scientific, led Cardiomed to a lucrative exit, and served roles at Smiths Medical, Ivera Medical, 3M, and Integer. Yiorgos has a Bachelor’s in Exercise Science focusing on Cardiovascular Physiology and an Executive MBA from the University of California, Irvine.
It seems that today’s market requires device companies to accomplish more with less, to be faster, and to get the job done with fewer resources. Meanwhile, it has become increasingly difficult to utilize multiple vendors to accomplish everything. As OEMs struggled to meet all the criteria, end-to-end outsourced service providers became the go-to solution that could do more without the need for piecemealing regulated services across increasingly disconnected channels.
Facility Utilization
Emerging medtech startups are pivotal to the medical device industry, leading the charge in innovative solutions that have the potential to revolutionize healthcare and transform lives. These nascent ventures are spearheading change, and early engagement with a contract manufacturing organization (CMO) can expedite their market entry. This timely access to the market often becomes the defining line between a startup's success and failure. Furthermore, many CMOs present startups with the unique advantage of facility utilization. This means these startup companies can utilize advanced cleanrooms and equipment that would typically be beyond their reach, thereby sidestepping the immense costs associated with procuring such resources.While most incubators offer labs, research personnel, testing tools, and office space, their focus is primarily on short-term goals. In stark contrast, there are a few forward-thinking CMOs that recognize the value of long-lasting partnerships and they provide comprehensive solutions tailored to their client's needs. For startups, the chance to tap into such facilities isn’t just about physical resources; it's an opportunity to absorb invaluable expertise and mentorship, setting them on a trajectory for sustained success in the competitive medical landscape.
The rise of integrated services
Original equipment manufacturers can now work with reliable outsourcing partners that offer in-house talent, state-of-the-art facilities and equipment, and expansive resources. Aligning with such a partner ensures not only manufacturing excellence, package testing, sterilization, and more, but also proper documentation and regulatory expectations. Access to turnkey medical device solutions enables you to achieve your go-to-market goals.Resolving labor shortages and availability costs is easier than ever when your team can work with integrated services from one end-to-end solutions vendor who can easily pivot into new strategies and solutions that not only help you, but ultimately benefit the entire medical device industry. They can offer comprehensive medical device services that easily address regulatory needs within tight timelines, stay on top of all regulatory requirements, and offer a high-quality path to production to ease supply chain and labor burdens.
Risks of outsourcing to multiple vendors
Outsourcing to multiple vendors not only requires more time and effort, it also demands more relationship building and added due diligence. It opens your company and its products to exponential risks:- Improper documentation and resulting regulatory gaps
- Delays in manufacturing, packaging, or sterilization
- Lack of communication and collaboration or problem-solving
- Limited in-house expertise
- One vendor can become a roadblock that prevents next steps
Identifying the right outsourcing partner
OEMs have many requirements to support delivering their medical device to market quickly, efficiently, and with cost-effective outcomes. The right outsourcing partner will likely need to offer solutions across medical and pharmaceutical start-ups and original equipment manufacturers in orthopedic, biopharmaceutical, in vitro diagnostics, and more. They should have the capability to help you plan, construct, and commercialize your products quickly—all while navigating regulatory environments. Many will offer specialized manufacturing specialties, electromechanical assembly, and engineering specialties that include process development, tooling, and documentation.An effective end-to-end outsourced partner should offer the following services to ensure your current and future growth needs can and will be met.
Fulfillment and distribution
Supply chain issues continue to have a negative impact on all aspects of delivery and execution. The extreme lead times that are needed for internal and external commitments remain a high concern of medical device companies and OEMs, especially as they have a lasting financial impact magnified by inflation aspects.Early planning can alleviate the limited availability of materials, as can agile solutions like pre-validated packaging. With one outsourced vendor managing this process, you’re more likely to reap the benefits of such strategic approaches to meet your production goals and substantially reduce your time to market. Verify that they can offer timely and cost-effective logistics as well as supply chain management services, and domestic and international solutions.
Packaging and package testing
Pre-validated packaging is one asset when working with an end-to-end solutions vendor. Such packaging reduces risk while increasing the leverage of associated lead times and to production and to market, ultimately solving labor availability issues across account management and even manufacturing. It can also eliminate design qualification or stability testing processes, exponentially increasing efficiency and speed to market.
Cleaning and decontamination
Medical devices often need cleaning and decontamination services in addition to packaging. Working with a trusted outsourcing partner that offers end-to-end services and expertise allows you to engage them in both needs. The right partner can streamline the decontamination process and reduce your costs with many in-house services: cleaning, decontamination, sterilization, loaner kit processing, quality inspection and sterility assurance level services along with packaging or transport guidelines.Sterilization and validation
An outsourcing partner with a wide array of services can also take on your sterilization and validation needs. As a decontamination service provider, they may offer a wide range of options, such as ethylene oxide (EtO), gamma or e-beam, steam sterilization, and dry heat sterilization. Look for in-house expertise, such as on-staff validation engineers and microbiologists. They will likely have facility sterilizer equipment, in-house BI testing, supply chain simplification, and a long history of validation work. They should have knowledge and capabilities to select the ideal sterilization methodology for your device and be backed by a quality assurance system. This will give you confidence in the proper sterility level for your devices and ensure that protocols and documentation is an effective and compliant process.
Global strategy with a personal feel
An effective, broad services outsourcing partner should have extensive reach across the U.S. and even globally to meet your current or future demands. By providing services across a larger geographical area, they can support your medical device or diagnostic organization with their accelerated development and manufacturing capabilities, allowing you to start up, speed up, and scale up.
The right outsourcing partners can make delivering your medical or diagnostic device to market easier and more convenient, but in the end, they can also save your supply chain and eliminate risks from using several outsourced options. Utilizing many vendors can result in painful conclusions such as communication roadblocks, improper documentation, uncertain regulatory outcomes, and limited in-house capabilities. These will all impact your bottom line in a negative way. But identifying the right end-to-end outsourced partner can help build strong business relationships established on trust and expertise, allow for future growth, and deliver your much-needed device to market where it can do the job it was created for.
About the author
Yiorgos Polizos is Vice President of Sales & Marketing at Life Science Outsourcing, a medical device contract manufacturer with over two decades of experience perfecting services designed to support innovators and entrepreneurs with expertise handling various sterilization methods and in-depth knowledge with the correlating ISU standards to support validation paths.As the VP of Sales & Marketing at LSO, Yiorgos has vast leadership experience from various sectors. His background spans clinical and commercial sectors, making him a pivotal force in advancing LSO's integrated services, including assembly, kitting, packaging, and sterilization. He started in cardiovascular care, has published works, and is an active reviewer for the American Journal of Cardiology.
In the commercial arena, he's worked with Medtronic, Boston Scientific, led Cardiomed to a lucrative exit, and served roles at Smiths Medical, Ivera Medical, 3M, and Integer. Yiorgos has a Bachelor’s in Exercise Science focusing on Cardiovascular Physiology and an Executive MBA from the University of California, Irvine.
