Medical device startups and OEMs face varying challenges when it comes to the development, manufacturing, and regulatory requirements of their up-and-coming products. Pitfalls of not overcoming such challenges can include wasted investment dollars and potential failure – and that’s before a product even hits the market.
Another common issue is scalability. Perhaps your product drives a decent revenue now but can dramatically increase in coming years. Does your company have an ability to scale to such growth? Obstacles like these can seem overwhelming, whether for a new startup or even a seasoned OEM with a new product.
How do successful companies navigate such hurdles? Experienced contract manufacturing partners are the secret, including their versatile facility offerings and in-house services under one roof, which can mitigate risk and give your company the flexibility it requires for continued product launch success. Life Science Outsourcing (LSO) is one such contract manufacturing partner that has achieved all of these benefits for medtech companies in orthopedics, diagnostics, minimally invasive devices, cardiac rhythm management and more.
Facility utilization doubles efficiency and expedites market success
Strong contract manufacturing partners like LSO can provide incubator solutions to meet your startup needs. We offer physical resources such as labs, researchers, testing equipment, and office space. Whereas some contract partners are focused primarily on short-term objectives and may not have the ability to provide long-term support with end-to end solutions, we can do both: We excel at solving your short- and long-term product manufacturing needs, all under one roof.
We offer robust versatility via a broad range of in-house facility offerings and services, and even individual requirements such as clean room space, assistance with sterilization, or answers to your packaging questions. LSO will help from the beginning of your initial R&D builds all the way through to commercialization, guiding you to success throughout your development and manufacturing stages.
The following are four important aspects of a quality end-to end solutions provider, including facility offerings, for your startup:
Company vision and manufacturer expertise should align
Startups who begin a working relationship with a contract manufacturer such as LSO at inception of the device benefit from aligning expertise with their vision from the beginning. Collaborating very early on in the process enables eventual expedited market entry – which can be the differentiator for success or failure for any medical device startup.
Your partner should demonstrate commitment to quality, deep expertise, and dedication to strong outcomes. They should be as committed to the success of your product as you are and offer facility utilization opportunities to make it happen. This includes the physical set up with labs and more to fast-track your product.
Facility clean rooms and equipment at your disposal
Working with a strong contract manufacturing partner can help you mitigate risk by avoiding the high cost of developing a clean room and purchasing equipment. For example, LSO facilities are equipped with CEPA-certified Class 5, 6, 7, and 8 cleanrooms, including a Class 7 dry room. Bioabsorbable polymers benefit from our dedicated spaces for low-humidity manufacturing and solvent scouring. And you gain the benefit of being able to closely observe product assembly from outside and inside the clean room. Our expertise and mentoring is available when considering a facility utilization. We offer flexible arrangements for clients and can work with both short- and long-term needs. Careful scheduling ensures that facility usage has no overlap and can guarantee privacy and IP protection.
Cybersecurity practices to protect your sensitive data
Your privacy and IP protection should be maintained at all times by your contract manufacturing partner. They should establish and maintain stringent security parameters to ensure your data is safeguarded. At LSO, we take such measures seriously. We are NIST 800-171 compliant to protect electronic IP and have a security and surveillance system to prevent unauthorized access to sensitive areas, in addition to other extensive security enhancements.
Certification maintenance and audits
Certifications are a must when it comes to medical devices – and it can be a daunting task to fully understand all the ins and outs of what is needed. This is where a strong partner can really benefit startups, from early on and going forward into future growth. LSO can establish and maintain FDA and ISO certifications and undergo annual ISO 13485 surveillance audits and full quality management system (QMS) certifications for all our facilities. Included in our offerings are lot traceability, controlled labeling processes and lot release (including sterilization release). We offer hands-on support during regulatory audits and beyond.
Medical device startups facilitate growth with an end-to-end solutions provider
Whether you need a full range of services, or a specific facility requirement, LSO has you covered with assembly, packaging, sterilization, testing, and fulfillment. Above and beyond these include the many added benefits of working with a comprehensive, end-to-end solutions provider:
Skilled operators and on-staff microbiologists
Highly skilled in-house operators and experts offer capabilities that can streamline the development process. That impact translates to increased efficiency and faster time to market. LSO has such talent in-house, including a microbiologist, which is fairly unique in the industry.
Product engineering and prototyping
On-site capabilities support quick turn prototyping and product engineering. The key is developing validated processes that are necessary for product launch. LSO has the fundamental expertise and resources to make it happen.
In addition to a wide array of services, LSO also offers assembly, kitting, packaging, and quick-turn sterilization under one roof to expedite development and manufacturing processes – allowing you to focus on future growth and innovation.
Quality Management System (QMS)
Having an efficient QIS system is necessary to establish traceability, manage supply chains effectively, and create effective packaging strategies. LSO guides clients around developing a QMS that will meet FDA and ISO 13485 requirements.
LSO guides startups and OEMs to become industry leaders by sharing their over 26 years of expertise in medical devices. It is our mission to nurture innovation, support development and be a key part of the process that brings life-changing medical devices to market. We can help to streamline your operations and support your company at every stage of your product journey, helping you to bring life-changing medical innovations to the market. Contact us today to learn how our facilities and services can make your next big product come to life.
Looking for more information on medical device manufacturing? Read Medtech Startups Benefit From Comprehensive Incubator Services for Long-Term Success.
Start up. Speed up. Scale up. Founded in 1997, Life Sciences Outsourcing is an FDA-registered and ISO 13485-certified organization with services and capabilities spanning the entire medical device product life-cycle – from turnkey manufacturing, testing, validation, and sterilization to precision packaging, fulfillment, and distribution. Email us at firstname.lastname@example.org or call (714) 672-1090 today to get started.