By Sean Fenske, Editor-in-Chief
Ideas for new medical devices can come from virtually anywhere. Patients can think of a way to provide them with better care, doctors may seek a technology to improve a procedure, or a student may conceptualize a new innovation for enhanced treatment. The real questions come when they try to develop it into a finished medical device.
Fortunately, there are companies that get involved with medical device incubators and innovation competitions who are experts in the design and manufacturing processes. They can provide expertise for the creation of an idea to ensure it meets with the rules and regulations put forth by the FDA.
One such company is Life Science Outsourcing (LSO). The firm provides a variety of services alongside its knowledge of medical device development. Participating in this Q&A to reveal more about how (and why) one full-service supplier is aiding early-stage innovators are three representatives from the company: John Nino, CEO; Mireya Lozano, director of quality & regulatory/incubator services; and Andrew Gladd, sales & program manager.
Sean Fenske: What made your company get involved with medical device incubators?
John Nino: LSO originally engaged with medical device incubators to help identify startup companies that could benefit from our contract manufacturing services. In doing so, we learned that inventors, startup companies, and medtech incubators could all benefit from utilizing our FDA-regulated facilities and ISO-certified quality management system (QMS). By providing these service offerings, we became a truly unique product development partner/facilitator.
Fenske: What services are most beneficial to or sought after by medical device incubators?
Mireya Lozano: Start-up companies need a physical place to fabricate prototypes and products—and a place to perform validation activities. Performing these activities under the LSO-certified umbrella enables them to operate within the structure of a proven quality management system they can count on to attain FDA approval.
During a recent quality conference, most of the quality consultants and strategists shared that the biggest roadblock start-up companies face when developing new medical devices is the lack of knowledge of the quality and regulatory process. That is where start-ups need the most assistance since it delays time to market.
Fenske: Does your company provide the services to the incubator or to the individual companies involved?
Nino: The answer is both. Our services are directed toward medical device inventors, startup companies, OEMs, design houses, and medical device incubators. Companies that utilize our incubator services often become lifelong customers because they see the value in using a “one-stop-shop” subcontractor that allows the use of their regulatory address. After successfully facilitating our customers through 510(k) and PMA regulatory pathways, we are the natural partner to facilitate their path to commercialization as well.
Fenske: In addition to the services, how important is it to offer space, such as office space and/or cleanroom space?
Lozano: This is incredibly important as it eliminates the need for our customers to establish and maintain FDA-regulated facilities. LSO offers controlled office, prototyping, and cleanroom facilities; in doing so, we learned companies (especially virtual companies) prefer quality system support along with utilizing these facilities. In addition, due to the pandemic, clients preferred their offices to be close to where most of their key employees live and may prefer to send only a few employees to our location as needed. Even though remote work is much more prevalent now, we continue to offer limited office space as needed while our clients are at our facility. That allows them to have both office space, which is convenient for them, and an incubator facility that will help them achieve a faster time to market.
Fenske: How do incubator firms take advantage of you sharing your certificates and/or physical address for use with the FDA?
Lozano: By utilizing LSO’s regulatory address, we help to minimize the risk of our medical device incubator service clients being audited at their facility where they may not have all the proper quality documents or knowledgeable individuals to successfully support an audit.
This is how it works: Our client’s auditors come to our facility. Most of their questions revolve around validations, qualifications, and producers. An LSO quality representative is assigned to assist with the audit and will handle those items for our clients. For questions regarding the design and design history files, our clients may be able to respond. Still, an LSO representative is there to assist during the entire audit, ready to step in and help. This type of assistance has been deemed invaluable by our clients.
Fenske: Can you share some of the success stories you’ve seen come out of this collaboration?
Andrew Gladd: Confidentiality prevents us from mentioning our customers by name, but we can share our most recent success associated with a customer that was able to get their product to market quickly and, soon after, was acquired by a large medical device OEM.
It started by cutting the cost of having a quality and regulatory employee on salary. Instead, they used LSO’s internal team’s knowledge to establish a QMS and provide ongoing support.
Since they were a virtual company, they used our address as their regulatory and physical address. We then assisted in setting up their QMS and were present for all their audits.
After successfully receiving FDA approval, LSO supported the product’s transition to commercialization. In addition, we helped them ramp up manufacturing since they were already working in our cleanroom. Even though they were acquired soon after that by a large OEM, we remain their manufacturing and sterilization partner. We’re proud to have been a critical part of the foundation that allowed them to achieve their strategic goals.
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: Most inventors and startup companies have product development milestones that must be achieved with limited funding available. By offering regulated facility utilization and QMS support, LSO provides a cost-effective alternative to establishing an FDA-regulated facility and ISO 13485-compliant quality management system. Our services have, time after time, accelerated our customers’ product development while enabling them to achieve their milestones within budget. We take pride in helping our customers achieve their goals and being part of continued customer success stories.
Click here to find out more about LSO >>>>>
Ideas for new medical devices can come from virtually anywhere. Patients can think of a way to provide them with better care, doctors may seek a technology to improve a procedure, or a student may conceptualize a new innovation for enhanced treatment. The real questions come when they try to develop it into a finished medical device.
Fortunately, there are companies that get involved with medical device incubators and innovation competitions who are experts in the design and manufacturing processes. They can provide expertise for the creation of an idea to ensure it meets with the rules and regulations put forth by the FDA.
One such company is Life Science Outsourcing (LSO). The firm provides a variety of services alongside its knowledge of medical device development. Participating in this Q&A to reveal more about how (and why) one full-service supplier is aiding early-stage innovators are three representatives from the company: John Nino, CEO; Mireya Lozano, director of quality & regulatory/incubator services; and Andrew Gladd, sales & program manager.
Sean Fenske: What made your company get involved with medical device incubators?
John Nino: LSO originally engaged with medical device incubators to help identify startup companies that could benefit from our contract manufacturing services. In doing so, we learned that inventors, startup companies, and medtech incubators could all benefit from utilizing our FDA-regulated facilities and ISO-certified quality management system (QMS). By providing these service offerings, we became a truly unique product development partner/facilitator.
Fenske: What services are most beneficial to or sought after by medical device incubators?
Mireya Lozano: Start-up companies need a physical place to fabricate prototypes and products—and a place to perform validation activities. Performing these activities under the LSO-certified umbrella enables them to operate within the structure of a proven quality management system they can count on to attain FDA approval.
During a recent quality conference, most of the quality consultants and strategists shared that the biggest roadblock start-up companies face when developing new medical devices is the lack of knowledge of the quality and regulatory process. That is where start-ups need the most assistance since it delays time to market.
Fenske: Does your company provide the services to the incubator or to the individual companies involved?
Nino: The answer is both. Our services are directed toward medical device inventors, startup companies, OEMs, design houses, and medical device incubators. Companies that utilize our incubator services often become lifelong customers because they see the value in using a “one-stop-shop” subcontractor that allows the use of their regulatory address. After successfully facilitating our customers through 510(k) and PMA regulatory pathways, we are the natural partner to facilitate their path to commercialization as well.
Fenske: In addition to the services, how important is it to offer space, such as office space and/or cleanroom space?
Lozano: This is incredibly important as it eliminates the need for our customers to establish and maintain FDA-regulated facilities. LSO offers controlled office, prototyping, and cleanroom facilities; in doing so, we learned companies (especially virtual companies) prefer quality system support along with utilizing these facilities. In addition, due to the pandemic, clients preferred their offices to be close to where most of their key employees live and may prefer to send only a few employees to our location as needed. Even though remote work is much more prevalent now, we continue to offer limited office space as needed while our clients are at our facility. That allows them to have both office space, which is convenient for them, and an incubator facility that will help them achieve a faster time to market.
Fenske: How do incubator firms take advantage of you sharing your certificates and/or physical address for use with the FDA?
Lozano: By utilizing LSO’s regulatory address, we help to minimize the risk of our medical device incubator service clients being audited at their facility where they may not have all the proper quality documents or knowledgeable individuals to successfully support an audit.
This is how it works: Our client’s auditors come to our facility. Most of their questions revolve around validations, qualifications, and producers. An LSO quality representative is assigned to assist with the audit and will handle those items for our clients. For questions regarding the design and design history files, our clients may be able to respond. Still, an LSO representative is there to assist during the entire audit, ready to step in and help. This type of assistance has been deemed invaluable by our clients.
Fenske: Can you share some of the success stories you’ve seen come out of this collaboration?
Andrew Gladd: Confidentiality prevents us from mentioning our customers by name, but we can share our most recent success associated with a customer that was able to get their product to market quickly and, soon after, was acquired by a large medical device OEM.
It started by cutting the cost of having a quality and regulatory employee on salary. Instead, they used LSO’s internal team’s knowledge to establish a QMS and provide ongoing support.
Since they were a virtual company, they used our address as their regulatory and physical address. We then assisted in setting up their QMS and were present for all their audits.
After successfully receiving FDA approval, LSO supported the product’s transition to commercialization. In addition, we helped them ramp up manufacturing since they were already working in our cleanroom. Even though they were acquired soon after that by a large OEM, we remain their manufacturing and sterilization partner. We’re proud to have been a critical part of the foundation that allowed them to achieve their strategic goals.
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: Most inventors and startup companies have product development milestones that must be achieved with limited funding available. By offering regulated facility utilization and QMS support, LSO provides a cost-effective alternative to establishing an FDA-regulated facility and ISO 13485-compliant quality management system. Our services have, time after time, accelerated our customers’ product development while enabling them to achieve their milestones within budget. We take pride in helping our customers achieve their goals and being part of continued customer success stories.
Click here to find out more about LSO >>>>>