There has been an increase in the number of start-up med device companies joining, or being founded in conjunction with, Incubators. Medical Device Incubators have traditionally catered more to the business plan development or product research/design aspects of the business. And in most cases these incubators require an equity stake in the company in return for their services. But no one deals with the activities following this phase – the actual production stages. At that juncture, start-ups either spend large amounts of time and resources locating various vendors for manufacturing and other activities, or must incur huge costs to build the capabilities in-house. Essentially they find themselves choosing between a rock and a hard place.
But what if there was a third option, for people who have a product design, who know how to develop it and want to bring the product to market as quickly as possible. One that takes the start-up all the way through from R&D to product distribution?
Well now there is.
We, at LSO, have developed a new model of Incubator, where the startup company would have an abundance of resources under one roof, and where they could develop, test, build, package, sterilize and ship a finished product. Just like all Incubator services, LSO offers its clients office space and other administrative support. But as a medical device contract manufacturer, LSO can also offer clients with production space and equipment for manufacturing, packaging, sterilization, package testing, warehousing and finally distribution. And unlike other places, we do not ask for equity in the incubator company, making us unique in our field.
So when companies come to us, they have instant access to a fully functional manufacturing facility that can considerably reduce their time to market. But what’s even more significant is that clients also have available to them a fully functional FDA approved quality system. This is a first-in-kind service provided by LSO, where clients choosing to operate under the purview of our Quality System, truly become a part of our Quality system process.
As comprehensively as possible – Clients opting for this service, can expect the following:
1. Clients can customize LSO’s Quality system to fit their own business:
- ISO 13485:2012 Medical devices, Quality Management System
- FDA 21 CFR Part 820 Medical devices, Quality System Regulation
3. LSO would represent the client at FDA and ISO audits
4. LSO would guide clients through their 510K approval process, including validations:
- Cleaning Validations
- Sterilization Validations
- Package testing Validations
- Manufacturing process validation (this should be “a” item)
5. LSO would provide clients with Documentation Control
- Initiation of Documentation
- Control & Maintenance of created documentation
6. LSO would perform vendor qualification for clients. In addition, clients would have access to LSO’s existing supplier network.
7. Quality Inspections:
- Incoming-receiving inspection of components
- In-process inspection
- Final product inspection
- Final release
LSO has focused on meeting the unique needs of start-up medical device companies for over 15 years. We are very excited about the possibilities our Incubator service brings to the industry. We feel this service can have an immediate impact on newly formed companies looking to get off the ground and look forward to bringing these ingenious concepts to market faster and more cost effectively than what was ever previously possible.
For additional information on our Incubator services please fill out the form here and someone from LSO will immediately get back to you, or call 714-672-1090