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Michael Groosman, REV.1 Engineering - Medical Device Development Company | LSI USA '24

Rev.1 Engineering is a premiere medical device development company located in Southern California.
Speakers
Michael Groosman
Michael Groosman
REV.1 Engineering

Michael Groosman  0:03  
REV.1 Engineering is a contract development company. We're based in Temecula and Marietta right in between Irvine and San Diego. company got founded back in 2008 by two former guidance engineers, we've grown since to about 50 people 35 engineers and technicians, where we developed over 150 devices for more than 80 clients, both domestic and international, we got acquired back in 2021 by Asahi Intek. Since then, we have added our ISO 1345 certificates, and we have added strategic manufacturing to our development capabilities. So we are a part of Asahi Intek, where we are very independent in how we operate. So we can choose with who we want to work with in whatever field. But because we are a group company, we have the possibility to source components from them for very good rates and expedite lead times. And if the opportunity is there, we can also scale to their large scale manufacturing sites in Southeast Asia. core businesses, custom device development and early manufacturing. We have worked on several occasions with especially startup innovators, where we act as their entire development team and take them from back of the napkin sketch all the way to transfer to manufacturing and commercialization. But we also work ala carte. So if you just need a temporary extension of your core team, and ready to do product development, just the DFM activities are vnv This is something that we can do and then go separate ways again, tend to create a lot of IP during these phases. We don't own any of our of this IP, we always assign it to our clients. So we have experience in a lot of fields. And we're very agnostic to what type of work we take. Um, but I would say that about 50 to 60% of what we have done is either minimally invasive instruments, or catheter based devices for both mechanical delivery or energy delivery. But we also have experience in drug device combinations of two wearables to a capital equipment as well. We like to work in all these different fields, because it gives us a lot of opportunity to cross pollinate, which makes us work especially well with first of kind type of device innovators, because you can source from these type of different experiences. So we have a lot of capabilities, we have our own machine shop. But we can also source from Asahi in tech in order to facilitate rapid prototyping. And importantly, we have a strategic manufacturing site locally in Marietta in California. So we wanted to start the strategic manufacturing side, because we noticed working with our startup innovators, how difficult it can sometimes be to get a contract manufacturer, especially at an early stage. So difficult contract manufacturers want to have high volumes, long runs, predictable demands, which is something that a startup usually cannot offer at an early stage. So we want to be that manufacturing sites where you can do variable volumes, short runs, and we evolve with your demand, just to make sure that you have the products available to do your V and V and your clinical trials, get the data and then get next to that next funding round. So of my presentation, I'll be around here, feel free to reach out to me through the app, or just come over to Temecula. We'd be happy to have you over. Thanks very much.


 

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