Brady Hatcher, Switchback Medical, Device Development
Brady as spent a career developing novel catheter technologies for neurovascular, cardiovascular, and peripheral vascular applications. He brings deep engineering expertise combined with comprehensive capabilities in the design and fabrication of your device. Switchback Medical helps customers meet their targets and accelerate their time to market.
- Device Development and Manufacturing:
- Finished Devices
- Balloon Catheters
- Delivery Systems
- Reinforced and Steerable Catheters
- Flex Circuit Technologies
- Nitinol Components & Frames
- Biomedical Textiles
- BioSim Innovations:
- Biosimulator Model Development
- Physician Training
- Lab Services Utilizing Human and Animal Tissue
- Cell, Tissue, and Organ Culture
Rajan Ramawamy, NOVO Engineering: “Better products to market. Faster.”
NOVO Engineering is a MedTech design and development firm that supports product development from inception through commercial launch and beyond. For nearly two decades, NOVO has provided system-level hardware and software development for major medical device companies and startups. Strong program management and a robust development process promote innovation and efficiency. Project plans are built around risk management and requirements verification. The process is integrated into NOVO’s purpose-built eQMS, which is certified to ISO 13485:2016. NOVO has developed FDA Class I, II, and III devices in a range of clinical applications that include drug delivery, diabetes care devices, catheter-based delivery systems, surgical robotic systems, and diagnostic platforms.
NOVO employs more than 60 full-time technical and support staff in Minneapolis and in Southern California facilities. NOVO’s engineers will blend seamlessly with customer’s internal development team or operate independently as a stand-alone development team – in either case, delivering rapid commercialization of unique and outstanding devices.
Andy Schieber, Ingenarious Consultants
Ingenarious consultants specializes in early stage medical devices, our expert team guides start-up companies through all stages of the product development process. Ingenarious employs a phased approach to product development that is uniquely tailored to early stage design feasibility. This approach provides a growing set of resources as the phases progress to bring your idea from proof-of-concept to clinical studies and beyond. In addition to engineering consulting services we also provide regulatory, quality and clinical consulting services. We assemble a custom team for your project that utilizes the expertise you need. Our staff includes experienced engineers in Mechanical, Manufacturing, Electrical, Software, Optics, Fluid Dynamics, Ultrasonics and Material Science. Ingenarious also provides prototype fabrication such as 3D printing, machining, silicone molding, device assembly and testing. Our full service lab can tackle prototyping challenges big and small.
Kirsten Scholte, Cortex Design: “Advancing the human experience.”
Advancing the human experience. This ethos manifests itself through every element of Cortex Design. As an award-winning ISO 13485:2016 and ISO 9001:2015 design and engineering firm established in 1999, we focus on how the products we develop advance the human experience. Our clients engage us when they need a flexible, responsive team to support and / or augment their internal resources. While we have the formality of our QMS and internal processes to deliver for some of the biggest clients in the world, our Design for Commercialization™ methodology is creative and agile in nature. As a result, our team can meet a client where they are and engage in a project however the client needs us to.
Areas of expertise include; Stakeholder Engagement, User Experience, Empathy-led Industrial Design, Mechanical Engineering, Electronics & PCB Design, Embedded Firmware, Quality & Regulatory Services, Product Testing, and Production Management.
Emily Rusk, Device Development Consultant
Emily has spent 20+ years in medical device engineering and product development, across a wide range of products – from bioabsorbable drug-eluting scaffolds to complex minimally invasive delivery catheters and multi-component systems with capital equipment. She recently worked with a team that was granted emergency authorization from FDA (EUA) on a ventilator for use during the COVID-19 emergency. Emily particularly enjoys helping teams advance innovative products into the clinic.
Brett Williams, Volare
Volare, Inc. was founded with the vision of leveraging decades of experience in contract design, development and manufacturing to improve the medical device startup model. Volare was established to accelerate development timelines, streamline business activities, align incentives and maximize value for life changing medical device technologies.
Volare partners with entrepreneurs with novel technologies, forming joint ventures with aligned vested interest in success. Each joint venture leverages Volare’s infrastructure to reduce upfront costs for the product development process, facility, quality system, etc. By aligning incentives for all stakeholders (founders, employees, investors, strategic partners) we can more efficiently develop novel technologies while maximizing value for acquisition in a compressed time frame. Volare’s focus on design for manufacturing saves development timelines and reduces cost on potential manufacturing transfers to strategic acquisition partners.