Our
Projects
Grasp Health has performed many successful projects thus far. Here are some examples that showcase our framework and capability.
Intravascular Device and its Accessory Devices
CLIENT NEEDS
• Contracted by a US manufacturer to develop an intravascular device and its sterile, disposable medical device accessory, as part of their product portfolio.
• A multi-disciplinary team was requested to lead the product development effort from project inception to 510K clearance.
MISSION
• Reduced product development lifecycle time and resources spent
• Concurrently supported non-clinical and US clinical studies for the client’s product portfolio.
ENGAGEMENT
• Led the specification development, device development, device verification and validation, regulatory submission
• Provided weekly updates to clients following an established Gantt chart at project inception
OUTCOME
• Achieved 510K clearance within 24 months
• Achieved an estimated cost saving of 65% of all pre-market activities (up until 510K clearance)
• Achieved an estimated per unit cost saving of 40% by establishing a new production line with a local (Taiwan-based) contract manufacturers
Medical Imaging SaMD
CLIENT NEEDS
• Contracted by a US start-up spun out from an academic institution to develop a medical imaging software as medical device.
• Require a multi-disciplinary team to lead the software development effort from project inception to 510K clearance.
MISSION
• Define software iterations based on customers’ business objectives to ensure feasible software development timeline can be projected.
• Ensure the software development lifecycle is established and all the OTS tools can be fully utilized and integrated to the SaMD.
ENGAGEMENT
• Software infrastructure design and implementation.
• Leveraged deep technical modeling methods, ranging from simulations of first-principle physical laws to statistical inference-based methodologies, to develop dedicated computation engines.
• Provided weekly updates to clients following an established Gantt chart at project inception.
OUTCOME
• Achieved 510K clearance within 21 months on a PACS viewer application for intravascular indications.
• Other SaMD portfolio include medical imaging 3D reconstruction, intravascular device development simulation, noninvasive iFR for coronary stenosis, cancer risk prediction-based on imaging biomarkers.
• Achieved an estimated cost saving of 25% of all pre-market activities (up until 510K clearance) with unique set of skillsets in the medical imaging SaMD arena