Medical Device Development Services
Trusted by industry leaders
Trusted by industry leaders
In complex, highly regulated industries like MedTech, Delve helps accelerate innovation and avoid costly missteps. We offer:
Delve ensures cross-functional alignment from project kickoff to launch with a proven orchestration process for high-stakes medical device development programs.
Our focus on organizational alignment brings industrial design, interaction design, and engineering together to reduce disconnects and develop a more cohesive product earlier.
Our cross-functional teams collaborate from day one to ensure seamless integration of embedded software, hardware, enclosures, digital interfaces, and mechanical components.
Delve’s ISO 13485–certified processes and multidisciplinary approach helps ensure your product meets technical specs, safety standards, and regulatory requirements.
BD Diabetes Care - See case study
Otometrics: Otoscan- See case study
HDM-Breas IoT Ventilator Platform - See case study
Penumbra REAL™ Immersive System - See case study
Delve’s expertise in user research and design significantly improved our product’s user experience. Delve brings strengths that we don’t have, which is why I’m looking forward to working with them again.
They were really passionate about making something that looked beautiful and behaved in beautiful ways.
The technical innovation in Otoscan combined with unprecedented simplicity makes customization a great experience for our patients and audiologists.
Working with our UX lead, the design team came up with a wonderful visual interface with intuitive designs for certain features. This has helped triple engagement in the platform.
Delve helped us define a patient environment that is a true differentiator for our new company.
How Dexcom turned a complex clinical task into a simple, everyday action—and unlocked mass adoption in the process.
In order to better serve the needs of people with Type 2 diabetes, BD set out to create a central, digital hub for people to manage all aspects of their care.
A device that is used in the neonatal critical care environment that is designed to reduce device-related workflow.
Delve helped BK Ultrasound bundle its game-changing technology into a widely adopted, easy to use, award-winning medical device.
Delve brings ISO 13485, IEC 62366, and FDA compliance expertise with deep experience in documentation and quality control for medical device development.
Our in-house prototyping process reduces risk by providing iterative prototypes, from proof-of-concept builds to production equivalent assemblies ready for clinical or usability testing.
Delve prepares your product for launch and scale with engineering that supports DFM, tolerance stackups, material selection, test planning, and manufacturing transfer.
From contextual inquiry to formative studies and usability testing, we help you meet HFE/UE expectations for Class I, II, and III devices.