Medical Device Development | Delve

Medical Device Development Services

Delve is a product innovation services firm. As an end-to-end design and development partner, we combine breakthrough creativity with rigorous de-risking and a deep focus on organizational alignment to help you bring medical devices to market faster, with no requirement missed. Reach out and a member of our team will be in touch.

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End-to-end medical device development services

In complex, highly regulated industries like MedTech, Delve helps accelerate innovation and avoid costly missteps. We offer:

ISO 13485-certified QMS
Product strategy, industrial design, interaction design, electrical, mechanical, and software engineering expertise
Digital and physical device design and development
Deep expertise in drug delivery, diagnostics, surgical robotics, and digital health platforms

Answer critical questions about medical device development

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

BD Diabetes Care - See case study

otometrics-otoscan-ear-scan

Otometrics: Otoscan- See case study

HDM-Breas IoT Ventilator Platform

HDM-Breas IoT Ventilator Platform - See case study

Trice Medical: - Mi-Eye+
Trice Medical: - Mi-Eye+ - See case study
Penumbra REAL™ Immersive System

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.
Vamsee Pamula
Founder and President, Baebies
They were really passionate about making something that looked beautiful and behaved in beautiful ways.
Co-Founder
EO Care
The technical innovation in Otoscan combined with unprecedented simplicity makes customization a great experience for our patients and audiologists.
Lennart Goth & Nils Hampel
Owners of Rhein-Neckar-Akustik, for Natus (formerly Otometrics)
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.
Ed Liebowitz
Digital Diabetes Product Leader
Delve helped us define a patient environment that is a true differentiator for our new company.
Joe Matteo
President

Expertise across the medical device development lifecycle

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. 

Develop medical devices with confidence