Delve | End-to-End Medical Device Engineering

Medical Device Engineering

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

Trusted by industry leaders

  • Abbott logo
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  • Boston scientific logo
  • Dexcom logo
  • GE HealthCare logo
  • Johnson and Johnson logo
  • Mallinckrodt logo
  • Stryker logo

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End-to-end medical device development

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

ISO 13485-certified QMS
Mechanical, electrical, human factors, software, systems, and quality engineering expertise embedded throughout product development
Digital and physical device development capabilities, including embedded software and cloud system integration
Experience in drug delivery, diagnostics, surgical robotics, and digital health

Answer critical questions about medical device engineering with Delve

Delve works through technical, regulatory, and usability risks with iterative design, early prototyping, and human factors research to help ensure no requirement is missed.

From component selection to design for manufacturability and supply chain alignment, Delve engineers support a smooth transition into manufacturing at scale.

Our cross-functional teams collaborate from day one to ensure seamless integration of embedded software, hardware, mechanical components, and digital interfaces.

Delve’s ISO 13485–certified processes and multidisciplinary approach helps ensure your product meets technical specs, safety standards, and regulatory requirements.

Nurse using medical device

Lazurite ArthroFree Wireless Camera - See case study

ProNova SC360

ProNova SC360 - See case study

Baebies: Rapid, Intuitive Newborn Screening

Baebies: Rapid, Intuitive Newborn Screening - See case study

Otometrics Otoscan
Otometrics: Otoscan - See case study
Penumbra REAL™ Immersive System

Penumbra REAL™ Immersive System - See case study

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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

Engineering expertise across the medical device development lifecycle

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Delve engineers ensure performance, manufacturability, and reliability in designing, prototyping, testing, optimizing, and sourcing components for critical mechanical systems. 

We deliver custom hardware, integrated electronic systems, wireless connectivity, miniaturization, and EMC compliance to help meet safety, regulatory, and user needs.

From contextual inquiry to formative studies and usability testing, we help you meet HFE/UE expectations for Class I, II, and III devices. 

We align software and hardware engineering, compliance standards, and user workflows throughout our process to unify embedded firmware, hardware systems, and user interfaces.

Delve provides an ISO 13485-certified QMS, along with FDA compliance expertise and deep experience in documentation and quality control for medical devices.

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.

Develop medical devices with confidence

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