Medical Device Design and Development Services

Design & Development Services

Our design and development solutions are aligned with your objectives, parameters, and timelines to ensure the best pathway to success. With our flexible business model, we can provide a solution that meets the scope and scale of your project, from a full development program to a simple, discrete task—or anything in between. Our design and development services include:

  • Brainstorming and Concept Generation
  • Prototyping
  • Product Design and Engineering
  • Design for Manufacturability (DFM)
  • Project Management
  • Testing and Validation
  • New Product Introduction
  • Quality Systems

Brainstorming and Concept Generation

Our approach to generating concepts can launch an innovative design down a successful development path. It can lead to a breakthrough idea that kick-starts a stalled project. Or it can provide technical insights that empower your internal project team. Whatever your business needs, we bring cross-functional expertise and industry experience to every challenge. We’re here to make sure the project is started right.

3i Project Booster Session

Inspiration. Ideation. Innovation. A 3i Project Booster Session is a stand-alone, affordable, refined brainstorming event that can deliver rapid response, creative concepts, and breakthrough solutions. Your team meets with a Vention team with expertise tailored to your needs for a one-day collaboration focused on a specific topic or challenge. The product is a comprehensive summary report that helps you plan for future development. 3i Project Booster Sessions may address:

  • Design Concept Generation
  • Design & Performance Improvements
  • Reliability Improvements
  • Polymers Applications
  • Clinical Approach Definition
prototype design and development expertise


Our prototype development process compresses delivery time into days or weeks versus months. This accelerated process saves you time and cost throughout each phase of your project, from concept to clinical. It’s all about flexibility. We offer:

  • High- or low-volume prototypes
  • Instant access to the largest inventory of in-stock components
  • Ability to custom create almost any type of prototype, from a one-off model for benchtop testing to a fully documented cleanroom build

Product Design and Engineering

Vention provides elegant, robust, and manufacturable design solutions for finished devices, full prototypes, and components. Our experienced technical team is well-equipped with engineering design and analysis tools to ensure the functionality and quality of the end product. Our focused expertise and extensive industry experience allows us to customize our development approach to each project for the quickest learning curves and most efficient timelines.


Review. Research. Recommend. Our 3R Design Review Service can reduce technical risk by forging a path for optimizing medical device designs at any stage. Our team can conduct a thorough review and recommend opportunities to refine your product design, improve your manufacturing process, address yield issues, and reduce costs. The result is a comprehensive summary report with detailed, pragmatic recommendations to reduce risk and improve design reliability.

Why 3R?

  • Need your prototype design to be more scalable and cost effective to manufacture?
  • Challenged with low cost-of-goods-sold (COGS) targets?
  • Concerned about reliability and scalability in production?
  • Need to improve product performance?
  • Moving a development project to a new supplier?

…3R can help.

Design for Manufacturability (DFM)

At Vention, we build Design for Manufacturability (DFM) into the process up front to ensure our designs are production ready and scalable. Our cross-functional teams include in-house experts in design engineering, process development, packaging development and supply chain management, all collaborating to facilitate a smooth transfer from design to manufacturing.

Project Management

Skilled, experienced project management is critically important to the success of your design and development project. Our structured and disciplined approach to project management allows us to manage medical device programs of any scale and scope, including full transparency in timeline and budget tracking.

Testing and Validation

Testing and Validation

Our in-house testing capabilities and strong knowledge of test standards across product technologies enables efficient design iterations and process development. We can recommend test plans, create device-specific protocols, manage test activities, and create submission-ready test reports. Our focus on risk mitigation and quality in both design and manufacturability ensures that design verifications, design validations, process validations, and packaging validations result in a market-ready product backed by robust documentation.

New Product Introduction

New Product Introduction

At Vention, the New Product Introduction process is led by a team of experienced engineers who focus on identifying risk, analyzing feasibility, developing sustainable processes, and managing the successful pilot manufacturing and launch of complex medical devices. To ensure seamless introductions from design to manufacturing transfers, we staff our design and development facilities and our commercial production sites with dedicated New Product Introduction specialists and in-house manufacturing technicians.


Our expertise in manufacturing scalability ensures that each design has a clear and cost-effective pathway, from a one-off concept prototype to mature, high-volume, low-cost manufacturing at our Costa Rica facility. With 13 locations worldwide, we have the capacity and the flexibility to handle all your manufacturing needs.

Quality System Services

Our dedicated quality team of more than 20 quality engineers and technicians can work with you to:

  • Support your existing quality system with audit-ready documentation
  • Create and manage your design history file and design controls within the Vention quality system
  • Design and map a hybrid quality system
  • Create new quality management systems for startup companies

Our quality system services include:

  • Full documentation, including design document control, risk management files, design history files, device master records, and quality system guidance documents
  • Technical support and documentation preparation for regulatory submission packages, including premarket approval documents and package filing support

Certifications, registrations, and compliance include:

  • ISO 14971 Certified for Risk Management
  • Compliance with FDA 21 CFR Part 820
  • ISO 13485:2003 Certified
  • Class 7 & 8 cleanroom facilities co-located with the development team
  • Customer and FDA audits