Medical Device Design and Engineering Services

Medical Device Engineering and Product Development, from the most specific non-invasive product to high tech or invasive surgical instruments, can take many years and thousands of dollars. Products in the medical field typically need more than the usual rounds of engineering and prototyping due to the precision and accuracy required and the use on or near the human body. In addition, the FDA approval and certification process can be daunting.

IDP works with many doctors and medical professionals who come up with unique and helpful product ideas from their experience and working in real-life scenarios. Some individuals and start-ups do not have the capital required to complete full medical device engineering, product development, and FDA approval.

IDP utilizes a proof of concept prototype development process that effectively assists doctors and medical professionals validate and feasibility so the innovative concept can be monetized down the road.

Medical Device Proof of Concept

A proof of concept prototype is a great way to demonstrate a products’ functional effectiveness and design features. IDP’s skilled medical product designers, with robust medical product engineering background can develop a high-grade functional medical device prototype. This concept prototype still usually requires several rounds of engineering and prototyping. Still, the time and cost are a fraction of what it would take to bring the device to manufacturing and FDA approval.

IDP’s medical prototype experts can make proof of concept medical device prototypes with custom components, existing products, and usually a combination of the two. They are never intended to be used or tested on human subjects. Often, engineers can use a human model/dummy for demo purposes. While the IDP development team understands medical products and FDA approvals, we can skip the formal FDA process since there is no plan to manufacture- resulting in lower development time and fees.

Once a high-grade prototype has been produced, the concept can be effectively explained and demonstrated. Funds can be raised, or the product can be sold/licensed to a medical device company in the appropriate field with development, production, and FDA approval resources.

Depending on the industry and the product’s uniqueness, it may also be advisable to seek patent protection or a Non-Disclosure Agreement before sharing an idea with a large medical device company.

IDP’s medical product and device engineering services can help take your idea from infancy to a professional prototype. Our engineers guide you through the entire product development and design control process, ensuring your device can meet regulatory compliance standards while remaining safe and effective.

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Comprehensive Medical Devices Engineering & Development Services

At Innovative Design Products (IDP), we bring ideas to life through precision-driven medical devices engineering and human-centered design. Our team delivers comprehensive support for medical product development, from concept to commercialization, ensuring your device meets clinical needs and regulatory standards, such as FDA and 510K

If you’re developing a new healthcare product or looking to refine an existing one, IDP, a trusted medical device design firm, offers the experience, tools, and insight needed to deliver successful medical device design solutions.

Our Medical Device Services 

  • Medical device design and human factors engineering
    We create intuitive, safe, and effective devices by combining innovative design with human factors research.
  • Medical device prototyping (rapid + functional prototypes)
    From 3D printing to fully functional prototypes, we accelerate development while ensuring accuracy and usability.
  • Medical product development and testing
    Our team manages the full product lifecycle, integrating risk management, clinical insights, and rigorous testing.
  • Design for medical devices with regulatory compliance in mind
    Every design incorporates FDA and ISO 13485 standards to streamline approval and reduce regulatory delays.
  • Support for FDA 510(k) and CE/MDR submissions
    We provide documentation, testing data, and design controls that help your device meet U.S. and EU regulatory requirements.

Why IDP for Medical Device Engineering Services? 

Medical device engineering is not just about technology—it’s about saving lives through better design and performance. At IDP, we blend innovation with regulatory compliance and usability, offering world-class solutions tailored to healthcare.

What Sets Us Apart:

20+ years of medical engineering expertise

Certified engineers and industrial designers

ISO 13485-aligned product development process

Support for FDA, CE, and MDR regulatory pathways

Ready to start your project?
Schedule a call today!

Full-Spectrum Medical Product Development Services 

We specialize in medical product development across all stages—from user research and risk assessment to design validation and manufacturing support.

Services include:

Market and competitor analysis

Regulatory planning and documentation

Concept development and prototyping

Whether you’re launching a new device or updating a legacy product, our medical product development process is designed for speed, safety, and scalability.

Speak with our development experts today!

User-Focused Medical Device Design Firm

Medical device design is the end-to-end process of creating safe, effective, and compliant healthcare products. It includes human factors engineering, material selection, risk management, prototyping, verification, and regulatory documentation. At IDP, our process ensures every design meets clinical needs, passes safety standards, and aligns with FDA/CE requirements.

Our team creates functional, ergonomic, and compliant medical device design solutions that serve both end-users and healthcare professionals. We prioritize ease of use, safety, and manufacturability—while staying ahead of Healthcare Device Design Trends in 2026, ensuring startups and OEMs can align their innovations with future market demands.

We design:

Diagnostic and imaging tools

Minimally invasive surgical devices

Home-use medical wearables

Drug delivery systems

With every medical device design, we ensure adherence to FDA Design Controls, ISO 14971, and IEC 62366 standards.

Contact us to explore your design options!

Fast and Functional Medical Device Prototyping 

Need to validate your concept quickly? We build fully functional medical device prototypes to test usability, form factor, and functionality before full-scale production.

Our prototyping capabilities:

3D printing: SLA, SLS, FDM

CNC machining for precision parts

Electronic hardware integration

Silicone & soft-touch casing

Each medical device prototype is custom-built for investor pitches, clinical validation, or regulatory testing.

Get a quote for your prototype today!

How to Develop a Medical Device Prototype with IDP

At IDP, we guide startups, OEMs, and healthcare innovators through a structured Medical Device Prototyping Journey. Our step-by-step approach ensures your concept evolves into a functional, compliant, and market-ready prototype while reducing time to market and regulatory risk.

Step 1: Define Requirements

  • Collaborate with IDP engineers to create a comprehensive Product Requirements Document (PRD).
  • Identify functional, technical, and regulatory needs upfront.
  • Align project goals with clinical needs, market expectations, and compliance standards (FDA, CE, ISO 13485).

Step 2: Conceptualize & Design

  • Generate detailed CAD models, industrial designs, and ergonomic layouts.
  • Apply human factors engineering (IEC 62366) to ensure usability and patient safety.
  • Evaluate biocompatibility, material selection, and device ergonomics.

Step 3: Prototype Development

  • Build rapid, functional prototypes using 3D printing (SLA, SLS, FDM), CNC machining, electronics integration, or hybrid approaches.
  • Conduct internal testing to validate form, fit, and function.
  • Iterate designs based on feedback from clinical simulations or user testing.

Step 4: Regulatory Alignment

  • Ensure prototypes meet FDA, CE, and ISO 13485 compliance.
  • Prepare Design History Files (DHF) and documentation for regulatory submission.
  • Identify potential gaps early to minimize delays in approvals.

Step 5: Validation & Delivery

  • Test prototypes in real-world scenarios to assess usability, durability, and performance.
  • Refine the design to meet end-user needs and investor expectations.
  • Deliver a functional, compliant prototype ready for clinical trials, investor presentations, or full-scale production.

Why Choose IDP for Your Medical Device Prototyping Journey?

  • End-to-end support from concept to regulatory-ready prototype.
  • Expertise across medical device engineering, product development, and compliance standards.
  • Proven track record with startups, OEMs, and healthcare organizations.

Design for Medical Devices That Meets Global Standards 

Our Design for Medical Devices (DfMD) approach ensures your product is safe, manufacturable, and globally compliant. We integrate:

  • Design for Manufacturability (DFM) – Lower cost, simpler production, high reliability
  • Design for Assembly (DFA) – Reduced complexity, faster assembly
  • Material Selection – Biocompatible, sterilization-friendly materials
  • Design Controls (FDA/ISO 13485) – Requirements, verification, validation
  • Risk Management (ISO 14971) – Hazard analysis and mitigation
  • Human Factors Engineering (IEC 62366) – Safe usability and intuitive design

This framework reduces development risks and shortens approval timelines.

Key Focus Areas:

Human factors and usability engineering

Biocompatibility and sterilization

Material selection and device safety

Complete design history files (DHF)

From initial concept to production-ready designs, we make design for medical devices seamless, secure, and scalable.

Need help with compliance-driven design? Let’s talk!

Our Proven Medical Product Development Process

At IDP, we follow a step by step medical device development process that ensures every design is safe, effective, and aligned with FDA, ISO 13485, and CE/MDR regulatory standards. This structured approach minimizes risks, reduces costs, and shortens time to market while keeping patient safety at the center.

Discover – Product Requirements Definition

  • Collaborate with clients to create a clear Product Requirements Document (PRD).
  • Define functional, technical, and regulatory needs upfront.
  • Align project goals with client vision, market expectations, and compliance requirements.

Define – Product & Regulatory Requirements

  • Translate needs into clear product specifications.
  • Map out regulatory pathway options

Design – Concept Development & Human Factors

  • Generate design solutions through industrial design, mechanical engineering, and CAD modeling.
  • Apply human factors engineering (IEC 62366) to ensure usability and safety.
  • Evaluate biocompatibility, ergonomics, and material selection for medical environments.

Develop – Prototyping & Iteration

  • Build rapid prototypes using 3D printing, CNC machining, electronics integration, and other prototyping methods
  • Create functional prototypes for bench testing and simulated use.
  • Iterate designs based on clinical feedback and risk assessments.

Deliver – Manufacturing Transfer & Approvals

  • Finalize the Design History File (DHF) and documentation for FDA/CE submission.
  • Support manufacturing transfer with validated processes.
  • Provide assistance with 510(k), CE marking, and MDR submissions.

Industries We Serve 

We support medical innovation across a wide range of industries, helping transform ideas into safe, effective, and compliant medical products.

Hospitals & Surgical Centers

We collaborate with hospitals and surgical teams to design advanced tools and devices that improve patient outcomes. From minimally invasive surgical instruments to emergency care solutions, our medical device engineering services ensures precision, safety, and reliability in high-stakes environments.

Rehabilitation and Assistive Devices

Our team develops user-friendly rehabilitation products and assistive technologies that enhance mobility, independence, and quality of life for patients. We focus on ergonomics, ease of use, and long-term durability for both clinical and home-care applications.

Wearables and Diagnostics

We design and prototype cutting-edge wearables and diagnostic devices, including at-home testing kits, health monitoring sensors, and portable imaging tools. These innovations empower patients and clinicians with real-time data for better decision-making.

Physical therapy devices

Our expertise includes creating therapeutic devices that support recovery, strength building, and rehabilitation. By combining human factors engineering with durable, safe designs, we deliver solutions that meet the needs of both patients and physical therapists.

Biotech and pharmaceutical support

We partner with biotech and pharmaceutical companies to develop devices for drug delivery, laboratory automation, and clinical research support. Our process ensures compliance with FDA, ISO, and CE/MDR regulations while enabling fast, reliable product development.

Regulatory Compliance & Certifications 

Every medical device must meet strict U.S. and international standards. At IDP, we integrate compliance into every stage of development to ensure your product is safe, effective, and market-ready. 

  • ISO 13485:2016 – Quality Management System for medical devices
  • 21 CFR Part 820 (FDA QSR) – Design controls and documentation
  • IEC 60601 – Electrical safety testing for medical devices
  • ISO 10993 – Biocompatibility testing for materials
  • ISO 14971 – Risk management for medical devices

Our engineers ensure that every medical device prototype and final design is aligned with FDA and CE/MDR requirements, helping you reduce time to market and accelerate regulatory approval. In addition, our biomedical engineers work alongside electronics and mechanical experts to define clear design inputs and establish robust control processes that guarantee safety and reliability. By adhering to strict guidelines in the United States and global markets, we ensure your innovation moves seamlessly from prototype to market readiness. This compliance-driven development approach not only addresses regulations but also validates performance in real-world conditions, providing confidence that your medical device will meet user needs and regulatory demands simultaneously. At IDP, we guide clients through the complete Medical Device Prototyping Journey—from early concept sketches to fully functional prototypes—ensuring each stage of the process is transparent, efficient, and aligned with your end goals.

What Clients Say

“IDP delivered a flawless medical device prototype that met every functional and regulatory expectation. Their process and communication were top-notch.”
– Product Manager, UK-based MedTech Firm

“We partnered with IDP for complete medical product development and design. Their knowledge of design for medical devices was critical to our FDA approval.”
– Director of R&D, USA Healthcare Company

Medical Device Case Studies

 

AmniCheck – At-Home Test Strip

We developed the AmniCheck device, an at-home diagnostic that delivers 99% accuracy in detecting amniotic fluid in leakage towards the end of a pregnancy. Our team handled concept design, prototype engineering, and manufacturing, ensuring a user-friendly solution for expecting mothers.

Medical Device – Portable Crash Cart

 
IDP developed a portable crash cart system optimized for emergency care settings. Our team focused on ergonomic design, lightweight construction, and durable components to enable quick response in critical situations. A series of prototypes were produced and refined through human factors testing, ensuring reliability in high-pressure environments. 

Let’s Build the Future of Medical Innovation 

Whether you’re a healthcare startup or an established med-tech company, IDP is your go-to partner for:

  •  Medical devices engineering
  •  Medical product development
  • Medical device prototype creation
  •  Medical device design
  •  Design for medical devices

 

📞 Call us at 949.748.1902
📧 Email: [email protected]

Frequently Asked Questions

 

1. What does medical devices engineering involve?

Medical devices engineering involves applying mechanical, electronic, and biomedical design principles to create safe and effective healthcare tools. At IDP, we ensure each product meets clinical needs and complies with international standards.

2. How do you approach medical product development?

Our medical product development process is structured around clinical insight, risk management, and usability. We manage each stage—discovery, design, testing, and delivery—with full regulatory alignment (FDA, CE, ISO).

3. Can I get a working medical device prototype before full production?

Yes. As a medical device prototype manufacturer, we specialize in building custom medical device prototypes using 3D printing, CNC machining, and other rapid prototyping techniques. These functional models closely simulate final products and are ideal for testing, investor presentations, regulatory review, and clinical trials.

4. How do you ensure compliance in design for medical devices?

Our approach to design for medical devices includes usability testing, risk assessment, biocompatibility analysis, and thorough documentation. Every step is aligned with ISO 13485, IEC 60601, and FDA Design Controls.

5. What makes your medical device design process different?

As an experienced medical device design firm, IDP blends deep user research with innovative engineering to create intuitive, durable, and compliant medical device designs—without compromising on functionality or patient safety.

6. What is the difference between standard product design and engineering and medical device engineering?

In medical device engineering services, certain guidelines must be followed in order to ensure products can pass 501 (k) and FDA regulations. IDP has a great track record in ensuring medical devices can pass these rigorous processes.

7. Can IDP produce my medical device prototype?

Yes, IDP can assist in the engineering and prototyping of your medical product. We have a variety of prototype methodologies to help you realize your product vision.

8.What kind of product prototype methods does IDP use?

We offer a variety of different prototyping methodologies including:
3D printing
CNC machining
Electronics and PCB printing
Temporary molds
Soft Goods/Textile Sewing