MEDICAL DEVICE DESIGN SERVICES
End-to-End Medical Device Design
Class I, II, & III Devices
From initial concept through FDA submission and commercial launch — Synectic's medical device engineers deliver compliant, manufacturable designs that reach market faster.
ISO 13485:2016 Certified
40+ Years Experience
FDA Design Controls Expert
Concept to Production
ISO 13485:2016 Certified
WHO WE ARE
A Medical Device Design Company Built Around Regulatory Excellence
Synectic has been designing and engineering medical devices since 1981. Our team of expert engineers and regulatory specialists has guided hundreds of devices through the FDA design control process — from early-stage concept development through 510(k) and PMA submissions to full-scale manufacturing.
As a subsidiary of the Mack Group, we offer something most design firms cannot: a seamless, vertically integrated path from design to production. When your device is ready to manufacture, everything — drawings, DHF, tooling — stays in-house.
Whether you’re a startup with a breakthrough idea or an established company expanding your device portfolio, our team provides the engineering rigor, regulatory expertise, and manufacturing foresight your project demands.
40+
YEARS IN MEDICAL DEVICE DESIGN
I-III
ALL FDA DEVICE CLASSES
11+
MEDICAL DISCIPLINES SERVED
100%
US-BASED ENGINEERING TEAM
OUR SERVICES
Full-Spectrum Medical Device Design Services
We cover every phase of the medical device development lifecycle, applying FDA design controls at each stage to ensure your device moves from concept to clearance without costly redesigns.
Concept Development
We translate clinical needs and user requirements into viable design concepts. Early feasibility studies, risk assessments, and design inputs establish a strong regulatory foundation from day one.
Engineering & Detail Design
Full mechanical, electrical, and software engineering for your device. We produce complete CAD models, drawings, and design outputs that meet your design inputs — with verification built in.
Prototyping & Verification
Rapid prototyping and iterative testing validate your design against specifications. We conduct design verification activities and document all testing in your Design History File (DHF).
Regulatory & Design Controls
Our proprietary FDA documentation system accelerates submissions. We manage your Design History File, Device Master Record, risk management files, and support 510(k) and PMA applications.
Verification & Validation (V&V)
Systematic V&V activities confirm your device performs safely and effectively in its intended use environment. All testing is conducted scientifically and documented for FDA inspection.
Design for Manufacturing (DFM)
Every design decision is made with manufacturability in mind. Our Mack Group integration eliminates the design-to-manufacturing translation gap, reducing do-loops and time to market.
OUR PROCESS
How We Bring Your Medical Device to Market
Our structured, FDA-compliant development process ensures every phase builds systematically on the last — so your device reaches the market reliably, with full documentation and no regulatory surprises.
Define & Plan
Identify intended use, establish user needs, classify your device, and build a comprehensive design and development plan.
Design & Engineer
Develop design inputs, produce engineering outputs, conduct design reviews, and build working prototypes at each stage.
Verify & Validate
Execute V&V protocols to confirm design outputs meet inputs and that the device performs safely in real-world use.
Launch & Manufacture
Support FDA submission, finalize your DHF and DMR, transfer to manufacturing, and bring your device to the commercial market.
DEVICE CATEGORIES
Types of Medical Devices We Design
Our engineers have experience across a broad range of device categories — from simple Class I instruments to complex Class III implantables and robotic surgical systems.
Surgical Instruments & Tools
Ergonomic designs, high-performance materials, and sterilization compliance for tools that enhance precision and improve patient outcomes in the OR.
Implantable Devices
Rigorous biocompatibility, durability, and long-term functionality engineering for devices that live inside the body.
Wearble & Connected Devices
Real-time patient monitoring with seamless digital health platform integration. We design for user comfort, connectivity, and regulatory compliance.
Drug Delivery Systems
Autoinjectors, infusion pumps, and inhalers engineered for dosage accuracy, patient adherence, and manufacturability.
Robotic Surgical Systems
Advanced robotic platforms that enhance surgical accuracy and minimize invasiveness — including control systems and haptic feedback mechanisms.
Diagnostic & Imaging Devices
High-performance diagnostic tools, handheld instruments, and imaging systems designed for fast, reliable clinical results.
DEVICE CATEGORIES
Specialized Experience Across 11+ Medical Fields
Our team brings deep familiarity with clinical environments and discipline-specific regulatory requirements — so your device is designed for its actual context of use.
Cardiology
Orthopedics
General Surgery
Gastroenterology
Obstetrics & Gynecology
Pediatrics
Diagnostics & Radiology
Opthalmology
Hematology & Nephrology
Endocrinology
Physical Medicine & Rehab
Dentistry & Oral Surgery
WHY SYNECTIC
What Sets Our Medical Device Team Apart
You need more than good engineers. You need a partner who understands the regulatory landscape, builds with manufacturing in mind, and has the track record to prove it.
Deep Regulatory Knowledge — Class I, II & III
Our engineers are experienced in FDA 21 CFR Part 820 design controls, 510(k) submissions, PMA applications, ISO 13485 quality systems, and risk management under ISO 14971. We don't learn on your dime.
Seamless Path from Design to Manufacturing
As part of the Mack Group, we hand off directly to a manufacturing partner who already knows your device. No translation gap, no do-loops, no lost institutional knowledge.
User-Centered Design for Patient Safety
We apply human factors engineering principles from day one, ensuring your device is intuitive, ergonomic, and designed to minimize use-related hazards — as required by FDA guidance.
Proprietary FDA Documentation System
Our in-house quality documentation tools streamline DHF creation, design control records, and submission packages — compressing the path to FDA clearance.
Full-Scale In-House Capabilities
Mechanical, electrical, and software engineering under one roof. In-house prototyping and testing capabilities allow us to iterate faster and validate designs without waiting for outside vendors.
40+ Years of Medical Device History
Founded in 1981 to address the need for high-quality, cost-effective medical device design. We've retained institutional knowledge and client DHFs through decades of project work — consistency you can trust.
PORTFOLIO HIGHLIGHTS
Medical Devices We've Brought to Market
A sampling of completed medical device programs — from Class I instruments to complex implantable and robotic systems.
Blood Cleansing Device
Vessel Sealing System
Vitrectomy Drug Delivery Device
Hemodialysis Catheter Repair Kit
Pediatric Surgical Stapler
Cell Processing Capital Equipment
CLIENT TESTIMONIALS
What Our Medical Device Clients Say
Our team brings deep familiarity with clinical environments and discipline-specific regulatory requirements — so your device is designed for its actual context of use.
Synectic Engineering is my go to outsourcing option for everything from research, phase 0 initial concept development through complete product development services.
You guys have been the best partners we could have hoped for to bring our projects to life.
I have worked on and off with SYNECTIC for over twenty-five years, with the same group of engineers! Consistency, quality of engineering, and retention of past DHF’s is 2nd to none.
We have been working with Synectic through the entire development of our medical device. The company and team have been an integral part of our progress.
FAQ
Medical Device Design - Common Questions
What is end-to-end medical device development?
End-to-end medical device development covers every phase from initial concept through commercial launch: user needs definition, design inputs, engineering, prototyping, verification and validation, regulatory submission (510(k) or PMA), and manufacturing transfer. Synectic provides all of these services under one roof, including direct access to manufacturing through our Mack Group integration — eliminating the costly hand-off gap between design firms and contract manufacturers.
What FDA design controls does Synectic follow?
We operate under FDA 21 CFR Part 820 Quality System Regulation and its successor, 21 CFR Part 820 aligned with ISO 13485:2016. This includes formal design and development planning, design inputs and outputs, design reviews at each phase, design verification, design validation, and design transfer. All activities are documented in a Design History File (DHF) maintained throughout the project and available for FDA inspection.
Can Synectic design Class III medical devices?
Yes. Our team has experience designing Class I, II, and Class III medical devices. Class III devices — those that support or sustain human life or present potential unreasonable risk of illness or injury — require PMA approval and the most rigorous design controls and clinical evidence. Our regulatory specialists are experienced in navigating these requirements and building the documentation required for PMA submissions.
How long does medical device design and development take?
Development timelines vary significantly by device complexity, regulatory pathway, and whether clinical studies are required. Simple Class I devices may reach market in 12–18 months. Class II devices requiring 510(k) clearance typically take 2–4 years from concept. Class III devices with PMA requirements often require 5–7+ years. Synectic works to compress timelines by front-loading regulatory planning and using our proprietary FDA documentation system — catching issues early when they’re least expensive to resolve.
What is a Design History File (DHF) and why does it matter?
A Design History File is the complete record of your device’s design and development process. It documents every design review, design input, design output, verification test, validation activity, and change made throughout development. The FDA requires a DHF for Class II and III devices and it forms the backbone of your 510(k) or PMA submission. Maintaining a robust DHF from day one — rather than reconstructing it before submission — is one of the most important things you can do to streamline FDA clearance.
Does Synectic support 510(k) and PMA submissions?
Yes. Our team supports the preparation of 510(k) submissions for Class II devices and PMA applications for Class III devices. This includes organizing your Design History File, preparing test summaries, documenting substantial equivalence arguments for 510(k)s, and coordinating with FDA reviewers. Our proprietary quality documentation system is designed specifically to accelerate this process.
What industries and medical disciplines does Synectic serve?
We have deep experience across cardiology, orthopedics, obstetrics and gynecology, pediatrics, gastroenterology, general surgery, diagnostics and radiology, physical medicine and rehabilitation, endocrinology, ophthalmology, hematology, nephrology, and dentistry. Beyond medical devices, our engineering capabilities extend to capital equipment, consumer products, and defense — giving us broad design and manufacturing perspective that benefits our medical clients.
How is medical device design different from general product design?
Medical device design follows a fundamentally different regulatory framework than general product development. Every design decision must be formally documented — from user needs and design inputs through verification testing and design validation — in a Design History File (DHF) required by the FDA under 21 CFR Part 820 and ISO 13485:2016. Biocompatibility, sterilization compatibility, and formal risk management under ISO 14971 add further engineering requirements that commercial product development rarely demands. The result is a more structured, documentation-intensive process: where a commercial product might reach market in under a year, a Class II medical device requiring 510(k) clearance typically takes 2–4 years. Synectic designs both medical devices and commercial products — which gives our engineers an unusually clear view of where these disciplines differ, and how to navigate the transition efficiently when a client is entering the medical market for the first time.
Ready to Start Your Medical Device Project?
Our engineers are ready to discuss your device, your timeline, and the regulatory pathway ahead. The consultation is free.