Our Commitment to Excellence

In addition to schedule and budget controls, complex interdisciplinary programs require a system-level view and technical knowledge of the key elements to drive success.

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Project Management

Our project managers have technical backgrounds and MedTech industry experience, resulting in a deep understanding of the intricacies, challenges, and regulations associated with Class II & Class III product development.

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We work closely with clients and provide detailed tracking and projections for budget, schedule, and milestone completion.

  • Agile Methodology facilitates collaboration
  • Weekly Status Reports
    • Critical Dependencies
    • Dashboard View
    • Budget Status Reports
    • Upcoming goals

Listen to our Podcast:

Project Management is Most Successful When It’s Personal

Systems Engineering

Our systems experts look across disciplines and consider multiple approaches and tradeoffs to architect an optimal solution to meet your priorities and constraints. The systems team then stays engaged to ensure the design implementation is consistent with the architected intent.

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Our systems engineers apply their decades of MedTech experience to:

  • Architect and Implement robust, maintainable, and extensible designs to support future features
  • Define system, and subsystem requirements and designs
  • Create fail-safe and fault-tolerant architectures for safety-critical solutions when lives depend on it
  • Apply risk management intelligently to meet your needs without going overboard
  • Win praise from the FDA for providing clear and complete Design History Files (DHF) for our client’s submissions

Read our blog:

The 5 Step System Engineering Process

Human Factors Engineering

Sunrise’s broad understanding of patient and clinical users and use environments informs safe and effective user interface designs that address human factors, delight users, and drive adoption.

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Our process considers two equally important pathways – meeting regulatory expectations and aligning with your business strategy needs.

Sunrise Labs provided human factors engineering (HFE) documentation for a wide variety of medical products that have won regulatory clearance. This includes devices especially sensitive to FDA regulations, such as insulin management systems, infusion pumps, and dialysis machines.  Our complete set of HFE services is here to tell your product’s story, including:

  • Generative research and insights
  • Formative studies and summative usability testing
  • User needs/user requirements generation
  • User and use environment profiles
  • Task and Heuristic analysis
  • Competitive benchmarking and journey mapping
  • Medical device user-related risk analysis and use error FMEA
  • FDA HFE reports and IEC 62366 compliant human factors documentation

Read our blog:

Make the Most of Your Human Factors Usability Studies

Industrial Design

There is nothing like seeing, touching, and feeling to choose a design and the design language that works for you. Sunrise Labs provides models as early as possible in the design process to drive a solution that wow you and your end users and stakeholders.

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Our collaborative process brings industrial design early into a product discussion. We create a unique and defensible design that considers competitors, multiple users, and production costs. Here are the primary tools in our Industrial Design toolbox ready to apply to your design challenge:

  • Workflow mapping and Storyboarding
  • Concepting, strategy exploration, and concept refinement
  • High and low-fidelity experience prototyping
  • Fit to hand, fit to user, ergonomic studies
  • Touchpoints and interface mapping
  • 3D CAD sculpting
  • Holistic UX for connected systems

Listen to our podcast:

Episode 1: Leverage Your UCD Consultants Effectively

UX/UI Design

Our collaborative team of user experience and user interface engineers and designers offers full-stack UX/UI development, essential to defining user workflows to inform the overall system architecture and design.

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We create the same high-quality user interactions that users expect from consumer products. Our UX/UI includes:

  • User workflows
  • Information Architecture
  • Concept generation
  • Wireframing and visual design
  • Rapid tools for Interactive GUI prototyping
  • Documentation for engineering
  • Mobile medical apps
  • ​Embedded GUI design
  • Design of Instructions For Use
  • Brand adherence and expansion
  • Motion and micro-interactions

Listen to our podcast:

Episode 2: What is User Centered Design; Why Does it Work?

Software Engineering

Reduce risk and accelerate development schedules with our team of over 50 dedicated engineers with broad and deep expertise in full-stack software development.

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Sunrise Labs specializes in architecting, implementing, and testing Class II and III devices, leveraging a risk-based approach. Our modified Agile methodology provides visibility throughout the project. We provide complete lifecycle solutions to meet your needs for functionality, maintainability, and compliance.

Here is some of what our Software Team offers:

  • IEC-62304 based SDLC process
  • Full tech stack software development
    • Embedded Development
    • Application Layer Development 
    • GUI prototyping and development (Web, Mobile, and Embedded)
    • Local and Cloud Data storage and security
    • Cloud and Server Architecture
    • Wired and wireless communications
  • Risk Management per ISO 14971
    • V-Model Development
    • Software Safety Class A, B, C
  • Network protocols (Ethernet, TCP/IP, UDP, MQTT…)
  • Cybersecurity; threat modeling, FMEA, and mitigation, threat monitoring and mitigation for full device life-cycle
  • Advanced algorithm development
  • Machine learning (ML), and Artificial Intelligence (AI)
  • Unit Test Development and Execution 
  • DevOps tools and frameworks
  • CI/CD and Automated Testing Strategies

Watch the DeviceTalks Tuesdays On-demand session:

Best Practices for Continuous Integration and Delivery

Electrical Engineering

Measuring pico-amps is tough; measuring 10’s of femto-amps is the kind of challenge our team thrives on and delivers. Robust Bluetooth and responsive touchscreen implementations are things we do every day.

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Electronics systems and subsystems designs leveraging state-of-the-art engineering tools and libraries of proven circuits and algorithms help accelerate your product launch. Our team has a proven track record of designing to meet IEC 60601 including EMI and susceptibility. Many of our clients’ projects require very low-power circuits with low-noise analog front ends.

Sunrise Labs’ electrical engineers solve challenges by applying creativity, experience, and strong fundamentals. We design solutions for a broad range of medical devices, from small wearable IoT sensors to electro-mechanical life support systems. Specialties include:

  • Analog, digital, and mixed-signal components
  • FPGAs
  • Power Systems
  • Softcore processors, microprocessors
  • Custom motor controllers
  • Wireless communications
  • PCB assembly and test

Meet our director of electrical engineering:

Shannon Prescott

Mechanical Engineering

Solidly grounded in first principles, our team leverages decades of collective medical design experience to solve a wide range of design challenges from complex capital equipment, to high-volume disposables.

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Sunrise takes products from initial concept and prototyping through transfer to manufacturing. Our in-house capabilities include rapid prototyping and controlled builds for clinical trials. After years of successful product launches, our partnerships with contract manufacturers, including integrated processes, reduce risk and accelerate schedules. Sunrise will help you choose a contract manufacturer(s) that optimally matches your needs.

  • Complex mechanisms, systems integration, and enclosure design
  • Complex Electro-mechanical systems and mechatronics
  • Design for injection molding with complex surfaces
  • High-volume disposables and Consumables development and instrument integration
  • Microfluidics, Kinematics, Control Theory, Thermal, Fluid, CFD
  • DFx: Design for Manufacturing, Assembly, and Serviceability

In-House Prototyping for program risk reduction and rapid iterations of designs 

  • Tolerance Modeling, engineering analysis, simulations, and testing (FEA)
  • Rapid prototyping, and machining for design, development, and demonstration
  • State of the Art 3D printing, Laser Cutting, CAD-controlled 4-Axis Milling, Silicon Molding

meet our director of Mechanical engineering & design transfer:

Doug Browne

Optical Engineering

At Sunrise Labs, we design and build medical imaging systems from simple emitters and detectors up to sophisticated lens design and assembly. With decades of experience, our engineers develop complex, highly sensitive, low-noise optical systems.

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We optimize your system based on the interdependence between front-end optics, detectors, electronics, signal processing, and classification to control, compensate, and adapt to the variability that comes with real-life optical systems.

Here are some of our optical areas of expertise:

  • Optical systems
  • Sensors
  • Detectors
  • Imaging systems
  • Illuminators
  • Calibration methods
  • Optical filtering
  • Complex lenses
  • Packaging
  • Optical modeling

Download our Whitepaper:

5 Steps to Develop World Class Medical Imaging Systems

Quality & Test

Our extensive regulatory compliance expertise and lean ISO-13485:2016 certified processes help drive your product to a successful, first-time submission. We know what the FDA and international agencies look for and tailor the effort to your needs.

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Here are some of the Quality services we provide:

  • Authoring, contributing, and maintaining design history files
  • V&V Planning to essential requirements and medical safety standards including protocol development, Ad Hoc testing, Unit Testing, Formal Verification, Verification Reports, and Coverage Reports.
  • Navigating regulatory bodies including requirements review and regulatory strategy support (IEC-14971, IEC-62304, IEC-62366)
  • Working with you directly to provide the right compliance information for your FDA submittal including 510(k) Clearance for a Class II device, a Pre-market Approval (PMA) for a Class III device, or a de Novo 510(k)
  • Planning and strategizing the test plans and protocols for all disciplines including electrical, mechanical, software, usability, and systems; create, execute, and provide reports
  • Defining systems and software to ensure the most rigorous treatment is limited to the safety-critical code
  • Performing Gap Analyses for IEC-60601-1 for medical electronics, IEC-62304 for medical software, IEC 62366 for usability, IEC 61010-1 Safety Requirements for Electrical Equipment and other standards where needed

Read our Blog:

Design Verification of Medical Devices

Regulatory Strategy

Sunrise regulatory experts have led dozens of devices to successful clearance and market acceptance, and are well-connected with FDA personnel and policies. Work with us to define a regulatory strategy that fits your business needs and vastly improves your chances for success.

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Typically, this work starts with a Gap Analysis to determine what has been done vs. what needs to be done/defined including:

  • Device Classification
  • Clinical Assessment

The output of this initial work is a brief outlining directionally the strategy and pathway, which lays a foundation for the Regulatory Plan which should include:

  • Predicate analysis
  • Pre-code review
  • Clinical Protocol 
  • Sample size evaluation

Whether you need assistance with the Pre-Submission process and are seeking guidance on how to position your key messages to the regulatory agency or are looking for someone to develop all of your submissions and interface directly with FDA on your behalf, we have the experience. Our experience extends from PreIND, PreIDE, IDE/IND, 510(k), PMA, and BLA applications in the US and CE Mark Dossiers in the EU.

meet our senior clinical/regulatory advisor:

Lauren Baker, PhD

Clinical Builds & Design Transfer

The Sunrise Labs Team’s focus is not only on the design itself, but also on the assembly method, ensuring manufacturing readiness for prototyping Beta units, pre-production clinical units, and the pilot program.

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When you need to start your clinical study asap; Sunrise is here to rapidly build the units you need. When it’s time to bring in a contract manufacturer, Sunrise has a well-vetted network of contract manufacturers and we will help you choose one or more that best fit your technical and business needs.

  • Low Volume Unit builds for pre-clinical and clinical phases
  • Design transfer and documentation for strategic partner production
  • Integrated processes with multiple Contract Manufacturers

download our solution sheet:

Design & Development Transfer Checklist

Committed to your success

We invest in the people that make it happen.

We attract and retain highly skilled engineers that are passionate about bringing your ideas for improving lives to market.

We are extremely proud of the Sunrise Labs team built of industry-leading minds.

Headshot of Eric Soederberg, CEO of Sunrise Labs, Inc.
Headshot of Drew Sunstein, Chairman of the board & Founder of Sunrise Labs, Inc.
Headshot of Lisa Taylor, CFO of Sunrise Labs, Inc.
Headshot of Lauren Baker, PhD., Clinical Regulatory Advisor at Sunrise Labs, Inc.
Headshot of Adam Jacobs, CTO of Sunrise Labs Inc.
Headshot of Laurin Noel, VP of Business Development at Sunrise Labs, Inc.
Headshot of David Hibbard, VP of Engineering at Sunrise Labs, Inc.
Headshot of Doug Currie, Sunrise Labs, Inc. Fellow
Headshot of Nick Lesniewski-Laas, Senior Director of Systems Engineering at Sunrise Labs, Inc.
Headshot of Doug Browne, Director of Mechanical Engineering and Design Transfer at Sunrise Labs, Inc.
Headshot of Shannon Prescott, Director of Electrical Engineering at Sunrise Labs, Inc.
Christin Nason, Director of Software
Jeffrey Reaume, Sr. Software Engineering Manager