Medical Device Software Development

We can partner with you to design, develop, and document software for your medical device. Our team is fully US-Based. Whether you’re looking for support on a special project or a full-service software partner who can get you through the FDA, we can help.

Who We Work With

We work on both Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD) products.

We are proud to partner with a diverse array of clients, from visionary startups to industry-leading Fortune 500 companies. Typical clients include:

Clinician Founders

Venture-Backed Startups

Medical Device Companies

Academic Research Institutions

Let’s Meet

What Makes Innolitics a Reliable Software Partner

  • All we do is medical-device software development
  • Developed software for over 70 medical devices since 2012
  • Cybersecurity expertise in threat modeling, security risk management, SBOMs and more
  • Deep knowledge of medical-device standards, including DICOM and HL7
  • We comply with ISO 13485 and IEC 62304
  • We can write all the software and cybersecurity documents needed for FDA submissions
  • Four AI/ML and image-processing experts on our team, including three PhDs and two MDs
  • Six FDA regulatory consultants on staff
  • Medtech OS and its checklists, templates, and tooling is built on the experience FDA clearing more than 50 SaMD and SiMD products

Engagement Models

We engage with our clients in three different ways:

Project-Based

We help you complete software development projects with a defined scope. For example:

  • Custom Web-Based GUIs
  • Medical Imaging Software
  • SMART on FHIR apps
  • Adding DICOM or HL7 Integrations to existing products
  • Independent Software V&V for submissions
  • Refactoring Existing Software
  • Training New AI/ML Models
  • Image Processing Algorithm Development
  • Translating Research Code into Compliant Code
  • Developing Companion Apps

This engagement model works well when the scope of the project is understood. We will work with you to define a scope, cost-estimate, and timeline estimate for the project.

Get a Quote your Software Project

Staff Augmentation

We provide experienced medical-device software engineers to augment your in-house team.

Our engineers are trained on the FDA regulations and guidance and can work within your QMS.

We provide engineers at either half-time or full-time and at varying levels of experience. We can also increase and decrease staffing levels as needed.

This engagement model is appropriate if you have poorly scoped work or need ongoing support. Often, after completing a project-based engagement, our clients request to retain the engineers they work with in an on-going basis.

Augment your Team with Full- or Half-Time Engineers

End-to-End Software Partner

We can be your full-service software partner for a new medical product. This engagement model is often appropriate for:

  • Busy Clinician Founders
  • SiMD Startups without an in-house Software Team
  • Companies Fully Outsourcing Development of a new Software as a Medical Device Product

We will work with your team to design, develop, validate, FDA clear, and maintain the software for your new medical-device product.

If you don’t have a regulatory consultant, we can also be your regulatory partner. Read more about our regulatory services here.

Partner with Innolitics

Building the Future of Healthcare

Our expertise spans across a broad range of medical-device software applications. We specialize in creating solutions that are not only innovative but also compliant and secure, ensuring they meet the highest industry standards.

We have experience developing a variety of medical device applications, including:

Digital Diagnostics

Medical Image Viewers

Software for IVDs and LDTs

Mobile Medical Apps

Digital Therapeutics (DTx)

Software Accessories

Explore Selected Software Projects

Explore a few of our many case studies:

We went from idea to FDA clearance in 18 months and first Install for AI Tumor Tracking Software

Prototype → 510(k) → QMS → FDA audit passed. Multi-year partnership with ongoing development.

Read the case study →

Dr. Andrew Smith, MD PhD - Radiology

Software DevelopmentImage ProcessingDICOMWeb-App510k
Logo, AI Metrics - Dr. Andrew Smith

We helped build the CBCT module, got it FDA cleared, and supported them through the Varian acquisition.

Multi-Year Partnership: CBCT Development → FDA Clearance → Maintenance → Support → M&A Support

Read the case study →

Nathan Childress, PhD, DABR, Christof Baltes, PhD - Radiation Oncology

Software DevelopmentImage Processing
Logo, Varian Medical Systems Mobius 3D

We Helped Build OCT Software and Get It FDA Cleared

UI design, Custom C++, Qt, Python development, IEC 62304 and FDA software documentation for a successful 510(k) submission

Read the case study →

Ryan Shelton, PhD - Ear Nose and Throat

Software DevelopmentAI/MLImage Processing
Logo, PhotoniCare

We Turned a MATLAB Prototype Into 510(k)-Ready Software With Full Documentation

MATLAB to Python port with performance improvements, documentation, and verification

Read the case study →

Nick Schmansky - Neurology

Software DevelopmentImage Processing
Logo, CorticoMetrics
Add Your Device to the List

What Our Customers Say

I needed a software development partner to write the software, train the AI, and get FDA clearance. An investor once told me that it would take me $5 million and 5 years to get to where we are now. Innolitics got me here 3 years ahead of schedule and $4 million dollars under budget.
Dr. Andrew Smith, MD PhD

Dr. Andrew Smith, MD PhD

Co-Founder at AI Metrics & Chair of Diagnostic Imaging at St. Jude Children’s Research Hospital

Innolitics’s engineers seamlessly integrate with our existing team. They’ve consistently produced high quality work while helping us solve technical problems in the medical imaging space. In particular, they spearheaded development of a large module that extends our existing product suite. This module has since been cleared by the FDA and is live at hospitals around the world. Their work on the module involved software development, researching various image processing algorithms, analysis of these algorithms against real-world data, and writing detailed technical documentation of the system that justified its approach to the FDA.
Nathan Childress, PhD, DABR

Nathan Childress, PhD, DABR

Associated VP at Varian Medical Systems

We needed a team that would get it done right the first time and independently. As a physician, I was delighted to work with another physician engineer on the team that was able to implement complex clinical workflows with very little input from me or my team. Innolitics delivered ahead of schedule and exceeded expectations. Every step of the way, Innolitics demonstrated why they’re leaders in medical software development.
Dr. Mark Rosenberg, DO, MBA, FACEP, FAAHPM, FACHT

Dr. Mark Rosenberg, DO, MBA, FACEP, FAAHPM, FACHT

Co-Founder and Chairman of Retrieve Medical

Innolitics is an incredible partner and consistently surpasses our expectations. They have an extremely agile team, adapting to our needs across back-end and front-end tasks seamlessly. When we needed support around ISO 62304 compliance for FDA requirements, they jumped right in and provided us compliant documentation. They also assisted us as we developed a regulatory strategy around FDA Cybersecurity and HIPAA Compliance. The Innolitics team is efficient, fair, and highly ethical. They are an absolute pleasure to work with.
Ryan Shelton, PhD

Ryan Shelton, PhD

CEO and Co-Founder of PhotoniCare

We commissioned Innolitics to build a dashboard that integrated with our radiation-oncology EMR. Their team’s clinical experience greatly simplified communication and their perceptive questions and suggestions helped us arrive at a better set of requirements for the project. The final result was clean, easy for our doctors to use, and has already improved the efficiency of our workflow.
Jonas Fontenot, PhD

Jonas Fontenot, PhD

President and CEO of Mary Bird Perkins Cancer Center

The Clinical Perspective

Our engineering work is guided by a clinical perspective. One of our founders is an MD and we have a broad network of clinicians we leverage. We have experience in the following clinical areas:

Radiology

Digital Health

Radiation Oncology

InVitro Diagnostics (IVDs)

Dental

Cardiology

Pre-Clinical

Ear Nose and Throat

Neurology

Gastroenterology and Urology

Regulatory Compliance

Our ISO 13485 compliant quality management system and development process adheres to the highest standards of quality and compliance, including IEC 62304 for medical device software, ISO 14971 for risk management, and AAMI TIR 57 for cybersecurity. Whether working within our quality management system or integrating with yours, we guarantee excellence and compliance at every stage.

Technologies We Use

  • Full-stack web-development, including TypeScript, React, Sass and Django
  • Mobile app development (iOS and Android)
  • AI/ML model development, training, testing, and deployment
  • Cloud deployments on Amazon Web Services (AWS), Microsoft Azure, and Google Cloud
  • Native application development with Qt
  • Image and signal processing
  • Especially deep strengths in Python, TypeScript, Rust, C++, C, and MATLAB
  • Embedded and real-time systems
  • Linux, Windows, and macOS

Cybersecurity

Our cybersecurity team can help you develop secure software that will keep patients safe and your and your customer’s data secure.

Our Secure Product Development Framework (SPDF) incorporates:

  • Threat modeling
  • Security Risk Management (following AAMI TIR 57)
  • Security by Design
  • Software Bill of Materials (SBOM) generation
  • Cybersecurity Testing
  • Post-Market Vulnerability Monitoring

We can help you navigate navigate buyer’s IT concerns. We also help with HIPAA. This includes providing copies of the MDS2 form and ensuring your device makes it easy for your customers to comply with the HIPAA’s security rule.

Let’s Discuss your Cybersecurity Project

AI/ML-Enabled Devices

Innolitics has deep expertise in image processing, signal processing and AI/ML model development. Our algorithms have been deployed in several FDA cleared applications and we can build your algorithm as part of a new device or to augment an existing device. Our competencies include:

  • Deep neural network based algorithms for image classification and segmentation
  • Natural language processing and textual data mining
  • Time series signal processing and anomaly detection
  • Hybrid traditional and neural network based algorithms
  • Hand-crafted heuristics based algorithms
  • Analyzing images and text contained in medical file formats such as DICOM, NIfTI, and HL7
Let’s Discuss your AI/ML Project

Interoperability

Many medical device startups wisely keep their functionality to a minimum for their first premarket submission. Once you're on the market, customers often ask you to integrate with EMR Systems, Lab Information Systems, and PACS.

We are DICOM experts. In fact, over 10,000 engineers and radiologists visit our DICOM Standard Browser each month, and it is often the top result in DICOM-related Google searches.

Let’s Discuss your DICOM or HL7 Project

FAQ

How much does your typical project cost?

End-to-end SaMD projects can vary quite a bit depending on several factors:

  • Whether the core algorithms or models have been proven
  • The size and complexity of the user interface
  • The number of platforms that are needed
  • The risk-classification of the device (higher-risk devices require more documentation and testing)
  • The performance or hardware constraints
  • The number of integrations with external systems
  • And many other factors.

Historically, full end-to-end development of new SaMD projects has ranged from $250k through multiple millions.

Many of our project-based engagements are much smaller.

What are your hourly rates?

Please reach out to use and we can provide you a list of our hourly rates for the following roles:

  • Partner
  • Director
  • Senior Regulatory Consultant
  • Regulatory Consultant
  • Staff Software Engineer
  • Senior Software Engineer
  • Software Engineer
  • Data Annotation Associate

Do you ever work on a fixed-price basis?

No. We do not work on a fixed-price basis. For our project-based engagements and end-to-end engagements we provide detailed cost and timeline estimates. We refine and periodically update these estimates throughout the project.

Can you provide examples of past projects similar to our product?

Yes! Please review our case studies for a sampling of our past projects. If you don’t see anything relevant, please reach out as only a small number of our projects have case studies.

How do you handle project management and communication during the development process?

For staff-augmentation projects we assume you will be managing our resources along with the rest of your team.

For our project-based and end-to-end engagements we provide project management support. Here are a few of the highlights:

  • We set up preferred communication channels during kickoff (often Slack or Microsoft Teams)
  • We follow an agile process with one- or two-week sprints
  • During these meetings we demo our work and plan the next sprint
  • We provide periodic budget and timeline estimate updates

What experience does your team have with FDA regulatory submissions for medical devices?

We have deep experience with FDA regulatory submissions. We have three full-time regulatory consultants on our team. Collectively we have cleared over forty-five 510(k) submissions and several De Novos. Our engineers are also trained on writing the software and cybersecurity design history documentation required for FDA submissions.

In short, we are among the most experienced FDA regulatory experts in the world when it comes to medical device software.

Does your team do firmware development?

Several engineers on our team have experience with firmware development, however, we typically are not the best fit for firmware-heavy projects. We excel on Software in a Medical Device (SiMD) projects that involve a lot of application-level coding, such as web, mobile, or desktop UIs, cloud deployments, image processing, etc.

Can your team help design our user interface?

Yes. Typically we will develop an initial set of UI Mockups in Figma and will then have a Medical Device UI/UX designers polish and further refine the slides.

What if your engineers don’t know a core technology that we use?

Good engineers can usually become proficient using new databases, frameworks, or even programming languages pretty quickly. Tools like GitHub Co-Pilot and ChatGPT have made it learning new technologies even easier.

If this is a major concern, we occasionally will cover the cost for training engineers on new technologies.

Can your engineers work within our QMS?

Yes! We can work within your QMS or within ours QMS. We are happy to sign a quality agreement to coordinate quality activities. We can also train our engineers within your QMS. This often makes sense for Staff Augmentation engagements.

Can you help us set up a Quality Management System (QMS)?

Yes. We can get you set up on our Medtech OS platform. This is the platform we use for our QMS. You can read more about Medtech OS here.

Can you run our QMS?

Sorry, although we’re often asked to do this, we do not currently help companies run their QMS, however, we can provide guidance and support. We do have several partners whom we can recommend who can help you run your QMS.

Have other questions? Let’s talk!

Here are a few articles show-casing our medical-device software expertise:

To Rewrite or Not: From Prototype to FDA-Compliant Software

This article discusses engineering and regulatory factors to consider when deciding to rewrite or reuse existing prototype code. It should be useful to researchers or companies who are repurposing existing software into a medical-device.

Read more →

J. David Giese

ArticleRegulatorySoftware

Design Inputs: Best Practices, FAQs, and Examples

The FDA says developing your design inputs is “the single most important design control activity,” yet writing good design inputs is difficult. This article presents Innolitics’ answers questions our clients frequently ask us about design inputs and analyzes a number of poorly written example requirements.

Read more →

J. David Giese

ArticleRegulatorySoftware

How Frequently Can you Release Medical Device Software?

Medical-device software release frequency is a common question, particularly from software engineers familiar with agile development. The answer hinges on two key factors: whether the changes require regulatory submissions and the ability to produce all necessary design change documentation quickly.

Read more →

J. David Giese and Jim Luker

ArticleRegulatorySoftware

Tips to Speed up Medical Device Integrations

Are you losing customers because your software doesn’t integrate with their clinical workflow? This article provides regulatory and software tips for completing medical-device software integrations, helping you sell to more customers.

Read more →

J. David Giese

ArticleRegulatorySoftware

Off-The-Shelf Software: Best Practices, FAQs, and Examples

An in-depth guide to navigating the use of off-the-shelf software (OTS) in the medical device industry. OTS software is general purpose software you didn’t develop yourself that you use in your device, e.g., open-source packages, cloud services, and operating systems. The article starts with the basics and then delves into more detailed issues, including strategies for documenting OTS software for the FDA.

Read more →

J. David Giese

ArticleRegulatorySoftware


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