--- case_studies: - 141bd5b7-a754-80c4-8e9a-fa24807a2e59 description: You need a product-development partner for an AI-enabled imaging application. featured: false is_solution: true service_name: Medical Imaging AI Development sort_order: 13 title: Medical Imaging AI Development widget_icon: [] ---
# Medical Imaging AI Development
We can partner with you to design, develop, and validate your **AI-enabled medical imaging project**.
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.
Partner with Innolitics
![](/img/services/Medical_Imaging_AI_Development-124bd5b7a754807bbee8ca60833b9a5e.png)
## Medical Imaging AI has Unique Challenges Developing medical-imaging AI applications has unique challenges. These challenges are difficult for startups to address with small in-house teams or generalist development firms. Here are some of the unique challenges companies in this space will need to overcome: ## Challenge: AI Performance Validation FDA requires clinical validation of most AI models. Inexperienced teams can lead to costly delays. Common problems include: - Insufficiently diverse training or testing data - Inappropriate data management or controls - Insufficiently rigorous reference standard - Inappropriate validation study design To ensure your models get past FDA review, it is critical to have a team that understands FDA's expectations around training data coverage, data controls and AI lifecycle processes.
FDA is placing an increasing focus on the AI development lifecycle within their regulatory review.
### How Innolitics Meets this Challenge - We have 11 engineers (including 3 PhDs) with deep image-processing expertise in traditional image processing and AI-based methods. - Our team of six FDA regulatory consultants have helped over 100 companies FDA clear medical device software. We have a deep understanding of the relevant FDA guidance and regulations. ### What our Clients Say ### Resources ## Challenge: Design Documentation for FDA Submissions When you submit your 510(k) or De Novo application to FDA, you'll need to provide comprehensive documentation of your product\'s development process, risk management activities, software architecture, and verification and validation testing. It is not uncommon for companies to take 9 - 12 months **just producing the documentation!** This problem is so common that we offer our Fast 510(k) service to companies who are done with development but who didn't produce the necessary design documentation. This service typically takes 3 months and costs \$200k or more. For example, we've had to take over projects developed by over-seas teams who were unable to comply with this rigorous documentation. It is much more efficient to pay more up front for a development team that can provide all of the necessary design documentation.
Diagram showing the various information that needs to be documented and traced together during medical device AI development.
### How Innolitics Meets this Challenge - Our Medtech OS platform is purpose built for medical device software submissions. Our engineers are trained on its use and it provides all of the documentation required for FDA submissions. - We've helped over 100 companies FDA clear their medical device software and have a thorough understanding of the relevant guidance and standards. ### What our Clients Say ### Resources ## Challenge: Healthcare Integration and Deployment Integrating within the clinical workflow is critical for success. Doing so requires an understanding of DICOM, HL7, and FHIR. It also requires a real-world understanding of hospital IT environments. Although acceptance of cloud-based deployments is growing, many institutions still require on-site deployments. Furthermore, performance is critical. Radiologists are busy, highly paid professionals with low tolerance for waiting. They will not wait for large images to load. Solving these performance issues is challenging given the size and quantity of image sets (MRIs and CTs). ### How Innolitics Meets this Challenge - We have over 5 years of experience deploying and maintaining AI-enabled radiology software. - We are DICOM experts (e.g., our [DICOM Standard Browser](https://dicom.innolitics.com/) is used by over 10,000 people each month). ### What our Clients Say ### Resources ## Challenge: FDA Cybersecurity and HIPAA With an increase in malware-based attacks on hospitals and FDA's new statutory authority to regulate medical device cybersecurity, vendors must focus increased resources on secure product development. ### How Innolitics Meets this Challenge - We've helped dozens of companies resolve FDA cybersecurity deficiencies and have a keen understanding of FDA's guidance and requirements. - We can handle all aspects of cybersecurity, including threat modeling, security risk management, cybersecurity controls, SBOM generation, and cybersecurity testing. ### What our Clients Say ### Resources ## Who We Work With 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
## Video Testimonial ## Engagement Models We engage with our clients to in three ways: ### End-to-End Software Partner We can be your full-service software partner for a new medical imaging AI product. **We will work with your team to design, develop, validate, FDA clear, and maintain the software for your new medical-device AI product.** It is common for startups to have a couple of founding engineers who will manage the core AI model. In these cases, we can coordinate with your internal team while we develop the surrounding UI, deployment scaffolding, and cybersecurity requirements for the project. If you don't have a regulatory consultant, we can also be your regulatory partner. Read more about our regulatory services [here](https://innolitics.com/services/regulatory/).
Partner with Innolitics
### Project-Based We can work with your existing engineers or data-scientists to complete software development projects with a defined scope. Typical projects include: - Training novel AI models - Local and cloud deployments - Medical image viewer development - EMR, PACS and worklist integrations - HIPAA and FDA cybersecurity support - Validating and tuning research-grade image-processing models 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
## Technologies We Use - Web Development: Typescript, React, SASS - Desktop Apps: Qt, CMake - Programming Languages: Python, C++, C, and Rust - Operating Systems: Ubuntu, Debian, Windows, macOS - AI Frameworks: PyTorch, Tensorflow - Cloud Platforms: AWS, Google Cloud Platform, Microsoft Azure - Python Libraries: NumPy, SciPy, Pandas, Matplotlib, scikit-image, OpenCV, Pillow - Medical Imaging Libraries: pydicom, ITK, VTK, SimpleITK, DCMTK - Containerization and Orchestration: Docker, Kubernetes
Some of the technologies we use when developing medical imaging AI for our clients.
## FAQ

Can you help us collect and annotate data for our model?

Yes, since we’ve been working in the radiology space for over a decade, we have a broad network of data providers and clinicians. In most cases, we can help procure data and clinical specialists to help annotate the data.

Do you work on non-imaging AI applications?

Yes! Although our deepest expertise is in the imaging domain, we also have experience with IVDs and other signal-processing applications. Let’s talk and we can explore if we’re a good fit for your needs.

How much does your typical project cost?

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

Our project-based engagements typically start at $50k.

Full end-to-end projects tend to start around $200k.

Do you ever work on a fixed-price basis?

We do not work on a fixed-price basis for large projects, but in some cases we may begin projects with a fixed-price scoping phase or a small fixed-price initial engagement.

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:

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

We have deep experience with FDA regulatory submissions. We have six 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 AI 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 may cover the cost of training engineers on new technologies.

Can your engineers work within our QMS?

Yes! We can work within your QMS or within ours. 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!
## Explore Selected Software Projects Explore a few of our [many case studies](https://innolitics.com/portfolio/?tags=software-development):
Add Your Device to the List
## Featured Resources Here are a few [articles](https://innolitics.com/articles/software/) show-casing our medical-device software expertise: