Beyond Open Source Software Customization: Kitware’s Holistic Approach to Medical Software Product Development

At Kitware, our expertise goes far beyond software customization. We have a strong track record of successfully helping numerous medical device companies and commercial clients transform their ideas into market-ready products using open-source software platforms such as 3D Slicer, Insight Toolkit (ITK), Visualization Toolkit (VTK), Pulse Physiology Engine and MONAI. But, our value goes beyond our leadership in these open-source communities.

Understanding Your Vision

When customers approach us to address their unique challenges by customizing our open-source software, they often expect us to jump straight into implementation. However, our approach is more comprehensive. We begin by understanding the broader vision and strategy behind their product. This means asking critical questions to grasp the intended application, its purpose, and its value.

Strategic Exploration

For instance, if a customer requests customization of 3D Slicer for a niche application, we first explore the fundamental goals of the application by asking:

• What specific problem does the application solve?
• Who are the target users and customers for this application?
• What needs and desires of the customers does the application address?

By evaluating these aspects, we help our clients refine their ideas and ensure their products align with user needs and business goals.

Evaluating options

We don’t limit our proposed solutions to a single platform or technology the customer uses when initially approaching Kitware. We consider alternatives and suggest innovative approaches to serve the project’s objectives better. This could involve exploring:

• The feasibility of a desktop versus a web-based application (For example, a customized VolView application instead of a 3D Slicer).
• A cloud-based deployment for scalability, accessibility, and availability.
• The appropriate software development process or tool corresponding to the product development stage, such as CI/CD workflows, DevOps, or MLOps, to enhance the product development process and maintenance.
• Functional and non-functional requirements, ensuring a holistic approach to development.

Comprehensive Requirement Gathering

Our collaborative efforts with customers include the following:

• Documenting comprehensive business requirements, including functional requirements, user stories, and acceptance criteria.
• Aligning these requirements with user needs and business objectives.
• Developing detailed user stories and product specifications to guide the development team.
• Creating and maintaining a product roadmap outlining short-term and long-term goals, prioritizing features based on customer demand, market trends, and strategic importance.

Functional and Non-Functional Requirements

For medical image analysis and visualization applications, in particular, we delve into specific requirements such as:

Functional Requirements:

• DICOM support: Import, export, and processing DICOM files, supporting various modalities. Loading data from the local file system or through connection to a Picture Archiving and Communication System (PACS) server
• Analysis algorithm support: Advanced segmentation and registration algorithms, real-time enhancement, and filtering.
• Machine learning: Managing large medical image datasets, annotating, and training deep learning models.
• Measurement and annotation tools: Tools for measuring distances, angles, and annotating images.
• Integration with clinical workflow: Seamless integration with PACS and  Radiology Information System (RIS), support for HL7 standards.
• User Interface and Experience: Build an Intuitive, customizable interface with multi-monitor support.
• Visualization: High-quality 3D rendering, volume and surface rendering, and Maximum Intensity Projection (MIP)

Non-Functional Requirements:

• Performance and Scalability: Efficient processing of large datasets, scalability for data and users.
• Security and Privacy: Compliance with HIPAA, data encryption, and user authentication.
• Reliability and Availability: High system uptime, robust error handling for cloud deployment
• Usability: User-friendly interface, comprehensive documentation, and training.
• Maintainability and Extensibility: Modular architecture, easy updates, extensible frameworks.
• Compliance and Certification: Adherence to industry standards and capability for validation and certification.

FDA Approval Support

Understanding the complexities of regulatory requirements, we partner with third-party companies to assist our customers in pursuing and securing FDA approval. This collaboration ensures that our client’s products meet the stringent standards necessary for market entry and compliance, facilitating a smoother path to commercialization.

Building Strong Community Relationships

Our strong relationships with the open-source community behind the libraries we utilize enable us to support product development effectively. This community engagement benefits our clients and enhances the open-source projects themselves.

Conclusion

At Kitware, we extend beyond software customization to provide comprehensive product development support. From understanding your vision and strategic exploration to detailed requirement gathering, we meet functional and non-functional needs. Our expertise in medical image analysis, visualization, and partnerships for FDA approval positions us as a unique ally in bringing innovative products to market. Collaborate with Kitware for a holistic approach that aligns technology with your business goals.