Medtech OS

The Medtech Operating System

It is not just a set of templates or an eQMS system, it is a full operating system to getting your device FDA cleared and maintaining your device in the post-market.

It is built on top of Notion, a world class knowledge management system used by big names like Figma, Pixar, Doordash, Nike, Amazon, GE, and Uber.

Notion is not only a joy to use for software engineers, it is also not a foreign language to non-engineers. Notion offers a familiar markdown interface with engineer centric features like code blocks and mermaid diagram rendering. At the same time, it has an intuitive interface that non-engineers can quickly learn.

We know because we have a team of 14 software engineers and 4 regulatory consultants that all use Notion simultaneously and harmoniously.

Did I mention we practice what we preach? We use Medtech OS on all of our engineering projects and even as our Innolitics QMS.

The Solution

Medtech OS is our all-in-one workspace designed to streamline your medical device startup’s operations. Medtech OS goes beyond being a mere collection of templates; it integrates powerful project management tools to ensure seamless workflow and regulatory compliance. Drawing from our extensive expertise in both regulatory affairs and software development, we have crafted a robust and intuitive system that supports the different stages of your product lifecycle.

Product Documents

Starting from planning in Phase 1 all the way to validation and design transfer in Phase 4, Medtech OS’ Product Documents database contains all of the necessary templates for documenting a comprehensive Design History File (DHF) for your medical device. This ensures that every step of your development process is meticulously recorded, meeting regulatory requirements and supporting efficient project management.

Product Documents database showing the list of documents that are part of Phase 1.

Phase Checklists

Our Phase Checklists do an excellent job at outlining all the documentation deliverables that are required to complete each phase of medical device development. These checklists provide a clear overview of the necessary documents produced at each stage and streamline collaboration by assigning specific tasks to team members. The checklist format ensures efficient tracking of completed items and outstanding tasks, enhancing project management and accountability throughout the development process.

Phase 1 Checklist, demonstrates how different deliverables are broken down with clear descriptions of who should be involved in the different activities that comprise each phase of development.

510(k) Deliverables

Medtech OS provides the capability to filter views within the Product Documents database. The 510(k) view specifically highlights all the documents necessary for a 510(k) submission, ensuring a streamlined and organized process.

510(k) view of our Product Documents database.

Similarly, the eSTAR view within our Product Documents database organizes the various 510(k) deliverables into their respective sections of the eSTAR. This feature enhances the visualization of your eSTAR submission status, providing a clear and organized overview for better management and tracking.

eSTAR view of our Product Documents database.

Traceability

One of the standout features of Medtech OS is its ability to effortlessly maintain traceability across various databases and documents.

Traceability diagram showing traceability relationships between various regulatory items.

We have created multiple databases for each essential building block of a medical device, such as User Needs, Requirements, Risks, and Verification Protocols, among many others. Utilizing Notion’s relation property, we can effortlessly establish relationships between these elements, (No more navigating between spreadsheets to find the correct ID number!)

Requirements database showing relationship between Verification Protocols, User Needs, and System Items.

Consistency

Another standout feature of Medtech OS is its ability to maintain consistency across numerous documents effortlessly. Have you ever had to update your Indications for Use across multiple documents or revise your entire submission just to change your device’s trade name? Our Product Variables database solves this problem by offering a centralized space for documenting specific content. These entries can be easily referenced across multiple documents using Notion’s @ mention feature. This not only simplifies content drafting but also ensures consistency, eliminating the risk of discrepancies across documents.

Example of how we can @ mention different pieces of content that are typically repeated across different documents in a DHF and 510(k) submission.

Project Management

Notion offers a range of project management tools, including task management, timeline and calendar views, and to-do lists. Medtech OS seamlessly integrates these tools into the different Product Documents, simplifying and centralizing the management of your medical device project. This integration ensures that all aspects of your project are efficiently managed from a single platform.

Example of how Medtech OS can be used to track tasks and timelines of different documentation and project deliverables.

Customizable

Life is not one-size-fits-all, and neither should your quality management system be. Medtech OS provides the perfect solution, enabling you to customize templates and processes to meet your unique requirements. For example, you can create filtered views of documents based on ownership or status. With Medtech OS, the possibilities are nearly endless, ensuring your quality management system is as adaptable as you need it to be.

Pricing

  Seed Startup Scale Competitor Products
Qualification Criteria <$100k in annual revenue and <$1M raised <$1M in annual revenue and <$10M raised >$1M in annual revenue or >$10M raised Varies
Requirements Capture Yes Yes Yes Yes
ISO 14971 Risk Analysis Yes Yes Yes Yes
Substantial equivalence template Yes Yes Yes Yes
Device description template Yes Yes Yes Maybe
Verification and validation plan Yes Yes Yes Maybe
Test management system Yes Yes Yes Usually no. You require a third party test management system.
User manual template Yes Yes Yes No
IEC 62304 compliant software development plan template Yes Yes Yes Maybe
User needs Yes Yes Yes Yes
User groups Yes Yes Yes Yes
System items Yes Yes Yes Yes
V&V Capture Yes Yes Yes Yes
Unresolved Anomalies Yes Yes Yes Yes
Template updates in response to FDA changes. We keep up to date with the reg so you can focus on the dev. Yes Yes Yes No
CFR 820 part 11 compliant signatures Yes Yes Yes Yes
Document versioning Add-on Yes Yes Yes
Document redline Add-on Yes Yes Yes
Consulting Add-on 2 hours per quarter 10 hours per quarter No. SaaS only
Everything you need to prepare and submit a 510k or De Novo Yes Yes Yes Yes but comes with a lot of additional baggage you don’t need until after FDA clearance
ISO 13485 Compliant QMS Yes Yes Yes Yes
CAPAs Yes Yes Yes Yes
Vendor Database Yes Yes Yes Yes
Learning management system Yes Yes Yes Maybe
Attribution Optional Optional Optional Varies
Case Study + Video testimonial Optional Optional Optional Varies
Innolitics submission Optional Optional Optional Varies
Traceability Management Yes Yes Yes Yes
DRY (do not repeat yourself) editing Yes Yes Yes No. You still need to mess with data duplication and playing intended use change whack-a-mole
UI that both engineers and non-engineers can understand Yes Yes Yes Either engineering loves it and regulatory hates it or vice versa
Cybersecurity templates Yes Yes Yes Varies.
Cybersecurity Consulting Add-on Add-on Add-on Usually separate vendors who may or may not work well together
All docs from a recently cleared 510k using Medtech OS Add-on Add-on Add-on No. This is unprecedented from only Innolitics.
Word Export Yes Yes Yes Yes
PDF Export Yes Yes Yes Yes
Automatic document signing workflow Yes Yes Yes Yes
Access control Yes Yes Yes Yes
Number of users Unlimited Unlimited Unlimited Limited by arbitrary caps
Epic / Sprint / Task / Issue management Yes. Highly customizable. Yes. Highly customizable. Yes. Highly customizable. Often in separate system
Software development consulting Add-on Add-on Add-on Usually separate vendors who may or may not work well together
AINN review Add-on Add-on Add-on Usually separate vendors who may or may not work well together
510k Review Add-on Add-on Add-on Usually separate vendors who may or may not work well together
Generative AI Tools Add-on Add-on Add-on Varies but most implementations suck
Vendor Lock-in No. Your data lives in Notion and Word document exports are available. No. Your data lives in Notion and Word document exports are available. No. Your data lives in Notion and Word document exports are available. Yes. Usually difficult to export with APIs being locked.
APIs Rich APIs available through Notion Rich APIs available through Notion Rich APIs available through Notion Usually enterprise level feature
Specialized for SaMD Yes Yes Yes No. Often comes with confusing non-SaMD baggage like “shelf life.”
Step by step DHF preparation checklists Yes Yes Yes No. You are given the “what” and “why” but left on your own for the “how”.
Pricing model Transparent Transparent Transparent Suspenseful
User Limits None None None Arbitrary
Step by step 510k preparation checklist Yes Yes Yes No. Needs an external consultant.
Project management (Gantt charts, velocity, Scrum) Yes Yes Yes No. Needs separate tool.
Price $2k initiation + $2k / quarter $5k initiation + $5k / quarter $10k initiation + $10k / quarter Varies between $10k to $100k / year
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