End-to-End Design & Development

If your software is “intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease” then the FDA considers it a “medical device” and regulates it as such.

Medical devices that consist only of software are often called Software as a Medical Device (SaMD).

Yes! We have more experience with SaMD but we can also help with SiMD (Software in a Medical Device). Furthermore, we can prototype certain types of hardware devices. We would then transfer the design to a contract manufacturer. (There are a few we’ve worked with in the past.) Get in touch with us to learn more about our capabilities here.

To legally market your medical device in the US, you will likely need to do a premarket submission. A 510(k) is the most common type of premarket submission. Your premarket submission will need to include an intended use statement, a software requirements specification (SRS) document, and an initial hazard analysis. The SRS describes what your software does, including its functional requirements, performance requirements, user interface design, other software it integrates with, etc.

The primary output of our discovery phase is an SRS. Usually it’s about 50 pages long and is quite detailed. Writing your SRS is the natural place to start because not only will you need such a document for your 510(k) submission, but it will also let us estimate the budget for the project.

In most cases, we can work alongside your existing team, although we can provide the most value to our clients if we follow our established software development processes. Get in touch with us to learn more.

We’ve helped several radiologists commercialize academic software (e.g., an algorithm written in MATLAB). In these situations, the nature of the discovery phase shifts to include an assessment of your prototype. In some cases, we can skip the prototype stage and move on to the investment phase.

The FDA requires that certain best practices (e.g., design reviews, requirements traceability, risk analysis, automated unit tests) be followed when developing medical device software. Although it’s possible, it can be expensive to retroactively apply these processes to existing software.

If you have an existing software product that you would like to get FDA clearance for, we can perform a gap analysis of your source code and documentation to help you identify what is needed to submit a 510(k).

We can also help develop some of this documentation, although you should be aware that often this will identify technical gaps that take significant technical resources to fill.

In addition to helping with private investment, we can also help write grant applications. We’ve written and reviewed technical aims for many grants. We’ve helped our clients win Phase I and Phase II grants (including ones that have been rejected due to lack of engineering experience). We can provide biosketches for key team members as well as letters of support.

Time spent working on grants is billed on an hourly basis at our standard rates.

We’ve worked with many regulatory consultants in the industry. Our processes are flexible and can adapt to various Quality Management Systems and SOPs. There is often some extra cost to adapting our processes to an existing system.

When there aren’t clear milestones, as is usually the case during the support phase, we work at an hourly rate.

The medical device industry is highly regulated, and mistakes made early in the process can be expensive to correct. Therefore, a team that’s brought several medical devices onto the market will usually be cheaper and faster than a team that hasn’t done it before. Hiring such a team can be done but is challenging, especially if you haven’t been through the process yourself. Our team has the regulatory, clinical, and software-engineering experience to turn your vision into a reality. We also bring experience in AI/ML, DICOM, and HL7.

Another benefit of outsourcing engineering over hiring is that we can scale our resources up and down throughout the project. For example, it often makes sense to scale down engineering resources while looking for investment and while we’re waiting for FDA clearance.

Once you’ve gotten over the hump of your first submission and have started generating revenue, it may make sense to begin hiring staff engineers for support and ongoing feature development. At this stage, many of the highest risk questions (where our deep experience is critical) have been answered. When you get to this stage, we can help you with technical hiring. We’ve helped several of our clients build out internal engineering teams. Usually, we remain involved in a consulting capacity.

We can handle most 510(k)s in-house, but we have a network of regulatory advisors we’ve worked with before who can help with PMAs, De Novos, and Humanitarian Device Exemption.

If you’ve undergone a 510(k) submission and the FDA has given you the green light to market your device, then your device is said to have FDA clearance.

If you’ve undergone a PMA submission (which is much more expensive and time-consuming and is usually only done for new types of devices), then once the FDA has given you the green light to market your device, you’re device is said to have FDA approved.

Using the terms correctly, especially in user manuals and marketing material, can avoid legal problems with the FDA.