Frequently Asked Questions
Solving Medical Device Software Development Challenges
Looking for additional information? Our Frequently Asked Questions provide answers to our clients’ most common inquiries. If you can’t find an answer to your question here, please reach out, and a team member will get back to you shortly.
Can Syncro build a prototype or help with a proof of concept?
We have in-house resources. Can Syncro fill gaps for specific roles or parts of a project?
- For modules or features that their internal staff just cannot get to… or do not have the appropriate skill set for.
- For work on a new product while in-house staff wraps up development on the existing product line. Or vice versa.
- For non-core modules of the software, so that in-house engineers can focus on the key, proprietary components.
How involved will I need to be throughout the development process?
How many team members can I expect to be dedicated to my project?
- The number of engineers assigned to your project depends on the size and complexity of the effort. We are very careful not to over-staff projects, which can result in inefficiency.
- With respect to “dedication” – all of the project engineers assigned to your project will be 100% dedicate to just your project. They will have no other distractions.
We have an on-site project, can Syncro Medical work at our location?
However here is how we address the very legitimate need for on-site presence:
- For every project, we will spend the needed amount of time at your site. Most often, this occurs during the ramp-up stage, and again during final testing/hand-off.
- Using our agile development approach, we will minimize the amount of travel by using readily available tools to connect with your on-site hardware for development and testing.
Does Syncro Medical provide a dedicated project manager or will I work directly with a team of developers?
Can Syncro Medical assist us with developing a new iteration of an existing device/software?
Does Syncro Medical provide assistance in market research and product positioning?
Can Syncro Medical help us if we choose to outsource the entire software development?
What kind of training does Syncro Medical offer once the project is complete? What about documentation?
- By virtue of the Agile Development process, your staff will be very familiar with the design, code, and operation of the new product/feature.
- We provide thorough documentation for all of our work.
- Our hand-off process includes details training as needed.
Will Syncro Medical be available to change the product in the future if needed to modify or add features? How quickly?
How can I be assured that the end product will meet our needs?
- We will carefully review the requirements with you prior to starting design and implementation. Together, we will eliminate gaps and ambiguities.
- Because we use the Agile process, you will receive a release every 3 weeks for testing, and to evaluate progress to date. If course corrections are needed, they can happen early in the process when the cost of change is at its lowest.
How does Syncro Medical handle post project completion troubleshooting?
What role does Syncro Medical play in customer complaint, recall or CAPA situations?
How does Syncro Medical ensure that we won't encounter bugs when using our software?
While it isn’t credible to ensure 100% bug-free software, it’s very unusual for a significant problem to surface after product release. However, if that should happen we’ll react as quickly as possible to identify and fix the error.
What testing parameters do you have in place to make sure the product works as intended?
Can Syncro Medical help us with FDA applications, registrations, and approvals?
Does Syncro Medical assist clients with product testing during development/pre-launch?
How does Syncro manage product traceability, documentation, revision control, and electronic signatures?
Can Syncro Medical help us with product validation, such as ``intended use`` and ``indications for use`` issues?
Does Syncro Medical work with my preferred technology?
With technology changing so rapidly, will Syncro Medical discuss the expected life cycle of our software?
How does Syncro Medical ensure that it's on the cutting edge of currently available technologies?
We also strive to assess which of the newer technologies are ready for prime time. Frankly, some are not, and we feel that part of our value-add is to advise our clients of these potential pitfalls.
How does Syncro Medical address technology/interconnectivity security issues?
- User authentication
- Confidentiality of patient information/PHI/HIPPA
- Encryption of data storage and external communication
- Potential restriction of OS access/application lockdown
- Potential anti-virus/malware protection
Does Syncro Medical turn down projects? If so, for what reasons?
- There is a technology mismatch. For example, if your project was to create a large, retail e-commerce system.
- Your project is quite small (usually less than 3-4 staff months). We would want to make sure the project is a sufficient size, so that you will benefit from leveraging our engineering team.
We are a startup and are working with first-round funding. Can Syncro Medical still help us?
- Perform proof-of-concepts
- Develop functioning prototypes for demonstration to your investors and potential customers
- Recommend hardware and operating systems platforms
- Map out the architecture
We have found that firms providing the capital are pleased to see Syncro Medical’s decades of experience, and view that as lowering the risk of their investment.