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.

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    Can Syncro build a prototype or help with a proof of concept?

    Absolutely.  It’s very common for us to be brought in for early concept-stage work.  You can learn more about our process here.

    We have in-house resources. Can Syncro fill gaps for specific roles or parts of a project?

    Most of our clients have in-house SW engineers.  Here’s how these clients utilize Syncro Medical:

    • 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?

    One of the reasons you’ll engage Syncro Medical, is to be able to leverage your time, and that of your internal staff.  Therefore, we work hard to strike an optimal balance between keeping you well informed, and not requiring too much of your time on day-to-day issues.  What works best in terms of client involvement, is to have someone assigned with sufficient time available to review progress, and to promptly answer and make decisions regarding technical and project questions.

    How many team members can I expect to be dedicated to my project?

    There are two questions buried here:

    1.  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.
    2.  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?

    We understand that in some unusual situations, it’s imperative that the engineering team be at your site for the entire project.  If that is the case, Syncro Medical probably can’t meet your needs.

    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?

    Your team will include a Technical Project Manager (TPM).  Syncro Medical’s TPMs are among our most senior staff members.  The TPM will be your primary (but not exclusive) point of contact during the project.  For efficiency, we encourage direct engineer-to-engineer contact when needed to answer questions, resolve technical issues, etc.

    Can Syncro Medical assist us with developing a new iteration of an existing device/software?

    Yes.  Much of the work we do involves adding new features to existing software, developing next generations of existing products, addressing obsolescence, etc.

    Does Syncro Medical provide assistance in market research and product positioning?

    Our expertise is focused on software architecture, design, implementation, and testing.  While we don’t provide market consultation services per se, Syncro Medical can take on UI prototyping in support of market/customer research.

    Can Syncro Medical help us if we choose to outsource the entire software development?

    Yes, in fact many of our clients rely on Syncro Medical for aspects of their software development needs.  These clients have made a strategic decision not to invest in internal software capabilities, and focus instead on the core technologies that differentiate their product in the marketplace.

    What kind of training does Syncro Medical offer once the project is complete? What about documentation?

    We understand that in most cases your engineering team will be handling the ongoing support for the project Syncro Medical developed for you.  Therefore, we make sure that your staff is completely up to date on our work:

    • 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?

    Yes, it’s very common for clients to ask us to modify or add features after their product is released.  Because we have a very stable staff, it’s quite likely that the same engineers who developed the initial release will be available to help with follow-on work.

    How can I be assured that the end product will meet our needs?

    Our development process ensures that you have complete visibility throughout the project.  Here’s how:

    •  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?

    Post-release support can be handled in a number of ways, depending on your needs.  In many situations, the Syncro Medical team is working on a subsequent project for you, and our staff can be redirected to handle troubleshooting on your released product.  In other situations, we provide post-release support on a best efforts basis.  We’re very flexible, and will respond in a way that works best for you.

    What role does Syncro Medical play in customer complaint, recall or CAPA situations?

    While all direct end-customer interaction is handled by our client, Syncro Medical can play a supporting role.  When needed, Syncro can be engaged to assist with troubleshooting and problem resolution, included CAPA-related activity.

    How does Syncro Medical ensure that we won't encounter bugs when using our software?

    While it may seem hard to believe, it is pretty infrequent that we are called on after product release to fix software problems. That’s because we design in quality from the architecture stage forward, and then perform thorough unit testing, and work closely with our clients on integration and verification testing. (See prior question for details on how we work to ensure that your product is as bug-free as possible.)

    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?

    Syncro Medical develops unit test code while creating functional product code, which is integrated into the company’s continuous integration build environment and automatically run every time the code compiles.  This ensures capturing and fixing coding errors as early in the process as possible.  The Syncro Medical team also regularly performs integration testing throughout development, and at the end of every sprint an updated version of the product is tested and sent to our client for review.  In many cases, Syncro Medical is also asked to create formal Verification Test Plans.  These are based on the product’s documented requirements, providing traceability to ensure that all stated requirements have been successfully met in the code.  The Verification Test Plan and test results become part of the regulatory submission package.

    Can Syncro Medical help us with FDA applications, registrations, and approvals?

    Syncro Medical will play a supporting role in your FDA submission.  The actual submission is always done by our client who is the owner of the product.  We will provide supporting documentation needed for your Design History File (DHF).

    Does Syncro Medical assist clients with product testing during development/pre-launch?

    Syncro Medical works with our clients to define and execute software testing throughout the development effort.  As launch approaches, we collaborate closely on integration and formal verification testing, usually with Syncro Medical focusing on software testing while our client is executing system-level verification and validation.

    How does Syncro manage product traceability, documentation, revision control, and electronic signatures?

    Whether the project is using Syncro Medical’s documented Quality System or our client’s, our development process ensures traceability from requirements to test, along with creating and managing product documentation and approval trail for the final DHF (Design History File).

    Can Syncro Medical help us with product validation, such as ``intended use`` and ``indications for use`` issues?

    Our clients always handle product validation.  However, many of our clients use Syncro for software verification.  Formal verification test plans are traceable back to specified requirements, and help support the client-based validation effort.

    Does Syncro Medical work with my preferred technology?

    Chances are, we do!  Our engineering team offers expertise across a wide range of platforms – mobile, embedded, Windows, browsers.

    With technology changing so rapidly, will Syncro Medical discuss the expected life cycle of our software?

    Absolutely!  We believe in helping our clients to ‘future-proof’ their products.  Given the sometimes prolonged development and certification process for medical products, we’ll offer suggestions if we feel the target platform or technology could potentially be eclipsed by newer options.

    How does Syncro Medical ensure that it's on the cutting edge of currently available technologies?

    There are a number of ways we stay abreast of current technologies.  Through training programs, our Principal Engineers keep us up-to-date on many of the latest tools and technologies.  Through a combination of research and certification programs, we ensure that our engineering team is knowledgeable about new cutting edge 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?

    Syncro Medical works closely with our clients to ensure that various aspects of cyber-security are addressed from the very beginning of the project.  Requirements and architecture need to address issues such as:

    • 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?

    Yes, every once in a while we do turn down projects.  Here are some reasons why:

    •  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?

    Absolutely.  In fact, many of our clients are start-ups or early-stage companies.  Rather than divert attention from their core technologies to interview and hire a software department, these companies rely on Syncro Medical’s best-in-class capabilities to jump start the software component.  We will quickly and efficiently handle the following for you:

    • 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.

    Does Syncro Medical have the ability to work with our existing software or is Syncro Medical only interested in new product development?

    We do both new product development and enhancements to existing products.

    Can Syncro Medical provide a demo of (or provide references for) a client project that is similar to what we're looking for?

    We can definitely provide references, and we encourage you to call them.  Given confidentiality restrictions, we’re usually not able to demonstrate another client’s product, particularly if it hasn’t yet been released to the market.  However, we can certainly characterize the effort.

    What if we need our product as soon as possible? Do you provide an expedited service?

    Syncro Medical is all about meeting deadlines.  That’s why we’re in the business.  If you’re in a real pinch, we’ll focus on ways to speed the process right from our first conversation.  For example, there are options to speed the proposals process.  Once engaged, we’ll discuss your MVP (Minimum Viable Product), phased releases, rapid prototyping, and other ways to beat your competition to market.

    What makes Syncro Medical's proposal process different from its competitors?

    We are often told that we ask lots of very good questions during the proposal preparation process.  The reason we do so is to present a realistic, honest estimate of the effort.  Also, as a result of this detailed dialog with prospective clients, certain issues/trade-offs surface which hadn’t yet been considered.

    Does Syncro Medical make any copyright or patent claims on projects it works on?

    Absolutely not.  The work product we develop for you is entirely your property.  Our philosophy is “You pay for it. You own it”.