Blue Goat Cyber is one of those companies that keeps flooding our inbox and so we thought that we had to check it out. The security firm helps medical device manufacturers meet complex regulatory requirements while protecting their customers from data theft and hacking.
Because Blue Goat Cyber is in such a small niche, it can be challenging for device manufacturers to find reliable information about whether the service is any good and how it can help them. Fortunately, that’s where this in-depth review comes into the picture. It explains what Blue Goat Cyber does in more detail and how the company has a knack for ensuring you get the most from your innovations, whatever they happen to be.
Blue Goat Cyber: What It Does
Blue Goat Cyber’s business model is pretty straightforward. It sees itself as a one-stop-shop for medical device manufacturers’ cybersecurity requirements, aiming to outsource as much of the challenging processes and legwork as possible.
Of course, with something as complex as medical device manufacturing, services aren’t off-the-shelf. Many are tailored to your company’s specific requirements. However, the outfit aims to be as comprehensive as possible and ensure that you need the FDA’s cybersecurity expectations first time around.
One of Blue Goat Cyber’s goals is to simplify the complexities of risk management and threat modeling, enabling more secure development, testing and documentation. This approach means that the outfit excels at helping you avoid costly delays and security risks that might derail your attempts to move forward with your plans.
The other pillar of Blue Goat Cyber’s appeal is its proven track record of dealing with the FDA on behalf of medical device manufacturers, something that it has done countless times in the past. This means that many of its clients experience a level of peace of mind that wouldn’t be possible otherwise.
The Pros Of Blue Goat Cyber
So, what did we really like about this service?
Cybersecurity Lifecycle Assistance
One of the things we liked most about Blue Goat Cyber’s approach was the fact that the company was able to help us with every step of medical device cybersecurity compliance. A single partner for all of the stages just made life so much easier for us and meant that we could proceed with more confidence.
If you decide to use the service, you will also benefit from this holistic approach. For example, you’ll get a suite of services that cover things like SPDF, risk analysis, and documentation research along with SBOMs and penetration testing (which are standard in the industry). You’ll also receive additional support in the postmarket phase, which is another thing that we loved, and makes you feel like you’re never out of the loop.
Regulatory Compliance Assistance
Another way you’ll benefit from using Blue Goat Cyber is via the outfit’s regulatory compliance assistance. The company has so much expertise in this area that it gives you confidence that they’ll be able to resolve your problems, no matter what happens.
For example, they are well-versed in ISO 27001 and IEC 81001-5-1 on the manufacturing side. They are also up to date with all the latest FDA Guidance, UL 2900, AAMI TIR57 and NIST 800-115, meaning that they can give you a 360-degree view of where you are now, and where you need to be if you want to bring your devices to various markets across the globe.
Project Stage Compatibility
As a medical device manufacturer, you know that your compliance requirements change depending on your product stage. Sometimes, you’re in a situation where you just need a specific type of service to meet the next hurdle.
Again, that’s where Blue Goat Cyber could potentially help. We found that it was easy to go to them regardless of the stage we were at and ask them for assistance. They have an understanding of each phase of the premarket and postmarket journey, meaning you can go to them for design, testing, submission, patching, monitoring and legacy support, depending on what you need.
Track Record
Finally, Blue Goat Cyber has an extensive track record of providing support to medical device manufacturing companies, just like yours. Again, we found this fact highly appealing and it was one of the reasons we liked the idea of using them so much. They have already shown that they can do it, giving you more confidence that they can help you, too.
Were There Any Downsides?
No service is perfect, but Blue Goat Cyber was pretty close in our experience. We actually struggled to find things we didn’t like as much about the service, which is why this section is shorter than usual.
One issue was the unclear pricing. If you want to know how much it is going to cost to assist your medical device company, you’ll need to hop on one of the outfit’s free discovery calls and see what they say. The amount you’ll pay will depend on your intrinsic requirement and the stage you’re at. If you’ve already done a lot of the FDA-related legwork, you may benefit from lower fees.
We’d also like to see more information on the expertise of individuals in the firm. While Blue Goat Cyber has been in business for over 10 years, we didn’t feel like we had much of a connection to the team behind it.
Should You Use Blue Goat Cyber?
Whether you should use Blue Goat Cyber depends extensively on your circumstances. These include:
- The level of collaboration you want, and if you are willing to engage in a partnership with Blue Goat Cyber
- The stage of your project and if Blue Goat Cyber has the support you need
- The type of regulatory compliance you need and if Blue Goat Cyber can assist with that
Final Verdict: Should You Use Blue Goat Cyber In 2025?
Ultimately, Blue Goat Cyber is one of our top picks for medical device manufacturers in 2025. It’s the ultimate destination we feel for those looking for support throughout all phases of the development and implementation process.
