From idea to on-the-market is a long and winding road for medical devices. It requires substantial development time and investment. The regulatory environment is complex, and there’s inherent risk in internet-connected devices. So much so the Food and Drug Administration (FDA) has guidance and requirements for this healthcare category. With all these factors and competing priorities, you should consider the value of cybersecurity in your go-to-market plan.
Cybersecurity Is a Pillar of Medical Device Development
There isn’t any device that could achieve FDA approval without cybersecurity measures. Manufacturers are well-versed in the submission requirements for premarket submissions, along with responsibilities after the device is in use. Those include monitoring for vulnerabilities and a patching and updating plan to remediate them.
The importance of cybersecurity as a regulation has influenced the industry to be secure by design. Security is not an afterthought. Instead, it’s a priority from the beginning.
The embrace of this philosophy has occurred not only in response to the FDA. It’s also good for business. Healthcare providers and patients are well aware of cyber threats posed to devices, and any hint of security gaps elicits fears for their safety. While most medical device cybersecurity concerns focus on data breaches, malware, and ransomware, it is a possibility that hackers could compromise the device, leading to patient harm.
All the work of bringing a medical device to market related to cybersecurity needs touting. It could actually be a competitive advantage.
Medical Device Go-to-Market Strategies Already Consider Risk and Compliance
Any go-to-market strategy for any product includes minimizing risk and adhering to compliance. In risk and compliance, cybersecurity should be at the top of the list.
As part of your premarket submission, you’re already developing a cybersecurity plan and identifying any potential threats and how you’ll address them. Beyond the FDA requirements, there’s also HIPAA and its rules for protected health information (PHI).
So, how can you turn a regulatory requirement into a meaningful part of your go-to-market strategy? It’s an opportunity to define messaging that’s about your commitment to security.
Abating risk and strengthening compliance can foster confidence and trust in your product, two of the most important things in healthcare relationships.
4 Ways to Incorporate Cybersecurity into Your Go-to-Market Plan
These strategies can elevate your medical device’s cyber-secure reputation.
- Create a vulnerability disclosure program. You’ll need a defined process for users and stakeholders to provide feedback on possible vulnerabilities. This should be a collaborative effort that you discuss openly.
- Be transparent about your updating and patching protocols. These are also part of the FDA requirements. Communicating these to healthcare professionals and patients can give them peace of mind. This is what being proactive about cybersecurity looks like in action.
- Build more trust with information about access controls. You are actively trying to prevent unauthorized access, as that’s the beginning of a cyber incident. Having access control mechanisms like authentication and authorization protocols protect against breaches. Ensuring your market knows this could be valuable.
- Include your security measures in your value prop. Every go-to-market strategy must explain how it solves a market problem. Most of the emphasis would be on the patient results, but security should have a place in this proposition as well. It shows that it was and will continue to be a priority.
You can think of these action items in the same way that manufacturers talk about security for consumer electronics. The end users of your devices are all too aware of data breaches and have likely been victims. Being upfront and deliberate about cybersecurity can ease minds and ensure providers and patients will consider your device for the good it can do rather than the risks.
Need help with premarket or postmarket cybersecurity requirements? We can help. Contact us today to learn more.
