Problems We Solve
Supporting All Software and Hardware Needs
Providing support for any hardware and software need, from affordable enterprise-grade Wi-Fi, to BOYD strategy and beyond. Our procurement network and buying power often beats market prices.
Regulatory and Compliance Readiness
Helping startups navigate hospital, lab, and healthcare IT security requirements to avoid prospect rejections and lost opportunities due to inability to fulfill IT and cybersecurity requirements.
Tech Strategy And
Selection
Guiding early IT choices to align with long-term needs from day one to prevent costly and cumbersome migration efforts down the road.
Cybersecurity and Risk Management
Ensuring startups meet security standards from day one, mitigating risk of breaches and alleviating compliance concerns.
Scalable IT
Infrastructure
Supporting growth at scale with the right cloud, SaaS, and infrastructure solutions tailored to your organization’s unique needs in the present while focusing on long-term scalability.
Why Inoculis?
Innovation is the beating heart of life sciences, making the world a better place for all. But it’s not enough just to have a great product. Compliance and IT security are essential components of success. Poorly planned technology choices in the early phases of development can inhibit your success, leading to vendor rejections and misalignment with regulatory frameworks during the sales cycle.
In our experience, choosing the wrong tools early will almost always come back to bite you down the road. This is especially critical when preparing to launch your go-to-market sales plan. Poor decisions can make it impossible to obtain the certifications you need and will almost always require a costly, time-consuming migration, delaying your sales and revenue by months. Plus, not having the right certifications might land you in hot water with your prospect’s buying center.
During a sales cycle to place your instrument or product, the prospect’s IT and Cybersecurity will always get involved. Not having the right answers will almost certainly lead to a veto from them and possibly end your opportunity with that customer.
With over 25 years of experience in large-scale SaaS, IoT, infrastructure, and medical devices startups, Inoculis helps you avoid costly rework, preparing your company for regulatory readiness with HITRUST, HIPAA, ISO 27001, and FDA.
Compliance is a complex process requiring multiple security, administrative, and technical controls working together. While we can’t promise you a one-and-done solution, we can provide the guidance, tools, and strategies you need to build an enduring business.
Our Mission
A Trusted Partner from Startup to Scale
Inoculis supports Medical Devices and life sciences organizations with strategically managed IT, cybersecurity, and IT compliance services, ensuring regulatory readiness from day one.
We are dedicated to helping our clients achieve regulatory readiness, ensuring HITRUST, HIPAA, ISO 27001, NIST 800-53, SOC Type 2 and cybersecurity requirements are met early while helping to avoid cumbersome, costly migrations later on.
Our experience and expertise in the high-compliance life sciences landscape ensure our clients have the certifications and advice they need to launch successfully and scale when needed.
As a fractional partner, we are here when you need us most, overseeing the regulatory landscape while you focus on your mission.
Services
Fractional IT and Compliance for Medical Devices and Life Science Startups
Scalable, cost-effective fractional services to fuel innovation.
Fractional CISO
Hiring a full-time CIO or CISO costs in the range of $250K+ each annually, which is unrealistic for early-stage startups.
IT consulting firms push long-term contracts, but startups need flexible support that grows with them.
A fractional leadership model provides startups expert IT and cybersecurity guidance without hiring a full-time executive.
We provide flexible, fractional IT & compliance leadership for life science and medical device companies. Gain expert guidance without the full-time overhead and scale as needed.
Hardware Vendor Evaluations, Selection, and Sales
Medical Devices and life sciences startups are subject to stringent requirements before engaging with laboratories, hospitals, and research facilities. Hardware, software, network, and infrastructure must comply with current regulatory frameworks, a responsibility that also extends to your third-party vendors.
By choosing and implementing the right solutions and addressing compliance readiness early, we help you prepare for the road ahead, avoiding vendor rejections during sales conversations and mitigating costly risks.
Business Software Implementations
Compliance and security extend to every aspect of your business technology. The right solutions should support every stage of business evolution, enabling speed and agility at pace with innovation.
Our team works in step with yours to identify the most appropriate solutions and strategies to satisfy all present and future business software needs. Our tailored approach ensures compliance and security at every touchpoint, helping you gain efficiency as you grow.
Cybersecurity Vendor Evaluation & Selection
Startups must track and report all software components to pass vendor security reviews. Zero trust adoption is a barrier to integration for poorly designed IT stacks, and the FDA is enforcing more stringent rules and requiring a post-market cybersecurity plan, rejecting applications that do not meet guidelines. A software bill of materials (SBOM) is now mandatory for transparency on third-party code, and automated SBOM tools will be essential for compliance.
Compliance Frameworks
Inoculis offers deep expertise in HITRUST, HIPAA, NIST 800-53, and ISO 27001 certifications, guiding you through certification readiness to improve your chances of passing.
Compliance is never easy. It requires significant effort from internal stakeholders, audits, and meticulous documentation. Our platform streamlines the process and reduces complexity, providing guidance and tools to help your team achieve these essential milestones.
Vulnerability and Risk Assessments
Hospitals and labs are tightening requirements for third-party vendors. Each must pass comprehensive security assessments before integration, including ongoing compliance. Vulnerability and risk assessments prepare you for security audits early, leveraging GRC platforms to track compliance and support your market entry.
Our process ensures secure integrations with LIMS, hospitals, and cloud environments, mitigating third-party risk now and preparing your company for much more stringent requirements in the future.
Your Future Is Our Business
Inoculis is dedicated to advancing the startup mission. We’re located in Menlo Park, CA, at the heart of Life Sciences innovation. Get in touch to learn how we can support your evolution.