Home » What We Offer » Consulting

Consulting

The medical device industry is one of the most highly regulated and competitive markets in the world. Navigating it successfully requires more than a great idea...it requires foresight, planning, and disciplined execution. Our consulting services provide that foundation.

By combining strategic insight with hands-on execution, we help medical device companies move forward with confidence, avoiding costly missteps while building a strong foundation for success. Suntra takes a research-driven approach informed by deep insights into clinical and patient use environments. Before you build, we help you uncover hidden gaps that can derail progress.

Our consulting services include, but are not limited to:

Assessment & validation

We want to be sure you have done the technology readiness, risk mitigation, and requirement management needed to be successful. We help you identify 'what you didn't know, you didn't know'.

Competitive analysis

Validating that your product meets an unmet clinical need and is positioned for adoption will help you accelerate time-to-market and time-to-money

Risk assessment

Identifying and addressing potential design and development challenges early, reducing costly delays and ensuring project success.

Staffing & skills assessment

Helping you identify the teams, tools, and processes to institutionalize innovation into your culture.

Cyber risk assessment

Ensuring products are intuitive, safe, and effective in real-world clinical and patient environments.

Cybersecurity

Guiding companies in safeguarding their systems, intellectual property, and operations against evolving and increasingly complex cyber threats.

Regulatory strategy & compliance planning

Anticipating FDA and compliance requirements, we align product development with evolving standards to accelerate approvals and reduce costly delays.

Program management & planning

Establishing milestones, timelines, staffing, budget plans and risk to prove ROI and ensure you are prepared for success.

Early stage tech assessment

We distill decades of medtech experience into practical applications and advice to help early-stage teams accelerate development, avoid common pitfalls, and move forward with greater confidence and clarity.

If you want to dig deeper, take a look at some of our other consulting capabilities: 

Pile of papers with magnifying glass sitting on top

Regulatory Strategy

With our combined expertise, we’re here to help you navigate every stage of the medical product lifecycle, ensuring success today and into the future.

Cybersecurity Consulting Services from Sunrise MedTech

Cybersecurity

Cybersecurity in medical devices is a critical and evolving area of concern as healthcare systems become more interconnected and reliant on digital technologies.

Overhead shot of schematic

Medical Device Development

Suntra MedTech Solutions has been providing medical device development consulting for over 30 years. We have extensive experience bringing class II and class III medical devices to market.

Custom Medical Device Development & Innovation Consulting

Let’s operationalize your ideas.

Contact us today to set up a consultation and learn how our medtech consulting expertise can strengthen your strategy and accelerate results.

Start the conversation today.

Meet Our Consulting Team

Our Latest Insights

What It Takes to Engineer a Truly On-Demand, Life-Saving Medical System

In emergency medicine, minutes matter. But behind every “rapid response” clinical innovation is years of disciplined systems thinking, engineering rigor, and regulatory foresight. One of the most complex challenges facing trauma care today isn’t treatment, it’s access. Plasma, a critical component in emergency transfusions, has traditionally been constrained by freezing, storage, transport logistics, and slow […]

Pioneering medical device development and innovation consulting.

Let’s start a conversation today.

Set up a consultation and learn how our medtech consulting expertise can strengthen your strategy and accelerate results.

Website by onDemandCMO