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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: 

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.

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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.

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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.

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

Navigating the Product Development Maze: The Essential Role of Risk Management in Medical Devices

Bringing a new product to market is an exciting journey—but one filled with risks that can derail even the best-laid plans. In our latest blog, Navigating the Product Development Maze: The Essential Role of Risk Management, we explore how proactive risk management helps teams stay focused, informed, and aligned at every stage of development. Learn how setting clear goals, evaluating multiple concepts, and building a flexible project plan can drive your product’s success. For an in-depth guide to mastering each phase, download our whitepaper, New Product Development: Managing the Risks.

Navigating the Challenges of MedTech Innovation

Bringing a new medical device to market is a complex and high-stakes endeavor. Companies face numerous challenges, from securing funding and managing product development to navigating stringent regulatory requirements. Success requires a strategic approach, combining innovation with disciplined execution. 1. Identifying the Right Problem to Solve One of the biggest factors in MedTech success is […]

Navigating the Challenges of Developing Safety-Critical Medical Devices

Developing safety-critical medical devices is a complex process that requires careful planning, rigorous testing, and cross-functional collaboration. The stakes are high—not only because of regulatory and market risks but also because patient safety depends on every design decision. Below, we explore key strategies that can help ensure the success of safety-critical medical device development. Understanding […]

Exploring Innovations in Medical Device Product Development

The future of healthcare is being shaped by incredible advancements in medical device product development. From wearable monitoring devices to cutting-edge diagnostic tools, innovation is revolutionizing the way we approach healthcare. These developments are enabling personalized medicine, enhancing patient outcomes, and improving the efficiency of healthcare delivery. In this article, we will explore the latest […]

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.

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