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Entrepreneurship in MedTech: Strategies to Minimize Risk and Maximize Success
Discover how to streamline nedtech engineering processes with strategic connections. Schedule a call with Concise Engineering today.
Optimizing MedTech Engineering: Simplify Your Process with Strategic Connections
Discover how to streamline nedtech engineering processes with strategic connections. Schedule a call with Concise Engineering today.
Mastering the Art of the Manufacturing Supply Chain
For many entrepreneurs and investors on the verge of scaling their operations, navigating the manufacturing supply chain is like steering a ship through uncharted waters. The journey is full of challenges, from sourcing materials to securing a partnership that scales with your business—any one of which could “crash the line.”
Proper Funding Speeds Innovation—But Only If You Can Get It
Taking a medical device from a ground-breaking idea to a tangible product is a journey fraught with challenges — not least securing the necessary funding.
When Does Small-Batch MedTech Manufacturing Make Sense?
For several reasons, small-batch manufacturing in the medical device industry is gaining traction as an approach that can both cut costs and power market adoption.
Mastering Risk Management in Medical Devices
In this blog, we demystify risk management by exploring the five crucial steps to make it more comprehensible and manageable so you can confidently bring your device to market.
Future-Proofing the Healthcare Industry
Innovative medical technologies are reshaping healthcare at a remarkable pace, but keeping up with these changes can feel like an uphill battle. This article will help you navigate this dynamic landscape and stay informed about what to watch for in the future. We explore the latest MedTech trends, including early diagnostics, robotics, AI, and SaMD, so that you can stay ahead of the curve.
Verification and Validation in Medical Device Development: Getting It Right
In medical device innovation, one topic separates the game-changers from the wannabes: Verification and Validation (V&V). If you're not yet familiar with V&V, you're in the right place. This article will provide a comprehensive understanding of V&V, its importance in the medical device industry, and essential best practices for successful implementation. So, let's explore the world of V&V and its vital role in crafting top-tier medical devices.
The Game-Changing Power of AI in MedTech Design: Trends, Challenges, and Opportunities
Bringing a medical device to market can be an intricate and lengthy process made up of multiple stages, from ideation to commercialization. In this delicate dance of innovation and compliance, navigating each obstacle works to refine the device itself. But that doesn’t mean that each step is free of headaches. We’ll look at 4 common challenges that engineers face on the road to market approval.
4 Routine Roadblocks in Achieving Market Approval
Bringing a medical device to market can be an intricate and lengthy process made up of multiple stages, from ideation to commercialization. In this delicate dance of innovation and compliance, navigating each obstacle works to refine the device itself. But that doesn’t mean that each step is free of headaches. We’ll look at 4 common challenges that engineers face on the road to market approval.
Tips for Engaging with Stakeholders
Building strong relationships with stakeholders is vital for success. Let’s think through effective strategies for collaborating with healthcare providers, clinicians, regulatory bodies, reimbursement agencies, and potential investors. We need to leverage these connections to gain valuable insights, secure funding, and build credibility for your medical device.
Tips for Addressing the Regulatory Pathway
Regulatory compliance is a fundamental aspect of medical device development. Let’s discuss the regulatory landscape, including FDA requirements and international standards.
Tips for Identifying Unmet Needs In The Medical Device Market
One of the most critical steps in developing a successful medical device is identifying unmet needs within the a given procedure or market. We'll discuss techniques to conduct thorough market research, analyze existing solutions, and engage with healthcare professionals and potential end-users.
Tips for Along your Design Path
A well-defined product development plan is essential for managing timelines, resources, and risks effectively. We will briefly cover some of the key elements of a comprehensive plan, including setting clear objectives, establishing design controls, managing intellectual property, and implementing quality management systems.
Design Outputs
Congratulations. You’ve successfully navigated the pitfalls of the previous design control phases. You’ve now reached the Design Outputs phase. This means you’re ready to consider Design Inputs from all the stakeholders and implement your design into tangible outputs, using appropriate documentation. Read on to avoid major pitfalls during this phase.
Design Process
Starting the Design Process can be a bit daunting, especially for Med Device Startups, who have limited time, resources, and expertise—and are therefore concerned about ensuring design details are addressed correctly the first time.
Design Inputs
We continue our series on common FDA Design Control pitfalls.
In this post, we discuss Design Inputs.
User Needs
As you continue your 2020 product development activities, we wanted to provide our thoughts on some of the most-common pitfalls our staff has seen, broken down by phase of the Design Control process. Over the next few weeks, we will provide our rationale and some simple mitigation for each.
We start first with User Needs.
The Five Greatest FDA Myths
I recently had the pleasure of sitting down with Monir El Azzouzi of Easy Medical Device, about the Five Greatest FDA Myths, to which we find startup companies often (mistakenly) subscribe.