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.

Regulatory compliance is a fundamental aspect of medical device development. Let’s discuss the regulatory landscape, including FDA requirements and international standards.

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.

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.

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.

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.

We continue our series on common FDA Design Control pitfalls.

In this post, we discuss Design Inputs.

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.

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.