If you are an entrepreneur with a vascular or neuro medical device idea, services that may be of interest to entrepreneurs include helping to determine the FDA oversight for their emerging technologies in the neuro space, identifying the regulatory pathways for your device, and best practices for contacting the FOOD and Drug Administration (FDA). The JI’s goal is to help get safe and effective medical devices to patients SOONER, and the goal of the Office of Regulatory Services is to reduce risk and identify an effective pathway forward to bring your devices to the marketplace.
If you’re a startup with a medical device in the prototyping stage, the best first steps include initiating contact with the FDA early – if you think it’s too early to contact the agency that’s the BEST time to initiate contact. Early engagement with FDA can help you gain a better understanding of the regulatory landscape and requirements to get your medical product to the market and, ultimately, to patients.
The JI is here to help.
It can be a challenge to identify objectives in the research, development, and marketing of a medical device. We help you understand what steps to take in order to move your medical device to market, answering questions like — How does the regulatory process work? What challenges might arise? What are the best practices when submitting an application? How can we best navigate the process?
With deep knowledge of the various offices and divisions within the FDA, we can help you determine a high-level strategy for moving your device to the U.S. marketplace.
If you are working with the FDA for the first time — whether you are new to the medical device world or new to the U.S. regulatory process — we can help determine the appropriate pathway for your device or drug-device combination product (e.g., Pre-Market Approval, 510K, DeNovo, or Humanitarian Device Exemption).
We take the guesswork out of whom to contact at the FDA, helping you establish contact with the right people to answer your questions and facilitate the process.
When developing novel technologies, the identification of challenges as well as potential paths forward in bringing a medical device to market are extremely important. We assess the uncertainty you may face when moving from idea to reality via a clinical study and help to identify solutions to mitigate those risks and facilitate regulatory engagement.
We will evaluate your strategy for submitting to the FDA, as well as your submission, while considering the type of device technology and your stage or status in the submission process.
Let us review what you have submitted to the FDA, to help you anticipate regulatory feedback and potential challenges.
In addition to identifying potential challenges with bringing your ideas to reality, we propose solutions that enable a path forward. We can identify potential solutions and provide you with trusted partners along the way.
We are here to help streamline the FDA application process and increase the probability of success in reaching the U.S. marketplace.
We assist in the groundwork before submitting to the FDA and supporting agency engagement over the total product life cycle of the medical device. We can focus your engagement with the FDA, whether we assist in pre-submission or in helping prepare your final submission.
We can help build an outline for your submission and assist with the development of your regulatory strategy.
If you haven’t submitted to the FDA before, we can help every step of the way, introduce you to the process, identify the appropriate contacts, and support your idea to reality.
The Jacobs Institute is focused on accelerating the research, design, development and manufacture of innovative high-quality, clinically relevant engineering solutions and products to impact the treatment of vascular, neurological, and related diseases.
We are registered to ISO 13495:2016 by SRI Quality System Registrar. Learn more about our quality management system
Get to Know Our Regulatory Process
Carlos Peña, PhD, MS, is Chief Regulatory Officer and Chief Quality Officer, leading the newly-established Offices of Regulatory Services and Office of Quality Services at the Jacobs Institute. Carlos served 20+ years as a public servant in federal government. Prior to the JI, Carlos served as the Director of the...
The JI is proud of its strong ties with its medical industry partners. Through these collaborations, we are able to provide excellence in medical device innovation, training, and educational programs.