“Do your research, understand the principles, the anatomic principles, the materials. Understand the history of that material with the FDA. Understand the regulatory pathway. Ask!”
Will a pre-submission meeting with the FDA speed up or delay your 510(k) approval process? Can companies redefine how some devices are regulated? Glen shares his perspective of the FDA regulatory process from his experiences of working in the FDA versus working in the industry. He identifies trends and observations of how technology has evolved and provides advice to companies entering the med-tech industry.
Mr. Stiegman manages and directs the clinical and regulatory affairs departments for MCRA and its clients. Mr. Steigman is responsible for the management of approximately 45 clinical and regulatory professionals at MCRA. He leads the firm’s submission process, regulatory strategy, analysis, and development: from pre-clinical testing, to FDA submission, to market approval and post commercialization. He also oversees the planning and execution of the clinical studies managed by MCRA’s Clinical Research Organization.
Prior to joining MCRA in February 2006, Mr. Steigman served as the Chief of the Orthopedic Devices Branch for US Food and Drug Administration. As Branch Chief, Mr. Steigman managed a team of scientists, clinicians, and engineers in the regulation of all Orthopedic devices marketed in the United States.
“a huge component of the future in innovation in medical technology is the diagnosis. Human-like diagnosis. A lot of the data gathering appliances. Whether it’s a watch, whether it’s a patch, whether it’s a belt. They are coming out with all sorts of biometric wearables that are gathering data for the patient, for the physician.”
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Today’s Podcast Topics:
- What are some recent trends/observation regarding regulatory affairs and clinical strategies observed by Mr. Stiegman?
- Should an early start-up (Med Tech) consider a pre-submission meeting?
- When should a Med Tech start-up begin communicating its regulatory strategy with the FDA?
- Smartwatch technologies offering human-like diagnosis … will they pursue FDA De Novo pathway?
- Mr. Steigman provides prospective on the once Europe first strategy for Med Tech with new MDR 2020.
- Finally, Mr. Steigman’s perspective to people who are newly entering the Med Tech Industry.
Links and Resources Mentioned in this Podcast:
- Website: www.MCRA.com
- Email: gstiegman@mcra.com
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