INNOVATION THAT MAKES SENSE
Brainstorm ideas that that are incrementally or fundamentally innovative that solve a specific clinical goal with simple and easy to manufacture engineering principles.
Design and develop the idea following well-established iterative principles. Start with customer needs to develop design inputs, and use FMEA or other risk analysis tools to iterate the design.
Verification and Validation
Create testing protocols for bench testing, animal testing, and clinical testing to verify the design and validate its clinical use.
Regulatory / IP Submisisons
Create and respond to FDA 510(k), EU, and Health Canada submissions, as well as the rest of the world. Create value by filing design and process patents.
Marketing and Sales
Create a well-formed marketing strategy using word-of-mouth, clinical studies, conferences, publications, and medical leaders. A great idea doesn't sell itself - focus the sales strategy for greater success.
Clinical / Technical Services:
- Research and Development (R&D)
- Intellectual property (IP), Patents
- Clinical Study Design, Data Analysis
- Preclinical Study Design, Data Analysis
- In Vitro Models
- In Vivo Models
- Data and Statistics, Bayesian and Frequentist
- Medical Writing, White Papers, Publications
- IDE, 510(k), PMA, ANDA, NDA
- Liaison with FDA
Mahmood has over 10+ years in medical device design and development, along with a medical degree. Mahmood can deliver presentations and tutorials for your employees, customers, engineers, sales staff, or management on medical topics relevant to your company and aimed at the appropriate audience.
- Anatomy, Physiology, and Pathology of Desired Application Area
- Medical Device Design for Young Engineers
- Basic Medical Sciences for Engineers