Do You Have What It Takes To Be An MDEA Winner?

The MDEA competition accepts entries worldwide from companies and individuals involved in the design, engineering, manufacture, or distribution of finished medical devices. The MDEA competition is open to finished medical devices, including instruments, machines, implants, in vitro reagents, mobile medical applications, or other related products that are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease or other conditions in humans or animals. Product components by themselves are not eligible.

Entries Are Accepted In 11 Product Categories:

1. Cardiovascular Devices—devices and equipment used to diagnose or treat conditions of the heart and circulatory system

2. Digital Health Products and Mobile Medical Apps—devices or applications that use digital technologies to monitor patients, deliver healthcare, or make medicine more personalized

3. Drug-Delivery and Combination Products—devices such as pre-filled syringes, misting devices, dry powder inhalers, patches, pouches, or combination implants with biologic agents, etc.

4. ER and OR Tools, Equipment, and Supplies—devices such as critical care, general surgery, plastic surgery, and anesthesiology products

5. Gastrointestinal and Genitourinary Devices—products such as gastrological, urological, gynecological, and obstetric devices

6. Implant and Tissue-Replacement Products—devices such as cochlear, corneal, orthopedic, neurological, and tissue implants and instruments

7. Nonsurgical Hospital Supplies and Equipment—products such as general medical equipment and supplies used in hospitals and doctor's offices, such as stethoscopes, blood lancets, medical carts, ventilators, hospital beds, blood pressure monitors, etc.

8. Over-the-Counter and Self-Care Devices—devices that can be purchased without a prescription or that allow patients to monitor, treat, or help prevent a health condition without assistance from a clinician or other healthcare professional

9. Radiological, Imaging, and Electromechanical Devices—devices that use medical radiation, imaging, or an electromechanically powered system to diagnose or treat diseases

10. Rehabilitation and Assistive-Technology Products—products such as wheelchairs, walkers, crutches, hearing aids, prosthetic devices, etc.

11. Testing and Diagnostic Products and Systems—products that fall into FDA categories of chemistry, hematology, immunology, microbiology, pathology, and toxicology

Entries can be submitted by the product’s manufacturer of record or by suppliers that provide materials, components, or services with the manufacturer's written consent.
To be eligible for entry in the MDEA competition, products must be commercially available (able to be ordered or purchased) by December 31 in the year prior to the competition.

Additional Eligibility Requirements Are As Follows:

Products commercially available in any country are eligible. Eligible products must meet FDA’s definition of a medical device. Products previously entered but not selected as finalists or award winners may be entered again. Products previously selected as finalists or award winners may not be entered again unless significant design or engineering changes have been made to the product. Entries are not accepted from jurors, their companies, or those companies’ subsidiaries in the year they act as jurors. Any product thus disqualified may be entered in a subsequent year. Entries are accepted from sponsoring organizations, but our independent jurors are not made aware of sponsorships until after finalists and winners have been selected. All entrants must fill out the official MDEA entry form via our online submission portal and pay the entry fee(s) by the specified deadline in order to be entered in the competition.