Biomedical Engineering Design Quiz

Biomedical Engineering Design I - BME 251

• The BME design process includes: Design Team Development & Planning, Project Statement, Specification, Solution Concepts & Selection, Detailed Design & Prototype, Validation and Verification Testing, Standards, Regulation & Ethics, Commercialization & Post-Market Surveillance.
• The lecture was delivered by Dr. Daniel Akwei Addo.
• The course covered Biomedical Engineering Design, Medical Device Determination, and Medical Device Classification.
• One learning objective was identifying elements determining a product's qualification as a medical device.
• Another learning objective was classifying medical devices.
• A third learning objective was describing how the stage-gate model, engineering design process, and spiral model affect medical device design decisions.

What is Biomedical Engineering Design?

• Biomedical engineers systematically develop solutions addressing healthcare challenges.
• The process combines engineering principles, biological and medical knowledge, and creativity to design devices, systems, or processes improving patient care, diagnosis, and treatment.
• In essence, the role of biomedical engineers is designing medical devices.

Is My Product a Medical Device?

• A medical device is defined by the World Health Organization (WHO) as any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material, or related article, intended by the manufacturer to be used for a medical purpose.
• The U.S. Food and Drug Administration (FDA) defines a medical device as an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or related article (including components) used in the diagnosis, cure, mitigation, treatment, or prevention of disease, or in the alteration of structure or any function of the human body, that doesn't rely on chemical action within or on the body for primary function.
• Factors determining if a product is a medical device include the intended use, and function of the device.
• Clearly describing the general purpose or function of the product,
• Describing the disease condition, and whether the device will diagnose, cure, mitigate, treat or prevent a condition.
• Identifying the intended patient population.

Special Considerations for Product Classification

• In Vitro Diagnostics (IVDs): These include reagents, instruments, and systems for diagnosing diseases, such as home pregnancy tests and glucose test strips. These devices typically involve collecting, preparing, and examining specimens from the human body, either in a laboratory setting or at home.
• Radiation Emitting Products: These are electronic products containing electronic circuitry that emit electronic radiation. The majority of radiation-emitting products are not considered medical devices, although some may qualify if used with medical applications and claims.
• Mobile Medical Applications (SaMDs): Software intended for one or more medical purposes, such as viewing MRI images from a smartphone.
• General Wellness Products: Products intended for general wellness use and present a very low risk to users. These generally do not perform functions categorized as medical in nature. Examples include fitness trackers and apps.

Medical Device Classification

• Medical devices are classified based on risk.
• The higher the risks, the higher the class.
• Class I devices involve low risk. They require general controls, and most examples are 510(k) exempt.
• Class II devices present a higher risk than Class I and require both general and special controls (510k).
• Class III devices present the highest risk and require a pre-market approval (PMA) process.
• General controls include provisions for adulteration, misbranding, device registration and listing, and banned devices.
• Special controls (510k) have specific sections required for submission.

Medical Device Regulation, De Novo Classification

• For medical devices not in the FDA database, the FDA classifies them under Class III.
• The de novo classification, introduced in 1997, allows for new devices with low risk to be classified under class I or II.
• The de novo classification process requires general and special controls.

### Medical Device Definition Questions.

• Is the device intended to diagnose, cure, mitigate, treat or prevent disease?
• Is it intended to affect human body structure or function?
• Does it achieve its intended purpose through chemical action or metabolism?
• Based on the answers to these, the product can be determined to be a medical device of a certain class.

Existing Product Classification.

• To determine if an existing product classification exists, use resources like the FDA's product classification database accessed at: https://www.accessdata.fda.gov/