Biomedical Engineering Design Strategies Exam Review

These flashcards cover key concepts and questions from the lecture notes on Design Strategies for Biomedical Engineering, helping students to effectively review and prepare for their final exam.

What is the main purpose of design verification in medical device development?

To confirm that design outputs meet the defined inputs.

True or False: Verification and validation accomplish the same goals during medical device development.

True.

What are the primary purposes of verification and validation?

Verification is to show conformity to specific design requirements, and validation is to establish that the developed device meets user needs.

What activity reflects a design thinking approach to evaluating a new medical device concept?

Conducting a user-needs discovery that defines the problem, evaluates existing alternatives, and includes a preliminary risk/benefit and viability assessment.

Which of the following is NOT one of the Nine Parts of Design Controls?

Transfer.

What is the most accurate statement about biocompatibility evaluation?

Biological evaluation must occur within an ISO 14971 risk-management process.

True or False: If a device ‘passes’ ISO 10993 testing, you can claim its materials are biocompatible for any intended use.

False.

Which step of the waterfall design process doesn’t require review?

All of them require review.

What does ‘fully loaded’ testing in the verification process entail?

Testing a device together with its packaging, accessories, and final components.

Which international standard highlights the importance of beginning the verification process early in the design process?

ISO 13485.

How is design verification correctly defined?

Confirming that design outputs meet the established design input requirements.

What assessment is needed to determine whether to move forward with a medical device after the initialization phase?

A feasibility assessment to evaluate whether current technology and resources can realistically support the proposed device.

What does design control in the Quality System Regulation do?

It oversees and documents the full design and development process to ensure the device is manufactured according to defined requirements.

What is the primary purpose of the FDA’s Quality System Regulation (QSR)?

To establish, maintain, and document a consistent design control and quality management process for device development.

True or False: The medical device development process is finished once a medical device completes its design control activities.

False.

What factor did the ACA shift in medical device reimbursement?

From procedure-based payment to outcome-based payment.

True or False: It is extremely expensive to bring a design concept into the market.

True.

What mindset shift must teams make during the reimbursement approval stage beyond 'FDA cleared'?

Recognize that FDA evaluates safety and efficacy, while CMS evaluates comparative benefit against the current standard of care.

Early planning to capture data desired by stakeholders is called what?

Value-differentiated Product.

True or False: Economic and procedural claims are becoming less important than clinical claims when marketing medical devices.

True.

What effect does developing a value-differentiated product have?

It becomes more challenging to generate clinical evidence because additional expectations must be supported.

What are other factors that can move a product from low value to high value? (Select all that apply.)

It lowers the overall cost of care, reduces rehospitalization rates, improves the quality of life, and enhances clinicians' workflow efficiency.

True or False: Reimbursement is often one of the first elements a company will consider when developing a product.

True.

What is the benefit of Agile Product Development for medical devices?

It shortens overall development time by enabling faster cycles of testing and refinement.

True or False: It is often challenging for companies to achieve both FDA clearance and CMS coverage for a medical device.

True.

What are Class II studies of medical devices and why are they valuable?

They are structured surveys that collect user feedback to incorporate into design.

How should teams address funding challenges from a design thinking perspective?

Balance design across desirability, feasibility, and viability to ensure the concept is valuable and fundable.

True or False: Government healthcare agencies define the value of a device in terms of national health outcomes and cost efficiency.

True.

Which major US legislative act introduced formal design controls into medical device regulation?

Medical Device Amendments of 1976.

What type of regulatory approval is necessary for a Class III medical device?

Premarket Approval.

Which class of devices is completely exempt from 510(k) pre-market notification?

Class I.

What is the main purpose of ISO 14971 in biomaterial development?

To guide biological risk assessment.

True or False: All medical device manufacturers in the U.S. are required to obtain a facility license from the FDA.

True.

For U.S. premarket clearance, which statement is accurate?

The De Novo pathway provides an option for low- to moderate-risk devices without a valid predicate.

Who is credited for galvanizing action in the 1970s for control over medical device safety?

Dalkon Shield.

What purpose does MAF hold in the FDA regulatory process?

It allows confidential submission of proprietary material information directly to the FDA.

True or False: An ISO 13485 certificate grants a U.S. company FDA approval for marketing medical devices.

False.

True or False: It is solely the responsibility of the manufacturer to identify changes in products or services from other vendors.

True.

True or False: Post-market surveillance is crucial in medical device regulation.

True.

Why is early stakeholder engagement likely critical in medical device development?

It helps align product design with diverse stakeholder needs.

Which U.S. law first gave the FDA explicit oversight of new devices entering the market?

Federal Food, Drug, and Cosmetic Act of 1938.

Why was FDA’s NEST created?

To systematically gather real-world evidence from hospitals to strengthen post-market evaluation.

Under FDA regulation, which process establishes a device's substantial equivalence to a marketed product?

Premarket Notification (510(k)).

True or False: Startups in the U.S. not targeting international markets are best advised to focus initially on ISO 13485 compliance.

False.

True or False: Good manufacturing practice guarantees the success of products.

False.

True or False: Overly narrow or overly broad standards can be problematic in biomaterial development.

True.

What is the purpose of applying standards like ISO 10993-1 to tissue-engineered medical devices?

To identify relevant biological evaluations based on risks and clinical use.

Which are the two major standard development organizations in the medical materials field?

ASTM International & International Organization for Standardization (ISO).

What do documentary standards consist of?

Written documents providing requirements, guidelines, specifications, and characteristics.

What is meant by a voluntary consensus standard?

A standard developed through collaborative agreement among stakeholders requiring broad approval.

What is NOT described as a reference material?

A sample material intended primarily for design template or prototype use.

True or False: Documentary standards are static documents that rarely need to be revised.

False.

What do regulatory agencies recognize consensus standards for?

To streamline regulatory review by relying on established, validated methods.

Which are risks of not developing standards?

Consumer confidence falters, collaboration struggles, and communication slowdowns with regulators.

Which standard type does Hydroxyapatite not fall under?

Documentary standards.

Which answer is an example of ideation in the SDO process?

All stakeholders meet to explore ideas and discuss potential regulatory approaches.

Which statement is NOT included in the definition of a standard?

The location where a product must be manufactured.

What is the main purpose of reference data?

To compare experimental results with established measurement values.

How do standards assist regulatory submissions for biomaterial-containing devices?

Standards streamline review by providing accepted, well-validated evidence of performance.

True or False: Standards development remains an active process that will influence future research.

True.

True or False: Documentary standards for hydroxyapatite have only been developed by ASTM International.

False.

Which area of law protects manufacturers when a patient misuses a medical device in an unforeseeable way?

Assumption of risk.

True or False: Patents provide exclusivity for 20 years for inventions.

True.

What is the benefit of maintaining a detailed inventor's notebook?

To support patent applications by documenting conception and reduction to practice.

In an employment agreement, what does an ‘assignment of inventions’ clause mean?

The employer owns inventions created in the course of employment.

True or False: Not establishing inventorship early in a collaboration does not create significant issues.

False.

Which describes why biomaterials engineers must understand employment agreements?

They often include post-employment restrictions that can impact future work.

True or False: Ownership of an invention is granted to the party who creates it first.

True.

True or False: Legal issues are only of concern to lawyers; engineers don’t need to understand contracts.

False.

True or False: Verbal disclosures of confidential information are automatically protected under an NDA.

False.

What happens if a freedom-to-operate analysis indicates infringement with no possible work-arounds?

The invention may be abandoned.

True or False: After filing a patent application, the discloser has 30 years before anyone can use the patent.

False.

True or False: Intellectual property protection may conflict with user-centered design.

True.

What legal concept directly supports responsible risk mitigation in medical device design?

Product liability and failure-mode analysis.

Which is NOT a legal concern medical device professionals can expect to encounter?

Government grant taxation.

Which is a likely legal area medical device professionals encounter?

Confidentiality and materials use agreements.

At what point in collaboration is an NDA often signed?

Before substantive discussions occur.

Which categories may be areas of legal concern for medical device professionals?

All the above.

True or False: Beneficence is a principle of the Belmont report establishing that no harm should be done to patients.

True.

Which ethical approach relies on widely agreed-upon moral concepts?

The virtue approach.

Which guidelines govern the use of humans and animals in experimentation?

IRB.

Which set lists the Belmont Report’s three principles?

Respect for Persons, Beneficence, and Justice.

True or False: The Declaration of Helsinki emphasizes independent review before human research proceeds.

True.

What favors decisions leading to equitable benefits and burdens in society?

The Justice Approach.

True or False: Ethical issues are most important before a medical product has passed regulatory approval.

True.

Which is not emphasized by medical ethics?

Clinical Trials.

True or False: Somatic gene editing raises fewer ethical concerns than germline gene editing.

True.

What approach does engineering ethics often take?

All the above.

Which virtue is essential to medical product development?

Compassion.

What ethical decision-making approach best correlates to empathy concerning stakeholders?

Virtue Approach.

What is the importance of the Nuremberg Code?

It provides foundational rules for conducting ethical research on human beings.

How is 'scenius' defined?

A word used to emphasize group intelligence and creativity over individual genius.

True or False: Engineering ethics takes the approach of aspirational ethics.

True.

When rushing biomaterials to market without validating safety, which ethical tension arises?

Safety vs. innovation.

When developers hide material limitations to maintain a competitive edge, which violation occurs?

Lack of transparency.