Medical Technology Management and Strategic Planning

Vocabulary flashcards covering key definitions, regulatory institutions, life cycle phases, evaluation dimensions, and economic analysis methods in Medical Technology Management.

Management (Gestión)

The organized set of actions and processes designed to achieve a specific objective efficiently and effectively through planning, organizing, directing, and controlling resources.

Medical Technology

Any technique, tool, device, apparatus, supply, reagent, software, or system used to prevent, diagnose, monitor, treat, or relieve disease, or to replace a physiological function in human healthcare.

Medical Device

An instrument, apparatus, utensil, machine, software, implantable product, diagnostic agent, or material used in humans for diagnosis, prevention, monitoring, treatment, life support, or anatomical/physiological substitution.

Medical Equipment

A complex set of devices, electromechanical tools, or software used in clinical care that requires patient exploration to provide diagnosis, treatment, or rehabilitation, needing continuous maintenance, calibration, and training.

Health Technology Management (HTM)

A systematic process of planning, evaluating, acquiring, installing, operating, maintaining, and disposing of health technologies to optimize care quality, patient safety, and resource utilization.

Medical Technology Life Cycle

The complete sequence of stages a health technology goes through, from planning and selection, acquisition, installation and commissioning, operation and maintenance, to performance evaluation, retirement, and final disposal.

Request for Proposal (RFP)

A procurement document sent to multiple suppliers asking for comprehensive technical and financial proposals to address complex healthcare operational needs.

Request for Quotation (RFQ)

A simplified procurement document used to request commercial quotes and pricing when equipment technical specifications are already defined and finalized.

Service Level Agreement (SLA)

A contractual commitment specifying quantifiable service standards, including technical response times, resolution times, guaranteed uptime percentage, and preventive maintenance intervals.

Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)

A series of systematic acceptance tests performed during equipment commissioning to verify correct physical installation (IQ), proper functional operation (OQ), and reliable performance according to clinical specifications (PQ).

Food and Drug Administration (FDA)

The United States federal regulatory agency responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, food, and radiation-emitting products.

European Medicines Agency (EMA)

The European Union's decentralized agency responsible for the scientific evaluation, supervision, and safety monitoring of medicines and for participating in conformity assessment processes for medical devices (CE marking).

Secretaría de Salud (SS)

The highest health authority in Mexico, responsible for defining national health policies, issuing Official Mexican Standards (NOMs), and overseeing healthcare programs.

COFEPRIS

The Comisión Federal para la Protección contra Riesgos Sanitarios, an organ of the Mexican Secretaría de Salud that regulates, authorizes, and supervises medical devices, sanitary registrations, imports, pharmacovigilance, and tecnovigilance.

CENETEC

The Centro Nacional de Excelencia Tecnológica en Salud, a Mexican institution providing evidence-based information for health technology management, decision-making, and high-technology equipment evaluation.

Dictamen de Validación de Equipo Médico

A planning instrument developed by CENETEC to promote proper clinical use and efficient resource allocation for medical equipment included in Mexico's Compendio Nacional de Insumos para la Salud (CNIS).

Certificado de Necesidad de Equipo Médico

A decision-support planning tool developed by CENETEC to evaluate capital investments in high-technology medical equipment based on technical, demographic, epidemiological, and coverage criteria.

CENAM

The Centro Nacional de Metrología, Mexico's national metrology institute responsible for measurement standards, calibration reference, and metrological traceability.

CNSNS

The Comisión Nacional de Seguridad Nuclear y Salvaguardias, a Mexican regulatory body under SENER overseeing nuclear safety, radiological protection, and ionizing radiation equipment.

ISO 13485

An international quality management system standard specific to the design, manufacture, installation, and servicing of medical devices.

ISO 14971

The international standard specifying the application of risk management principles to medical devices throughout their entire life cycle.

IEC 60601

A technical standard series governing the electrical safety and essential performance requirements for electromedical equipment.

NOM-241-SSA1-2025

The Official Mexican Standard establishing minimum good manufacturing practices (GMP) for the design, development, production, storage, and distribution of medical devices.

NOM-137-SSA1-2008

The Official Mexican Standard establishing minimum labeling requirements for domestic or imported medical devices commercialized in Mexico.

Health Technology Assessment (HTA / ETS)

A multidisciplinary, systematic process that evaluates the technical, clinical, economic, organizational, social, and ethical implications of adopting and using a health technology.

Technical Evaluation in HTA

An HTA evaluation type focused on verifying design, manufacturing quality, functionality, electrical safety, reliability, precision, and physical/technological infrastructure compatibility.

Clinical Evaluation in HTA

An HTA evaluation type assessing the clinical performance, efficacy, safety, usability, alarm accessibility, and user satisfaction of a health technology during patient care.

Economic Evaluation in HTA

An HTA evaluation type comparing the financial costs of acquiring, operating, and maintaining a medical technology against its expected clinical benefits.

Social Evaluation in HTA

An HTA evaluation type analyzing the cultural acceptance, equitable access, public perception, and broad social impacts of implementing a medical technology.

Organizational Evaluation in HTA

An HTA evaluation type examining how a new technology impacts hospital infrastructure, patient workflows, departmental staffing, and operational management.

Ethical Evaluation in HTA

An HTA evaluation type addressing moral principles such as autonomy, beneficence, non-maleficence, justice, informed consent, patient privacy, and equitable distribution of health resources.

Budget Impact Analysis (BIA / AIP)

An economic evaluation method measuring the financial variation caused by adopting a health device on a healthcare budget, calculated using the Budget Variation Rate \text{TVP} = \begin{pmatrix} \frac{P_2}{P_1} - 1 \text{}\begin{pmatrix} \times 100 where \text{TVP} \begin{pmatrix} 10\begin{pmatrix} is considered viable.

Cost-Effectiveness Analysis (CEA / ACE)

An economic evaluation comparing healthcare options by expressing costs in monetary units and clinical outcomes in natural health units, using the Incremental Cost-Effectiveness Ratio $\text{RCEI} = \frac{C_1 - C_2}{E_1 - E_2}$.

Cost-Minimization Analysis (CMA / AMC)

A partial economic evaluation comparing health technologies with established, equivalent clinical effectiveness to identify the least expensive alternative.

Cost-Benefit Analysis (CBA / ACB)

An economic optimization method where both health benefits and costs are quantified in monetary units to evaluate financial profitability via the Benefit-Cost Ratio $\text{RCB} = \frac{B_1 - B_2}{C_1 - C_2}$.

Cost-Utility Analysis (CUA / ACU)

An economic evaluation comparing monetary costs against patient-centered health utility metrics, such as Quality-Adjusted Life Years ($\text{QALYs}$ / $\text{AVAC}$), expressed as $\text{RCUI} = \frac{C_1 - C_2}{U_1 - U_2}$.

Quality-Adjusted Life Year (QALY / AVAC)

A standard health utility metric combining both the quantity (number of life years gained) and the quality of life experienced as a result of a health intervention.

SOMIB

The Sociedad Mexicana de Ingeniería Biomédica, the leading professional association in Mexico dedicated to promoting biomedical engineering research, education, and professional development.

IEEE Engineering in Medicine and Biology Society (IEEE-EMBS)

The world's largest international organization of biomedical engineers, focusing on applying engineering principles and technology to biology, medicine, and healthcare.