What is state-of-the-art in medical devices?
The term “state of the art” is widely used to refer to the highest level of development, achievement, or progress in a particular field.
However, the definition of state-of-the-art in the context of medical devices is different. State-of-the-art is the current knowledge or good practice acceptable in the medical devices industry.
The term state-of-the-art may be used in two different contexts in medical device innovation:
- State-of-the-art (SotA) evaluations: The current knowledge and good practices acceptable for a particular medical device (the subject of this article). This may also be called a SotA assessment.
- State-of-the-art standards: The current standards apply to a medical device development or management process. For example, the state-of-the-art for medical device Quality Management Systems (QMS) is ISO 13485:2016. This is the international standard for establishing and maintaining a QMS for economic operators in the medical device sector.
This article focuses on SotA evaluations or assessments as they apply to medical device innovation.
What are state-of-the-art evaluations
SotA evaluations use systematic approaches to identify evidence from existing data sources on current, generally accepted clinical practices to determine if a new product’s risks are outweighed by its benefits.
The SotA evaluation is the clinical landscape for a medical device. It provides the clinical context for a new product. All health technologies are assessed against the current state-of-the-art to determine whether the risks they pose are outweighed by their benefits. This information is used to support regulatory submissions and commercial decision-making.
State-of-the-art evaluations should identify existing solutions used to meet a medical need. Existing solutions typically belong to three main groups:
- Predicate devices: A predicate device is an existing legally marketed device that serves as a point of comparison for a new device seeking approval. It is substantially equivalent to a new device in terms of technology, safety, performance, and intended use.
- Devices in development: These devices are future medical products not yet available on the market. They can be future predicate devices or alternative technologies.
- Alternative technologies: Technologies, processes or procedures that achieve the same medical need through a different technology.
This information is useful in providing context to the development of medical devices. Regulatory authorities and payers evaluate the benefits and risks of new technologies in the context of the current state-of-the-art. Accurately identifying existing solutions will help to:
- Define design controls for the device, including design inputs and verification and validation activities.
- Highlight existing and emerging competitors (including alternative technologies) to inform commercial strategy.
- Identify potential predicate devices for regulatory submissions
Understanding patient demographics and epidemiology helps manufacturers identify target markets and assess market size and demand. It can be tempting to focus on the general population when designing a medical device to get the largest total addressable market size, but it is important to consider specific patient populations that may have unique needs or characteristics.
A medical device’s effectiveness may vary across different patient populations. Age, gender, ethnicity, comorbidities, and disease severity can impact device performance and clinical outcomes. Specific patient populations may have unique anatomical, physiological, and clinical characteristics that influence the design and functionality of medical devices. Some populations may be more vulnerable to adverse events or complications associated with device use. Understanding the makeup of the patient population can help manufacturers plan design and development activities, particularly clinical investigations and post-market surveillance activities to ensure the device’s safety and effectiveness across patient populations.
By addressing diverse patient populations’ specific needs and preferences, innovators can improve market acceptance and adoption of their products by developing marketing strategies that resonate with the intended user base.
Clinical guidelines are pivotal in healthcare practice. They provide evidence-based recommendations and standards of care, guiding clinical decision-making and optimising patient outcomes. These guidelines, rooted in scientific evidence, expert consensus, and best practices, offer healthcare professionals a framework for delivering safe, effective, and patient-centred care across diverse medical specialities and clinical scenarios.
Multiple clinical guidelines often cover a single disease, each focusing on a specific part of the care continuum, such as diagnosis, treatment, prevention, or monitoring. Medical device innovators can use current and historical clinical guidelines to understand established clinical workflows in different settings and predict how their innovation would affect current best practices.
Applications for SotA evaluations
Early-stage research and feasibility:
State-of-the-art evaluations can help identify evidence related to technological development aspects such as clinical, performance or safety. To uncover gaps in current knowledge, identifying areas where further research or development is needed to improve the device. For example, a review of the medical literature can identify the clinical performance of existing devices, including their strengths and weaknesses.
They summarise data on how well the device performs in clinical settings, including its ability to achieve the intended medical outcomes compared to existing alternatives. Reviews of existing evidence can identify key performance indicators, such as accuracy, sensitivity, specificity, and usability, offering insights into how existing devices function in real-world conditions. Medical literature reviews can also extract safety and performance endpoints for designing clinical investigation strategies.
State-of-the-art evaluations are useful in risk management. They can identify probable complications or hazards that can inform risk assessment. They collect data on adverse events, complications, and long-term safety outcomes, helping to assess the device’s risk-benefit profile.
Regulatory submissions:
Background: The clinical context of a medical device must be described in regulatory technical documentation. The SotA analysis supports justification of the patient population, clinical setting, technology choice, within the context of the intended use and indications. This information also includes an estimate of the number of devices sold per year. This number is used to calculate the risk associated with the device, which is a key component of the risk management process.
Risk assessment: SotA evaluations are used to identify the risks associated with a device and to determine whether those risks are acceptable in the context of current clinical practice. This information is used to support risk management activities and to demonstrate that the device’s benefits outweigh its risks.
Clinical Evaluation: State-of-the-art evaluation is a required component of Clinical Evaluations (CEs) under EU regulations and current guidance. Most national regulators require a detailed analysis of the state-of-the-art, although it is not always called a clinical evaluation. It summarises accepted clincial practices and evidence supporting the risk/benefit profile for the device’s intended purpose. This analysis enables manufacturers and regulators to assess the device, including whether its benefits and risks are acceptable relative to current best practice.
Reimbursement and pricing negotiations:
Health Technology Assessments (HTA) as they provide the clinical context for technology adoption.
Best practice for SotA evaluations
- Starting SotA activities early in development is good practice as this knowledge provides a solid foundation for ideation, conception and early-stage research. Reviews can uncover gaps in current knowledge, identifying areas where further research or development is needed to improve the device.
- Use industry best practices. Systematic Literature Reviews (SLRs) or an abridged review protocol will help collect the evidence systematically, reducing bias. Use reputable data sources.
- Identify all stakeholder requirements for SotA early so that processes can be designed around those requirements. For example, publishing a SotA evaluation as a systematic literature review in a peer-reviewed scientific journal for marketing purposes requires a protocol similar to the Cochrane Handbook. However, a review that forms part of the clinical evaluation report (CER) for a regulatory submission to a notified body does not.
Resources
Medical Devices Regulation (MDR) 2017/745:
- Chapter VI clinical evaluation and clinical investigations, Article 61 Clinical evaluation and Part A of Annex XIV.
*Benefit-Risk Analysis: The comparison of a medical device’s benefits to its associated risks, often used in regulatory decision-making.
Clinical Context: The specific medical conditions, patient populations, and healthcare settings in which a device is intended to be used, influencing its design, functionality, and regulatory requirements.
Clinical Evaluation: A methodologically sound ongoing procedure to collect, appraise, and analyse clinical data about a medical device and to verify its safety and performance, including its clinical benefits. Also see Clinical Investigation.
Clinical Guideline: A systematically developed statement to assist healthcare practitioners and patients in making decisions about appropriate healthcare for specific clinical circumstances.
Conception The initial phase of product development, during which an idea is generated and conceptualised into a feasible product design, considering market needs, technical feasibility, potential benefits, and risks.
Equivalency: Demonstrating that a new device is as safe and effective as an already marketed device by comparing its technical and functional characteristics.
Healthcare Professional: An individual trained and licensed to provide medical care, treatment, and advice to patients, encompassing a range of roles such as physicians, nurses, pharmacists, and allied health professionals.
Ideation: The creative process of generating, developing, and communicating new ideas.
ISO 13485: An international standard that specifies requirements for a quality management system (QMS) specific to the medical devices industry.
Manufacturer: A legal entity that designs, produces, assembles, or labels a medical device with the intention of placing it on the market.
Medical Device: An instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material, or other similar or related article intended for diagnosis, prevention, monitoring, treatment, or alleviation of disease. Each regulatory authority has a formal definition of a medical device, which should be referred to for regulatory compliance.
Payer: An entity or organisation, such as an insurance company or government agency, responsible for reimbursing or funding healthcare expenses related to using health technologies.
Post-Market Surveillance (PMS): The proactive collection and review of experiences and data related to a device after it has been released onto the market to ensure continued safety and performance.
Predicate Device: An existing on-market device that provides a basis for comparison or reference in demonstrating substantial equivalence for regulatory purposes.
Quality Management System (QMS): A formalised system that documents the structure, responsibilities, and procedures required to achieve effective quality management.
Regulation: The rules, laws, standards, and requirements set by regulatory authorities to ensure the safety, efficacy, and quality of devices intended for medical use.
Regulatory Authority: An official body overseeing and enforcing laws, regulations, and standards within a specific industry or sector to ensure compliance and protect public interests. Also known as a Regulatory Authority. Also see Competent Authority and Notified Body.
Regulatory Submission: The formal process of submitting documentation and data to regulatory authorities for review and approval to market or sell the device within a specific jurisdiction.
Reimbursement: The process of receiving payment from insurers, government health programs, or healthcare facilities for the use of medical devices in patient care.
Risk Management (RM): The systematic application of management policies, procedures, and practices to the tasks of analysing, evaluating, controlling, and monitoring risk.
Standard: A document that provides guidance, requirements, or specifications established by regulatory bodies, industry organisations, or international consensus groups.
State-of-the-art (SotA): The current knowledge or good practice acceptable in the medical devices industry.
Systematic Review: A structured and comprehensive synthesis of research studies that aims to identify, select, assess, and summarise the findings of all relevant individual studies on a particular topic.
Technical Documentation: All documents that demonstrate the design, manufacture, and performance of the device, essential for ensuring compliance with regulatory requirements. This is also known as the Technical File.
User Requirements: The requirements and preferences of the intended users, which must be considered and addressed in the device design. Also known as User Needs or Customer Specifications.
