Introduction
Ideation is the first stage of the medical device innovation lifecycle. It is a creative phase, where the goal is to identify unmet needs and find innovative solutions to meet those needs. Ideas can originate from many sources, including healthcare professionals, patients, researchers, state-of-the-art (SotA) evaluations, and market analyses.
Identify an unmet need
The first step in ideation is recognising a problem or a gap in the current medical landscape. This is often called an “unmet need” in medical device innovation.
Understanding a disease’s clinical characteristics, natural history, and patient population across the care continuum is critical in identifying and characterising problems or gaps.
The current medical landscape of a disease or condition is developed using information from a range of reputable sources, including:
- Clinical guidelines: Systematically developed recommendations to assist decision-making about appropriate healthcare for specific clinical circumstances.
- Literature: Published, usually peer-reviewed articles describing the current clinical practice, risks and hazards, and economic and social context to unmet medical needs.
- Databases: Demographic, health and epidemiological databases.
- User research: Consulting with healthcare professionals and patients to understand their pain points and areas where solutions fall short.
Identify existing solutions
The next step in ideation is to identify existing solutions that address the unmet 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 safety, performance, and intended use.
- Devices in development: These devices are future predicate devices not yet available on the market.
- Alternative technologies: Technologies, processes or procedures that achieve the same medical need through a different technology
Information about existing solutions comes from multiple sources, including scientific literature, patents, medical device databases and market research.
It’s worth investing time in developing a thorough understanding of the disease or medical condition early in development. It improves the likelihood of achieving a good product-market fit. The evidence gathered also forms the basis of state-of-the-art (SotA) evaluations required in formal documentation for regulatory submissions, reimbursement and market access negotiations. Regulatory authorities and payers require a thorough, documented review of the clinical landscape to understand a medical device’s benefits and risks in the context of existing clinical care.
Innovation frameworks
An innovation framework is a structured approach or set of principles and methodologies designed to guide and support the process of generating, developing, and implementing innovative ideas within an organisation. It helps to foster and manage innovation systematically. In the ideation phase, frameworks can help guide brainstorming sessions and generate ideas.
There is no standard innovation framework used in the medical device industry. Organisations can experiment with different frameworks and processes to suit their needs. Common frameworks include:
Evaluation of ideas
Once a pool of ideas is generated, they must be evaluated for their potential and prioritised for further development. An initial evaluation helps narrow the ideas to those with the highest potential. Once a short-list has been considered, those ideas progress to the next lifecycle stage: conception.
Resources
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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.
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.
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.
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.