Innovation is the cornerstone for driving progress in medical and health technologies. It fosters the design of novel solutions to address unmet clinical needs, improve patient care, and optimise healthcare delivery.
However, the medical device innovation landscape evolves continuously, propelled by technological advancements, changing compliance requirements, and shifting market demands.
Bringing a medical device to market is challenging, and the journey can prove unexpectedly complex for novice device innovators.
Medical device development is rarely a solo endeavour. Successful product development is a collaborative journey among multidisciplinary teams, including engineers, clinicians, users, regulatory and quality professionals, market access and marketing and sales specialists.
Medical device innovation is highly process-driven, and the development lifecycle involves multiple stages with interconnected processes. As products transition through the lifecycle, they are subject to new processes, testing, and regulatory requirements. Each lifecycle stage requires multiple iterative processes, with feedback loops to other stages.
Navigating the complex terrain of innovation in medical device development requires systematic frameworks and methodologies tailored to the industry’s unique challenges and constraints. Developing a well-thought-out strategy can alleviate anxiety and ambiguity from the journey while boosting prospects for successfully launching a product.
Early research: Building a business case
The medical device innovation process begins with robust early-stage research to establish a strong business case. This is essential for guiding development and securing stakeholder support. A strong, evidence-based business case attracts funding, optimises resource use, and supports regulatory and payer discussions, accelerating development processes and increasing the likelihood of market success.
Early-stage research identifies unmet clinical needs and assesses the feasibility of potential solutions, laying the foundation for product-market fit. It involves gathering evidence on technical, clinical, economic and regulatory aspects, ensuring proposed products effectively address real-world problems. Early research reveals the competitive landscape, highlights potential risks, and uncovers manufacturing and market access challenges. Key practices for successful early research include systematic, comprehensive evidence gathering that follows best practices and international standards and prioritises reputable data sources.
Ideation
Every medical device starts as an idea.
Ideas for new or improved medical devices or other health technology products can come from almost any source. Patients, relatives, carers and medical professionals have unique insights into unmet needs in the care continuum. Scientists and engineers know of emerging technologies that could apply to health innovations.
Ideation is a structured process that focuses on identifying unmet needs and brainstorming solutions. The goal of ideation is to generate a pool of ideas, each of which must be evaluated for its potential and prioritised for further development. Innovation frameworks support structured ideation, helping generate and evaluate ideas systematically.
Ideation begins with problem identification, which requires understanding a disease, its clinical characteristics, and the current medical landscape [known as the State-of-the-Art (SotA). Existing solutions are identified, including predicate devices, devices in development, and alternative technologies. The initial problem recognition triggers brainstorming sessions, where ideas and concepts for new or improved medical products craft innovative solutions to existing medical problems.
The objective is not just to find easier, cheaper, or more effective ways to address medical challenges but to do so in a way that benefits us all. This goal is shared by all, and it drives us forward in this journey.
Conception.
An initial evaluation narrows down the ideas to those with the highest potential. The best are prioritised for the next lifecycle stage: conception.
Conception, or concept development, involves selecting ideas to expand into detailed, evidence-based product concepts. This stage focuses on defining the product’s intended purpose, features, and functionality at a high level.
The primary output of conception is a draft intended purpose statement, with multiple versions often created for exploration during the research and feasibility phase. Clear, detailed concepts form the foundation for subsequent development activities.
Research and feasibility
The research and feasibility phases refine the draft intended purpose statement and define user requirements (or user needs) and design specifications (or design inputs) for the final product. If multiple concepts were developed earlier, this phase narrows them.
Technology landscaping is a strategic approach to systematically collecting, analysing, and interpreting data on current and emerging technologies within the sector. It is the most important (and cost-effective) tool for medical device innovators. By thoroughly analysing interconnected landscapes, innovators can make well-informed strategic decisions and maintain competitiveness in the fast-evolving medical device market.
Research and feasibility studies aim to assess the product’s technical, clinical, IP, regulatory, market, and economic feasibility. Landscaping is predominantly a desk research activity. However, there may be outstanding questions that can only be answered through technical research (bench studies, in silico studies, or prototyping) and user research. The outputs from early research activities include:
- Feasibility determination (technical, clinical, and financial).
- User requirements for design and development (D&D).
- Design Inputs outlining technical and functional specifications.
- IP management strategy and plan.
- Market access strategy (regulatory strategy, business model development including financing and pricing strategies/models and reimbursement strategy).
- A final business case and plan for the product.
When research and feasibility studies are complete, a formal review determines whether the concept proceeds to design and development (D&D), where formal design controls are applied. If multiple concepts are viable, they can be prioritised, and a technology roadmap created for future product development.
Risk Management
Risk management, guided by ISO 14971, is a systematic process for ensuring the safety and effectiveness of medical devices by identifying, assessing, and mitigating hazards. It usually starts during early-stage research activities and continues throughout the medical device lifecycle. Key steps include risk analysis, evaluation, control and continuous monitoring.
Design and Development
The Design and Development (D&D) phase is a resource-intensive stage of the medical device lifecycle. It transitions the project from creative exploration to formal, regulated processes. Thorough early-stage research helps to ensure a smoother D&D process, although iterative optimisation may still be necessary.
D&D activities are governed by Quality Management System (QMS) standards (e.g., ISO 13485:2016) and design control requirements. Design controls are a systematic process mandated by regulatory authorities to ensure that medical devices are designed to meet user needs, intended purposes, and regulatory requirements. They encompass planning, documenting, reviewing, and verifying each design development stage, from establishing user requirements to design transfer.
The culmination of D&D is a manufacturable product and the generation of technical documentation to support regulatory submissions.
Manufacture
Manufacturing is central to the medical device lifecycle, transforming design specifications into tangible products while meeting quality, regulatory, and cost requirements. Early consideration of manufacturing processes, materials and verification and validation activities helps ensure the final product’s manufacturability, scalability, and cost-effectiveness.
By adopting best practices, leveraging technology, and forming strategic partnerships, manufacturers can optimise processes, strengthen supply chains and ensure product quality and regulatory compliance.
Market Access
Market access ensures medical devices are available to those needing them by addressing regulatory, clinical, economic, marketing, sales and service challenges. It includes:
- Regulatory Submissions: Submitting technical documentation substantiating the clinical and safety benefits and risks to regulatory authorities. Obtaining certifications to market the device legally is a prerequisite for market access but does not guarantee adoption.
- Health Technology Assessment (HTA): HTA is the structured process of evaluating a medical device’s value to inform financing and adoption decisions. HTA assesses clinical and safety benefits and risks, but also evaluates the economic, social, organisational and ethical implications of a medical device product. Payers and healthcare providers use this information to guide the adoption and financing of medical devices.
- Pricing: Developing strategies that balance affordability with profitability while engaging payers and customers to secure payment for medical device products.
- Financing: Exploring different payment mechanisms, including public/private reimbursement, capital expenditure purchases, leasing models, or out-of-pocket purchases.
- Marketing: Building awareness and demand through branding, thought leadership, and outreach to healthcare professionals and patients. It may also involve building awareness with key stakeholders such as payers and the government.
- Sales: Equipping commercial teams with training, tools, and systems to engage customers effectively and drive revenue.
- Service: Providing user training and support, preventative and corrective maintenance and value-added services.
A comprehensive approach to market access integrates regulatory strategy with payer and user engagement to promote adoption. Continuously evaluating and expanding reach into new markets, patient populations, and indications to sustain long-term growth also helps market success.
Post-market activities
Once a medical device product is placed on the market, a range of activities ensue to ensure its continued safety, efficacy, and regulatory compliance. Marketing, sales and service continue as long as a product is available. Regulatory compliance also continues throughout the whole lifecycle. Post-market surveillance is a regulatory requirement that has two components:
- Vigilance: Monitoring for adverse events, customer complaints and quality issues.
- Post-market studies: Proactive clinical and user studies in the real world.
The aim of post-market surveillance is to address any issues that arise in a timely manner and to continuously improve a product based on its performance in the market.
Resources
MedDev Central Academy:
MedDev Central Knowledge Hub:
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.
Conformity Assessment: A process used to determine whether a product, service, system, or entity meets specified standards, regulations, or requirements.
Design Control: A systematic process that ensures a device is designed to meet user needs and intended uses.
Design and Development Plan: A comprehensive document outlining the systematic process and stages, including timelines, responsibilities, and resources, required to bring a medical device from concept to market-ready product, ensuring compliance with regulatory standards.
Design Freeze: The point in the medical device development process where the design is finalised and no further changes are allowed, ensuring a stable basis for validation, regulatory submission, and production.
Design Inputs: The physical and performance requirements of a device that are used as a basis for device design. Also known as Technical Specifications.
Design Outputs: The results of a design effort at each design phase and at the end of the total design effort used to evaluate conformance to design input requirements.
Design Review: A formal evaluation process to assess the completeness, feasibility, and compliance of a device’s design with specified requirements (design inputs).
Design Transfer: The process of transitioning a product’s design from development and manufacturing into production while ensuring all specifications and requirements are met.
Design Verification: The process of ensuring that design outputs meet design inputs.
Design Validation: The process of ensuring that devices conform to defined user needs and intended uses.
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.
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.
Quality Assurance (QA): The systematic activities implemented to ensure that devices consistently meet regulatory requirements and standards while meeting user needs and expectations.
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.
Risk Management (RM): The systematic application of management policies, procedures, and practices to the tasks of analysing, evaluating, controlling, and monitoring risk.
Safety: The condition of being protected from or unlikely to cause danger, risk, or injury.
Standard: A document that provides guidance, requirements, or specifications established by regulatory bodies, industry organisations, or international consensus groups.
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.
Technical Specifications: Detailed descriptions of the requirements, characteristics, and standards that a product, service, or system must meet or adhere to, ensuring clarity and consistency in its design, production, or implementation. Also see Design Inputs.
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.