Ideation

Constructive brainstorming of medical device ideas

Introduction

Ideation is the first stage of the medical device innovation lifecycle. It is the 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.

It’s worth investing time in developing a thorough understanding of the disease or medical condition early in development. It will improve the likelihood of achieving a good product-market fit and is also required in formal documentation for regulatory submissions, reimbursement and market access negotiations.

Problem identification

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. It forms part of the State-of-the-art (SotA) evaluations that are required to inform design and development. SotA assessments are also important in the technical documentation required for regulatory submissions and reimbursement and pricing negotiations.

The current medical landscape of a disease or condition is compiled based on information from multiple 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 identified unmet medical needs. 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 that are 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.

Best practices in problem and solution identification

The evidence gathered during ideation and conception forms the foundation for future development activities. 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.

Some activities that can ensure early-stage research is successful include:

Develop processes for identifying and analysing evidence that are systematic and comprehensive
Use industry best practices and follow international standards and guidelines when available
Carefully consider the data sources used to gather information, prioritising reputable sources that are widely recognised in the industry
Document evidence systematically from the beginning of the ideation process
Use tools and processes that can be updated throughout the medical device lifecycle to ensure that evidence can be gathered and analysed through development, regulatory submissions, reimbursement and post-market surveillance.

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 are no standard innovation frameworks used in the medical device industry, but common ones include:

Design thinking is a problem-solving approach that prioritises empathy, ideation, and prototyping to address complex challenges. It places the end user at the centre of the creative and iterative process.

Porter’s Five Forces is a framework for analysing the competitive forces within an industry, including the bargaining power of buyers and suppliers, the threat of new entrants, the threat of substitute products or services, and the intensity of competitive rivalry.

The Jobs-to-be-Done innovation framework centres around identifying and fulfilling the fundamental needs and goals customers are trying to accomplish. It emphasises focusing on the “job” or task requiring a product or service. We specialise in helping clients understand the tasks required by healthcare professionals across clinical settings.

Blue Ocean Strategy is a business strategy framework that advocates creating uncontested market space by innovating and offering unique value propositions, making competitors irrelevant. We help clients identify new markets and business models for disruptive healthcare innovations.

Frugal innovation involves the creation of cost-effective and simplified solutions to meet the essential needs of a wide range of users, often emphasising resource efficiency and affordability without compromising quality. We help clients apply frugal innovation principles to address the unmet needs of marginalised or underserved populations, especially in low and middle-income markets.

This proprietary innovation framework is a toolkit that integrates best practices from popular innovation frameworks while maintaining compliance. “Innovate to Value” is a full-lifecycle product development approach that focuses on optimising the value delivered by a product or service. It aims to create medical technology solutions that effectively meet the needs of all stakeholders, including healthcare providers and professionals, patients, and payers, while managing costs and ensuring regulatory compliance. It ensures that innovations maximise their value-creation potential.

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.

Updated on 18 May 2024