The Process of Medical Device Concept Development and Feasibility

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Early-Stage Innovation: Concept Development and Feasibility Assessment

At the beginning of every medical device development effort, an unmet need (problem to solve) has been carefully identified and there is an initial solution defined. The solution may be a new diagnostic or prognostic test, a new digital therapeutic, or even a clinical decision support system that involves Artificial Intelligence (AI). But, since medical device development can be and often is a lengthy, costly, and challenging process, how do these ideas advance from the drawing board to reality and what prompts regulatory and commercial product success?

One of the keys to success is establishing a solid business case that addresses an unmet need in healthcare and has a value proposition. Another key to success is the strategic use of resources along the way, at the right times, to reduce risk and advance a product down the road to viability, development, and launch. Across the medical device development industry, organizations follow various “Pre-concept” or “Phase Zero” approaches leading up to the commissioning of a development project and securing supporting funds. The idea is to execute the right-sized process at the right time to de-risk the project before incremental investment is necessary and costs steadily increase.

At Innovenn, we define these crucial early development stages as a Concept Development and Feasibility Assessment. These stages should be completed before design control begins. Design control mandates that formal methods are used to test and document device development in a way that meets regulatory requirements.

Before beginning design control, the objectives are to evaluate the device potential, identify possible challenges or business/project risks early, and determine whether a medical device should move forward to the design control stage of product development.

Concept Development Stage

The Concept Development stage is when the viability of a medical device is evaluated. During this stage, the following factors should be considered:

Business Case Development
Business case development is the process of evaluating why and how it makes sense to invent, design, produce, and introduce a medical device to the market. This involves analyzing the market and competitive landscape, estimating development and commercial costs, evaluating product/project risks and predicting return on investment.
User Need Identification
At the heart of medical development lies the identification of user needs pertaining to health conditions lacking sufficient diagnosis, treatment, and/or management options. The critical role of Concept Development is to identify and confirm the existence of tangible unmet needs for a medical device that can effectively address healthcare issues. At its core, is the concept useful to the users and patients it is intended for? Examples of methods used to identify user needs include field observation, ethnographic research, comprehensive literature review, and interviewing end users such as doctors and patients.
Proof of Concept
A medical device proof of concept is a process in which an idea for a new medical device is paired with a new or existing technology. At this point, manufacturers outline the steps needed to determine whether the technology is capable and sufficient. A proof of concept is developed by establishing preliminary design specifications that outline the key components, functionality, and how the device will address the identified problem or user needs.

Feasibility Assessment Stage

The Feasibility Assessment stage builds from Concept Development to reduce project risks through a multi-dimensional, methodical approach to increasing viability in advance of full-scale product development. This involves evaluating the technical, clinical, regulatory, and economic feasibility of the concept to enable further investment by the sponsor. These efforts should begin after the initial Concept Development stage and before significant resources are invested in the formal design control process. A thorough Feasibility Assessment stage should include the following activities:

Risk Identification
Manufacturers should proactively identify various technical, clinical and market risks associated with the device. Identifying these risks early allows manufacturers the time and ability to make informed decisions, ultimately resulting in an overall better product. Some examples of risk evaluation tools used in the industry include Failure Modes and Effects Analysis (FMEA), Fault Tree Analysis (FTA), and SWOT (Strengths, Weaknesses, Opportunities, Threats) analysis.
Resourcing
Developing medical devices is a complex process and can be resource intensive in terms of time, money, and personnel. The feasibility stage provides time to assess the resource requirements and plan to allocate those resources accordingly.
Market Analysis
Building upon the initial business case, manufacturers should further gauge the market need for the medical evidence and measure proposed end user interest. A comprehensive market analysis should be conducted which takes a lot of critical factors into consideration such as market size, growth trend, competition, and barriers to entry. Market analysis techniques can include literature research, surveys, and interviewing key stakeholders.
Regulatory Analysis
Identifying the correct regulatory path for a medical device is critical in ensuring the success of its marketing approval. Manufacturers should assess the device’s intended use against the regulatory requirements and identify any potential regulatory roadblocks that need to be addressed. Identifying a regulatory path will also help the manufacturer in gauging the extent of development activities required to provide evidence for safety and effectiveness of the product. This will help them to estimate the development costs. Finally, manufacturers should evaluate the regulatory requirements for each country where the product will be marketed to identify any extra steps they might need to take for successful clearance and launch.
Clinical Feasibility
Defining the proposed clinical validation plan, including exploratory or pilot studies, needed to determine the clinical performance and test the relevance will support the value proposition.
Technical Feasibility
Early identification and evaluation of key technology feasibility points allows manufacturers to further gauge the specific technical viability of a design concept. This can be assessed through the iterative prototyping and benchtop testing process.
Human Factors Feasibility
Conducting early usability testing enhances design and synchronizes unmet needs with product design and performance. These studies inform risk assessments and have a strong impact on development and refinement of risk mitigations. This work provides an opportunity to fully develop and understand the device’s Context of Use so adjustments can be made more easily. Also, this is a key opportunity to ensure user centered design principles are applied to most clearly align to user needs and improve the outlook of product adoption.
Cost Analysis
Manufacturers should conduct a comprehensive cost analysis that will help determine the cost of developing, manufacturing, and launching the medical device.
Reimbursement Strategy
A reimbursement strategy can help determine a plan for how the manufacturer will generate revenue by educating payors about the unmet need, the solution and the impact it will have on patient outcomes.
IP Landscape
To protect a concept’s intellectual property and mitigate any risks of patent infringement, it is important to complete a patent search and consult with IP attorneys regarding a patent filing strategy. Manufacturers should conduct comprehensive research online to determine if their medical device can be protected through patents, trademarks, or other forms of intellectual property. The investigation will also help determine if the manufacturer’s device infringes upon existing patents, which can bring costly lawsuits down the line.

Advancing to a full-scale product development process without the pre-design control stages can result in risks to development. Consequences may include poor design, product safety concerns, increased development costs, regulatory roadblocks, and other delays to development, approval, and launch.

Why Choose Innovenn for Your Concept Development and Feasibility Assessment?

At Innovenn, we recognize the vital role of early-stage medical device evaluations in designing safe and effective devices. We help you maximize the opportunity for early risk identification and to determine a pathway to efficient development/approval so your company can deliver a true medical solution to a clearly identified unmet medical need. Our primary focus is aligning your device development with the needs of end-users. Our aim is to support you in successfully bringing your medical device to market.

Our team of experts is ready to assist you by reviewing your early-stage evaluation plans and addressing any identified gaps. We can also offer guidance on various early-stage evaluation strategies, including the creation of a business plan, conducting risk assessments, conducting Human Factors feasibility studies, and market analysis. In addition, our team includes skilled technical writers who can assist in preparing technical and/or regulatory submissions documents.

To learn more about Innovenn’s Concept Development and Feasibility Assessment services, contact us to discuss your specific needs.

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