When bringing a medical device to the market, the definition of its intended purpose is paramount. But what makes this intended purpose, also known as intended use, so vital for your business?
Just as a compass helps travellers find their way, the intended purpose of a medical device directs efforts towards solving specific healthcare challenges. While nuances in terminology, scope, and regulatory frameworks may exist, the core concept of intended purpose – referring to the primary function or use for which the device is designed – remains consistent across different authorities.
Intended purpose definition as a starting point for future decisions
This blog provides an overview of the crucial regulatory aspects regarding the intended purpose of a medical device in general. Independent of the target market, the intended purpose of a medical device serves as the foundation for its clinical evaluation and market positioning. As it is the core of your technical documentation, the formulation should occur early and must align with the definition provided by the applicable regulations and authorities.
Imagine a scene of innovation where brilliant minds spot potential game-changing solutions or identify gaps in healthcare services. Yet, bridging the gap between an ingenious idea and a marketed medical device is a challenging ride.
Before innovation can be translated into a new, market-disrupting MedTech solution, it requires you to take a step back and walk yourself through several fundamental considerations, for example:
- Why do we want to build the device?
- Why do we want to qualify our device as a medical device?
- Who will benefit from the device?
- Who will use the device?
- Who will pay for the device?
- How will we build the device?
- How will we bring the device to the market?
Intended purpose and its impact on development and marketing strategies
Drafting a clear intended purpose for your medical device is paramount to effectively shape your business strategy. Every aspect, from design to functionality, must align with the goal of enhancing patient care and medical practices. Even the most groundbreaking innovation may struggle to find its niche in the MedTech market without a clearly defined healthcare need to support its positioning.
This underscores the importance of being well-informed about the current state-of-the-art within your area of focus when defining your device's purpose. Considerations such as critical functions, medical indications, contraindications, user profiles, target patient groups, body contact, and usage environments play pivotal roles in this process. By thoroughly understanding these variables, you can ensure that your device meets the specific needs of healthcare professionals and patients.
These variables will significantly influence your regulatory and clinical strategies, as well as impact raw material selection, manufacturing processes (including packaging and labelling), time-to-market, market size, and, ultimately, budget constraints. Moreover, the intended purpose serves as a cornerstone for risk analysis, marketing claims or sales materials, risk acceptance criteria, and ultimately, the benefit-risk evaluation. Furthermore, the intended purpose should accommodate your reimbursement strategies across different markets.
Possible mistakes in defining the intended purpose include:
- Lack of clarity: Ambiguity can compromise the performance and safety of the technology.
- Scope too broad or too narrow: Wide scopes may be challenging for achieving meaningful clinical outcomes and demand a large budget and timeframe. With an overly narrow scope, the user may be tempted to use the device outside its specifications.
- Ignoring user needs: Focusing solely on technological capabilities, while overlooking the needs and preferences of end-users, can result in solutions that fail to address real-world challenges.
- Failure to align with regulations: Misalignment between the defined intended purpose and subsequent regulatory obligations, such as classification, validation, and available clinical data, may result in approval delays or even enforcement actions by regulatory agencies
- Incomplete benchmark evaluation: Neglecting to assess the state-of-the-art may result in misalignment with the market expectations and reimbursement criteria, as well as delays in the clinical evaluation process due to incomplete assessment of clinical risks.
- Ignoring ethical considerations: Healthcare poses intricate ethical dilemmas, especially concerning patient demographics, data security, and fair allocation of healthcare resources. Disregarding these factors when defining the intended purpose can narrow your market position and even lead to reputational challenges.
By taking a thoughtful, inclusive approach to defining the intended purpose, organizations can increase the likelihood of developing MedTech solutions that genuinely improve healthcare delivery and patient outcomes.
Once defined, changes to intended purpose have far-reaching consequences
Once the intended purpose is defined, it is vital for the management team to firmly adhere to that definition on the path to the market. Developing a novel device is naturally exciting, but this enthusiasm easily leads to scope creep, which may become very expensive when this leads to an adaptation of the intended purpose.
Intended purpose adjustments are typically considered significant modifications by regulatory authorities, which must follow strict regulatory requirements. Even minor changes in your intended purpose may trigger a new regulatory and clinical strategy. It potentially influences the risk classification or may even disqualify your product as a medical device. By holding on to this compass, stakeholders can navigate challenges, innovate effectively, and ultimately deliver impactful solutions to the healthcare ecosystem within budget constraints.
This does not mean that innovation should be placed on hold. Quite the contrary; with the right tools in the clinical and regulatory strategy, scope extensions can develop alongside the primary market pathway, enabling continuous growth without delaying market access.
Karin Ackema, PhD
Clinical & Scientific Affairs Manager