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Developing a medical device requires precision, compliance, and a deep understanding of the market’s needs. Unfortunately, many teams fall into costly traps that delay their progress and inflate budgets.
To help you, we’ve gathered insights from CLEIO’s experienced experts on the most common mistakes seen in the industry. Below are the top ten pitfalls and how to avoid them.
1
Poor Problem Definition
Problem definition is the foundation of medical device development, shaping its direction from the start. It involves clearly identifying the clinical or operational challenge the device is intended to solve. This ensures that development efforts remain focused on creating solutions that deliver true clinical value and meet regulatory requirements.
Why is it a mistake?
Poor problem definition leads to misaligned goals, ineffective solutions, and wasted resources. It can cause teams to pursue non-essential features, overlook critical pain points, or pivot direction midstream.
How to avoid it?
Engage with stakeholders early in the process to validate the problem. Leverage research methodologies to gain a thorough understanding. Use these insights to establish problem statements that guide the design and development phases, ensuring the project remains on track from start to finish.
2
Skipping Early-Stage User Research
User research is the foundation of a successful medical device project. It is the process of understanding the end-users’ needs, preferences, and pain points before beginning product design.
Why is it a mistake?
Without early-stage research, your team may end up developing features that users don’t want or need. This oversight results in wasted time on redesigns and reworks. By integrating thorough user research from the start, you can validate design concepts and anticipate human factors considerations that influence usability and patient safety.
How to avoid it?
Engage with clinicians, patients, and other stakeholders early in the process. Use their insights to define clear user requirements that guide the development phase. Consider methodologies such as user interviews, surveys, and contextual inquiries to gather meaningful data.
3
Underestimating Regulatory Requirements
Navigating the regulatory landscape is often one of the most challenging aspects of medical device development. It is an ongoing process that requires constant vigilance, robust documentation, and planning over time.
Why is it a mistake?
Ignoring or underestimating regulatory requirements can lead to project delays and additional costs. For instance, non-compliance may result in rejected submissions or costly recalls. Regulatory bodies like the FDA have specific requirements for design controls and risk management that must be followed precisely to avoid setbacks. If documentation and risk management are not integrated from the start, teams often need to backtrack to create these elements.
How to avoid it?
Integrate regulatory experts into your project from the beginning. They can help map out the necessary standards and ensure compliance throughout the product lifecycle. Take a proactive approach by documenting every phase of development. Additionally, stay informed about changes in the regulatory landscape to avoid unpleasant issues at the end of the project.
4
Poor Project Management Practices
Why is it a mistake?
Without a robust project management approach, critical tasks may fall through the cracks leading to problems such as scope creep, unrealistic timelines, undefined roles, poor communication, insufficient resources, and inadequate budgeting. These issues can derail the entire product development process.
How to avoid it?
Utilize project management frameworks like Agile or Waterfall to establish clear goals, milestones, and deliverables for the entire team. Appoint a skilled project manager to oversee the workflow and facilitate regular team meetings to ensure everyone is aligned with the project’s objectives.
5
Neglecting Risk Management
Why is it a mistake?
Failing to manage risks adequately can lead to serious consequences, such as patient harm, product recalls, or regulatory penalties. Effective risk management helps in detecting potential issues early, reducing the likelihood of costly failures later on.
How to avoid it?
Implement risk management activities in your development process in accordance with the ISO 14971 standard. Conduct regular risk assessments and maintain a risk management file that documents identified risks, controls, and mitigation strategies. Use tools like Failure Mode and Effects Analysis (FMEA) to systematically assess potential issues.
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6
Lack of Coordination Between Design and Engineering Teams
Why is it a mistake?
When design and engineering teams work in silos, misaligned goals can result in developing incompatible solutions. This can lead to significant issues at a later in the process, requiring extensive product redesigns and causing budget overruns.
How to avoid it?
Facilitate ongoing communication between design and engineering teams by conducting joint design reviews at each stage to validate assumptions and align goals. Use cross-functional tools for real-time communication to stay aligned on requirements.
7
Inadequate Usability Testing
Why is it a mistake?
A device that is difficult to use may result in use errors, which could compromise patient safety or require extensive user training. FDA guidance emphasizes usability as a key component in evaluating a device’s safety and effectiveness.
How to avoid it?
Conduct usability testing early and often. Whenever possible, incorporate simulated use environments to mimic real-world conditions. Gather feedback from a diverse group of users, including both expert clinicians and novices, to ensure the device is intuitive for its intended users.
8
Over-Engineering the Solution
The desire to create the “perfect” product can lead to adding features or specifications to a medical device that go beyond what is necessary to solve the core problem.
Why is it a mistake?
When a device includes too many unnecessary features, it can drive up costs, extend the development timeline (and shorten your runway), and harm the user experience by increasing the risk of errors. Additionally, more complex designs often require more rigorous testing, validation, and compliance checks, all of which consume valuable time and resources.
How to avoid it?
Focus on developing a minimal viable product (MVP) that meets essential user needs. Make a list of must-have features, leaving optional enhancements for later iterations. Use design reviews and iterative testing to refine the product based on user feedback, ensuring that every added feature serves a specific, validated purpose.
9
Overlooking Supply Chain Reliability
Why is it a mistake?
Any disruptions or quality failures in the supply chain can have a domino effect, leading to production delays and increased costs. Undetected problems with components or materials may compromise the product’s regulatory compliance. Additionally, relying on unreliable suppliers exposes the project to risks such as stock-outs or price fluctuations.
How to avoid it?
Partner with reliable suppliers who have a proven track record in the medical device industry, or collaborate with a development firm to leverage its network of approved suppliers. Establish quality agreements that define expectations for components and materials. Regular audits and inspections can help identify potential issues before they become critical.
10
Not Leveraging Data-Driven Decision-Making
Why is it a mistake?
Data-driven approach allows teams to optimize product design, manage risks, and predict potential challenges. Without data insights, decisions may be based on assumptions rather than evidence, increasing the chance of errors.
How to avoid it?
Use all available data and analysis methods to drive your project forward. Data collection and analysis should be integral to your development process.
Have you seen or even made any of those mistakes? We know we did in our early days. Want to share your experience?
