A How-To for Early-Stage Medical Device Innovators
The medical device development process involves a number of moving parts, all of which must combine precisely to create a streamlined experience that efficiently and effectively delivers on promises. Anticipating common mistakes and circumventing them before they become a problem saves time, energy, and money, a worthy goal for any innovator.
“The more time spent upfront in planning, designing, and researching pays huge dividends as you approach the tangible activities later in development. A few days of pre-engineering work can save weeks or months of backtracking later. Do your due diligence now, reap the rewards later.”
– The Occam Team
Common Mistakes Made Before Medical Device Development
Ignoring Regulatory Requirements
If you fail to understand and incorporate relevant regulatory requirements for your specific device classification, or seek an inaccurate device classification, you risk delays, safety violations, and potentially costly non-compliance issues.
Insufficient Market Research and Stakeholder Engagement
You must fully comprehend who your device is for. If you don’t adequately understand the clinical need, target patient population, and potential competitors, you may produce a useless product that doesn’t solve a real problem. Medical device development requires input from clinicians, healthcare providers, and potential users early in the design process to avoid critical usefulness and usability issues.
Overly Ambitious Design
Attempting to create an overly complex device with too many features in the initial design can seriously increase development time and cost, without always increasing usefulness, marketability, or profitability.
Insufficient Anticipation of Future Needs
Your device needs to be useful now, and in 10 years. Failure to integrate technological capacity to adapt to future medical needs can build-in obsolescence, wasting your efforts in a short amount of time.
Common Mistakes Made During Medical Device Development
Poor Design Documentation
If you fail to document design decisions, testing protocols, and concept changes thoroughly, it becomes difficult if not impossible to track progress and ensure product quality.
Inadequate Prototyping
You can’t skip prototyping steps. Jumping directly to a fully functional prototype without creating low-fidelity prototypes means you can’t adequately test design concepts and will not sufficiently identify flaws early on.
Neglecting User-centered Design
Failure to effectively consider user needs and abilities when designing the device will lead to poor usability and potential patient harm.
Underestimating Manufacturing Feasibility
If you fail to consult with potential manufacturers and consider supply chain management early in the process, you may incorporate design features that are too difficult or costly to produce.
Insufficient Testing and Validation
Not conducting rigorous testing to verify and validate device functionality and safety increases the risk of product failure. This can extend your project timelines and waste significant amounts of money.
Common Mistakes Made After Medical Device Development
Poor Post-market Surveillance
If you don’t actively monitor the performance of the device once launched, you will miss opportunities to identify potential issues and make necessary improvements.
Inadequate Risk Management
Failing to proactively identify and mitigate potential risks associated with the device can lead to serious safety concerns, regulatory violations, and physical harm or even death.
Insufficient Regulatory Submissions
If you don’t stay ahead of regulatory submission requirements, including comprehensive documentation and adherence to deadlines, you will likely experience significant delays and potential rejection.
Lack of Commercialization Strategy
Not having a well-defined plan for marketing, sales, and reimbursement can hinder the successful adoption of the device. If people don’t hear about your device, they won’t use it, making your efforts fruitless.
Critical Aspects of Medical Device Development to Remember
Some straightforward preparation before development begins can make an enormous difference in the efficiency, cost-effectiveness, and timeliness of your projects. We’ve told you what not to do; now, we offer you some considerations for what you should do.
Focus On User Needs
Make the needs of the end user a guiding principle throughout the design process.
Implement Iterative Development
Use a staged approach, incorporating continuous feedback, to refine your design
and mitigate risks.
Collaboration Is Key
Involve stakeholders like clinicians, engineers, regulatory experts, and potential manufacturers early and often in the development process.
Thorough Documentation
You need to know how, and why, processes work. Maintain detailed records of design decisions, testing results, and regulatory compliance activities to ensure your process is repeatable and well documented.
Occam Design Avoids Common Mistakes Because of Expertise and Experience
We encourage all early-stage innovators use this review of common development mistakes to guide the device development process. If you find yourself bogged down in the development process, consider partnering with Occam Design. Occam Design has the expertise to develop products that deliver strong returns on investment for innovators while enhancing the quality of life for those in need of cutting-edge health technologies.
If you’re looking for experts in ensuring regulatory compliance for your medical device design, look no further than Occam Design. Our ISO 13485:2016 certification and FDA registration, alongside 30 years of experience developing medical devices means we have the expertise and experience needed to make your device concept a regulatory-compliant reality.