Erol Erturk, Senior VP of R&D Engineering, Ascential Medical & Life Sciences11.01.23
Embarking on the journey of developing a new medical device demands more than just a groundbreaking idea—it requires a strategic approach that encompasses careful planning, meticulous testing, and stringent adherence to regulatory standards. The road to successfully commercializing a medical innovation is laden with challenges, with regulatory requirements posing significant hurdles.
From the initial ideation to the final marketing of the product, attention to detail should be the guiding principle. Skipping or underestimating any crucial step can lead to non-compliance with regulatory agencies, potentially sidelining your device from ever reaching the market.
Delayed problem discovery equates to higher project expenses. This is because addressing issues in later phases becomes more challenging due to various constraints, such as limited time and design flexibility. Consequently, adopting a holistic approach that integrates considerations of design validity, quality control, and regulatory compliance at every stage of development is essential.
Here, we’ll explore the key strategies for the early stages of medical product development, focusing on Phase I and Phase II, which are key for achieving FDA approval and ensuring a seamless path to market.
The definition and planning of the complete solution ideally come after the science and engineering of the invention is well understood. Engineering the alpha design, a functionally complete unit but not yet intended for commercialization requires a broader set of requirements to be contemplated. Having a solid understanding of the invention enables the definition and architecture of the end solution that will meet the market needs.
Example questions to ask include:
Management and key technical staff must delicately balance the risks of moving beyond the planning and feasibility stages to the intricate engineering design and development of alpha prototypes. The challenge lies in ensuring that the end product strikes a balance – it must not be overly complex, nor should it miss the mark concerning the needs of the intended users.
Complexity can arise when products lack precise definitions, forcing engineers to devise solutions for specific corner case requirements. Failure to accurately address the users' needs, such as providing inadequate images or detection methods that don’t replace existing procedures, can be detrimental.
In this context, redoing alpha designs and altering requirements later in the process could prove to be considerably more expensive and time-consuming than spending a few additional months in the feasibility phase. It becomes imperative to determine the optimal moment to transition from feasibility in the lab to the design phase. This strategic decision-making is critical for optimizing overall project costs and potentially reducing time to market, ensuring the product meets both technical and user requirements effectively.
As you move from concept to alpha prototype, the challenge is to ensure repeatability, measurability, and testability of results. While commercial pressures might push you to move quickly, rushing this transition can lead to technical debt, potentially compromising your product's viability. Balancing the risks by thoroughly exploring the innovation in the lab and making informed decisions on when to transition to the design phase is critical.
Rapid iterations are possible at this stage due to the streamlined configuration management process, exclusively managed by the engineering team. This means that changes can be swiftly implemented without the constraints of internal change management procedures within the company’s quality management system, which are subject to FDA audits. Managing a specific configuration and tracing the solutions results to the requirements defined back in Phase I is a more onerous, time-consuming, and therefore a more expensive effort. This process is reserved for Phase III, during which the documented design verification results undergo scrutiny by the FDA based on beta units, as defined in the project.
There is always pressure to move from feasibility to commercializing the invention. However, not discovering unknown sensitivities or potential problem areas during the engineering of the alpha where rapid prototypes can be done will build technical debt into the development of the product. That technical debt will be more expensive and more time-consuming to pay back in Phase III.
In a world that values rapid development, finding the right partners who can collaborate effectively and communicate openly is key. Investing in Product Lifecycle Management, Quality Management Systems, and Material Requirements Planning systems can be expensive, especially for startups and small growth companies. It may make sense for such companies to look for external development partners that not only can help them with development but also have the appropriate systems in place to successfully arrive at the steps of the FDA.
By implementing these strategies, medical device innovators can accelerate innovation, ensure regulatory compliance, and ultimately improve patient care. A well-planned and well-executed development process can make all the difference in bringing your medical innovation to market successfully and within budget constraints.
Erol Erturk is the Senior Vice President of R&D at Ascential Technologies, where he leads innovative projects in medical device design and commercialization. Previously, he held a similar role at D&K Engineering before its acquisition by Ascential. Erol's expertise encompasses regulated medical instruments, optics, and consumables. He's dedicated to solving complex problems in Medical Life Sciences, pushing the boundaries of existing technologies for imaging detection and microfluidics. Erol holds dual master’s degrees from MIT and a BS in Mechanical Engineering from the University of Wisconsin-Madison.
From the initial ideation to the final marketing of the product, attention to detail should be the guiding principle. Skipping or underestimating any crucial step can lead to non-compliance with regulatory agencies, potentially sidelining your device from ever reaching the market.
The Importance of Early Testing
The extent of testing conducted, especially early in the development process, plays a pivotal role in determining the robustness of your solution. It also significantly influences the time it takes to bring your product to market and the associated costs.Delayed problem discovery equates to higher project expenses. This is because addressing issues in later phases becomes more challenging due to various constraints, such as limited time and design flexibility. Consequently, adopting a holistic approach that integrates considerations of design validity, quality control, and regulatory compliance at every stage of development is essential.
Phase Gate Development Model
When launching a product, a Phase Gate Development model is often used to help guide projects from idea to product launch. This methodology takes a holistic, big-picture view of product development by breaking it down into phases, each ending with a review gate. At these gates, appropriate stakeholders evaluate how well the phase meets its goals and decide whether and how the project should continue based on the remaining technical and business risks.Here, we’ll explore the key strategies for the early stages of medical product development, focusing on Phase I and Phase II, which are key for achieving FDA approval and ensuring a seamless path to market.
Phase 1: From Concept to Alpha Prototype-Setting the Foundation
At the core of medical innovation lies the imperative to address unmet medical needs effectively. Phase I is a critical stage for vetting out the invention to properly specify the design intent required for FDA 510(k) approval. This phase involves constructing prototypes of subsystems, such as a software module, or a reagent applied to a biological specimen, that demonstrates the value and intent of the novel application.The definition and planning of the complete solution ideally come after the science and engineering of the invention is well understood. Engineering the alpha design, a functionally complete unit but not yet intended for commercialization requires a broader set of requirements to be contemplated. Having a solid understanding of the invention enables the definition and architecture of the end solution that will meet the market needs.
Example questions to ask include:
- How consistent are the intended results of the innovation being achieved?
- How are the error cases handled?
- Who will be the ultimate user of innovation and how will they use the product?
- How will the solution be sold and at what prices can it command?
Navigating the Unknown: Managing Risk in Early Product Development
Under the pressure to meet schedules, some critical areas of innovation may be left unexplored, such as in-depth margin studies and establishing statistically significant signal-to-noise ratios in results. This technical debt can lead to defects that prevent the product from shipping or result in an unviable value proposition in the later phases of development.Management and key technical staff must delicately balance the risks of moving beyond the planning and feasibility stages to the intricate engineering design and development of alpha prototypes. The challenge lies in ensuring that the end product strikes a balance – it must not be overly complex, nor should it miss the mark concerning the needs of the intended users.
Complexity can arise when products lack precise definitions, forcing engineers to devise solutions for specific corner case requirements. Failure to accurately address the users' needs, such as providing inadequate images or detection methods that don’t replace existing procedures, can be detrimental.
In this context, redoing alpha designs and altering requirements later in the process could prove to be considerably more expensive and time-consuming than spending a few additional months in the feasibility phase. It becomes imperative to determine the optimal moment to transition from feasibility in the lab to the design phase. This strategic decision-making is critical for optimizing overall project costs and potentially reducing time to market, ensuring the product meets both technical and user requirements effectively.
As you move from concept to alpha prototype, the challenge is to ensure repeatability, measurability, and testability of results. While commercial pressures might push you to move quickly, rushing this transition can lead to technical debt, potentially compromising your product's viability. Balancing the risks by thoroughly exploring the innovation in the lab and making informed decisions on when to transition to the design phase is critical.
Phase II: Transitioning from Alpha to Beta-Uncovering Unknowns
Phase II involves engineering and testing of fully featured prototypes, referred to in this article as alphas. This is the phase to document your design intent properly via appropriate methods in order to support the claims that the solution meets the requirements of the intended invention as well as the remaining elements that enable users to achieve their goals. Testing and iterating on these prototypes will allow the development team to quickly refine the product subsystems. This ensures that the solution is:- Capable of handling errors and important corner cases
- Safe and effective
- Accurate and consistent, producing clear, repeatable, and correct results
- Easy to use and service
Rapid iterations are possible at this stage due to the streamlined configuration management process, exclusively managed by the engineering team. This means that changes can be swiftly implemented without the constraints of internal change management procedures within the company’s quality management system, which are subject to FDA audits. Managing a specific configuration and tracing the solutions results to the requirements defined back in Phase I is a more onerous, time-consuming, and therefore a more expensive effort. This process is reserved for Phase III, during which the documented design verification results undergo scrutiny by the FDA based on beta units, as defined in the project.
There is always pressure to move from feasibility to commercializing the invention. However, not discovering unknown sensitivities or potential problem areas during the engineering of the alpha where rapid prototypes can be done will build technical debt into the development of the product. That technical debt will be more expensive and more time-consuming to pay back in Phase III.
Iterative Prototyping and Documentation
Requirements to satisfy the FDA follow a similar framework to developing products. The documentation is the only means by which the FDA can determine whether the product invented meets the intended requirements safely, and reliably. Business pressures are not part of that equation. Failure to adequately document inputs or insufficiently capturing design intent will inevitably result in the development team having to revisit and address these deficiencies. This debt, regardless of how behind schedule the overall program may be, will ultimately need to be repaid. Implementing agile methods during Phases I and II can be advantageous in allocating the necessary time and attention to building a comprehensive Design History File (DHF) to mitigate such risks.In a world that values rapid development, finding the right partners who can collaborate effectively and communicate openly is key. Investing in Product Lifecycle Management, Quality Management Systems, and Material Requirements Planning systems can be expensive, especially for startups and small growth companies. It may make sense for such companies to look for external development partners that not only can help them with development but also have the appropriate systems in place to successfully arrive at the steps of the FDA.
Key Takeaways for Success
Success in early-stage medical device development hinges on several key strategies:- Balancing Innovation-Striking the right balance between scientific and engineering innovation is a key challenge. It's not enough to have a brilliant idea; you must effectively translate it into a robust product that can meet profitability requirements and is capable of being manufactured efficiently. This balance ensures that the final product isn't overly complex and meets both customer and business needs. Failure to plan for manufacturing during development can result in costly redesigns and changes down the line, potentially delaying the time to market.
- Mitigating Unknowns-The product development process is riddled with unknowns. To navigate these uncertainties successfully, it's crucial to actively seek out and mitigate potential issues and sensitivities during the development process. This proactive approach minimizes the risk of surprises later on, making your project more predictable and cost-effective.
- Iterative Prototyping: Iterative prototyping involves continuous refinement of your prototypes and diligent documentation of progress. This approach not only enhances the user experience but also helps in uncovering and addressing errors, risk factors, and unforeseen challenges. It's a cornerstone of efficient product development.
- Strategic Collaboration- Collaboration is an integral part of medical product development. Building effective cross-functional teams that include regulatory, legal, product management, engineering, and manufacturing for clear and open communication throughout the stage gates is key. Strategic investments in tools and systems, such as Product Lifecycle Management and Quality Management Systems, can significantly improve project efficiency, especially for startups and smaller companies.
- Regulatory Compliance-Embrace a culture of continuous documentation to meet regulatory requirements. Embracing a culture of continuous documentation throughout the development process not only fulfills a regulatory requirement – it's a great way of ensuring product quality and reliability. By documenting design intent and configuration along the way, you can avoid costly errors, ensure compliance, and facilitate smoother regulatory approvals.
By implementing these strategies, medical device innovators can accelerate innovation, ensure regulatory compliance, and ultimately improve patient care. A well-planned and well-executed development process can make all the difference in bringing your medical innovation to market successfully and within budget constraints.
Erol Erturk is the Senior Vice President of R&D at Ascential Technologies, where he leads innovative projects in medical device design and commercialization. Previously, he held a similar role at D&K Engineering before its acquisition by Ascential. Erol's expertise encompasses regulated medical instruments, optics, and consumables. He's dedicated to solving complex problems in Medical Life Sciences, pushing the boundaries of existing technologies for imaging detection and microfluidics. Erol holds dual master’s degrees from MIT and a BS in Mechanical Engineering from the University of Wisconsin-Madison.