In the dynamic world of medical technologies, developing a new medical device is a complex and challenging journey. >75% of all Medical device start-ups never make it to the market. From both innovation and regulatory standpoints, there are numerous obstacles to overcome on the path to success. To illustrate these challenges and learn valuable lessons, we look at one of the most well-known yet controversial stories in the medical startup world: Theranos.
>75% of all medical device start-ups never make it to the market.
This American company was lauded for its promise to revolutionize blood testing but quickly found itself at the center of allegations of fraud and deception. By understanding what went wrong at Theranos, we can gain profound insights into the essential pillars of successful medical device development. By learning from both successes and failures, we aim to provide guidelines for innovators, engineers, and entrepreneurs committed to improving healthcare through groundbreaking medical devices.
In the landscape of medical device development, harnessing the power of Proof of Concepts (PoC) can be a game-changer. Let’s see why PoCs are vital in the journey from concept to patient.
What?
The primary objective of a PoC is to verify the core idea or function behind a medical device concept. Unlike a prototype or a market-ready solution, a PoC focuses solely on validating the feasibility and viability of the fundamental concept.
Why?
The utilization of PoCs offers a strategic advantage by significantly reducing risk and conserving valuable resources. By investing time and effort in validating the core idea early on, potential flaws and challenges can be identified and addressed before substantial investments are made. This proactive approach helps to minimize risks associated with pursuing a flawed concept, ultimately saving both time and money.
How?
Executing a successful PoC involves a systematic approach:
1. Break down the concept into its core functions to pinpoint the critical aspects.
2. Identify functions with the highest risk or uncertainty.
3. Define a robust test setup, outlining the intended outcomes and establishing clear metrics for measuring success.
4. Execute the PoC to the defined test protocols and collecting relevant data.
5. Evaluate the results objectively, basing decisions on factual evidence1.
In the intricate realm of medical device development, establishing a strong product definition validated by stakeholders is paramount. Let’s dive deeper into why this aspect is crucial in the journey from concept to patient.
Some characteristics of medtech development:
Developing a successful medical device involves more than just having a great idea. While innovation is important, it’s essential to recognize that a great idea doesn’t always translate into a viable business proposition. Moreover, unlike other industries, pivoting in the field of medical technology is often impractical due to regulatory requirements and the complexities of healthcare systems. Additionally, the process of commercialization is frequently underestimated, requiring planning and execution to navigate regulatory pathways, secure reimbursement, and establish market acceptance.
In the process of medical device development, the role of suppliers cannot be overstated. Early involvement of suppliers can greatly enhance the efficiency and effectiveness of the development process, ultimately leading to superior outcomes for patients.
Access to Expertise: Suppliers often possess specialized knowledge and expertise in their respective fields. By involving them early in the development process, the team can tap into this wealth of knowledge to address technical challenges, optimize designs, and ensure feasibility.
Risk Mitigation: Suppliers can provide valuable insights into potential risks associated with materials, components, or manufacturing processes. Their input allows the team to identify and mitigate risks at an early stage, minimizing costly rework or delays later in the development cycle.
Accelerated Development: Collaboration with suppliers from the outset streamlines communication and fosters a more integrated approach to development. This can lead to shorter lead times, faster prototyping, and ultimately, accelerated time-to-market for the medical device.
Quality Assurance: Suppliers play a critical role in ensuring the quality and reliability of components or materials used in the device.
Cost Optimization: Engaging suppliers early allows for better cost estimation and optimization throughout the development process.
In this e-book, we look at one of the most well-known yet controversial stories in the medical startup world. By learning from both successes and failures, we aim to provide a guide for innovators, engineers, and entrepreneurs committed to improving healthcare through groundbreaking medical devices.
In the world of medical device development, ensuring the safety, efficacy, and regulatory compliance of a product is paramount. Verification and validation serve as essential pillars in this process, providing the necessary assurance that the device meets specified requirements and fulfills user needs and intended use(s). Verification and validation are critical aspects of the journey from concept to patient.
Verification: Rigorous examination and objective evidence to confirm device requirements met, including thorough testing, analysis, and documentation.
Identifying discrepancies early: Comprehensive verification activities minimize defects or failures in the final product by rectifying issues in the development cycle.
Validation: Establishing objective evidence of device specifications alignment with user needs and intended use through real-world testing, ensuring effective and safe performance.
8 recommendations for a realistic strategy:
1. Who is responsible for Quality & Regulatory?
2. Implement Quality Management System (QMS) according to ISO 13485-2016
3. Consider different regulatory submission strategies (ie. MDR vs FDA), gain advice!
4. Select and contract a Notified Body (NB)
5. Understand the core concepts of:
ISO 14971 – Risk management for medical devices
IEC 60601 – Safety and performance requirements for electrical medical devices
IEC 62366 – Human factors engineering (usability)
IEC 62304 – Medical device software
6. Start with Technical File (DHF) right from the beginning, not at the end… (and check your supplier)
7. Setup Quality Agreement with your supplier(s)
8. Validation of manufacturing processes (IQ/OQ/PQ) should not be underestimated.