The development of new devices often starts with researchers trying to find a solution for unmet needs in the medical community. In order to protect patients and reduce risk, there is a thorough approval process every device must go through, including design, testing, validation, and after-launch assessments.
The medical device development timeline depends on many factors: some devices have few regulations they must satisfy, while more complicated devices often have an arduous pathway to approval. In fact the average device takes three to seven years to come to market in the United States. While the stakes are high in the development of life-saving devices, one aspect remains true: using high-quality materials can be the difference between approval and rejection.
Phase 1: Discovery and Proof of Concept
Before medical device product development can truly begin, researchers must formulate a concept, assess the level of risk involved, and consider overall feasibility and potential market reception.
Additionally, this is the phase when regulatory compliance and safety requirements should be considered, as they will impact the overall device development process. In the United States, the Food and Drug Administration (FDA) has three classifications for medical devices, based on the risk posed by the device:
- Class I: General Controls. These devices pose the least risk to consumers, and therefore have a less stringent approval process. This class includes devices such as oxygen masks, bandages, or latex gloves.
- Class II: General Controls with Special Controls. These devices have moderate to high levels of associated risk, and have additional controls required during and after approval. This class includes devices like blood pressure cuffs, contact lenses, and blood transfusion equipment.
- Class III: General Controls and Premarket Approval. These devices are often implanted in the body or have the potential for unreasonable risk of illness or injury for their recipients. This class includes devices such as pacemakers, defibrillators, and implants.
While the requirements in the US differ from Europe and elsewhere, there is generally overlap between processes. It’s important to consider where a device will seek approval, and what regulations apply.
Phase 2: Prototype Design and Testing
Once a medical device concept has been created and researchers understand regulatory requirements they need to meet, the next step is to create and test working prototypes.
At this stage, completed prototypes will undergo rigorous testing in a controlled environment. Testing may reveal needed adjustments to the device, and may require several iterations. Devices are not yet approved for human use at this stage; instead, bench testing and, when appropriate, animal testing are conducted to evaluate overall safety and efficacy. The overarching goal is to reduce the risk of harm as much as possible prior to moving on to human trials.
This phase also includes sourcing materials, such as using a porcine heart for valve replacements or using pig’s blood for testing a finished device. Sourcing high-quality materials is especially important for Class 3 devices, due to their invasive nature.
Phase 3: Pathway to Approval
The FDA approval process for devices is directly related to the device class, with Class III devices requiring much more scrutiny than Class I devices.
Many Class I and some Class II devices may not require any clinical trials, especially if they have the same intended use or technological characteristics of a device that’s already approved on the market. This is called substantial equivalence, and offers a shorter approval process for many medical devices.
However, because they pose greater risks to patients, Class III devices generally require pre-market approval (PMA). This rigorous process requires clinical evidence and in-depth trials to support the device, and must show that the potential benefits outweigh the risks, and that it will significantly help a large portion of the target population.
In the US, it’s recommended that researchers engage with the FDA early in the process to make sure they’re on the correct pathway. This precludes inaccurate applications and ensures the appropriate trials have been completed.
Phase 4: FDA Review
Once researchers have enough evidence to support the effectiveness and safety of their medical device, they can file an application with the FDA to market the device to the public. There are three types of applications that can be filed:
- Premarket Notification. Also known as a 501(k), this application indicates that the device is similar to another on the market. This is often used for Class I or Class II devices.
- Premarket Approval Application. Application for Class III devices or others that do not have a substantial equivalent on the market. This application must include data from all completed studies, and the FDA will inspect all laboratories and facilities involved in the testing and manufacturing processes.
- Humanitarian Device Exemption. Any device that treats or diagnoses a disease that affects fewer than 4,000 people can use this exemption. Applicants must prove no similar, legally approved devices exist and there is no other way to bring the device to market.
If needed, the FDA will consult an Advisory Committee composed of groups of experts who can provide independent advice on a certain device. These panels are held in public meetings, and recommend whether a device should be approved or not.
While this specifically applies in the United States, other countries and regions have similar review processes and requirements.
Phase 5: Post-Market Safety Monitoring
The FDA ensures medical devices remain safe and effective even after they reach the market through inspections, reporting programs, and advanced monitoring systems. This post-market surveillance process helps the FDA continue to track device performance and address potential risks.
Ongoing Safety Monitoring
Even after a medical device is approved, new safety concerns may arise. The FDA continues to monitor device performance to ensure ongoing safety and effectiveness.
Manufacturer Inspections
FDA officials conduct routine and unannounced inspections of medical device manufacturing facilities to ensure compliance with safety standards. The FDA can shut down any facility that fails to meet these standards.
Reporting Issues
The FDA has programs for manufacturers, healthcare professionals, and consumers to report device-related problems:
- MedWatch: Allows users to report adverse events and receive safety alerts.
- Medical Product Safety Network (MedSun): A network of 350 healthcare providers reporting serious device-related injuries or deaths.
Active Surveillance
Through the Sentinel Initiative, the FDA uses large electronic health databases to track device safety in real-time, complementing its other monitoring tools.
Why High-Quality Materials Matter in Medical Device Development
The success and safety of medical devices depend not only on rigorous testing and regulatory approval but also on the quality of materials used throughout development.
High-quality porcine tissues can play a crucial role in ensuring accurate testing, improving device performance, and reducing risks before human trials. Particularly for Class III devices, where precision and reliability are paramount, sourcing top-tier materials can make the difference between approval and rejection. By prioritizing quality at every stage — from bench testing to clinical trials — manufacturers can enhance patient safety and bring innovative, life-saving devices to market with confidence.
We’ve proudly partnered with medical device researchers and developers for years, and take our role as a tissue supplier seriously. If you require porcine tissue in your device development or testing, we provide quality tissue you can trust. Contact us to learn more about how we can support your next project.