The medical device environment is shifting. Numerous challenges occupy the medical technology landscape: the cost and complexity of analytics to drive innovation, the volume and complexity of guidances from the FDA, EMA, and other global health authorities, and increasingly complex regulatory quality compliance standards. Device clinical trials provide unique challenges as well: trials tend to be smaller than drug trials, endpoints are highly diverse, and many are difficult to blind, randomize, and control.
We guide startup and large medical device companies through the challenges of developing various types of medical devices including:
- In vitro diagnostic device (IVD)
- Capital equipment and disposables
- Over-the-counter (OTC) devices
- Mobil health apps
- Delivery devices
Abundant opportunities exist within the medical device industry as well. Connecting devices to the Internet of Things (IoT), additive manufacturing (e.g. 3D printing), and the increasing feasibility and demand of wearable health technology each offer opportunities for new device innovators, software technology companies, and large scale medical device manufacturers. Passion to help medical device companies capitalize on these opportunities drive our advisors.
Pearl Pathways’ flexibility allows us to support simple to high-risk, complex implantable devices. To learn more about how we can support the development, validation, design, and submission of your device with the appropriate regulatory body, please see our full list of services.