Medical Device Development

The medical technology (MedTech) field's scale is massive, spanning stages of care including prevention, diagnosis, monitoring, treatment, and recovery. Having guided dozens of organizations to develop and launch highly-complex medical devices, the Fresh team can help you build products, navigate regulations, and go to market confidently.

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End-to-end medical device development

Developing medical devices is an intricate, multi-step process. Organizations in this increasingly competitive field face significant challenges in doing so:

  • Biomedical complexity: to navigate it, extensive industry expertise is essential.
  • Regulatory compliance: to build trust between agencies, hospitals, providers, and patients, technical precision and proven results are vital.
  • Dealing with big data: to handle the volume, best-in-class software solutions, technology architecture, and device integrations are required.

Our experienced team takes medical devices from ideation to market, navigating any obstacle. 

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A customizable, cross-disciplinary approach

One of Fresh’s primary differentiators is the ability to take clients from an initial strategy phase through designing, developing, building, and launching a solution. Not every client needs end-to-end services, though, and that’s why we offer standalone services depending on a company’s needs and roadmap.

Strategy: Ideate, refine, and validate medical device concepts, guided by an established approach to innovation.

Design: Bring your proof of concept to life with various creative services, including industrial design, UX, UI, and more.

Software: Plan your technology architecture to support secure, scalable solutions—and develop the software.

Hardware: Build the product, test it, and go to market.

Assistance for various use cases

Whatever sub-sector of MedTech you’re developing medical devices for—and whichever stage of patient care—we have the prior experience to help.

Devices in healthcare and laboratory settings “talk” and share data constantly. Fresh designers, developers, and engineers can assist with every aspect of IoT (Internet of Things) product development, from creating firmware to designing devices and piping data to the cloud.

We’ve helped numerous clients in MedTech deploy solutions to handle their massive data streams. Whether building a database, creating a technology roadmap, migrating platforms, integrating AI, or updating legacy systems to keep up with increased data volume, we have the software expertise to build and deploy solutions.

Fresh developers and engineers have an extensive background in creating Bluetooth, Bluetooth Low Energy (BLE), and Radio Frequency (RF) integrations to communicate accurate, up-to-date information for diagnosis, monitoring, and much more.

Our team follows best practices for verification & validation (V&V) to confirm that your product meets your requirements and specifications and those of the hospitals and regulatory bodies that decide whether or not to adopt your solution.

Building high-quality products that perform reliably and accurately is essential. We’ve designed testers for early product research and ongoing quality assurance for various medical device use cases.

In addition to building solutions, our strategic team also understands what it takes to approve Class 1, Class 2, and Class 3 medical devices. We help refine products to meet standards and navigate the process of getting a new device formally approved.

Our team is equipped to build advanced technology solutions and iterate on current products and services, allowing you to develop novel solutions quickly and go to market faster.

From designing surgical robots to robotic process automation (RPA) to streamline routine tasks, Fresh has deep experience in the practice of automating to empower people to do better work, always with a focus on human-centered design.

Our extensive design experience enables us to create physical products, choose materials, and build user-facing interfaces to operate medical devices.

Related product development capabilities

Explore our other engineering services, which allow our team to solve challenges for your organization and others, regardless of size, industry vertical, or product category.