Develop

Developing your technology is an iterative process that will require you to grow your knowledge of your technology’s market potential, the intellectual property landscape, regulatory requirements, prototyping, your financial roadmap, and even production or manufacturing. During development, keep meticulous documentation of the decisions you make and various iterations of your technology, making sure that your innovation still meets users’ needs.

Considerations

  • Develop a series of prototypes, each one being an incremental improvement over the previous, in your production materials. Develop a fully functioning prototype that meets standards for your medical device’s regulatory class.
  • Components of the development process may need to be outsourced to experienced organizations. Identify opportunities for collaborating with suppliers, manufacturers, designers, and software engineers in order to develop your technology. Find trusted partners with in-house regulatory experience that will ensure that processes used are well documented and validated when required.
  • Consider how HIPAA and/or PHIPA apply to your technology. Privacy and cyber security is of particular concern with digital health applications that require usage and disclosure of personal health data. Make sure that your innovation provides the high level of security and privacy necessary to deliver an optimal user experience.
  • If your technology interconnects or transfers sensitive information with other systems, determine the review process you will use to ensure that stakeholders are satisfied with data security.
  • Establish a robust design and development process that aligns with your regulatory pathway.
  • Determine the amount of capital that must be raised for development (see the fund section for more details).

Keep the following in mind when developing a medical device

  • Ensure that your design outputs (drawings, descriptions, and manufacturing instruction) describe all the components, as well as all assemblies and subassemblies of your device.
  • Document risks related to your technology and evaluate how risks can and should be reduced or mitigated.
  • Consider how production may impact your development process, and thoroughly consider how to test your medical device.

Keep the following in mind when developing a digital health solution

  • Establish clear requirements and a user interface that will allow your developer to proceed with early coding. Consider whether your technology will require any specific functionality, such as the use of an application program interface (API), to make the application accessible to mobile devices.
  • Perform system integration to bring your application together with other components of the business environment. For example, system integration for a digital health technology may involve combining custom software with existing electronic health records. Depending on the nature and complexity of the technology, you may be able to test this in a demonstration environment ahead of time.

Resources

FDA: Digital Health

The U.S. FDA provides information on laws and guidance documents that impact digital health innovations.

FDA: Design Controls

The U.S. FDA provides guidance on regulations to ensure that manufacturing design requirements are met.

Health App Developers HIPAA Q&A

The HHS provides information on how HIPAA privacy and security protections apply to digital health innovations.

Health IT Playbook

The Health IT Playbook helps small- and medium-sized physician practices implement and use health IT.

Artificial Intelligence for Health and Healthcare

The U.S. Department of Health and Human Services (HHS), with support from the Robert Wood Johnson Foundation, commissioned a study that assesses the impact that artificial intelligence could have on the future of public health, community health, and healthcare delivery.

Mobile Health Apps Interactive Tool

The Mobile Health Apps Interactive Tool helps innovators determine what federal laws apply to their digital health innovations.

Notice of Proposed Rulemaking to Improve the Interoperability of Health Information

The HHS proposed a rule to support seamless and secure access, exchange, and use of electronic health information. The HHS provides a variety of resources so that innovators can understand the proposed rule.

Fast Healthcare Interoperability Resource

The Fast Healthcare Interoperability Resource is a protocol for joining disparate data systems and a standard for exchanging healthcare information electronically.

International Organization for Standardization

The International Organization for Standardization develops and publishes international standards for medical devices and risk management.

International Organization for Standardization: ISO 13485

Medical device regulations in Canada require class II, III, and IV medical devices to be manufactured (class II) or designed and manufactured (class III and IV) under CAN/CSA ISO 13485:2003, an internationally agreed-upon standard that sets requirements for a quality management system specific to the medical device industry.

Interoperability Proving Ground

The Interoperability Proving Ground is an open community platform where innovators can share and learn about interoperability projects in the United States and beyond.

Investigational Device Exemptions for Early Feasibility Medical Device Clinical Studies

This document guides medical device innovators and other industry stakeholders on the development of investigational device exemption applications for early feasibility studies of significant risk devices. These studies allow for early clinical evaluation of devices to provide proof of principle and initial clinical safety data.

U.S. Core Data for Interoperability

The U.S. Core Data for Interoperability is a standardized set of health data classes and constituent data elements for nationwide, interoperable health information exchange.

EPICentre

EPICentre provides programs and services that are intended to help students and recent graduates start and grow their businesses.

Fast Forward Medical Innovation: Commercialization of Life Science Technologies

Fast Forward Medical Innovation provides information to help biomedical researchers accelerate their innovations from idea to impact. This presentation highlights medical device development, U.S. Food and Drug Administration (FDA) regulation, intellectual property, mentorship opportunities, and funding resources.

MaRS

MaRS provides venture services to support healthcare innovators and move them in the right direction toward commercialization.

Michigan Small Business Development Center

The Michigan Small Business Development Center provides counseling, training, and research for small businesses.

Office of the National Coordinator for Health Information Technology

The Office of the National Coordinator for Health Information Technology provides guidance on how digital health innovators can learn and track health information exchange standards and policies, consider consumer needs, and measure the clinical quality of health IT.

Small Company Innovation Program

The Michigan Corporate Relations Network Small Company Innovation Program, funded by the Michigan Economic Development Corporation, provides one-to-one matching funds up to $40,000 to Michigan small businesses to help cover the cost of conducting research projects at any Michigan public university.

SMART Health IT

SMART Health IT is an open standards-based technology platform that enables innovators to create applications that seamlessly and securely run across healthcare systems.

University of Michigan and Wayne State University

The University of Michigan and Wayne State University offer Michigan Translational Research and Commercialization Programs that support research projects in life sciences with high commercial potential.

WEtech Alliance

WEtech Alliance helps entrepreneurs launch new ventures and connect with academia; provides education and networking opportunities; and advocates for the region’s thriving technology and innovation companies.