An Introduction to Active MedTech - a Biannual Review

Written by Luke Sy on 22nd July 2020

This seminar is an overview of the steps involved in developing and bringing an active medical device to market. An active medical device is any medical device which functions using some power source, usually electrically powered.

Regulatory Requirements and Standards

The strict regulatory requirement in the medical technology industry is perhaps the biggest differentiating factor that sets apart this industry from other industries. And since the device involves people’s lives, the strictness is justifiable. In the world, there are two notable regulatory bodies, the Food and Drug Administration (FDA) for USA and the Global Harmonization Task Force (GHTF) for the rest of the world. Regulations tend to refer to technical standards which are a set of requirements for repeatable technical task, and can be thought of as a developer’s friend that guides them (forcefully) to adhere to best practices for product quality and safety.

Concept to Deployment

Bringing a medical device from concept to deployment is no easy feat. 6-12 months of development time from concept to release is typical. Documentation file count can easily reach 100s to 1000s! It involves the following components whose size may vary depending on the medical device.

  • Industry design, where the designer ensures quality human-centric design for function, ease of use, (mechanical) safety, and branding
  • Electronics, which is where the “active” of active medical device came from. The electronic should not just function correctly, but should also not interfere with other electronics (e.g., electromagnetic compatibility, EMC) and immune to interference.
  • Software, where usually most of the work is done. Planning is extremely important here as documentation cannot be done retrospectively. Also beware of the difficulties involved in the use of software of unknown provenance (SOUP) (e.g., open-source code, operating system).
  • Design controls, verify and validate that the medical device satisfies user needs and the design input.
  • Manufacturing, which includes electronic PCB design, parts selection and management, testing and inspection, and assembly. Each sub-component ultimately affects the total unit cost of manufacturing.
  • Quality management system, which is in a way part of the regulation. It requires good process mapping and control of documents/records to ensure full traceability.

Funding can come from incubators/accelerators, investors, venture capitalists, entitlement and competitive grants (e.g., R&D tax incentive, Medical Device Fund, CRC-P, BMTH), etc. For private investors, investments to a company in its early stage tend to be very risky, hence, a greater return of investment is often expected. Due diligence can cost as much as $50,000, which affects the scale of investments. Legal considerations are also important, from nondisclosure agreements (NDAs), shareholder agreements, contracts, intellectual property (IP) ownership, and much more. Having the right funding and legal partner is key to successfully deliver a medical device to market.