MEDICAL DEVICE HARDWARE AND SOFTWARE DEVELOPMENT

NOVO specializes in medical device development services for Class I, II, and III FDA-regulated devices. The scope of our ISO 13485:2016-certified quality management system (QMS) covers a five-phase product development process (PDP) from concept through manufacturing transfer, including support for clinical trials and regulatory submissions. Our medical device expertise extends to both hardware and software development.

Medical device development differs from commercial hardware and software development in the level of human risk and regulatory oversight. There is a formal requirement to demonstrate safety and efficacy. Mistakes in planning or execution during medical device development projects will have a greater impact on time to market and total investment. A partnership with an experienced engineering team, familiar with the regulatory environment, offers greater predictability for both medical device startups and established medical device companies.

A PROJECT WITH NOVO

NOVO-managed projects are characterized by a steady increase in confidence as each technical risk is retired and each incremental milestone reached. Thoughtful planning allows parallel development activities that lead to schedule compression. Frequent hardware and software integrations allow system-level testing and characterization of critical parameters. Materials and manufacturing processes are considered from the beginning of the development. Design control documentation is generated concurrent with the development for straightforward integration into the design history file.

At the outset of a new medical device project, NOVO’s senior-level medical device engineering team works with clients to identify key technical risks and resolve them. With the technology well characterized, system architecture and design input requirements can be confirmed. At this point, a complete project plan that addresses partner roles and responsibilities, design and development, risk management, verification testing, regulatory submissions, clinical trials, and manufacturing strategies can be drafted.

With the foundation for an organized and efficient development now laid, the design and development process can begin in earnest. The value of NOVO’s onsite development tools, product development processes, and curated engineering staff becomes evident during this period, evidenced by requirements verified and milestones met.

A prototype assembly line at NOVO for building the design verification devices also provides an effective method of transferring design intent knowledge to the contract manufacturing partner. Once the design is transferred, NOVO provides ongoing support for design validation activities including clinical trials and regulatory filings.

At all stages of development, our objective is to increase our client’s confidence that foreseeable issues have been addressed, and to demonstrate that the criteria for moving to the next phase of development have been met.

General Medical Device Development Services

  • ISO 13485-certified
  • Development of verifiable design input requirements
  • Concept development
  • Functional, marketing, and clinical trial prototypes
  • Risk and hazard analysis and FMECA
  • Device detail design and development
  • Preclinical trial management
  • Biocompatibility and toxicity test management
  • Sterilization validation
  • Device verification testing and software validation testing
  • Industrial design (ID), human factors (HF), and user interface (UI) design
  • Design control and DHF documentation
  • Compliance with ISO, IEC, FDA QSR
  • Process validation and automated test equipment (ATE) qualification

Specific Medical Device Experience

NOVO’s medical device development team has experience with the following therapeutic and surgical device types: