Process

Getting your Project Started

Collaboration with DeviceLab starts with a discussion. You tell us what you want to do and we learn what resources and expertise the project will need to include. Next, we prepare a Project Proposal which includes a description of tasks to be performed, estimated timelines and costs, and the deliverables to be provided. If our proposal meets with your expectations, a Development Contract is executed and DeviceLab begins work. We like to start projects with a Kick Off Meeting with all stakeholders present to make sure we receive all inputs available.

Project Management at DeviceLab

Once a project is underway, DeviceLab keeps you in the loop. A Project Manager is assigned as a main point of contact for all business issues (budgets, billing, and reporting), but who also serves as technical leader for the DeviceLab team. We appoint designers and engineers to the team so that it is properly resourced, and prepare detailed Project Plans so that you can see all of the required tasks and can track progress against each one.

Project Plans lay out all formal Design Reviews, but the Project Manager often schedules informal progress meetings between them.

The Development Process

Because DeviceLab operates in the highly regulated medical device space, we employ a formal design process. It’s not enough that your product passes compliance testing, you need proof that the design was produced by a controlled process and that all unacceptable risks have been mitigated. Our development processes comply with ISO 13485, ISO 14971, and 21 CFR 820 to assure that you have that proof.

DeviceLab thinks about projects along multiple parallel activity tracks, as shown in the Road Map below. Most projects will incorporate tasks from all of these tracks.

The Intellectual Property Support Track describes activities intended to support obtaining patents to protect your product and associated technologies. While we’re not lawyers, we can prepare disclosures and provide technical review for patent applications.

The Product Design Track describes the tasks from research to design validation. This includes all the technology development, design and engineering work, testing, and documentation of the design.

The Risk Management / Design Controls Track describes tasks necessary to assure your device is safe and complete the Design History and Risk Management Files needed for regulatory approval.

The Manufacturing Track describes tasks required to ensure that your device is properly and efficiently manufactured with reasonable cost and high reliability.

The Human Factors / Usability Track describes the tasks needed to ensure that the design of your device addresses user needs, precludes use errors, and garners loyalty among end users. Importantly, it also includes the formal studies often expected in filings today.

The Compliance and Regulatory Support Track describes tasks directly associated with planning and executing a regulatory strategy for your product that assures timely approval, wherever you intend to market it.

Agile Software Development

DeviceLab employs Agile software development methodology. This means we operate in sprints, focusing on delivering testable components frequently while maintaining flexible requirements. Working with the product owner (you), projects are planned out and mapped into 2-week sprints, allowing for mid-sprint retrospective and course correction.  This enables us to quickly adjust to changes, adapt to handle issues, take advantage of discoveries, and prioritize our effort with you toward a successful delivery.

Using self-organizing teams and close collaboration with constant and ongoing pace enables us to focus on technical excellence and proper design.  Our approach values simplicity, and because we’re hardware engineers too, we know how to write software that exploits the strengths and avoids the weaknesses of the hardware it runs on.

In the highly regulated Medical Device space, Agile practices have to be adapted.  Requirements are usually more detailed, but importantly, still regarded as flexible. Documentation and Design Reviews are more formal, and validation is more comprehensive. But the Agile approach of short cycles of development and frequent deliveries can still be leveraged to manage risk and accelerate development.

Methods:

  • Adaptive software development (ASD)
  • Agile modeling
  • Agile unified process (AUP)
  • Disciplined agile delivery
  • Dynamic systems development method (DSDM)
  • Extreme programming (XP)
  • Feature-driven development (FDD)
  • Lean software development
  • Kanban
  • Rapid application development (RAD)
  • Scrum
  • Scrumban

Practices:

  • Acceptance test-driven development (ATDD)
  • Agile modeling
  • Agile testing
  • Backlogs (Product and Sprint)
  • Behavior-driven development (BDD)
  • Business analyst designer method (BADM)[44]
  • Continuous integration (CI)
  • Cross-functional team
  • Domain-driven design (DDD)
  • Information radiators (scrum board, task board,
    visual management board, burndown chart)
  • terative and incremental development (IID)
  • Low-code development platforms
  • Pair programming
  • Planning poker
  • Refactoring
  • Retrospective
  • crum events (sprint planning, daily scrum, sprint review and retrospective)
  • Story-driven modeling
  • Test-driven development (TDD)
  • Timeboxing
  • User story
  • User story mapping
  • Velocity tracking

Project Costs, Timelines and Deliverables

Customers always ask us, “How much will this cost?”, right before they ask, “When can I have it?”. That’s why we do our best to provide you with cost estimates and timelines at the beginning of the project and update them regularly as we proceed through the phases of development. Tracking reports accompany every invoice identifying progress against budget so that you’ll feel confident that we’re on plan. It’s also important to have agreement about exactly what kinds of prototypes you want (and how many of them). We want to be sure when we deliver prototypes that they should serve the purposes you have for them.

DeviceLab recommends that medical device development projects undergo several rounds of prototype development. We find that much is learned when we make and test prototypes, resulting in a better product and easier V&V. For the most complex projects, this is likely to mean a mockup or Appearance Model, a Proof-of-Concept test bed, an Alpha Prototype, a Beta Prototype, and a run of Pilot Production before routine manufacturing begins.

To help you understand how the Medical Device Development process typically proceeds at DeviceLab, we’ve produced a guided tour based on the movie “IronMan”.  Inventor Tony Stark went through several phases of suit design, starting with a single proof of concept prototype made from scrap.  He subsequently made improvements in design and function, performed testing, and built more units, ultimately resulting in production of an IronMan army.  This story parallels medical device development in that an iterative approach leads to the best results.  Depending on the nature of your product, costs shown in the tour could be $20,000 or $200,000.  Same thing for durations, where tasks could range from a few weeks to more than a year.  But the patterns shown in this tour generally hold true in our experience, and we use wisdom such as this in preparing our proposals and ongoing budget estimates.