Pre-Development – Initiating Software as a Medical Device (SaMD) Project

by Tomasz Puk | Mar 09, 2020

When you, as a Client, would like to start a new software project with the goal to develop a Software as a Medical Device (SaMD) product, we would like to encourage you to start with a short Pre-Development phase. We will be working with you on gathering initial product requirements, adopt a regulatory strategy, and prepare for the official start of the Design and Development phase.

Why Pre-Development for Software as a Medical Device?

The main purpose of that phase is to align both the Client and Pro4People around the way the medical device software development project will look like. There is no further commitment on the Client’s side beyond the agreed Pre-Development phase which lasts between 2 and 4 weeks. Our basic team consisting of a Senior Project Manager and Business Analyst will be working daily with your product team on understanding and defining the product vision to be developed. The second goal of this phase is to prepare a set of initial documents required by ISO13485 chapters 7.2.1 (product requirements), 7.3.3 (design and development inputs) as well as ISO14971 standard.

As a tangible outcome, after this quick phase, both sides will have had a high level documented product vision, the initial set of Design and Development Inputs required to formally start Design and Development phase and, last but not least, more practical knowledge of how to work together. As a Client, you can commit yourself to proceeding to the Design and Development phase or just pause the project after its Pre-Development.

Face-to-face Product Workshop

The Pre-Development phase usually starts with a face-to-face one-week workshop. The workshop can take place either on Pro4People’s premises or at the Client’s location. All communication and documentation will be handled in English.

From the Client side, it is recommended to invite:

  1. Product Manager / Product Owner – a holder of the product vision
  2. Service Manager (optional) – a person who will be in charge of the solution provisioning phase after your product goes live
  3. Quality Manager (optional) – to discuss where the Client’s, and where Pro4Pople’s ISO13485 certified Quality Management System will be used (the so-called process tailoring activity)
  4. Optionally, other roles if required

From Pro4People side, we will usually bring:

  1. Senior Project Manager with the experience in developing Medical Device Software
  2. Senior Business Analyst who will be a communication proxy between the product team and the project team in the Design and Development phase
  3. Optionally, our Quality Manger or Regulatory Consultant – in order to support process tailoring but also, if needed, to take the leadership in respect of regulatory strategy, software safety classification etc.

During the workshop, the communication is centered around the understanding of the Client’s product vision. Our team will focus on grasping the product idea, value proposition, and business model. We will be looking for any tangible deliverables from the Client’s side to see how many of them can be later converted into formal Design Inputs.

During the meeting we will also go through the who-is-who activity assigning people both from the Client organization and from Pro4People to an already defined product and project team structures. The findings will facilitate the communication in the future and will be used next to create a Project Charter document.

After the Workshop

After the workshop, we will be working in a Kanban mode with your product team. We usually use the Confluence tool to create engineering documents, JIRA for project planning, and ins2outs platform for regulatory documents. Our efforts are usually focused on the three main streams:

  1. Building rudimentary product solution architecture
  2. Understanding and documenting your product and its value proposition on a high level
  3. Preparing required documents for the official Design and Development start

Solution Architecture

After the workshop we can break down your envisioned solutions into engineering components and present them in a high-level solution architecture context diagram. Our goal is to identify elements of the overall system, software units, and interfaces between them. That kind of the input helps to present which software development life cycle roles will be required to implement the overall solution. We will also be briefly discussing technology choices, cloud providers, local hosting issues in order to get ready for the GDPR compliance in the future. Additionally, we would like to understand the integration of your new product with the other ones, edge devices, interfaces or systems in your organization.

Product Vision – Value Proposition

The second stream of actions, lead mostly by the Business Analyst, is focused on your product vision. We would like to identify personas / users who will be working with your solution. On such basis, we will document user stories and other detailed designs in Confluence.

We will configure your Confluence and add our page templates so that the whole framework can be standardized, and nicely presented on your infrastructure.

Our Business Analyst will help your product team to work on your Product Requirements, prioritize them and prepare as an input for Design and Development. No worries, product requirements can always change after the project start but you will still need a certain version of them to be presented as one of Design Inputs to the auditor in the future.

The user stories will be prioritized and turned into the initial elements of the Product Backlog. As we value Agile approach to software development a lot, our Business Analyst will be working with your Product Manager on documenting these user stories, which shall be implemented in the first Minimum Viable Product (MVP).

To sum up, the main goal is to again align both product and project teams on product vision. Secondly, we need to understand the complexity of the product. As a result, we will create a ballpark estimate of the project cost, a high-level schedule as well as the proposed team configuration assuring successful project execution.

Preparation of Design and Development Inputs

The last stream of activities in our Pre-Development phase will be focused on formal deliverables required to prove compliance with the standards and regulations, such as ISO 13485, ISO 14971, IEC 62304, Medical Device Regulation (MDR) or 21 CFR 820. The goal here is to prepare the initial set of the documents which are required at the moment of starting the Design and Development phase in line with ISO 13485.

Our Project Manager, together with your product team, will be working on the following deliverables, using our document templates for that purpose:

  1. Intended Use (aka Intended Purpose) – the description of use for which a SaMD is intended in the medical context.
  2. Product Requirements Specification – a documented list of product requirements according to ISO 13485 7.2.1 applicable to Software as a Medical Device
  3. Documenting regulatory requirements – a list of regulatory requirements, which shall be provided as an input to Software Development Life Cycle Process
  4. Initial Regulatory Strategy – a plan presenting preliminary assumptions about classes of medical devices for a product as well as selected methods of launching a product onto a market
  5. Overall Software Safety Classification – an assumed software safety classification documented in the initial Solution Architecture
  6. Risk Management Plan – a document which shall be created at the beginning of a product life cycle. It provides obligatory input for risk management activities conducted during the Software Development Life Cycle in compliance with IEC 62304.
  7. Risk Control Measures to be implemented in the software – a list of risk control measures, if applicable, which shall be implemented in the software.
  8. Process Tailoring – an activity focused on identifying where in SDLC Client’s or Pro4People’s QMS shall be applied.
  9. Documentation Index – a list of formal deliverables, based on the software safety classification, expected at the end of the Design and Development stage.

Depending on your team’s expertise in working in a regulated project environment, we can take over the leadership and even provide training on IEC 62304. Our common goal is to turn the product vision into tangible documents, compliant with Documentation Management Procedure, which can be identified as inputs at the moment of starting the Design and Development phase of Software as a Medical Device (SaMD).

If needed, our Regulatory Consultant can advise you on the regulatory aspects of developing SaMD. We have expert consultants who have specialized in Software as a Medical Device regulations for over 10 years. Should you seek any advice, training, or even management system definition in the domains of ISO 13485, ISO 14971, IEC 62304, ISO 27001 or GDPR, we are ready to provide such a service as well.

Learning how to Work Together

The next important outcome of the Pre-Development phase is learning how to work together. We value Agile/Maturity approach to project development. That means our work will be usually divided into two-week-long sprints or a continuous Kanban phase. We will be communicating at the sprint planning meetings, reporting progress on daily stand-ups and exchanging communication online through such tools as JIRA, Confluence, ins2outs, or your own preferred project communication and collaboration tool. We value transparency in communication and embrace change in the project execution.

On the other hand, we will be working on regulatory deliverables, carrying out the obligatory activities derived from standards or regulations. That part addresses the Maturity aspect of managing SaMD projects.

During the Pre-Development phase both sides can learn that cooperation can result in a successful implementation of the medical software product.

Pre-Development for SaMD Summary

When we reach the end of the Pre-Development phase, you will be ready to officially start Design and Development as required by ISO 13485 and 21 CFR 820. Both sides will have a much better understanding of what the first MVP version of your product should comprise. The high-level architecture and technical feasibility will be assessed and communicated. Finally, you will know what working with Pro4People looks like. If you like, we will be able to prepare ballpark project schedule and much more reliable team configuration proposal. Now you are ready to take a decision to go into Design and Development and start developing your Software as a Medical Device product.

Should you wish to learn more, or talk to us about supporting you in such a project,
please feel free to contact us, use the form below.

Above we have discussed the Pre-Development phase of Product Life Cycle and Software Development Life Cycle. Should you wish to talk to us about supporting you in such a project, please check out one of the below links.

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