There’s no shortage of words in print and online written by regulators, consultants and software developers about the rigorous requirements governing medical device development. But what do you really need to be successful in this sector?
What could possibly go wrong?
Obviously, there's a lot to say about this subject and a lot that can go seriously wrong. That’s why the ISO 13487 handbook alone weighs in at 819 pages and retails at £119 - it’s an indispensable guide to everything you need to do to attain the standard and develop products safely - but maybe it’s a daunting place to start.
Likewise, there are many SAAS solutions designed to help businesses get to market with their med tech. But they tend to be targeted at mature organisations with large, distributed teams. These are the teams that have the time and resource to start organising their documents and commercial approach in highly prescriptive ways to ensure consistency and compliance. These solutions can take months to install and a similar length of time to learn to use effectively.
Too much process?
But for those starting out, or those with an existing business wishing to apply their technology to the medical device space for the first time, trying to start documenting their processes using these kinds of eQMS (electronic Quality Management Systems) may feel like using a sledgehammer to crack a nut.
On the other hand, there are those, who from the beginning, don’t take any steps to capture and record their procedures systematically. These are the developers who get ‘stuck in’ straight away, ideating and prototyping before they start worrying about governance and their approach to quality.
In time, though, they will likely find themselves bogged down or even stopped in their tracks, by all the operational and regulatory documentation that they will be called upon to evidence. In our experience, even those who set up DIY document management solutions, using Dropbox or Google Drive, soon find themselves butting up against their limitations as med tech development solutions. They often find those pieces of software inadequate against the change control, phase gating and auditing demands of the regulation.
What does the ideal solution look like?
But if some approaches will be too perfunctory to satisfy the regulation, while others are too complex and uncompromising to make commercial sense, what would an ideal solution look like for an agile SME with a great med-tech idea that they want to develop and bring to market?
The truth is, when it comes to medical device development, there are some things you really need. And beyond the initial product inspiration, all those basic needs around operational efficiency and regulatory compliance can be answered by deploying the right Document Management System.
Because it is your document management system (DMS) that will help you define and disseminate your quality processes across your organisation, impose the necessary change controls for your design iterations, phase gate your development cycle in line with regulation and provide the necessary auditing tools to evidence compliance.
In effect, it is your DMS that will become your Quality System, to demonstrate the way your approach enacts its principles and delivers the required quality outcomes for your business.
So, what do you really need for successful med-tech device development?
What you really need is a document management solution that:
1. Lets you easily store and index the documents that record all your quality processes and procedures.
It should make them visible and accessible to those who need to use them every day. This is the fundamental requirement of any Quality Management System, that its principles and procedures should be documented in such a way that everyone in the organisation knows what they are, how they work and their responsibility for implementing them.
2. Gives you rock solid change control.
Successful medical device development requires quality systems that have trackable, auditable version histories, showing how they have evolved over time and ensuring they cannot be changed accidentally. At the same time, these rigorous change controls need to extend the design processes themselves. You need a DMS that ensures that everyone in the business, can see the change history of vital plans and specifications, as well as can the difference between final drafts and issues of documentation.
In medical device development there can be no room for ambiguity about which iteration is the latest, approved version of the key documents from which everyone should be working.
3. Provides a means of supporting a phased gated design and build project.
Phase gating of the medical device design and build process is mandated by ISO 13485 and the regulation. A document management system should help you:
- Define the requirements of each design phase
- Gather all the input documents necessary to contribute to the output in one place
- Assemble the final outputs - the next iteration of designs, plans, specs etc.
- Get those outputs approved by key stakeholder against the established acceptance criteria
- Approve and publish those documents to green light the next phase
This a key element of the ‘risk based thinking’ approach, the cycle of plan, act, do, check that ensures the correct execution of a plan against its fundamental requirements.
4. Offers great communication tools.
The Document Management System you choose should support great communication within and beyond your organisation. It should support the gathering, sharing and approval of required documents through intranet and extranet between internal teams as well as external suppliers and other bodies. It should help keep information flowing between all project stakeholders, and ensure the project’s momentum through reminders, notifications and alerts.
5. Supports the verification and validation processes integral to the regulation
Verification and software validation are vital parts of medical device development. The right DMS can and should give you easy visibility of the design specifications and engineering requirements - and require those to be verified and validated against the final designs and the delivered product itself.
6. Helps you audit at ‘the touch of a button’
A seamless auditing function is also central to the successful delivery of a medical device development project. In most med-tech categories you must be audited before your product can legally be marketed. For example, the FDA describes at least 3 formal document compilations that you must prepare for auditing before your product can be approved. These include the Design History File, Design History Record and your Design Master Record. The right digital Document Management System can help you compile and publish Technical Files of this kind, practically ‘at the touch of a button’ and with minimum disruption to your business. Don’t forget, depending on the classification your product fits into, you may be liable to ongoing and random audits as well, so having a system that can automatically generate, on demand, the answers and file compilations you need, will make life much easier for you.
7. Scales with the challenge
A good DMS solution needs to be scalable. At the beginning of your development process, it needs to operate as a basic digital framework for your quality system, a repository for the regulatory and operational documentation that you are assembling. However, as you grow and begin to move beyond ideation it should be able to support more sophisticated project management and collaborative capabilities (phase gating, design control etc).
The regulation surrounding Medical Device Development is increasingly based around Risk Based Thinking, an approach which encourages the governance measures you take to be commensurate with the level of risk of harm, that the failure of those measures could represent.
Choosing a scalable, flexible DMS should allow you to work at the basic level of risk and compliance management to start with, then add the tools and functionality which will grow it into a fully blown, auditable medical device quality system as your project develops.
8. Makes compliance and risk management the ‘way you do things’
The most important element of all this is that you choose the tools that will help compliance, risk based thinking, and quality management become simply the ‘way you do things’.
Having the framework for ‘quality thinking’ in place from the beginning of your project - concentrating on what you really need in terms of document management - will help your business become process driven and compliant in everything you do.