Zero Margin For Error: Managing Change In Medtech
The medical device industry is heavily regulated for a reason. Without a rationale, checks and balances, evidence, and assurance of safety, change management in medtech could become potentially life-threatening.
The tiniest alteration to a device’s design needs a full evaluation and analysis of the potential impact. So it’s also critical to contain unrealized changes and their impact within isolated work-streams, before revealing them to the wider team.
This process ensure that checks and authorization are carried out before changes are rolled out across research and development, and into production.
Complex Change Audits
From a regulatory standpoint, the auditing of change can be overly-complex. Problems such as understanding verification and authorization arise if the correct processes are not in place. Ordinarily, this includes an audit trail using date and time stamps to record changes made by designers and regulators.
Furthermore, it’s vital to see what has changed from one point in time to another. Most devices are Class B (variants of a previous device). And when you’re working with a previous design, you’re making modifications that range from minor to major. Transparency is the key for seeing changes relative to the original design.
Iterative development from legacy products also involves meeting the latest regulatory updates, retrospectively incorporating changes, versions, product updates, and so on – but these become an issue in terms of cost benefit and have the potential for inherited errors.
Software like Compass enables medtech organizations to document their information in a controlled and auditable environment, helping them to author, review, and approve the documents required for regulatory submissions and audits.
Compliance As Part Of The Business Model
The alternative to tightly tracking changes to legacy products is abandoning their development altogether and switching instead to new product development.
At the very least, coming under scrutiny from the regulatory authorities, and having to revise and back track to check on the change history, is in itself an expensive exercise.
Managing change is a fundamental part of the business model – for medical device innovators, designers, and manufacturers. Technology is in a constant flux of change.
Connectivity with other devices creates complicated issues around safeguarding and compliance. And as the technology gets smarter, so do the protocols and processes needed to keep up with changes in the product lifecycle.
Realizing The Value Of Reusability
The challenge of assessing the impact of change is followed closely by the ability to manage changes to existing devices. This is not just iterative – it may mean mixing and matching across product sets, and having to update all evidence.
Making changes to a legacy device necessitates traceability in the context of the new regulations. A software tool like Compass can also be updated to accommodate perpetually evolving requirements, such as the EU Regulations for medical devices (MDR).
With Compass, medical device companies can repurpose base products, and reuse documents with only minor changes. Not only that, it enables you to iterate on multiple levels, and reuse entire projects.
Accounting for change needs to be considered carefully, and it doesn’t have to be a logistical nightmare. Using a software tool like Compass can improve efficiency and create a link between medical legacy products, future iterations, and totally new concepts.
All in all, that means you can manage change safely and more effectively, ultimately getting your product to market faster in an increasingly competitive environment.
