Creating A Clear Market Pathway For Medical Device Manufacturers
It’s hard to imagine an area that demands our utmost vigilance and attention to detail more than medical device manufacturing. One production error can potentially mean the difference between life and death.
Today, according to the World Health Organisation (WHO), there are an estimated 2 million different kinds of medical devices on the world market, categorised into more than 7000 generic device groups.
A medical device can be any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination for a medical purpose.
So, what is the common denominator and key determinant of market introduction for these disparate product groups? The answer is: Safety of use.
That demands a complete understanding of the manufacturing process from R&D, through prototyping and tests, up to approval by the appropriate regulatory organisations such as the FDA in the US and Notified Bodies in the EU and more recently in the UK the Medicines and Healthcare products Regulatory Agency (MHRA).
Provide An Accurate Record
An important window on the production process is provided by tests and records, and that has traditionally required a set of protocols, sometimes paper based to demonstrate what has or has not been done, or put another way ‘evidence’.
In the world of medical device manufacturing, this evidence is compiled in a ‘live’ dossier, by linking often disparate data and information to provide an accurate record and all important ‘traceability’.
The tried and trusted format for documenting product development has traditionally defaulted to common tools such as Word and Excel. Whilst many companies rely on these products to document their dossier these formats are not really geared for the purpose.
With multiple-sourced information sets across various development cycles it is imperative to ensure all references are updated to avoid any inconsistencies. The potential to compound mistakes and errors is obvious and of real concern.
A Clear Roadmap
In answer to these mandatory requirements Compass creates a streamlined and automated process to link information. Consistency is ensured through identifying and logging everywhere you use an artefact risk/requirement/test. That means one change is replicated everywhere and you will always know what’s lined in a trace table. These are critical and essential parts of the dossier to deliver along with the entire specifications.
Traceability is a crucial part of the medical device manufacturing process and plays a critical role in ensuring product quality and safety.
The function of a traceability framework is to provide a clear roadmap of the medical device development process. It details why and how a product has been developed.
Maintaining a traceability matrix throughout the design and development cycle provides a high-level view of the connections that exist between User Needs & Specifications and how these will be validated and verified, respectively.
Reducing Risk: A Primary Goal
In light of the recently adopted EU Medical Device Regulation remains in May 2022.), European manufacturers of medical devices will face even tougher regulations to ensure their products are safe to use under new EU laws that were scheduled to come into effect from May 26th 2020, but enactment was deferred by one year to due to the COVID-19 pandemic.
Let’s put this in context. What are the cost implications for a typical R&D programme? INCOSE (International Council of System Engineering) neatly sums this up through its explanation of a Systems Engineering approach (universally accepted as the preferred methodology for product development). As product complexity increases reducing the associated risk continues to be a primary goal for the engineering team.
In a typical cost model, medical device development requires substantial investment from the get-go, but this steps up incrementally across the phases: Concept. Design, Develop, Production/Testing, Operations.
With little room in budgets for significant corrective measures, mistakes not caught in early stages can potentially derail a product development programme or at best delay market entry. Leading indicators can be utilized to monitor a system and detect if a risk is present or increasing over time during key development phases such as integration and test.
Bringing a device to market takes an average of 3 to 7 years, compared with an average of 12 years for drugs, and in some categories this has been super fast tracked (for example COVID-19 related). However, not many new products represent the big bang introduction of a new invention, as most are the result of iterative or incremental improvement. The resulting shorter lifecycle of today’s products is also subject to increasing uncertainty, placing even more emphasis on a systemic and measurable approach.
This does demand a highly focused strategy that is navigated by insight to your process and the sense you’re on the right track. You can’t afford to divert into the wrong area. Enter traceability: helping you to understand that you are on track, and that you’re developing the right product through the optimal process.
This is where Compass takes on a real and predictive role. Traces from design inputs, tests, risks, all need to be visible, ensuring control and risk mitigation. The system automatically builds trace tables in Compass, through the work people do inside the product — alongside where all of the analysis is carried out. This helps with short time to market as all information is created from day one.
The Design Controls templates provided in Compass include a detailed set of out-of-the-box, non-editable trace matrices that can be exported to PDF for use as part of a larger submission. These trace tables automatically pull in information entered during the Design Controls exercise, building a larger picture of the numerous connections between requirement levels, as well as risks and tests.
If any info is changed, it will change across the dossier – including the trace table. The Design Controls template comes with a comprehensive workflow that includes approvals, reviews, and electronic signatures as required by 21 CFR Part 11. The workflow allows for total document and item control for any given project.
Dossier evidence is delivered using trace tables, also applicable for products that are replicated or changed such as e.g. handheld diagnostics devices for blood analysis. These could also be used to analyse saliva for drug testing. Each has specific requirements but different purposes yet the platform was almost exactly the same.
For variant products like these, most of the ground work is already there. In this case the manufacturer developed new generations of the platform and features– without having to start from scratch, demonstrating versatility and how the process can be built upon and adapted to suit different user needs.
Resolving Issues Quickly
Post-product analysis is also important. This information can be fed back and problems fixed. By providing a complete 360 degree view and traceability, issues can be resolved quickly for the next version of products.
This is why a powerful traceability tool is an essential part of the medical devices manufacturer’s fast track pathway to market introduction, whilst ticking all the regulatory and safety control boxes on the way.