Helping Medical Device Businesses To Balance Fast Development & Meet  Regulatory Frameworks

When does product development become a matter of life and death?

There are high stakes riding on the development of medical devices and manufacturers. Everyone from startups to global players often only get a limited opportunity to jump from prototype to a wider market acceptance. The price of failure can be punishing!

The development cycle of medical devices is very short – a third of the devices developed and sold are younger than three years.

Meanwhile, the forecasts – independent of COVID-related products – are significant with the European medical devices market projected to reach USD 60.31 billion (€49.9 billion) by 2025 from an estimated USD 47.99 billion (€39.6 billion in 2020, at a CAGR of 4.7% during the forecast period.

Considering that around 95% of all medtech businesses are small and medium-sized companies (SMEs) keeping pace with leading global players requires a nimble, agile approach.

This is why SaaS-based solutions like Compass enable customers to structure their data and automate their design, risk and test management processes – helping delivering their products to market faster and with less risk.

Truly integrates risk, requirement, and test management

Based on our track record as a software and technology consultancy, Synergio joined forces with US-based software developer Cognition to support the dynamic global medtech market.

The Synergio team, headquartered in the Netherlands, is spearheading the Europe-wide rollout of Cognition’s Compass platform – the only solution that truly integrates risk, requirement, and test management for a fully automated design control process. It includes built-in, enforced processes as prescribed by quality management and risk management standards and regulations to meet reporting and regulatory submission needs.

Founded 20 years ago as a consulting company, Synergio has worked across a range of sectors from banking and insurance to industrial applications and medical devices. Focused on helping clients, we ensure that requirements critical to the successful operation of a business and development of new products are met through state of the art processes and protocols.

These need to check off against regulatory and quality boxes that ensure a product meets stringent benchmarks, and in the case of medical devices, gain approval from statutory organisations such as the US FDA (Food and Drug Administration) and Notified Bodies in Europe.

Help deliver products to market faster, minimising risk

The necessity to provide evidence that medical device products deliver on their promise is central to the successful development of businesses in this highly competitive sector. Failure to comply can disrupt introduction at best and close down a medtech company at worst. With Compass, progressing through the design and development stages while enforcing risk and quality management processes, automatically submission-ready deliverables are created, allowing companies to deliver products to market faster, minimising risk

Smaller medical device developers can leverage the benefit of a SaaS tool

Through offering a full suite of tools – consulting, training and tooling – to provide a real solution to our customers, the Synergio team is able to optimally deploy and support the implementation of Compass with integrated reports from one environment. Importantly, because Compass allows for automation and data consistency it can reduce the time required by Regulatory Consultants so they can focus on real regulatory assistance, again helping new entrants and start ups.

For the first time smaller medical device developers can leverage the benefit of a SaaS tool – essentially an out of the box product with documented protocols and templated reports targeting both the development team as well as regulators and auditors. The enterprise solutions offered by other vendors in this market require significant investment in time and resources before they can be deployed, which commodities that start up don’t often have to hand!

In this way we are able to provide the entire bandwidth of the medical devices market from small (including university spin-offs) to large sized players (multinational manufacturers and pharma businesses) with consulting power and processes that can help them get to market, avoiding potential pitfalls and penalties.

Request a Demo and See How Compass Can Help You Get to Market Faster, With Complete Traceability.