Customer Insights Practice:
We provide custom and proprietary market research solutions and models to support Medical Device clients throughout the continuum of marketing process. Qualitative Research:
At Cetas Healthcare we believe that the art of qualitative research is best practiced by taking a disciplined and rigorous approach to gathering and analysing information. We use a repertoire of open-ended interviewing techniques, and informal method of analysis to gain an understanding of people’s attitudes, opinions, and behaviour.
Our specialist healthcare moderators are experienced in gaining insights through:
Quantitative Research:
Cetas Healthcare also offers full range of quantitative market survey methodologies including online surveys, personal quantitative interviews, and phone surveys. Our comprehensive portfolio of quantitative solutions for specific business issues includes:
Market Insights and Competitive Intelligence
Over and above the routine off-the- shelf market overview reports, often times our clients need a detailed view of the markets (market size, growth, forecasts, drivers, barriers, technology trends, pricing trends, etc.) and competitors (competitor characteristics, needs, views on supplier performance, investment plans, strategic direction, product pipeline, marketing strategies, financial data, expansion records and plans, etc.). We creatively identify and interview a variety of industry participants—including direct competitors—to provide a well-rounded, corroborated view of the salient competitive issues. We use ethical means to gather hard-to- find information on markets and competitors. Our specialists then analyze the findings, add insights, demonstrate clear implications to the client, and work with decision makers to develop action plans and strategies.
Medical Devices Strategy Consulting
We are a specialist consulting group, with a team dedicated solely to serving the medical devices/technology marketplace. We have domain experts and leaders in the industry, with decades of experience and background. Combined with our market research and customer insights capabilities, our output comes from integrating data, knowledge and intuition. Our expertise spans diagnostic imaging, interventional devices, monitoring systems, IT infrastructure, etc. Our breadth stretches from Asia to Europe to the Americas. Our competency includes business, technology, products, marketing, commercial and service. Our track-record includes successful projects in launching new products, troubleshooting existing markets, and making mission critical go/no-go decisions.
The road ahead is not the same.
On May 25th, 2017 a novel Medical Device Regulation (MDR) came into effect for the European Union, triggering a transition period of three years before the current Medical Device Directive (MDD) will be obsoleted by May 24th, 2020 .
Even before this date new revisions of the guidelines for the assessment of a Clinical Investigations (MEDDEV 2.7/2, 2015) and performance of a Clinical Evaluation (MEDDEV 2.7/1_Revision 4, 2016) came into force to ascertain an adequate Validation and Assessment of Regulatory Conformity for Medical Devices in Europe.
Simultaneously also for Medical Device Quality Management Systems (QMS) complying with the ISO 13485 standard the transition period to it’s most recent version (ISO 13485:2016) ends by February 28th, 2019. By then a risk based QMS approach needs to be demonstrated to comply with the new standard and obtain the re-certification under ISO 13485:2016, which is critical to our industry.
We offer advice in assessing how your current Medical Device Portfolio and future product releases will be impacted by these novel rules and standards, how to navigate the transition and how to establish an effective compliance to the latest Quality Standards and Regulatory Requirements for Medical Devices.