In-vitro Diagnostics
After rapid growth during the pandemic, the IVD industry is currently going through a partial reset against backdrop of changing regulatory frameworks and supply chain challenges. COALITION partners with organizations that provide devices to support the diagnosis of a wide array of medical conditions.
In 2022, the COVID-19 testing added about $30 billion to the revenue of the IVD industry. A significant decrease in device and testing sales in 2023 however confirms the predicted reduction in revenue in this area over the coming years. Challenging market conditions are further exacerbated by factors such as notable price drops for some IVD tests, and the emergence of lower cost IVD providers. These factors are contributing towards slowing the growth of the overall diagnostics industry, which has led the search for new avenues for expansion.
Future progress of the industry will hinge on developing more efficient, faster, user-friendly, and IT-compatible devices for a range of new protein and molecular markers. However, the speedy introduction of these products is somewhat hampered by global conflicts and changes in regulatory policies. For example, the regulations introduced by the European Union in the form of In Vitro Diagnostic Regulation (IVDR, EU 2017/746) have posed new challenges.
The IVDR has heightened the requirements for clinical evidence, performance evaluation, quality assurance processes, and after-market surveillance. This change has presented a complex scenario for many IVD manufacturers, especially since the availability of Notified Bodies continues to be a challenge. Despite the rise in costs and resources dedicated to regulatory compliance, the IVD industry is slowly adjusting to these changes and moving forward.
COALITION helps companies as they tackle conflicting requirements and strive to excel in the increasingly challenging global market. With a deep understanding of market dynamics, industry trends, and regulatory complexities affecting product development in the wider MedTech industry. COALITION works with IVD companies to develop collaboration excellence to supercharge strategic innovation and transformative change.
How COALITION helps
At COALITION, we support clients across the IVD industry. We work closely with organizations to get a deep understanding of their challenges and provide meaningful support. Our team of consultants consists of experts who have years of experience working with clients to solve complex problems. We pride ourselves on delivering high-quality solutions that make a significant impact on our clients’ businesses.
COALITION can work on an advisory basis or alternatively can embed experts within organizations to help drive the change that is required and deliver progress towards defined targets.
For more information please use the Contact form or email enquiries@coalition.ltd
Collaboration Management
Helping IVD organizations organize and manage development projects for optimal outcomes.
Business Transformation
Whether revolution or evolution is required, COALITION supports change programs required to allow organizations reach their full potential.
Innovation Management
Facilitating teams in selecting, prioritizing and driving IVD R&D projects to align with commercial targets.
Mat Stratton - Principal Consultant (MedTech & Combination Products)
Mat has over 20 years experience of establishing and leading technology and service businesses within highly regulated industries. During this time, he has been able to grow organizations successfully based on driving rapid development of complex new products as well as innovative services whilst ensuring compliance to all relevant regulatory frameworks.
Stewart McKinlay – Senior Consultant (MedTech & Combination Products)
Stewart is a pioneer in the development of products across an array of medical sectors such as Wound Management, Ortho-Biologics and sensors/data / Apps. With 20 years experience at a senior exec level in the UK’s largest MedTech organization, he has been instrumental in over 60 new product launches and 12 company and technology acquisitions.