The market opportunity for air treatment products has expanded as the world learns to live with COVID-19. Demand for solutions that improve indoor air quality is high across multiple sectors. It’s an area that’s ripe for innovation, and manufacturers are exploring new approaches for domestic, commercial and medical applications. One category gaining attention is air treatment devices. In this paper, Sagentia Innovation and TSG Consulting look at enabling technologies and the associated technical innovation challenges. We also consider the complexity of getting these products to market, spotlighting the regulatory landscape in the United States. Our goal is to help innovators and manufacturers accelerate progress with the creation of compelling products that satisfy customer needs and stringent regulatory requirements. 

TSG’s Laurie Clarke and Sagentia Innovation’s Rob Morgan and Eduardo von Ristow have a round table discussion about how to integrate FDA regulatory strategies and a well-crafted value proposition into medical device development, and the benefits of this one-team approach. The discussion focuses on real issues faced by those involved in developing, assuring compliance and quality, investing in, and marketing medical devices. Kate Marchio asks the table questions on how to navigate the 510(k), De Novo, and PMA routes to market, translate concepts into products and maximize their chance of success by better understanding different stakeholders' needs, technology feasibility and commercial viability. They share real-world examples of design, approval, and value-based product differentiation challenges, as well as practical tips for overcoming them based on their experiences with a wide range of medical devices. 

On 14 October 2020, the European Commission published a Chemicals Strategy for Sustainability (CSS) which will have a major impact on the chemicals supply chain. The CSS promises to remove endocrine disrupting and other hazardous chemicals from everyday products such as cosmetics, detergents, furniture, textiles and food contact materials, and put forward actions to achieve a non-toxic environment.

In anticipation of the changing regulations, a multinational corporation with a large portfolio of products that use food packaging approached TSG and Leatherhead Food Research for help in identifying substances which may not be available for food contact use in the future.

In the EU, certain packaging must meet the requirements of Regulation (EU) 10/2011, which sets out safety requirements for plastic materials and articles intended to come into contact with food. Only the substances included in the Union List of authorised substances, as set out in Annex I, may be intentionally used in the manufacture of plastic layers in plastic materials and articles.

The CSS states that the generic approach to risk management used in REACH & CLP will be applied to food contact materials, including those on the Union List. Substances on the Union List with certain intrinsic hazards may not be available for food contact use in the future.

TSG’s toxicology specialists and Leatherhead’s food contact experts worked together with the client to define those intrinsic hazards that may be of concern, for example substances with carcinogenic, mutagenic and endocrine disrupting properties. Our consultants then used their own expertise, along with other sources such as CLP notifications and endocrine disruptor lists, to identify all potential substances of concern and then cross-referenced their list with the substances on the Union List.

Our specialists advised the client that approximately 10% of the Union List are substances of concern that may not be available in the future. Armed with this information, the client is currently working to substitute the substances of concern with less harmful alternatives as part of its commitment to protecting the planet.