como a urgência de Mudança climática O número de regulamentos de ESG na União Europeia aumentou rapidamente e mais é esperado nos próximos anos. Em seguida, as empresas precisam se preparar para cumprir. Eles também estão incorporando políticas ambientais, sociais e de governança (ESG) e de conformidade em sua cadeia de valor de maneiras inovadoras. A Lei da Alemanha sobre a due diligence corporativa nas cadeias de suprimentos, por exemplo, estipula multas de até 2% da receita média anual. E quando as empresas vão além de apenas o cumprimento, suas ações os colocam em uma posição melhor em várias frentes: licitar competitivamente em compras e criar uma vantagem de custo, obtendo acesso a financiamento atraente para tecnologias verdes, fornecendo maior transparência para investidores e clientes, e tornando a empresa mais atraente como um empregador. ambiente. As emissões de gases de efeito estufa de saúde (GEE) representam quase 5% das emissões globais. Se o setor de saúde fosse um país, seria o quinto maior emissor de gases de efeito estufa. (Veja a exposição.) Esse aumento está em cima de uma proliferação de requisitos regulatórios do produto para proteger a saúde do paciente-por exemplo, protegendo-os do risco de infecção-e para garantir que os produtos beneficiem pacientes. Dessas quatro áreas, a conformidade com o produto é especialmente relevante porque mais de 50% das emissões de GEE de Medtech decorre do próprio produto, uso de uso e descarte de produtos. Além disso,
To navigate this increasingly complex environment, European medtech companies must understand the current regulations (including the European Sustainability Reporting Standards) and those that are being considered (such as a directive on corporate sustainability due diligence). Then, companies need to prepare to comply.
Leading medtech companies are deploying a regulatory-watch process in their value chain—a novel way to track new and upcoming regulations. They are also embedding environmental, social, and governance (ESG) and compliance policies across their value chain in innovative ways.
These actions protect companies from noncompliance-related fines, which can be quite high. Germany’s Act on Corporate Due Diligence in Supply Chains, for example, stipulates fines of up to 2% of average annual revenue. And when companies go beyond merely complying, their actions put them in a better position on several fronts: bidding competitively in procurement and creating a cost advantage, gaining access to attractive financing for green technologies, providing greater transparency for investors and customers, and making the company more attractive as an employer.
Environmental Regulation Is on the Rise
Medtech companies, like others in the health care industry, have had a significant impact on the environment. Health care greenhouse gas (GHG) emissions account for almost 5% of global emissions. If the health care sector were a country, it would be the fifth-largest greenhouse gas emitter.
Over the past 20 years, the number of ESG-related regulations relevant to medtech companies has risen dramatically. (See the exhibit.) This increase is on top of a proliferation of product regulatory requirements to safeguard patient health—for example, by protecting them from the risk of infection—and to ensure that the products benefit patients.
Currently, ESG-related regulations fall into four key areas: product compliance, compliance of the company’s internal operations, third-party risk management, and reporting compliance. Of these four areas, product compliance is especially relevant because more than 50% of medtech GHG emissions stems from the product itself, product use, and product disposal. Moreover, Produtos MedTech Contribua significativamente para os resíduos hospitalares através de produtos de uso único, embalagem e expiração do produto. Para atingir esse objetivo, muitos estão direcionando o design e o desperdício do produto. Isso inclui:
The increasing number of product regulations have a specific ESG-related goal: to reduce negative environmental impacts. To accomplish this goal, many are targeting product design and waste.
Product Design. Several EU regulations and directives regarding product design are especially important for medtech companies. These include:
- The directive on the restriction of use of certain hazardous substances in electrical and electronic equipment (the so-called RoHS directive)
- The regulation concerning the registration, evaluation, authorization, and restriction of chemicals (REACH)
- The restriction of lead in polyvinyl chloride and copolymers products under the REACH regulation
- A proposta de proibir substâncias perfluoroalquil e polifluoroalquil
No entanto, não há regulamentação ou diretiva específica de plásticos de produto no horizonte. Em vez disso, a estratégia de plásticos da UE é transformar a maneira como os produtos plásticos são projetados, produzidos, usados e reciclados na UE. Eventualmente, todos os plásticos usados na UE provavelmente serão recicláveis, embora as empresas Medtech possam ser parcialmente isentas, uma vez que alguns produtos plásticos da Medtech se contaminam durante o uso.
Gerenciamento de resíduos e reciclagem. A diretiva sobre resíduos de equipamentos elétricos e eletrônicos (a chamada Diretiva WEEE) exige que as empresas evitem ou reduzam o impacto da embalagem secundária no meio ambiente. A Diretiva da Estrutura de Resíduos se concentra na redução de resíduos de fabricação e no descarte de produtos de uso único. E a proposta de regulamentação sobre embalagens e resíduos de embalagens exige que a embalagem seja reutilizável ou reciclável e tenha um rótulo com o nome do fabricante. Em 2017 e foi revisado em 2021, também fornece orientações sobre o reprocessamento de produtos Medtech, postulando que as empresas devem assumir a responsabilidade pela segurança dos produtos reprocessados. Para cumprir esse regulamento, além de realizar benefícios comerciais, as empresas da MedTech precisam fazer alterações em toda a cadeia de valor, desde o design do produto até o estágio de final de vida. The EU has also developed some important waste management regulations that companies should keep an eye on. The directive on waste from electrical and electronic equipment (the so-called WEEE directive) requires companies to prevent or reduce the impact of secondary packaging on the environment. The waste framework directive focuses on reducing manufacturing waste and the disposal of single-use products. And the proposal for a regulation on packaging and packaging waste requires that packaging be reusable or recyclable and have a label bearing the manufacturer’s name.
To comply with these different regulations and directives, companies need to start thinking about waste management and developing a strategy to produce and use reusable or recyclable packaging for their products.
Article 17 of the EU’s medical devices regulation, which took effect in 2017 and was revised in 2021, also provides guidance on the reprocessing of medtech products, postulating that companies must assume responsibility for the safety of reprocessed products. To comply with this regulation while also realizing business benefits, medtech companies need to make changes across the value chain, from product design through the end-of-life stage.
Adotando uma mentalidade proativa
To ensure continuous compliance across the value chain, medtech companies need to adopt a proactive mindset to the changing ESG regulatory landscape. This means developing and implementing a regulatory-watch process that ensures agility so companies can respond.
Designing and Implementing a Regulatory-Watch Process
Staying on top of emerging regulations requires medtech companies to deploy a regulatory-watch process: a novel way to monitor new and upcoming regulations—including laws, bills, and guidelines—as well as market standards. There should be a checkpoint for identifying legal amendments on a regular basis so that there is sufficient time to respond. In addition, companies should evaluate whether there are areas where they want to do more than comply in order to create a strategic advantage in the market.
There are three key steps for ensuring that a regulatory-watch process is designed and implemented effectively.
Clarify the roles and responsibilities for different types of regulatory risk. Before setting up a process, medtech companies should conduct a holistic overview of the regulatory landscape and the relevant risk types that need to be monitored, with a focus on ESG-related regulations. Such an assessment enables companies to identify the roles and responsibilities needed to anticipate and respond to the regulations that affect them.
Develop a regulatory-screening hub. Medtech companies should develop and implement a regulatory-screening hub, comprised of external experts (usually lawyers or regulatory experts) who will monitor relevant risk types and pertinent regulations, laws, and directives.
Define response and escalation processes. Companies need to define and implement a process for assigning compliance responsibilities—that is, a way that clarifies which function or role will be accountable for complying with new regulations, laws, and directives. For example, if a regulation will impact the materials used in products, the responsibility needs to be assigned to product development so that accountability is clear. In cases where compliance responsibility is not clear, such as when the regulation pertains to end-of-life handling of devices, organizations need to have an adequate escalation process for assigning responsibility.
Responding to New and Upcoming Regulations
After a new or upcoming regulation, law, or directive has been identified, companies need to adapt their operational processes across products’ life cycle, consider product and packaging innovations, and revise their business models. These are key for companies that want to leverage ESG as competitive advantage.
melhorar Processos operacionais. As empresas MedTech devem se concentrar em fazer melhorias na produção, logística, compras e outros processos principais. Algumas melhorias não apenas terão um impacto positivo de ESG, mas também gerarão um caso de negócios positivo para a mudança. Por exemplo, aumentar a eficiência na produção, como reduzindo a demanda de sucata ou energia, cria economia de custos enquanto reduz as emissões e resíduos de GEE. O mesmo vale para a adoção de práticas de logística verde, que incluem a mudança dos modos de transporte do ar para o oceano e o uso de embalagens mais eficientes.
Purse Produtos e embalagens inovadores. (Os requisitos atuais do cliente já cobrem a pegada de carbono do produto e os resíduos relacionados ao produto.) Existem várias maneiras de fazer isso. Os materiais de base biológica estão começando a ser usados para produtos, enquanto os materiais reciclados são mais comumente usados para embalagens. Considere os seguintes exemplos: Companies should be innovative when it comes to making their products and packaging compliant with ESG requirements and fit for customer requirements in the future. (Current customer requirements already cover the product’s carbon footprint and product-related waste.) There are various ways to do this.
Medtech companies can optimize input materials by considering more sustainable materials for both products and their packaging. Bio-based materials are beginning to be used for products, while recycled materials are more commonly used for packaging. Consider the following examples:
- Medtech Mölnlycke sueco, especializado em cuidados de feridas e suprimentos cirúrgicos, lançou um conjunto de cortinas cirúrgicas e luvas operacionais feitas de plásticos de base biológica em vez de plástico virgem. Essa inovação reduziu os pegadas de carbono desses produtos em 20% a 25%. a quantidade de material e energia usada. Por exemplo:
- In its orthopedic division, Johnson & Johnson is using boxes made of postconsumer recycled paperboard, in place of 100% virgin paperboard, to package more than 250 items.
In addition, companies can rethink product design to extend a product’s lifetime, improve its recycling potential, and reduce the amount of material and energy used. For example:
- Medtronic projetou seus conjuntos de infusão de insulina a serem usados por sete dias em vez de três. Essa mudança reduziu o desperdício plástico em mais da metade, aproximadamente 1,9 kg por paciente por ano. Segundo, ele fornece atualizações, como as atualizações de ajuste da Biomatriz, para melhorar a eficiência energética dos produtos existentes.
- Siemens Healthineers has enabled energy efficiency in two ways: First, it has designed new products such as the Magnetom Free.Star MRI scanner, which requires 30% less energy than conventional MRI machines. Second, it provides upgrades, such as the BioMatrix Fit Upgrades, to improve the energy efficiency of existing products.
revisar modelos de negócios. Algumas empresas estão adicionando uma oferta de serviço e manutenção, uma atualização ou uma empresa de produto como serviço para expandir a utilização de um produto e prolongar sua vida útil. Por exemplo: Companies can revise their business models to establish a new logic around how they generate value while improving sustainability. Some companies are adding a service and maintenance offering, an upgrade, or a product-as-a-service business to expand a product’s utilization and extend its lifetime. For example:
- Philips Remote Services fornece suporte remoto e manutenção preditiva apoiada pela IA para as máquinas de ressonância magnética e CT da Philips. Esse serviço aumenta a capacidade das máquinas para o cliente final, enquanto reduz os custos da empresa. Essa estratégia não apenas maximiza o uso do produto, mas também aumenta o acesso aos cuidados de saúde e abre novos mercados. Para garantir que suas empresas estejam preparadas para os regulamentos futuros e novos, os CEOs da Medtech precisam seguir as cinco etapas seguintes agora:
- Siemens Healthineers is refurbishing medical equipment to sell to customers in developing countries. This strategy not only maximizes product use but also increases access to health care and opens new markets.
Key Next Steps
ESG regulations are a fact of life for European medtech companies. To ensure that their companies are prepared for upcoming and new regulations, medtech CEOs need to take the following five steps now:
- Definir e criar um processo de observação regulatória para ativar uma mentalidade proativa. Sustentabilidade e habilidades jurídicas para apoiar o processo de observação regulatória e impulsionar a inovação além do mínimo necessário. Requisitos regulatórios ou legais. Baixe o artigo
- Clarify the roles and responsibilities for each risk type or regulation, law, and directive for those on your team.
- Set up a cross-functional team with business, sustainability, and legal skills to support the regulatory-watch process, and drive innovation beyond the minimum that is required.
- Establish targets and define initiatives to achieve compliance via process improvement and product and packaging innovation, as well as by leveraging new business models.
- Determine the potential strategic advantages and the type of regulatory risk that is involved if your company wants to do more than meet the minimum regulatory or legal requirements.
Companies that adopt a proactive mindset today will gain a competitive advantage tomorrow.
This article represents a joint effort with CMS, an international law firm.
The authors thank their colleagues in the BCG Center for Climate & Sustainability Policy & Regulation for their contributions to this article.
