The 2025 Medtech Standoff: navigating EU-China Procurement barriers unlocking the In-Country advantage

I. The Geopolitical Chessboard:
A New Era of EU-China Medtech Trade

 The global medical technology landscape has been fundamentally reshaped by a recent and escalating trade dispute between the European Union and China. What began as a move by Brussels to enforce market reciprocity has triggered a calculated and strategically nuanced response from Beijing. This exchange of measures transcends a simple tit-for-tat trade spat; it represents a new phase of industrial policy being conducted through procurement regulations. For European medtech executives, understanding the precise mechanics of these new rules, and, most importantly, the strategic exemptions embedded within them, is critical not only for mitigating risk but for uncovering a significant, time-sensitive opportunity.

The EU’s First Move: Wielding the International Procurement Instrument (IPI)

The European Commission’s decision to restrict Chinese access to its public procurement market was not an impulsive action but the culmination of years of mounting frustration over perceived market access imbalances. The EU has long contended that while its public procurement market, one of the most open in the world, welcomed Chinese firms, European companies faced significant and recurring barriers in China.¹ Chinese exports of medical devices to the EU, for instance, more than doubled between 2015 and 2023, a period during which European firms reported increasing difficulties accessing the Chinese market.¹

This grievance led the Commission to launch its first-ever investigation under the International Procurement Instrument (IPI) on April 24, 2024.¹ The IPI, a regulation that entered into force in 2022, is designed to provide the EU with leverage to open third-country procurement markets by promoting reciprocity.³ The investigation focused on China’s longstanding industrial policies, such as « Buy China » and the « Made in China 2025 » strategy, which explicitly mandate that government entities prioritize domestic goods and aim for domestic market share targets as high as 85% for certain medical device components.³

The findings of the EU’s investigation, published in early 2025, were stark. The Commission concluded there was « clear evidence » of unfair practices, finding that a staggering 87% of public procurement tenders for medical devices in China contained exclusionary and discriminatory measures against EU-made products and suppliers.¹ Despite repeated attempts at dialogue, the Commission stated that China had not offered satisfactory commitments to address these structural barriers.¹

Consequently, the EU moved to apply for the IPI. Effective June 30, 2025, and set for a five-year period, the following measures were imposed on Chinese medical device manufacturers ⁵:

• Chinese-origin companies are barred from bidding on EU public procurement contracts for medical devices with an estimated value exceeding €5 million.¹
• Successful tenderers in these contracts are prohibited from sourcing more than 50% of the total contract value in the form of medical devices originating from China.¹

The EU’s stated objective is to « level the playing field » and incentivize Beijing to grant European firms market access comparable to that which Chinese firms enjoy in the EU.¹ The measures are designed to be proportionate, with exceptions for cases where no alternative suppliers exist, and are framed as consistent with the EU’s international obligations, as it has no binding procurement commitments with China under the WTO framework.¹

China’s Calculated Retaliation: A Swift and Precise Countermeasure

 Beijing’s reaction was swift and unequivocal. The Chinese Ministry of Commerce (MOFCOM) and Ministry of Finance (MOF) characterized the EU’s IPI measures as protectionist and unilateral.⁷ In official statements, Chinese authorities asserted that despite their « goodwill and sincerity » expressed through bilateral dialogue, the EU had « insisted on going its own way, taking restrictive measures and building new protectionist barriers ».⁷ As a result, China declared it was « compelled to introduce reciprocal restrictive measures » to safeguard the legitimate rights and interests of its enterprises and maintain a fair competitive environment.⁷

Drawing from official notices published by the MOF and confirmed in state-affiliated media, the Chinese countermeasures took effect on July 6, 2025.²⁰ The restrictions are as follows:

• Enterprises based in the European Union are barred from participating in Chinese government procurement projects for a specified list of medical devices when the project’s budget exceeds 45 million RMB (approximately $6.3 million).⁴
• The affected product categories are primarily high-value capital equipment and implants, including surgical instruments, magnetic resonance imaging (MRI) equipment, blood-based pharmaceutical preparations, orthopedic implant components, and medical laser devices.¹⁵
• For non-EU companies participating in such tenders, the value of any medical devices or components imported from the EU is capped at 50% of the total contract value.⁷

The Critical Exemption: The « In-China-for-China » Loophole

While Beijing’s response was framed as « reciprocal, » a closer examination reveals a critical and deliberately crafted asymmetry. The most significant feature of China’s countermeasures is a crucial exemption clause. The official notices from the MOF and MOFCOM explicitly state that the procurement ban does not apply to EU-funded businesses operating in China.⁴

This distinction is not a minor detail; it is the central pillar of China’s strategic response. It means that a medical device manufactured in a Chinese facility owned by a European parent company is considered a « domestic » product for the purposes of government procurement and is therefore exempt from the ban. A second, narrower exemption exists for projects where only EU-imported devices can meet the technical procurement requirements, though this is expected to be applied sparingly and subject to administrative discretion.¹⁵

This carefully constructed loophole reveals that the conflict is not merely a trade dispute but an extension of industrial policy conducted through trade instruments. The EU initiated the conflict by using its IPI tool to challenge China’s protectionist industrial strategies. In response, China has not simply erected a retaliatory wall but has engineered a policy that actively serves its own long-term industrial ambitions. A truly reciprocal measure would have been a blanket ban on all EU-origin devices. The inclusion of the exemption for locally operating EU firms is a significant and intentional deviation from that path. This clause aligns perfectly with the overarching goals of national strategies like « Made in China 2025 » and successive Five-Year Plans, which aim to domesticate advanced manufacturing, absorb foreign technology, and upgrade China’s industrial base.¹¹ The policy is therefore not designed to push European companies out of the Chinese market, but rather to pull their most valuable assets—their manufacturing capabilities, technology, and R&D—into it. It creates a powerful incentive for European medtech firms to transition from a traditional « export to China » model to a localized « In-China-for-China » strategy.

II. Navigating the Fallout:
Quantifying the Impact on European Medtech

 For European medical technology companies that maintain a purely export-oriented strategy, the new procurement landscape in China presents a multifaceted and severe challenge. The official restrictions on market access are merely the visible tip of an iceberg. Beneath the surface lies a more challenging operating environment characterized by the likely over-zealous enforcement of new and existing rules, the amplification of non-tariff barriers, and disruptive ripple effects across global supply chains.

Direct Market Access Restrictions: The Tip of the Iceberg

 The most immediate consequence of China’s countermeasures is the direct loss of access to a significant segment of its public procurement market. While a precise valuation of the affected Chinese market segment is difficult to ascertain, its importance to European exporters is undeniable. China is a primary trade partner for the EU medtech industry, with Europe enjoying a positive trade balance in the sector.³³ Major European medtech exporting nations, including Germany, Ireland, the Netherlands, and Switzerland, will feel the impact directly.³³ In 2024, Germany alone exported goods worth €90 billion to China across all sectors, highlighting the scale of the trade relationship.³⁴

The ban on tenders exceeding 45 million RMB for high-value equipment such as MRI systems, orthopedic implants, and advanced surgical instruments effectively closes the door on a lucrative market for many of Europe’s most innovative companies.¹⁵ This direct market foreclosure represents a tangible and immediate revenue risk for any firm reliant on exporting these products from European manufacturing sites. The scale of the EU market now partially closed to Chinese firms offers a sense of the potential stakes; the EU’s medtech public procurement market is valued at approximately €150 billion annually, with tenders over €5 million accounting for roughly 60% of this value, or about €90 billion per year.³⁵ Losing access to a correspondingly significant portion of China’s market will have a material impact on European exporters.

The Unwritten Rules: « Over-Zealous » Enforcement and Non-Tariff Barriers

 Beyond the explicit text of the new regulations, a more profound challenge lies in their likely implementation. China has a well-documented history of utilizing a complex web of non-tariff barriers, opaque administrative hurdles, and selective regulatory enforcement to protect and promote its domestic industries.³⁶ These tactics can range from creating unique and burdensome licensing requirements to leveraging broad national security laws to control data, technology, and intellectual property.³⁷ It is highly probable that the new procurement restrictions will be enforced with a degree of patriotic zeal by provincial and municipal procurement authorities, who are already under pressure to favor local champions.

This new procurement ban must be understood not in isolation, but as an enforcement mechanism for pre-existing industrial policies. Two key policies will be amplified by the new rules:

1. Volume-Based Procurement (VBP): This system, through which the government centralizes the purchasing of medical supplies and drugs to negotiate aggressively lower prices, already places immense margin pressure on foreign brands, which often struggle to compete on price with subsidized domestic rivals.³ The new procurement ban adds another layer of difficulty: imported products are not only at a price disadvantage but are now explicitly disqualified from many high-value tenders, further strengthening the negotiating position of domestic suppliers.
2. « Made in China 2025 »: The procurement ban provides local officials with a clear legal and political mandate to advance the goals of this overarching industrial strategy.¹¹ The policy’s explicit target of achieving 80% domestic market share for core medical device components by 2025 creates a powerful incentive for procurement decision-makers to reject imported products.³⁰ The new rules effectively give these officials the legal cover to do so, transforming a strategic goal into an operational reality.

Ripple Effects Across the Global Value Chain

The impact of China’s countermeasures extends far beyond the EU’s borders, creating significant collateral damage for global medtech firms. The rule stipulating that non-EU companies cannot source more than 50% of a contract’s value from the EU introduces a major compliance burden and supply chain challenge.⁷

An American, Japanese, or Swiss medical device company that relies on critical, high-value components from Germany, Ireland, or France for devices assembled in the US or Southeast Asia will now face a difficult choice. To compete for large tenders in China, they must either conduct a costly and complex audit of their entire bill of materials to ensure compliance with the 50% cap or undertake a strategic and potentially disruptive re-sourcing of key components away from their trusted European suppliers.⁵ This forces a supply chain re-evaluation upon a wide range of global players who may have had no direct involvement in the initial EU-China dispute.

Simultaneously, the dynamics of the European market itself are set to shift. With Chinese medtech firms now facing restrictions in the €90 billion EU public procurement market, they are likely to redirect their competitive efforts. This could lead to increased price pressure in the EU’s private healthcare markets or in other global regions where they will seek to offload capacity. At the same time, American and other international firms may view the EU’s restrictions on Chinese suppliers as a strategic opportunity to capture market share within Europe, intensifying competition for all players.³

The architecture of China’s countermeasures appears deliberately designed to create a bifurcated risk environment. For companies committed to a pure export model, the political, regulatory, and commercial risks of serving the Chinese market have been amplified dramatically. The official ban is the starting point, but the unwritten rules of zealous local enforcement and the weaponization of existing industrial policies like VBP make the de facto barriers even higher than the de jure ones. In contrast, for companies willing to localize their operations, these escalating risks are not only mitigated but are replaced by a suite of powerful incentives. The Chinese government is thus actively managing the risk landscape to channel foreign corporate behavior. It is systematically making the status quo—exporting from abroad—commercially hazardous while making the desired future—localizing production within China—an attractive, de-risked proposition.

III. The Strategic Pivot:
Turning Crisis into Opportunity with an « In-China-for-China » Strategy

 While the escalating trade friction presents formidable challenges for unprepared European medtech firms, it simultaneously unveils a clear strategic pathway for growth and long-term success in the Chinese market. The very structure of China’s retaliatory measures contains the solution. Localization of manufacturing is no longer merely a cost-saving tactic or a « nice-to-have » element of a global footprint; it has become a fundamental strategic imperative for market access, risk mitigation, and competitive advantage in China.

The ‘Golden Ticket’: How In-Country Manufacturing Bypasses Procurement Barriers

 The most direct and powerful benefit of establishing a manufacturing presence in China is the ability to completely bypass the new procurement restrictions. As explicitly stated in the official government notices, a medical device produced within China—even in a facility that is wholly owned by a foreign parent company—is classified as a « domestic » product.⁴ This « golden ticket » transforms a company from a target of the protectionist measures into a participant, and potential beneficiary, of the domestic industrial ecosystem.

Simply avoiding the ban is only the first step. By achieving « domestic » status, products from foreign-invested enterprises (FIEs) may become eligible for preferential treatment in government tenders. A draft notice circulated by China’s Ministry of Finance in late 2024 proposed granting a 20% price review discount to domestic products compared to non-domestic products in government procurement bids.¹¹ While this remains a draft, it provides a clear signal of the policy direction and the tangible financial advantages that localization can confer. This shifts the competitive dynamic from being penalized for being foreign to being rewarded for being local.

Beyond Circumvention: The Compounding Benefits of Localization

 The strategic rationale for localization extends far beyond circumventing the immediate procurement crisis. The Chinese government has constructed a holistic and integrated policy ecosystem designed to attract and support advanced manufacturing. This ecosystem provides a powerful set of compounding benefits across regulatory, financial, and operational domains.

Regulatory Tailwinds

• Expedited Approvals (Order 104): Recognizing the need to facilitate localization, China’s National Medical Products Administration (NMPA) has created an accelerated registration pathway for foreign companies wishing to manufacture their already-approved imported devices in China. Known as Order 104, this policy allows for the reuse of up to 80% of the original import application documents, dramatically reducing bureaucracy and speeding up time-to-market for localized products.³⁰
• Marketing Authorization Holder (MAH) System: Perhaps the most transformative regulatory reform, the MAH system decouples the marketing authorization (the product license) from the manufacturing license. This allows a foreign entity to hold the product registration and be fully responsible for the product’s quality and lifecycle, while outsourcing the physical production to a qualified local contract manufacturer (with limited exceptions). This model provides enormous flexibility, significantly lowers capital expenditure, and is an ideal pathway for companies seeking an asset-light entry into local production.³¹

Economic and Financial Incentives

• Access to Government Funding: Localized operations, particularly those involving R&D and advanced technology, can become eligible to tap into a growing network of government-backed venture capital and industrial investment funds. The city of Shanghai, for example, has established an RMB 89 billion industrial fund with a specific allocation of RMB 21.5 billion for high-end medical devices and innovative drugs.⁴⁴
• Tax Benefits and Subsidies: China offers a suite of powerful financial incentives to promote high-tech manufacturing and innovation. A key incentive is the R&D « super deduction » policy, which allows qualified manufacturing firms to deduct 200% of their eligible R&D expenditures from their taxable income, substantially lowering their corporate tax burden.⁴⁵ Additionally, local governments frequently offer their own packages of grants, subsidies, and other financial support to attract strategic investments.³²

Operational and Supply Chain Advantages

• Cost Efficiency and Proximity: Manufacturing in China provides direct access to a deep and efficient ecosystem of raw material suppliers, component manufacturers, and skilled labor, which can significantly reduce overall production costs.⁴⁷
• Supply Chain Resilience: An in-country manufacturing footprint insulates a company from the volatility of global shipping, cross-border tariffs, and geopolitical disruptions. Proximity to the vast Chinese end-market shortens product lead times, reduces logistics costs, and enables greater responsiveness to shifting customer demands.

Conclusion. A Blueprint for Action:
Recommendations for European Medtech Leadership

The convergence of these policies demonstrates that China’s localization push is a deeply integrated, whole-of-government strategy. The procurement ban from the MOF creates the « stick, » while the regulatory fast-tracks from the NMPA, the financial incentives from tax authorities, and the investment from local governments provide a powerful array of « carrots. » For European medtech leaders, recognizing this interconnected policy ecosystem is the key to understanding the full magnitude of the strategic opportunity at hand.

The new reality of EU-China medtech trade demands more than a reactive, wait-and-see approach. It calls for a decisive strategic pivot. For European medtech leadership, the current challenges should be viewed as a catalyst to reconfigure their China strategy for the next decade.

• The first step is a rigorous and unsentimental evaluation of the company’s entire product portfolio through the new lens of China’s market realities. This assessment should move beyond simple revenue figures to analyze vulnerability and opportunity.
• Once priority products have been identified, the next step is to determine the most appropriate market entry and manufacturing model. This decision should be a deliberate strategic choice based on the company’s unique circumstances.
• With a clear strategy and chosen model, the focus must shift to disciplined, on-the-ground execution. Navigating the complexities of the Chinese business and regulatory environment requires meticulous planning and expert guidance.

The process of establishing a legal entity, securing NMPA approvals, qualifying for tax incentives, and complying with local labor and environmental laws is highly complex. Engaging experienced, on-the-ground advisors who possess deep expertise in China industrial localization is crucial for ensuring a smooth, compliant, and efficient implementation, minimizing unforeseen delays and costly missteps, and ultimately maximizing the return on this critical strategic investment.

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Une avancée majeure en Chine : la première guérison du diabète de type 1 au monde

Une avancée médicale révolutionnaire

Pour la première fois, une jeune femme chinoise de 25 ans a entièrement guéri du diabète de type 1 grâce à une thérapie développée par des chercheurs chinois. Cette approche, menée à l’hôpital principal de Tianjin en collaboration avec l’Université de Pékin, est fondée sur la régénération cellulaire. Les chercheurs ont prélevé des cellules du pancréas de la patiente, qu’ils ont ensuite traitées chimiquement de manière à les faire retrouver un état de cellules souches. Une fois modifiées, les cellules ont été ré-implantées, par voie micro-invasive, dans le pancréas de la patiente. A la suite de cette opération, le taux d’insuline sécrétée a augmenté de 700 %. Le résultat de cette opération furent rapides et durables : dès 75 jours après l’intervention, le taux de glycémie se régulait sans besoin d’injection d’insuline extérieure, et la patiente ne présentait plus aucun des symptômes du diabète. Cette guérison complète marque une révolution thérapeutique majeure.^[1]

Une épidémie silencieuse

Malgré cette avancée, le diabète demeure une véritable urgence de santé publique. Avec plus de 140 millions de personnes touchées, la Chine enregistre l’une des prévalences les plus élevées au monde, représentant environ 12 % de sa population adulte^[2]. D’ici 2040, la Chine pourrait compter 166 millions de diabétiques, consolidant sa place parmi les pays les plus touchés.^[3] Fait préoccupant, le diabète de type 2 touche également 1,77 % des enfants chinois âgés de 3 à 18 ans^[4].  À cela s’ajoute une prise de conscience insuffisante : seulement 36,5 % des diabétiques chinois connaissent leur état et, parmi ceux traités, moins de la moitié (49,2 %) réussissent à contrôler leur glycémie efficacement^[5]. Or les complications liées au diabète sont nombreuses et peuvent être graves^[6] :

• Maladies cardiovasculaires : principal facteur de mortalité chez les diabétiques.
• Problèmes rénaux : l’insuffisance rénale est fréquente.
• Atteintes neurologiques et oculaires : des neuropathies, pouvant conduire à la cécité, sont également courantes.

Les causes sous-jacentes de cette épidémie

Le diabète en Chine n’est pas uniquement une question de prédisposition génétique. Plusieurs facteurs sociaux, économiques et environnementaux convergent pour alimenter cette crise.

Urbanisation

Le développement rapide des villes en Chine a transformé les modes de vie. Les populations urbaines, qui représentent une part croissante de la société chinoise, affichent une prévalence de diabète bien supérieure à celle des zones rurales (12,1 % contre 8,3 %).

Changements alimentaires

La modification des habitudes alimentaires a également joué un rôle crucial. La consommation accrue de sucres, d’aliments transformés et de fast-foods au sein des populations aisées expose davantage au risque de diabète. Cette transition, autrefois limitée aux grandes villes, s’étend maintenant aux zones rurales en raison de l’accès croissant aux produits alimentaires industriels.

Sédentarité et stress

Avec l’essor des emplois de bureau, l’activité physique a considérablement diminué. Parallèlement, l’environnement urbain et les défis socioculturels croissants génèrent un stress chronique, connu pour perturber les mécanismes hormonaux et métaboliques.

Vieillissement de la population

A l’instar de nombreux pays, la population chinoise vieillit rapidement. Ce phénomène amplifie mécaniquement la prévalence du diabète, une maladie qui touche davantage les personnes âgées.

Solutions stratégiques : prévenir plutôt que guérir

Pour parvenir à enrayer l’épidémie de diabète, la Chine investit dans des politiques de prévention et de sensibilisation :

Éducation et dépistage

En augmentant la sensibilisation au diabète, il est possible d’augmenter le taux de dépistage précoce et la prise en charge adaptée.

Encourager une alimentation équilibrée

Promouvoir des régimes alimentaires riches en fibres et faibles en sucres contribue à améliorer la santé des populations à risque.

Promotion de l’activité physique

Intégrer l’exercice dans la routine quotidienne via des incitations, la promotion des bienfaits du sport, la création d’infrastructures plus accessibles dans les zones urbaines pourrait contribuer à réduire la prévalence de la maladie.

Renforcement des infrastructures médicales et de leur équipement

Les régions rurales manquent encore de moyens pour diagnostiquer et traiter efficacement le diabète. Renforcer les capacités des centres de soins locaux est essentiel pour combler cet écart. Des investissements massifs dans les appareils de gestion du diabète tels que glucomètres, pompes à insuline et autres dispositifs médicaux innovants sont réalisés pour répondre à ce défi de santé publique.^[7]

Un terrain d’opportunités pour les entreprises étrangères

La lutte contre le diabète en Chine offre de nombreuses opportunités pour les entreprises européennes et françaises, notamment dans :

• Les dispositifs médicaux innovants comme les glucomètres connectés.
• Les solutions numériques pour le suivi et la gestion du diabète.
• Les traitements avancés (tels que les médicaments GLP-1 comme l’Ozempic), tant contre le diabète lui-même que contre ses complications.

La clé du succès réside dans une compréhension approfondie du marché local, des acteurs  et des réglementations en vigueur. VVR Medical, département de VVR International, expert des marchés pharmaceutiques et médicaux chinois, accompagne les entreprises dans leur stratégie de développement en Chine. N’hésitez pas à nous contacter à l’adresse contact@vvrmedical.com pour recevoir les conseils et le soutien de nos experts dans votre projet.

^[1] Première mondiale : une Chinoise guérit du diabète de type 1

^[2] https://www.federationdesdiabetiques.org/information/diabete/chiffres-monde

^[3] https://fr.statista.com/statistiques/571668/pays-avec-le-plus-grand-nombre-previsionnel-de-personnes-diabetiques-en-2040/

^[4] https://www.thelancet.com/journals/lanpub/article/PIIS2468-2667(24)00250-0/fulltext

^[5] https://www.dbl-diabete.fr/tout-sur-le-diabete/societe/classement-diabete-pays-monde

^[6] https://www.thelancet.com/journals/lanpub/article/PIIS2468-2667(24)00250-0/fulltext

^[7] https://www.mordorintelligence.com/fr/industry-reports/china-diabetes-devices-market/market-size

L’adoption d’Ozempic en Chine : implications pour la santé publique et le contrôle de l’obésité

En 2022, 38 % de la population était en surpoids et 8 % était obèse. La Chine connaît une hausse rapide de l’obésité. Ce phénomène inquiète les autorités sanitaires et a suscité une réaction du public. Parmi les nombreuses techniques et régimes à la mode pour perdre du poids, on observe un essor des médicaments spécialisés tels que l’Ozempic (semaglutide).

Les Médicaments GLP-1 et ozempic

L’Ozempic, produit par Novo Nordisk sous le nom de NovoCare en Chine, appartient à la classe des médicaments GLP-1. Initialement approuvé pour le diabète de type 2, son champ d’action a récemment été étendu au traitement de l’obésité. Ces médicaments agissent en mimant une hormone qui régule la glycémie et aide à supprimer l’appétit, ce qui les rend utiles pour la perte de poids.

Avancées réglementaires et marché

En 2024, la NMPA a approuvé l’Ozempic pour la gestion du poids à long terme, une première pour les médicaments GLP-1 dans le pays. Cette approbation est vue comme une réponse à l’augmentation des taux d’obésité. Parallèlement, le tirzepatide d’Eli Lilly a également été autorisé, indiquant une ouverture du marché à ces traitements. Pour l’instant, les deux entreprises représentent ensemble environ 94% des ventes totales de médicaments GLP-1 en Chine.

Interrogations et avis partagés

Malgré la popularité de l’Ozempic et des autres médicaments GLP-1, des inquiétudes subsistent concernant leurs effets secondaires et leur coût élevé, ce qui pourrait limiter leur adoption. De plus, les réseaux sociaux reflètent des opinions partagées, oscillant entre l’enthousiasme pour leur efficacité et la méfiance due aux expériences négatives.

Perspectives pour les médicaments GLP-1 sur le marché chinois

La forte demande et les préoccupations de santé publique continuent de stimuler l’intérêt pour les médicaments GLP-1. Les acteurs du secteur pharmaceutique chinois ont initié leurs propres recherches et développement pour mettre au point des médicaments GLP-1. Actuellement, le beinaglutide de Shanghai Benemae, le premier médicament GLP-1 développé en Chine, fait l’objet d’essais cliniques pour le traitement de la perte de poids, et son approbation potentielle est attendue prochainement.  Les entreprisesHengrui Medicine

, Gan & Lee Pharmaceuticals et Haosen Pharmaceuticals investissent également massivement dans la recherche et le développement pour mettre sur le marché des traitements à base de GLP-1.

Source : 36Kr, Designed by daxue consulting, Des médicaments GLP-1 contre l’obésité en cours de recherche en Chine

Avec l’expiration prochaine des brevets et l’émergence de produits locaux potentiellement moins coûteux, le marché pourrait devenir plus compétitif et accessible. La transparence sur les effets et les résultats à long terme sera cruciale pour gagner la confiance des consommateurs.

Pour lire l’article complet et obtenir plus de détails, consultez le dossier de Daxue : Behind the burgeoning popularity of weight loss drug Ozempic in China

VVR Medical et Daxue Consulting sont spécialisés dans l’accompagnement stratégique et opérationnel des entreprises du secteur médical sur le marché chinois. N’hésitez pas à nous contacter à l’adresse contact@vvrmedical.com pour recevoir les conseils et le soutien de nos experts dans votre projet.

Le secteur biomédical et hospitalier chinois poursuit son ouverture aux innovateurs et investisseurs étrangers

Introduction

Le 7 septembre dernier, la Chine a publié une notification très importante quant à l’ouverture du secteur médical, et particulièrement de l’innovation médicale, aux acteurs internationaux. En effet, à compter de cette date, sont à présent permis, pour les sociétés à capitaux étrangers :

• L’exploitation clinique directe de thérapies géniques et cellulaires, ainsi que de diagnostic génétique, aux fins d’enregistrement réglementaire (NMPA), dans les zones économiques spéciales des trois grandes villes côtières (Pékin, Shanghai, Canton) et sur l’île de Hainan ;
• L’ouverture d’hôpitaux internationaux à capitaux 100% étrangers (hors médecine traditionnelle chinoise et acquisition d’un hôpital public) à Beijing, Tianjin, Shanghai, Nanjing, Fuzhou, Suzhou, Guangzhou, Shenzhen et l’île de Hainan.

Comment interpréter cette annonce ?

Cette annonce résonne en quelque sorte comme un « contrepoint » au VBP (Volume Based Procurement, déployé en 2020), dont les intentions, logiques et louables en termes macro-économiques, ont démontré lors de l’implémentation du système qu’il pouvait parfois se révéler contre-productif sur l’aspect « innovation ». En effet, dans bien des cas, l’équation économique des produits innovants sur le marché chinois peut se révéler intenable pour les innovateurs étrangers, les donneurs d’ordre se tournant préférentiellement vers les produits dits « de musée » dans le contexte VBP.

Par conséquent, cette annonce illustre la prise en compte de cette situation, et la volonté continue du gouvernement chinois d’attirer l’innovation « produits » et « services » en santé humaine sur son territoire, dans des conditions économiques à nouveau attractives pour les innovateurs internationaux de la santé.

De façon concrète, après les efforts très importants consentis notamment post-Covid sur la digitalisation du parcours de soins (celle-ci étant d’ores et déjà en avance par rapport à de nombreux pays occidentaux), l’objectif est de continuer à susciter la progression continue de toute l’industrie médicale :

• en matière d’offre de soins, les procédures d’achat de l’hôpital public et de validation du niveau de prise en charge par la sécurité sociale chinoise retardant bien souvent de plusieurs mois voire années le déploiement de nouvelles approches thérapeutiques et diagnostiques ;
• en matière de gestion hospitalière, afin d’éviter les nombreux gaspillages toujours présents à différents échelons de l’administration hospitalière ;
• en matière de satisfaction des patients, les niveaux de satisfaction mesurés auprès des Chinois vis-à-vis de l’hôpital public laissant en effet toujours à désirer.

En outre, comme il est de coutume avec le gouvernement chinois, la décision prise se révèle, à l’examen, multifactorielle. Ainsi, les conséquences positives de cette annonce pour le pays, sa population, et l’environnement général de l’industrie de la santé sont plus nombreuses qu’il n’y paraît ; en voici les principales :

En ce qui concerne les patients

1. Mobiliser l’épargne des classes moyennes et supérieures vers l’économie réelle, le taux d’épargne des Chinois étant considéré comme trop élevé par de nombreux spécialistes macro-économiques. Est ici fait le pari que les Chinois aisés alloueront une part toujours croissante de leur budget familial au poste « santé », ce qui se vérifie d’ores et déjà dans les hôpitaux internationaux existants, où la patientèle chinoise est de loin majoritaire vis-à-vis de la patientèle étrangère – ce qui était loin d’être le cas il y a seulement dix ans ;
2. Accélérer la croissance du secteur de l’assurance médicale privée, en volume et en termes de compétences actuarielles, afin de continuer à maîtriser les dépenses de santé publique et de développer tout un pan des services financiers quelque peu embryonnaire à l’heure actuelle par rapport aux grands pays occidentaux – à noter que la situation dans ce domaine s’améliore déjà depuis quelques années, grâce entre autres à d’innovants partenariats public-privé ;

Pour les personnels de santé

3. Apporter de nouvelles opportunités de carrière au personnel stricto sensu « médical » de l’hôpital public, les médecins-chercheurs ayant quant à eux a priori vocation à poursuivre leur carrière dans le système étatique ou para-étatique – l’hôpital privé étant, en Chine comme ailleurs, connu et reconnu pour verser de meilleurs salaires et proposer de meilleures conditions de travail ;
4. Poursuivre le processus de spécialisation de l’hôpital public sur la recherche translationnelle et clinique (on se souvient que de nombreux grands hôpitaux publics sont affiliés à une université comportant un cursus médical), en augmentant les financements aux médecins-chercheurs et en multipliant les centres d’essais cliniques de niveau international – une tendance déjà à l’œuvre depuis 2018 ;
5. Ce faisant, créer un appel d’air vers les filières médicales et médico-scientifiques pour les jeunes Chinois, en leur rendant l’attractivité qu’elles avaient quelque peu perdu ces dernières années, sur fond de déséquilibre entre rémunération et charge de travail, mais aussi de « plafond de verre » trop vite atteint ;

Pour les innovateurs du secteur

6. Favoriser l’innovation médicale, en facilitant l’entrée rapide sur le marché de médicaments et dispositifs médicaux / de diagnostic innovants via le canal des hôpitaux privés : en effet, ceux-ci ne sont pas soumis aux règles drastiques des appels d’offres publics (VBP ou autres), et achètent donc leurs produits de santé peu ou prou aux tarifs « internationaux ». La population cumulée des villes précitées et de leurs alentours immédiats excédant 150 millions de personnes, il fait peu de doute qu’un tel marché, à terme, se révélera intrinsèquement rentable ;
7. Favoriser l’émergence de distributeurs médicaux spécialisés sur le canal des hôpitaux privés: ce type de distributeurs étant pour l’heure encore assez rare, il est très probable que de nouveaux acteurs de bon niveau apparaîtront dans les prochaines années – ainsi, vos produits de santé innovants pourront attaquer le marché chinois via de multiples canaux, les profits accélérés captés sur le canal « privé » venant soutenir l’entrée progressive sur le canal « public ».

Conclusion

Dans le contexte toujours très changeant de l’industrie de la santé humaine et des technologies médicales en Chine, il est essentiel pour vous, innovateurs, avant toute prise de décision, d’obtenir vos informations et données auprès de sources en prise directe avec les évolutions réelles du pays, loin des stéréotypes parfois véhiculés. C’est ainsi que vous bénéficierez de recommandations claires et étayées, accompagnées d’un plan d’action réaliste et chiffré.

VVR Medical / Daxue Consulting, leaders de l’accompagnement stratégique et opérationnel des entreprises du secteur médical sur le marché chinois, sont à votre disposition pour sécuriser et pérenniser votre présence en Chine. N’hésitez pas à nous contacter !

Regenerative Medicine, the Coming Revolution of Cancer Treatment

In the relentless pursuit of cancer treatment, one field is poised to revolutionize our approach: regenerative medicine. This isn’t just another incremental advance; it is a paradigm shift in how we understand and treat cancer. This article will guide you through the intricacies of regenerative medicine, its transformative research, and why it could be the cornerstone for cancer treatment in both developed and developing nations. For medical companies eyeing international expansion, particularly in China, this is an innovation you cannot afford to ignore.

What is Regenerative Medicine?

Regenerative medicine is a multidisciplinary field that aims to repair, replace, or regenerate damaged tissues and organs. It’s not a new concept; the idea has been around for decades. However, recent advancements in technology and research have propelled it into the limelight.

The Science Behind It

At the core of regenerative medicine is the manipulation of cells and tissues to treat diseases. This involves a range of scientific disciplines, including biology, chemistry, and engineering. Researchers are learning how to harness the body’s innate ability to heal itself, amplifying or directing these processes through scientific intervention.

Types of Regenerative Medicine

The field is broadly categorized into four types:

Tissue Engineering: Creating functional tissues in labs that can be implanted into patients.

Cellular Therapies: Using cells, often stem cells, to repair damaged tissues directly.

Medical Devices and Artificial Organs: Devices that can temporarily or permanently take over the function of an organ.

Combinations of the Above: Innovative treatments that combine elements of tissue engineering, cellular therapies, and medical devices.

The Ongoing Research and Methods

The field of regenerative medicine is bustling with research, much of which is focused on cancer treatment. From academic labs to pharmaceutical giants, the race is on to develop therapies that are both effective and safe. Recent articles highlight the significant challenges in treating cancer and how regenerative medicine is participating in the development of novel cancer treatments.

Cutting-Edge Methods

Several methods are at the forefront of this research:

Stem Cell Therapy: Utilizing stem cells to replace damaged cells. This is particularly promising for blood-related cancers like leukemia. Researchers are currently exploring stem cells that underlie various types of cancers.

Gene Editing: Techniques like CRISPR are being used to modify genes, potentially correcting mutations that lead to cancer.

3D Bioprinting: The creation of cellular structures using 3D printing technology, which can be used for testing drug responses or even creating replacement tissues.

Case Studies and Clinical Trials

Numerous clinical trials are underway to test the efficacy of these methods. For instance, CAR-T cell therapy, a type of stem cell therapy, has shown remarkable results in treating certain types of lymphoma.

The Revolution in Cancer Treatment

The efficacy of regenerative medicine therapies is often higher than traditional methods, with fewer side effects. Patients experience a more personalized treatment, tailored to their specific needs. For example, stem cells have the potential to treat numerous genetic and degenerative disorders, including cancers.

Importance in Developing Countries

The potential of regenerative medicine extends beyond the borders of developed nations. Developing countries, often burdened with limited healthcare infrastructure, can benefit immensely from these therapies. They offer a cost-effective and scalable solution, making quality cancer treatment accessible to a broader population.

Regulatory Landscape: EU vs China

When it comes to regulations, the European Union and China have different approaches. The EU has stringent regulations to ensure the safety and efficacy of these therapies. China, on the other hand, has been more aggressive in adopting regenerative medicine, often fast-tracking research and clinical trials. For instance, more than 450 cell therapy clinical trials are currently ongoing in China. This has made the country a burgeoning hub for regenerative medicine research.

Pioneering the Future of Cancer Treatment

Regenerative medicine is not just a scientific curiosity; it’s a transformative approach that is redefining the landscape of cancer treatment. Its potential is universal, offering hope to patients in both developed and developing countries. For medical companies looking to expand internationally, particularly in China, this is an area ripe for investment and innovation.

For European innovators in therapeutics, medical technology and diagnostics targeting the Chinese market, VVR Medical offers comprehensive market entry services. With over 15 years of hands-on experience in human healthcare in China, VVR Medical provides a unique, all-encompassing, personalized approach to accelerate your China market entry. From strategic diagnosis to implementation, VVR Medical assists you in clearing regulatory hurdles, identifying necessary resources, and preparing for efficient commercialization, setting you on the path to success in this burgeoning market.

The potential of biomarkers for early diagnosis

Imagine a world where debilitating diseases like cancer, Alzheimer’s, or heart ailments can be identified before they manifest symptoms, allowing for treatments that are not just less invasive but also significantly more effective. The technology that holds the promise to turn this vision into reality is already among us – it’s called biomarkers. By diving into this article, you’re taking the first step to understanding how biomarkers are revolutionizing the landscape of healthcare, especially in the realm of early diagnosis.

Unveiling the Power of Biomarkers

This section aims to unfold the transformative potential of biomarkers and their use in early diagnosis by explaining their unique diagnostic characteristics.

What are Biomarkers?

Biomarkers, or biological markers, are measurable indicators of some biological state or condition. They can be molecules, cells or cell fragments, genes, or characteristics observed through medical imaging. Biomarkers exist in various categories, primarily diagnostic, prognostic, and predictive. Diagnostic biomarkers identify whether a disease is present, prognostic biomarkers forecast the disease’s progression, and predictive biomarkers anticipate how a disease will respond to treatment.

The Revolutionary Potential for Early Diagnosis

Early diagnosis is an undisputed game-changer in healthcare. When diseases are identified in their initial stages, treatment outcomes are often significantly better, and healthcare costs can be reduced. Recent research has propelled biomarkers into the spotlight as a tool for early diagnosis. For instance, liquid biopsy, a non-invasive test, can now detect circulating tumor DNA in blood samples, providing a revolutionary way to identify early-stage cancer.

Studies have shown the increasing reliability of biomarkers in early diagnosis. For instances, in cardiovascular diseases, a high level of troponin – a type of protein – serves as an early warning sign of a heart attack; in cancer, the detection of circulating progastrin in the bloodstream has demonstrated its relevance in early diagnosis of various types of solid tumors. The utilization of such biomarkers has been instrumental in reducing mortality rates from heart attacks.

Methodologies and Challenges

In the quest to personalize medicine and revolutionize diagnostic procedures, biomarker discovery and successful clinical exploitation stands at the forefront, offering a glimpse into a future where treatment is tailored to the individual’s unique biological signature. The very advancements that promise a new era of medicine also beckon a host of ethical, financial, and technical conundrums.

Research Methodologies

Various methodologies are employed in biomarker discovery and validation. Some of the cutting-edge techniques include genomics, proteomics, and metabolomics.

Genomics: The entire genetic blueprint of an organism is the focus of this domain, with an exploration into how genes interact and function.

Proteomics: This area examines the structure and function of proteins, which are the products of gene expression.

Metabolomics: In this area, the emphasis is on the examination of small molecules, termed as metabolites, which originate from the actions of both genes and proteins.

High-throughput technologies like next-generation sequencing have revolutionized these fields, enabling the identification of new biomarkers at a faster rate. Multi-omics technologies encompass genomics, transcriptomics, proteomics, and metabolomics. These technologies act as efficient and effective tools for disease diagnosis, management, monitoring, treatment, and the discovery of novel biomarkers.

Challenges and Influential Factors

While the promise of biomarkers is immense, there are challenges that influence their widespread adoption. Ethical considerations, such as the privacy and security of genetic data, are a constant concern. Additionally, the cost factor cannot be ignored. Advanced tests can be expensive, which raises questions about accessibility, especially in developing countries.

The Global Landscape – From EU Regulations to Implications for Developing Countries

As we navigate the evolving landscape of global health diagnostics, biomarker regulation stands as a pillar of quality and safety. This section provides a comprehensive overview of the stringent regulatory frameworks of the European Union and their far-reaching implications for developing nations.

EU Regulations

The European Union has stringent regulations for the approval of biomarkers. All biomarkers must undergo rigorous clinical trials, most often conducted on the European soil, to establish their reliability and efficacy. The EU’s In Vitro Diagnostic Regulation (IVDR) serves as a comprehensive framework governing the approval and monitoring of in vitro diagnostic medical devices, including biomarkers.

Implications for Developing Countries

The stringent nature of EU regulations could serve as a benchmark for developing countries eager to adopt biomarker technology. However, challenges like inadequate healthcare infrastructure, low awareness, and limited financial resources make the situation complex. Despite these obstacles, the potential benefits of early diagnosis through biomarkers could be transformative for healthcare systems in these regions.

Conclusion: Toward a New Frontier in Early Diagnosis

Biomarkers have emerged as a potent tool in the world of healthcare, offering promising avenues for early diagnosis that can lead to more effective treatments and better patient outcomes. As we have seen, the European Union has set rigorous standards for the adoption of this technology, which could serve as a template for other nations, including those with developing economies. Yet, it is worth noting that countries like China are rapidly advancing in this sector (both technology-wise and cost-wise, with affordable full-genome sequencing devices adapted to single-patient diagnosis becoming a reality as we speak), with the potential to contribute to global healthcare by setting new benchmarks in the utilization of biomarkers for early diagnosis.

For European medical technology and diagnostic innovators looking to expand into the Chinese market, VVR Medical offers unparalleled expertise and assistance. Leveraging a deep understanding of both European and Chinese regulatory landscapes, VVR Medical provides services that range from strategic diagnosis to commercial development and supply chain management. By partnering with VVR Medical, businesses can navigate the complexities of the Chinese healthcare ecosystem, thereby securing and strengthening their foothold in one of the world’s most lucrative and fast-growing markets.

Advancing Frontiers: The Rise of Minimally Invasive Surgical Techniques

In the realm of medical science, the evolution from open surgical procedures to minimally invasive surgical techniques marks a significant stride towards better patient care and enhanced operational efficiency. This shift not only epitomizes the advancement of medical technology but also mirrors the relentless pursuit of reducing surgical invasiveness and the associated risks. The focus of this article is to unravel the various minimally invasive surgical techniques currently in use, the ongoing research aimed at honing these methods, and the global implications of such medical innovations.

Unveiling Modern Techniques

The scope of minimally invasive surgical techniques is continuously expanding, thanks to relentless innovations in medical technology. Here’s a glance at some of these modern techniques.

Laparoscopy

Known as keyhole surgery, laparoscopy is widely used in gastrointestinal, gynecological, and urological surgeries. Recent advancements include the integration of artificial intelligence (AI) and robotic assistance, enhancing surgical precision, but also Single-Incision Laparoscopic Surgery (SILS), Natural Orifice Transluminal Endoscopic Surgery (NOTES), and telementoring, which have shown promise in bettering surgical outcomes and patient recovery times. The global market for laparoscopy devices is projected to grow at a CAGR of 6.5% from 2020 to 2030, reflecting the escalating adoption of this technique.

Endoscopy

Utilizing an endoscope, this technique allows visualization of internal body cavities. Surgical polarimetric endoscopy, a recent advancement, has been employed for the detection of laryngeal cancer. The year 2023 saw the launch of Olympus’s EVIS X1™ endoscopy system, marking a substantial stride in endoscopic technology​. The convergence of artificial intelligence and robotics with endoscopy is a trend to watch, as these technologies are driving further advancements in this domain.

Robotic Surgery

Robotic surgery, once a futuristic idea, has become a reality with its application spanning across various surgical domains, including cardiothoracic, colorectal, urological (in particular with EDAP TMS’s FocalOne^® robotic HIFU solution), general, gynecology, and head-and-neck surgery, driven by ongoing technological advances. The surgical robotics market, now exceeding $3 billion, is poised for significant growth, with an increased demand for Robotic-Assisted Surgery (RAS) across the globe.

Laser Surgery

Laser surgery employs beams of light to cut, remove, or cauterize tissue, and is hailed for its precision and minimal damage to surrounding tissues. Recent advancements in refractive surgery, such as the rise of Small Incision Lenticule Extraction (SMILE) and the introduction of technically competitive laser systems, mark a paradigm shift in surgical precision, efficacy, and patient outcomes​. Improvements in aesthetic laser devices, including longer dye lives and increased wavelength capacities, contribute to the enhanced precision and accuracy of laser treatment​.

These techniques, each with its unique advancements, contribute to better patient care, faster recovery times, and reduced healthcare costs, showcasing significant strides in the surgical domain.

The Spectrum of Benefits

Minimally invasive surgical techniques hold a plethora of benefits that significantly enhance both patient care and operational efficiency. Here are the key advantages underscored by recent data:

Reduced Recovery Time

Smaller incisions expedite healing, enabling patients to resume normal activities sooner, substantiated by reduced postoperative complications and shorter hospital stays.

Lesser Pain and Scarring

Patients experience less post-operative pain and minimal scarring, contributing to better cosmetic results and an improved recovery experience​.

Lower Risk of Infection

The minimized exposure of internal body structures to potential contaminants lowers the risk of post-surgical infections, aligning with improved postoperative pain control and shortened postoperative hospitalization​.

Cost-Efficiency

Quicker recovery times, lower infection risks, and shorter hospital stays contribute to lower healthcare costs, aligning with the medico-economic benefits associated with MIS​.

Trailblazing Research and Emerging Techniques

The voyage of minimally invasive surgical techniques into new horizons is steered by groundbreaking research. Here’s a glimpse into the contemporary research and emerging techniques that are pushing the boundaries.

Robotic Assistance

The symbiosis of robotics with minimally invasive surgery is escalating surgical precision and control to unprecedented levels. The advent of sophisticated robotic systems is enabling surgeons to perform complex procedures with enhanced accuracy and minimal invasiveness. Recent innovations like the reconfigured robotic arm design, faster docking to reduce operative time, and fluorescence-detection to identify structures and lesions are notable advancements in this domain. Moreover, robotic-assisted surgery has become a popular trend offering prospective benefits to patients like shorter hospital stays, earlier recovery, and less pain, along with operational benefits to surgeons.

Artificial Intelligence (AI)

AI is the torchbearer of predictive analytics and real-time decision support during surgical procedures. It is fostering a paradigm of data-driven surgery, where AI algorithms aid in enhancing surgical precision and optimizing patient outcomes. While not aimed at replacing surgeons but rather at making most use of their experience and knowledge, AI has the potential to revolutionize surgery, particularly in technical skill assessment and integration into surgical robots, which paves the way for improved preoperative planning and intraoperative guidance.

3D Visualization and Augmented Reality (AR)

3D visualization and AR are revolutionizing the way surgeons interact with medical imaging data. Technologies like the XR90 augmented reality-based surgical visualization and navigation platform combine CT imaging with live ultrasound to perform minimally invasive procedures with enhanced precision. AR technology superimposes artificial targets onto a live view of patient anatomy, offering a more intuitive understanding of anatomical structures and enhancing surgical planning and execution.

Telemedicine and Remote Surgery

The combination of telemedicine with minimally invasive surgical techniques is greatly enhancing the application range for remote surgery and consultations. Telementoring, a form of remote teaching in surgery that includes more and more 3D/AR visualization modes, enriches the training options for surgical trainees, while telemedicine addresses some barriers to surgical care, especially in low- and middle-income countries, by providing remote healthcare services.

Advanced Imaging Technologies

Cutting-edge imaging technologies are the linchpin of successful minimally invasive procedures, offering clearer and more detailed visualizations crucial for surgical success. The evolution of medical imaging systems has been rapid, with the integration of artificial intelligence, cloud-based solutions, and mobile technology revolutionizing medical imaging.

Bridging Surgical Frontiers

The significance of minimally invasive surgical techniques extends beyond the operating rooms of developed nations to developing countries where healthcare resources are often limited. Moreover, the global reverberations of advancements in minimally invasive surgery are palpable, with countries like China embracing and investing in these techniques to foster a robust healthcare ecosystem.

VVR medical, a conduit for European innovators in medical technology and diagnostics, facilitates a smooth entry and establishment in the Chinese market, accelerating China market entry through strategic diagnosis, qualification, and efficient commercialization of products and services. This symbiosis of surgical advancements and market access strategies elucidates a promising trajectory towards a global surgical landscape that is not only efficient and effective but also inclusive and progressive, steering the global healthcare community towards a horizon where surgical care is more accessible, less invasive, and profoundly impactful.

 L’Intelligence Artificielle au service du diagnostic médical : des opportunités d’expansion mondiale à découvrir

Dans le secteur dynamique de la santé, l’intelligence artificielle (IA) s’est imposée comme une force révolutionnaire, en particulier dans le domaine du diagnostic médical. En combinant la puissance d’algorithmes sophistiqués avec des connaissances cliniques, l’IA facilite les diagnostics et les rend plus rapides et plus précis.  Cela bénéficie au patient, au praticien et à l’ensemble de la chaîne de soins de santé. Pour les entreprises visionnaires, c’est l’occasion rêvée d’élargir leurs horizons au-delà des frontières nationales et de prospérer sur la scène internationale.

L’essence de cet article réside dans l’élucidation du potentiel de transformation de l’IA dans les diagnostics médicaux, et dans la manière dont elle peut être un catalyseur pour les entreprises qui aspirent à une expansion mondiale. Alors que les besoins en matière de soins de santé ne cessent de croître dans le monde entier, l’exploitation de l’IA peut permettre aux entreprises de relever ces défis de front, tout en respectant les réglementations spécifiques et rigoureuses des différentes régions – dont certaines sont souvent peu familiarisées avec le sujet. Ainsi, s’intéresser aux prouesses de l’IA en matière de diagnostic n’est pas simplement une exploration du progrès technologique, mais un voyage vers l’ouverture de nouvelles voies de croissance et la réalisation d’avancées significatives à l’échelle internationale concernant les soins de santé.

Naviguer dans la transformation : Exploiter l’IA pour un diagnostic d’excellence

La place de l’IA dans la reconfiguration du secteur du diagnostic médical est tout à fait remarquable. Voici un aperçu des domaines actuellement concernés et des avantages de l’IA pour les entreprises liées au domaine du diagnostic médical qui souhaitent se développer à l’international :

• Détection et diagnostic précoces :

  • Les outils de diagnostic alimentés par l’IA sont une aubaine pour la détection précoce des maladies. Or le diagnostic précoce améliore considérablement les chances de traitement efficace et de guérison des patients. Cela est particulièrement vrai pour les pays en développement, où le diagnostic précoce est souvent la clé d’une amélioration spectaculaire de l’ensemble du système de santé et, par conséquent, de la santé des populations. The In-Vitro Diagnostics market post-Covid in China – VVR International, développement stratégique, production, sourcing, distribution…
  • Pour les diagnostics basés sur l’imagerie, grâce à la reconnaissance d’images et à l’analyse de données avancées, l’IA peut identifier des changements subtils ou des anomalies dans les images médicales bien plus tôt que l’œil humain.

• Amélioration de la précision et de l’efficacité :

  • En réduisant le risque d’erreur humaine et en résolvant les multiples problèmes de répétabilité et de cohérence, l’IA améliore la précision des diagnostics.
  • Elle accélère également le processus de diagnostic, fluidifie le parcours du patient et garantit une intervention rapide et de meilleurs résultats pour le patient. L’IA a par exemple pu diagnostiquer des problèmes cardiaques en 15 secondes seulement, alors que la moyenne humaine est de 30 minutes à une heure.

• Avantages potentiels pour l’expansion internationale des entreprises :

  • Répondre aux normes internationales en matière de soins de santé : Grâce à l’IA, les entreprises peuvent améliorer leurs services de diagnostic afin de satisfaire, voire de dépasser, les normes internationales en matière de soins de santé. Cela constitue un aspect essentiel pour s’implanter sur les marchés étrangers qui ont besoin d’innovations de pointe.
  • Surmonter les contraintes géographiques et de ressources : À condition que les solutions soient conçues et mises en œuvre conformément aux réglementations et aux normes applicables en matière de sécurité des données et de protection de la vie privée des patients, l’IA peut aider à transcender les barrières géographiques et les limitations des ressources en permettant des diagnostics à distance. Ces diagnostics permettent d’optimiser l’utilisation des ressources, ce qui rend l’expansion internationale plus faisable et plus durable.

L’intégration de l’IA dans les diagnostics médicaux n’ouvre pas seulement la voie à une amélioration de la prestation des soins de santé, mais aussi à un monde de possibilités pour les entreprises d’étendre leurs services à l’échelle mondiale. En s’alignant sur l’éthique mondiale des soins de santé, qui consiste à établir des diagnostics précoces et précis, les entreprises peuvent se tailler une place sur le marché international, ce qui leur confère un avantage concurrentiel considérable.

Paysage réglementaire et éthique : Se préparer aux marchés internationaux

Naviguer à travers les divers paysages réglementaires et éthiques est une condition préalable à une incursion réussie sur les marchés internationaux avec des diagnostics médicaux pilotés par l’IA. Voici quelques éléments clés à prendre en compte :

• Comprendre les différents cadres réglementaires :

  • Il est impératif de se familiariser avec les exigences réglementaires des marchés cibles, telles que le cadre de la FDA américaine ou la loi sur l’intelligence artificielle de l’UE, afin de garantir la conformité et une entrée facilitée sur le marché. Cela est particulièrement vrai pour l’expansion vers certains pays et territoires, comme la Chine, où l’autorisation des États-Unis ou de l’UE est souvent une condition préalable à un enregistrement local réussi.
  • Engagez-vous auprès des organismes de réglementation nationaux et sollicitez les conseils d’experts en réglementation locale pour aligner vos solutions de diagnostic IA sur les cadres juridiques en vigueur. Une attention particulière doit être porter sur les réglementations concernant la sécurité des données, la confidentialité des patients ainsi que sur les conditions de transfert et d’exploitation transfrontaliers des données.

• Considérations éthiques dans les diagnostics pilotés par l’IA :

  • Au-delà de la stricte conformité réglementaire et juridique, la résolution de dilemmes éthiques tels que la protection de la vie privée, les préjugés et la transparence est essentielle pour instaurer un climat de confiance avec les parties prenantes locales et les patients.
  • Établir des lignes directrices éthiques claires et documentées et veiller à ce qu’elles soient communiquées à tous les niveaux de l’organisation.

• Renforcer la confiance et la crédibilité :

  • L’établissement d’une réputation en matière de pratiques éthiques et de respect de la réglementation peut renforcer la confiance des patients, des prestataires de soins de santé et des autorités locales.
  • Élaborer un système solide pour traiter les griefs et garantir la responsabilité dans les processus de diagnostic pilotés par l’IA.

Alliances stratégiques : Favoriser les partenariats mondiaux

La formation d’alliances stratégiques est la pierre angulaire d’une navigation réussie dans le paysage mondial de l’IA dans le domaine du diagnostic médical. Ces partenariats peuvent fournir des informations locales inestimables et favoriser un environnement propice à la croissance et à l’innovation. Voici quelques étapes et considérations cruciales :

• Partenariat avec les prestataires de soins de santé et les autorités locales :

  • Établissez des partenariats avec les fournisseurs de soins de santé et les autorités locales afin de mieux comprendre les écosystèmes de soins de santé locaux, les paysages réglementaires et les besoins des patients. Des adaptations ciblées afin de répondre à ces besoins peuvent considérablement améliorer l’acceptation locale et l’impact de vos solutions de diagnostic pilotées par l’IA.

• S’engager dans la recherche et le développement collaboratifs :

  • Engagez-vous dans la recherche et le développement en collaboration avec des institutions locales, par le biais d’une recherche clinique ad hoc et publiable qui permet aux praticiens de se familiariser avec vos solutions, ce qui vous aidera à innover et à affiner les solutions de diagnostic IA en les alignant sur les défis locaux en matière de soins de santé et sur les normes mondiales.

• Exemples d’expansions internationales réussies :

  • Explorez des études de cas telles que la collaboration stratégique entre PathAI et Labcorp pour vous faire une idée des stratégies efficaces et des défis potentiels liés à l’expansion mondiale du diagnostic médical par l’IA.

Conclusion : Saisir l’opportunité mondiale : Vos prochaines étapes

Le panorama de l’IA dans le domaine du diagnostic médical offre un terrain fertile aux entreprises qui aspirent à étendre leur champ d’action à l’échelle mondiale. En exploitant le potentiel de transformation de l’IA, en comprenant les divers cadres réglementaires, en contribuant à la formation des organismes réglementaires locaux sur les avancées et les avantages de vos solutions, en formant des alliances stratégiques et en s’inspirant d’exemples de cas réussis, les entreprises peuvent naviguer dans les complexités des marchés internationaux.

VVR Medical accompagne l’innovation

VVR Medical est une passerelle pour les innovateurs européens en matière de technologie médicale et de diagnostic qui s’intéressent au vaste marché chinois. En effet, ce marché combine de manière unique un besoin massif de nouveaux paradigmes de diagnostic pour faire face aux défis de santé très étendus, un fort attrait pour l’innovation de pointe et un régulateur flexible qui est prêt à interagir avec vous à tous les stades de votre développement.

Grâce à sa connaissance approfondie de la réglementation et de la dynamique du marché, ainsi qu’à de nombreux cas de réussite, VVR Medical aide les entreprises à franchir les étapes de l’entrée et de l’établissement, garantissant ainsi une transition en douceur vers ce marché prometteur. Le voyage peut être semé d’embûches, mais les bénéfices de l’expansion de la Chine dans ce domaine en plein essor sont prometteurs. Le moment est venu d’élaborer une stratégie et de se lancer dans une aventure qui non seulement élèvera les normes de santé dans le monde entier, mais propulsera également votre entreprise sur le devant de la scène internationale.