From Regulatory through Commercialization
MedTech, or medical technology, is comprised of every product, service, or solution using medical technology to improve people’s health by preventing, diagnosing, monitoring, and treating disease. This includes medical devices, which are any instrument, apparatus, appliance, software, implant, reagent, material or other article intended to be used for medical treatment purposes.
Although critically important, the MedTech market can be especially demanding in terms of regulatory requirements. Additionally, the shifting MedTech market landscape can be difficult to navigate when creating and communicating value, and optimizing access.
- New regulations may lead to ambiguous regulatory outcomes
- Medical devices pose pricing and market access challenges as reimbursement requires the establishment of value for money to the payers
Certara’s MedTech Experts may lower the risk and accelerate the process, for medical devices from regulatory through market access with advanced technology, an integrated approach, and experienced team. We are uniquely positioned to anticipate risks early, provide concrete insights to make informed and critical decisions, and set your MedTech programs up for success.
一体化，商业化，同类最佳的方法
From regulatory services through commercialization, our integrated team of experts leverages extensive experience and knowledge of medical writing, regulatory pathways, commercialization, and lifecycle management to provide the support you need to advance your program and help to increase probability of success. With the most experienced team of experts in regulatory services and market access, we are dedicated to achieving and accelerating your success.
敏捷、沟通、质量和信任对我们的合作伙伴关系至关重要。Together with you, we are one integrated team that creates a robust strategy and delivers with seamless implementation.
降低监管流程的风险
Since the introduction of MEDDEV 2.7/1 Rev 4, EU Medical Device Regulation (MDR) 2017/745, In Vitro Diagnostic Regulation (IVDR) 2017/746, Brexit and multiple MDCG guidance documents, the regulatory submission process has become more complex. Technical document submissions, including clinical/performance evaluations, have been scrutinized by the notified bodies. Compliance with these regulatory changes requires a team of qualified experts. Manufacturers have noticed that the bar risen for author qualifications, as well as state of the art and literature review expertise and our experts will work with you to ensure that you are prepared to meet the new regulations.
Our medical device team consists of the following:
- Experienced experts who have performed gap analysis, written hundreds of technical documents.
- Experience with clinical/performance evaluations, spanning all classes of device
- Expert medical writers including, physicians, PhDs, nurses, and librarians
- Skilled staff to perform your methodologically sound literature reviews supporting your clinical data
创新定价，扩大市场准入
Reimbursement of medical devices require the establishment of value for money to the payers. 与 Certara 证据和准入团队合作，在报销过程的各个阶段优化价值、定位和证据综合。我们将科学与对公共卫生决策者所面临挑战的理解相结合，是有效市场准入和定价的关键。我们采用一系列方法来评估健康干预措施的价值。
预见挑战，确保成功：
- 战略与卫生机构和支付方/HTA 的期望相一致，以消除不必要的数据收集活动，并高效地实施开发计划
- 适应不断变化的市场动态
- 了解可改善价值传播和获取的历史比较基准的数据和证据来源
- 在基因疗法生产厂家跨越融资轨迹时，为投资者和被投资者的需求提供支持
A Digital Umbrella for Stakeholder Engagement
Certara’s BaseCase digital stakeholder engagement platform engages market access, medical affairs, advocacy and patient engagement, and commercial sales and marketing stakeholders with interactive, tailored, real time data driven content across the product lifecycle.
This advanced technology enables our clients to create fully customized interactive tools for key stakeholder communications, that clearly demonstrate value to decision makers and capture critical analytics in the process. The platform is revolutionizing digital stakeholder engagement remotely, internally, and through face to face interactions across the medical device and medical technology spaces.
Lee 负责为全球客户提供所有卫生经济和市场准入服务。她还负责监督纽约办事处的全面运作。Lee 是一位具有战略眼光和可操作性的领导者，管理着高素质、科学性强的跨职能和跨地域团队。
Lee 负责为全球客户提供所有卫生经济和市场准入服务。她还负责监督纽约办事处的全面运作。Lee 是一位具有战略眼光和可操作性的领导者，管理着高素质、科学性强的跨职能和跨地域团队。
