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 have contributed to unsuccessful regulatory outcomes, creating uncertainty in regulatory pathways
  • Medical devices pose pricing and market access challenges as reimbursement requires the establishment of value for money to the payers

Certara’s MedTech Practice de-risks and accelerates the process, 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.

Integrated, commercial, best-in-class approach

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.

Agility, communication, quality, and trust are critical to our partnerships. Together with you, we are one integrated team that creates a robust strategy and delivers with seamless implementation.

Integrated, commercial, best-in-class approach
De-risking the regulatory process

De-risking the regulatory process

自引入 MEDDEV 2.7/1 Rev 4、欧盟医疗器械法规 (MDR)2017/745 和体外诊断法规 (IVDR) 2017/746 以来,第三方指定机构对临床和性能评估进行了详细审查,以确保符合这些法规。制造商已经注意到作者资格、等效性、文献综述、临床数据、报告频率和上市后临床随访的标准已经提高。


  • 经验丰富的专家,他们进行了差距分析、编写、审阅和修改了数百份针对各类设备的临床评估报告
  • 合格的医学作家、医生、博士、护士和图书管理员
  • 技术过硬的工作人员,他们会以方法上可靠的方式撰写文献综述来支持您的临床数据



Innovative pricing to expand market access

Reimbursement of medical devices require the establishment of value for money to the payers. Optimize value, positioning, and evidence synthesis across all stages of the reimbursement journey with Certara’s Evidence and Access team. Our combination of science and understanding of public health decision-makers’ challenges is the key to effective market access and pricing. Using an array of methods, we assess the value of health interventions.

Anticipating challenges ensures success with:

  • Strategy aligned with health authority and payer/HTA expectations to eliminate unnecessary data collection activities and deliver development programs efficiently
  • Adaptive response to changing market dynamics
  • Understanding of sources of data and evidence for historical comparators that improve value communication and capture
  • Support for both investor and investee needs as gene therapy manufacturers move across the funding trajectory
Innovative pricing to expand market access
A Digital Umbrella for Stakeholder Engagement

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.

Certara Angela Siebeneck
Angela Siebeneck,MSN RN 监管策略和政策总监

Siebeneck 女士拥有超过 30 年的临床和设备经验。她已经为 100 多份针对各种设备的临床评估报告撰写并提供了指导和建议。在她作为护士的职业生涯中,她在开发和实施临床评估策略的许多类型的设备上获得了丰富的实践经验。她甚至还写了一本关于外周导入中心静脉置管 (PICC) 的著作,书中提供了关于如何插入和维护 PICC 的详细信息,并确保遵守使用建议。

Shawn Headshot
Shawn W. Bates Vice President of Global Business Development

Shawn Bates is Vice President Global Portfolio Leader for our BaseCase stakeholder engagement platform after gaining over 20 years’ experience working across the pharmaceutical and medical device industries. Having held a variety of senior leadership positions, his expertise lies in stakeholder engagement and management in the market access and medical affairs spaces.

Lee Stern
Lee Stern, MSc Vice President, Global Head of Consulting Operations

Lee is responsible for all health economic and market access engagements for global clients. She also oversees the full operations of the New York office. Lee is a strategic and actionable leader managing highly qualified and scientifically robust cross-functional and geographically disparate teams.


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