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.

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

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



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 年的临床和监管经验,其职业最初是一名医院注册护士。她在监管策略、临床和医学写作方面具有丰富的经验。她在监管审批方面的经验涉及欧洲、澳大利亚、美国和亚洲。她撰写或参与撰写了多项监管申报文件,包括技术文件、临床/性能评估、上市后监测 (PMS)、上市后临床随访 (PMCF) 计划和报告她的临床经验涉及数个领域,包括血管通路,骨科、介入性放射学、外科重症护理、创伤和家庭护理。

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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