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

MEDDEV 2.7/1 修正第 4 版、欧州医療機器規則(Medical Device Regulation、MDR)2017/745、欧州体外診断用規則 (In Vitro Diagnostic Regulation、IVDR)2017/746 の導入以降、臨床および実績評価は、公認機関による精査を受けることで、これらの規制への準拠が維持されてきました。オーサリングの検証、等価性、文献レビュー、臨床データ、レポートの頻度、市販後臨床経過観察の水準が上がっていることに製造会社は気付いています。


  • ギャップ解析の実施、あらゆる種類の機器にわたる何百件もの臨床評価レポートの執筆、審査、修正を行ってきた経験豊富なエキスパート
  • 高い技術を有するメディカルライター、医師、博士、看護師、司書
  • 秩序立った方法で理にかなった文献レビューを実施することにより、お客様の臨床データを立証する高い専門性のあるスタッフ



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 Director, Regulatory Strategy and Policy

臨床および機器の 30 年以上の経験を有しています。さまざまな機器に関して 100 件以上の臨床評価レポートを執筆し、ガイダンスおよび助言を提供してきました。看護師として、さまざまな種類の機器を用いた臨床評価戦略を策定・実施し、深い実地経験を積んできました。末梢穿刺中心静脈カテーテル(peripherally inserted central catheters、PICC)に関する本も執筆し、PICCの挿入方法や治療方法、使用の推奨事項を遵守できる方法について詳細に説明しています。

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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