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.
商業的視点も兼ね合わせた統合アプローチ
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.
俊敏性、コミュニケーション、品質、そして信頼が、私たちのパートナーシップには欠かせません。Together with you, we are one integrated team that creates a robust strategy and delivers with seamless implementation.
規制プロセスのリスク回避
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
市場アクセス拡大のための革新的価格設定
Reimbursement of medical devices require the establishment of value for money to the payers. サターラのEvidence and Access（エビデンス＆アクセス）チームは、償還までのすべての段階において、価値、ポジショニング、エビデンスの統合を最適化します。私たちの科学と公衆衛生の意思決定者の課題に対する理解を組み合わせることが、効果的な市場参入と価格設定のキーとなります。様々な方法を用いて、サターラは保健介入の価値を評価していきます。
課題を予測することで、成功により近づきます：
- 不必要なデータ収集活動を排除し、開発プログラムを効率的に提供するために、医療当局および支払者/HTAの期待に沿った戦略をとる
- 変化する市場力学への適応力
- 価値の伝達と捕捉を改善する過去の比較対象に関するデータと証拠の情報源を理解する
- 遺伝子治療メーカーが資金調達の軌跡をたどる中で、投資家と被投資家双方のニーズをカバーする
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は、グローバルクライアントの医療経済およびマーケットアクセスに関するすべての業務を担当しています。また、ニューヨーク・オフィスの全業務を監督しています。Leeは、戦略的かつ実行力のあるリーダーとして、高い能力を持ち、科学的根拠に基づいた部門横断的かつ地理的に異なるチームを管理しています。
Leeは、グローバルクライアントの医療経済およびマーケットアクセスに関するすべての業務を担当しています。また、ニューヨーク・オフィスの全業務を監督しています。Leeは、戦略的かつ実行力のあるリーダーとして、高い能力を持ち、科学的根拠に基づいた部門横断的かつ地理的に異なるチームを管理しています。
