Regulatory Thinking® for Startups
Empowerment as a Leverage to Competitive Advantage
Requirements in the area of regulatory affairs are very high for medical life sciences startups and therefore complex, expensive and risky. Their implementation takes several years and means absolutely new territory for most of the startups. Common education programs and services are too generic in order to be able to support them with this very specific challenges. For this reason, the members of the Regulatory Thinking® consortium developed startup-compatible services, a network of experts and educational formats in a very focused way. These offerings pursue the goal to enable founders to help themselves. Because we know: Expensive consultants are not always necessary!
In the following you get an overview about what the Regulatory Thinking® consortium has to offer for startups and founders in the categories Education, Hands-on, and Auditing & Reviews. Also, institutional startup supporters, which supervise founders, benefit from this offer.
The qualification program focuses on the 4Cs of medical life sciences: Commercialization, Certification, Clinical Studies, and Copyright. During 15 workshop days and a subsequent coaching phase, startups get equipped with new methods, ways of thinking and tools, to incorporate the 4Cs into their business model development. Thereby, they can reach faster investor readiness.
Due to the funding of the Ministry of Economics, Labor and Tourism of Baden-Württemberg and its Startup BW campaign, the B. Braun Stiftung, the Stiftung für Medizininnovationen, and the Hector Stiftung, the program is free of charge for its participants.
In the sense of Regulatory Thinking®, the certificate program is about the practical further development of one’s own regulatory roadmap and at the same time, one’s own business model. The program consists of two certificate courses: “Regulatory Thinking Basics” and “Regulatory Deep Dives”. Successful completion of both leads to the certificate “Expert for Regulatory Compliance and Certification Strategies.”
The obtained certificate is of great value for founders to prove the required professional work experience in regulatory affairs, when striving for a certified quality management system and an approved product (e.g., CE Mark).
Certificate of Advanced Studies Regulatory Thinking
In pharma, medicine and the medtech industry, human beings play the central role. Even if one rightfully thinks of the patient first and the attending physician second in this context, these stakeholders do not yet represent all interest groups that have a legitimate concern for healthcare products.
CAS RT is aimed at (non-)experts in the healthcare business who want to learn why it is important to know about development processes, validation instruments, alternatives in clinical trials, and different certification and reimbursement strategies for medtech, pharma, (digital) biomarkers, in-vitro diagnostics, software or AI as medical device. Participants will become generalists that are highly needed in the changing healthcare sector: Whether you’re a start-up or business leader looking to drive a business forward, a government employee looking to ensure the safety of healthcare products, a payer looking to reimburse healthcare expenses, or defining new reimbursement paths – Regulatory Thinking will teach you how to participate successfully in the healthcare business.
The MII offers support via start-up centered seminars, filled out templates and individual workshops in the topics: Quality Management System (QMS), technical documentation, risk management, usability engineering and clinical study planning.
All these services are developed and implemented together with MII’s network of experts, like surgeSupply, and are highly customizable to your specific product. The in-depth offerings focus on helping you to help yourself and are intended to gain speed in small digestible packages. In particular, the MII wants to ENABLE you to develop your own way of thinking in order to be able to evaluate further support independently and talk on eye-level with stakeholders and experts.
Auditing and Reviews
Together with carefully selected experts, like surgeSupply, the MII supports you in the preparation of documents for critical institutions like notified bodies, ethics committees or study centers. Offered are pre-assessments and audits of the quality management system, technical documentation, clinical study plan and protocol.
The goal is to maximize the chances of success for upcoming appointments and approvals by critical institutions, in order to save time and costs.