The journey from an idea in medical life science to the market entry of the final product is marked by many challanges, especially in terms of regulations and certification. A wrong strategy is costly and time-consuming and thus hinders an early and sustainable market success of potentially life-changing and -saving products.
We made a virtue out of this necessity and developed Regulatory Thinking® as a positive and enabling mindset. Norms and standards for example can be seen as a treasure chest filled with valuable methods that provide a common thread for business and product development. Therefore, we want to encourage innovators to proactively and strategically use those methods hidden e.g. in the ISO 13485, rather than seeing them as sticking points.
By Regulatory Thinking ® one gets the owl’s vision – deep and wide-angled – so that the pathway through the regulatory forest into the market becomes visible.
In this sense, Regulatory Thinking® implies more than just regulatory affairs. It implies thinking regulatory ahead. This includes an early understanding of relevant terms, an early definition of the intended use, the exact description of working principles, the setup of the device, and an early identification of relevant p(l)ayers. The aim is to integrate regulatory and certification requirements into the development of the business model or product policy right from the very beginning. For example: What is the risk class of one’s product and how does that influence financial planning? Is it a combination product? What are the core markets for the device? The implementation of Regulatory Thinking® as a team or company culture therefore enables projects to take important informed strategic decisions very early. This way one gets clarity about the right amount of needed resources. As a result, resources can be saved on the way from the idea to the market entry, both in terms of money and time, leading to a competitive advantage.
How to start with Regulatory Thinking®
To think regulatory, one first needs to know the literature as their toolbox. Understanding the Medical Devices Regulation (MDR) in its smallest fragments is key to using it as a strategic tool to enhance one’s business model.
Each Friday we release one fact with the motto:
Guiding you through the MDR, one article at a time.
In order to promote this approach of a positive, enabling mindset, we talked to several partners in the medical life science sector. They too are convinced that Regulatory Thinking® is the right approach for implementing medical innovations. Therefore, we came together as a consortium.
Each consortium member offers different kinds of support based on our shared mindset. Startups, representatives of industry or academia can find certification programs, workshops, template-packages, hands-on-, auditing- and pre-assessment services, etc. especially developed for their needs and for implementing Regulatory Thinking®.
The Regualtory Thinking® consortium unites industry, science, and the startup-ecosystem partnerswho share the same mindset. This brings the advantage of swarm intelligence: In a decentralized, but continuously enhanced manner, our consortium bundles knowledge, skills, and experience of each of its members. This gives us enormous opportunities, know-how, skills and exerpertise to support medical innovators in a targeted and focused way.
The merger as a consortium also offers a powerful tool to tackle future projects and topics from both a scientific and a practical/industrial perspective. Together we initiate sustainable changes in the healthcare market.
Read more about each member of the consortium in the following or visit their website.
Medical Innovations Incubator GmbH (MII) is a founding member of Regulatory Thinking®. It is based in Tübingen, Baden-Württemberg, and is specialized in the 4Cs of medical life sciences: Commercialization, Certification, Clinical Studies, and Copyright. MII supports startups with medical innovation in this complex industry in a very focused way. Its services, educational and networking formats follow a tailored qualification approach and are adapted to the needs and resource capacities of startups. In its work, the MII-team has been able to gain key knowledge about how regulatory requirements can be turned into a competitive advantage when founding a company. MII transferred this knowledge to its offers in order to pass it on to startups and founders.
RegulatoryExperts@ETHzürich focus on a human centric regulatory (HCR) approach and guide academia and industry in defining regulatory strategies and certification pathways to drive forward health-related research and to transfer academic research into industrial applications. In addition, there will be systematic research to establish new types of clinical research modes, including remote, decentralized trials and to utilize digital technology to characterize physiological function under real-world conditions.
HCR is a regulatory strategy in the sense of Regulatory Thinking® that considers the interests of the various stakeholders in medical technology: from medtech to pharma.
The Knowledge Foundation @ Reutlingen University is the non-profit further education foundation at Reutlingen University. In order to meet today’s requirements in the field of lifelong learning, the foundation offers a wide range of professional development opportunities to accompany companies and their employees at various levels. The programmes provide up-to-date knowledge from research and practice at the highest level, combined with interdisciplinary solutions. Therefore, the Regulatory Thinking® concept fits very well with our own approach. Only by linking existing disciplines to new ways of thinking can the challenges of the future be mastered.
QS International located and based in Switzerland and Malta is an accredited Certification Body and Notified Body. QS understands Regulatory Thinking® and human centric regulatory as a “certification culture” that transfers scope for action to the business of the customers, insofar as the applicable regulations permit this. QS Schaffhausen AG is accredited by the Swiss Accreditation Service. Partner companies and firms that are also committed to the QS performance standard contribute further accreditations and notifications of their own, which QS can arrange for the needs of its customers.
surgeSupply GmbH consultants train and assist to answer questions concerning company- and product-approval. We are experts for Modern Concepts, DiGAs, POCs but also for classical med-tech products. It provides Business Planning for Conventional and Future Technologies, Certification Strategies for Modern Treatment Concepts, Hands-on and Assistance in Document Development, Coaching and Teaching as well as Auditing and Pre-Assessments. surgeSupply defines Regulatory Thinking® as an interdisciplinary regulatory strategy that knows existing rules, regulations, common specifications, standards and norms, adapts them to common and future technologies, uncommon healthcare settings or any new or unknown challenges, and applies them in the spirit of the “original idea.”
Orion Additive Manufacturing focuses on scientific research and the development of additive manufacturing technologies to solve today’s complex problems and create innovative solutions for tomorrow. Originally focused on developing highly regulated aerospace solutions, Orion AM developed the A150 series printers using patented Thermal Radiation Heating technology. With knowledge of highly regulated environments and very complex parts using high performance polymers. The Orion Medical System is designed and structured to easily adapt to any clinical scenario and the patient-specific anatomy. In this way, surgeons can plan, visualize, simulate, and develop a better understanding of possible solutions for congenital or acquired pathologies.
Regulatory Thinking® helped us to translate our knowledge into the development of the first medical printer, the M150 series.
Odilia Vision GmbH faces a huge problem: Every year, there are 15 million stroke patients worldwide, more than 270,000 of them in Germany. One third of these patients suffer from visual field defects: That is 100,000 cases per year in this country alone. People with visual field loss suffer greatly from the resulting orientation disorder, as the patients lack information from the “blind area of the visual field.” A severely reduced quality of life is the direct consequence. The VISIOcoach medical training program (Software as Medical Device / DiGA), regulatory cleared and CE-marked in summer 2020, brings back quality into the daily lives of these patients.
VISIOcoach can be reimbursed by the health insurance companies after completion of the DiGA procedure. Regulatory Thinking® guided us through this jungle of legislations.
sync2brain GmbH commercializes a novel technology that for the first time enables effective, personalized therapy for patients with stroke or depression – with much less side-effects compared to conventional therapy. Their bossdevice combines devices for electroencephalography (EEG) with devices for transcranial magnetic stimulation (TMS) of the brain. It synchronizes the stimulation to the individual brain state making TMS most effective. The bossdevice is already available for researchers and will be certified as a medical device in the coming months. The long-term goal is to establish bossTMS therapy as a standard procedure for the treatment of stroke, depression and other neuropsychiatric disorders.
PolyMORE GmbH combines a broad spectrum of expertise in the fields of medical technology, implantology, additive manufacturing and polymer materials. While personalized or functionalized implants or medical devices made from metals have been reentering the market for years and in some cases define the golden standard in orthopedic applications, polymer materials are hardly used in this field.
Our goal is for as many researchers as possible from industry, academia, and the authorities to join our network. Now is the time to discuss smart polymers, smart manufacturing methods and smart regulatory strategies.
Fysor GmbH is developing a technological solution for sustainable pelvic floor training, which measures the muscle activity of the pelvic floor at various points using skin electrodes and converts these into control signals for serious games. These can be loaded onto standard smartphones and tablet PCs. The training system can be used unnoticed in public, e.g., at the bus station, at work and in other everyday situations. We have established Regulatory Thinking® as a corporate culture, as it enables us as a team to think along with regulatory requirements in every area right from the start. This is a clear cost and speed advantage.
stimOS GmbH, a research company and 13485:2016-certified legal manufacturer, was founded in 2015. stimOS develops innovative technologies and processes for the refinement, functionalization, and activation of implant materials. All stimOS surface functionalization technologies show superiority in terms of bone cell growth. In 2021 stimOS was awarded as Top 10 Orthopedic Company Europe by the most important industry portal Medtech Outlook.
For the benefit of the patient, we pursue the transfer of pioneering, medical technology concepts into industrial application. The aim is to comply with all regulatory requirements or to “redefine” them in the sense of MDR (EU) 2017/745 and all applicable laws.