Immanuel Bader, CEO, Johner Institute North America
Immanuel Bader, CEOJohner Institute North America, a subsidiary of the global regulatory consulting company Johner Institute, is bringing its parent company’s legacy and expertise around helping medical device manufacturers attain nirvana in regulatory adherence in the US.

Johner Institute supports medical device manufacturers in establishing ISO 13485:2016 compliant quality systems, defining global market access strategies, writing parts of technical documentation, human factors validation testing, and risk evaluation and management, to name a few.

The company combines its consultancy expertise with purpose-built tools and an e-learning platform to help medical device manufacturers stay updated with ever-changing regulations, standards, and directives across countries. This enables manufacturers to successfully complete audits and inspections quickly, so that they can bring innovative, high-quality and safe medical devices and software to market faster.

Digitalizing the Path Towards Regulatory Knowledge and Adherence

After its inception in Germany about 15 years ago, Johner Institute built an internal system designed to expedite workflow and processes for their consulting teams. The system included an extensive library of templates, educational and instructional videos, processes and procedures, all designed to support their consulting work and educate their teams. They soon realized that the system could be offered to directly help medical device manufacturers instead of using it only for internal purposes.

The idea led to the development of Johner Institute’s Medical Device University—an e-learning platform that allows medical device manufacturers to gain knowledge about the processes and problems that occur while taking a medical device to market. The platform encompasses all the information around MDR, IVDR, and various standards such as the IEC 62304 and IEC 62366 in Europe, and 510 K approvals in the US, and all other market access routes across the globe. Medical Device University has over 250 video lessons that provide step-by-step guidance to clients to get through regulatory adherence processes

Also, with ready-to-use templates, manufacturers can quickly write the technical documents necessary for approval. In a nutshell, Medical Device University helps clients, especially startups and smaller companies, educate themselves, understand regulations comprehensively, and overcome challenges associated with the medical device approval process.

Interestingly, Johner Institute works with organizations that develop the standards and regulations. The company also trains the notified bodies, workforce, and individuals in the regulatory field through seminars and master courses to help them in personal and professional development.

“We are on a quest of educating people in the regulatory field,” says Immanuel Bader, CEO, Johner Institute North America.

Apart from the e-learning platform, Johner Institute has also developed tools that automate the processes involved in medical device approval and post-market surveillance. The company brings to the table an AI-powered system—Regulatory Radar— that automatically notifies medical device manufacturers whenever there is a change in any law, regulation, or guidance document, and generates a report for them

Johner Institute’s consultants then offer guidance and recommendation to manufacturers on how the changes in a specific guidance document impact their business, and which changes are relevant to their product based on the medical device’s risk classification. The consultants also help manufacturers take the necessary steps to adhere to changes relevant to their product, and make modifications to meet the required quality and safety standards.

Johner Institute North America: Digitalizing Regulatory Consulting

On the other hand, with the Johner Institute’s Post-Market Radar—a market surveillance tool for medical device notifications—it is possible to obtain information about safety-relevant notifications and adverse events from various data sources in order to be able to react quickly as a manufacturer in an emergency. The post-market radar includes not only safety databases, such as the FDA Maude, or recalls and safety alerts from Health Canada, but also other data sources, such as clinical data (e.g., from ClinicalTrials. gov), IT safety databases (e.g., from NIST), and literature databases (e.g., from PubMed).

Post-market surveillance requirements and the amount of available data are growing exponentially. Therefore, it is becoming increasingly difficult to find all relevant information in a timely manner with reasonable effort. However, this is of enormous importance as legislation requires manufacturers to plan and operate effective systems to do so. Failure to comply with these requirements can lead to serious non-compliance in audits or inspections and, in the worst case, suspension of the certificate/clearance. Immanuel recalls a case in which a manufacturer’s market surveillance notification system failed to capture an event. The manufacturer would have had to recall its medical device if Johner Institute consultants had not identified the finding and notified it to the client in time.

We are on a quest of educating people in the regulatory field

Manufacturers who decide to place their products on the Post-Market Radar are given comprehensive, product-specific advice on the selection of databases. This means that you will certainly no longer miss any relevant information regarding safety notifications and adverse events about your own and your competitors’ products. “Thus, the Johner Institute’s Post-Market Radar not only ends the headache of how you as a manufacturer are supposed to keep track of and manage it all, but also saves you considerable time and resources,” adds Immanuel.

Helping Streamline Medical Device Approval

Johner Institute’s comprehensive client onboarding process begins with one-on-one consulting. Then, its experts conduct a personalized consulting session through video conferences or in-person meetings with clients to understand their products, including the risk classification of the medical device and targeted market.

The experts develop a high-level project plan specific to clients’ needs and introduce them to Medical Device University. This allows clients to gain the necessary knowledge on regulation, leverage ready-made templates to fulfill technical needs and utilize instructional videos to get through the regulatory process. The company then takes another session after a few weeks to reevaluate the clients’ progress and answer any queries that they may have.

Lastly, Johner Institute conducts sessions every week where senior consultants and experts—former FDA and regulatory bodies’ workers— share knowledge on specific topics, such as risk management and ISO 14971, human factors validation study, and clinical evaluation. Any client using Medical Device University can participate in these expert sessions

and get their queries addressed by senior consultants. Similarly, when it comes to the Regulatory Radar and Post- Market Radar onboarding, the company analyses the clients’ products, identifies relevant regulations and data sources based on their market, and feeds the relevant lists into these systems to ensure clients stay updated with regulations and adverse event reporting.
Johner Institute has recently helped a manufacturer update the compliance as per the MDR framework. The client had developed a standalone software application in class I medical devices, which numerous patients were using. However, with rule 11 of the MDR, the client had to build an ISO 13485 quality system from scratch.
They approached Johner Institute to make their software MDR compliant to keep their product in the market. The company performed a gap analysis on the quality system and recommended the client to use Medical Device University, which helped them to attain the essential information and knowledge to implement the standard operating procedures quickly and cost-effectively. They also helped the client quickly find a notified body to conduct the audits to achieve ISO 13485 certification. With the quality system built based on Johner Institute’s templates and gap analysis, the client was able to get through the audit with no major findings. As a result, they could bring a 13485 compliant quality management system to market within six months.

Broadening the Value Proposition

While Johner Institute has branched throughout Europe and established a strong presence, Johner Institute North America is fast establishing its presence in the US market to support as many medical device manufacturers as possible.

To further broaden its digital products portfolio, the company is working on a product that could streamline the medical device approval process through real-time approval for manufacturers and regulatory bodies. The product will allow manufacturers to add their information

as structured data in this new system and receive real-time feedback on the status of their approval process as it will be connected to the regulatory body or FDA’s systems. On the other hand, the regulatory bodies wouldn’t have to review multiple documents and papers at once. They can obtain and evaluate information from the system in real-time and immediately provide feedback to manufacturers if any document is missing for the approval process.

  • Our Post-Market Radar eliminates the headache of post-market surveillance and saves significant time and resources to observe data sources while ensuring manufacturers do not overlook their own product and information held by competitors

While the product is soon to be launched in Europe, it is in the initial stages in the US. The company has collaborated with Harvard University to speed up its efforts to complete the project and digitalize the approval process with the FDA in the US.
Not stopping there, Johner Institute has recently launched a new international program called World Medical Device Summit. The Summit will take place on May 12, 2022, where political members, EU representatives, FDA representatives, health providers, and medical industry experts will collaborate to figure out ways to reduce the burden of bringing medical devices to market. The Summit will also produce solutions to optimize and balance patient safety, availability, affordability, and effectiveness of patient care. It will also recognize the levers and processes to shape regulatory and healthcare systems to deliver the specified outcomes while identifying ways to accelerate the process from invention to application of knowledge in routine care

Johner Institute continually drives such initiatives to fulfill its mission of digitalizing regulatory consulting and enabling medical device manufacturers to become more independent