Johner Institute New Zealand
Bringing Groundbreaking Innovations to Life

Software as a Medical Device (SaMD) has emerged as one of the most significant digital transformation initiatives in New Zealand’s healthcare landscape. But just like commercializing any pioneering technology, SaMD manufacturers struggle to navigate the complex and often varying regulatory challenges to timely bring their products to market.

Johner Institute New Zealand is the guiding force bringing their SaMD innovations to life. It helps companies overcome regulatory hurdles and accelerate the entire process from conception to commercialization with its exceptional consulting and educational services.

“We are not just seasoned consultants helping manufacturers master regulatory challenges. We offer all the necessary guidance to turn them into regulatory experts,” says Anne Arndt, director of Johner Institute New Zealand.

The Journey through Time

Recognizing the daunting regulatory challenges associated with medical device manufacturing, Johner Institute set out in 2004 with a clear objective—to provide clarity and guidance in this intricate field.

Initially focused on regulatory education, it quickly realized the depth and breadth of the challenges its clients faced, particularly in the SaMD space. Within a broad spectrum of issues, SaMD commercialization was always subjected to an additional layer of complexity due to its distinct characteristics, rapid pace of technological innovation and a varying regulatory framework. The realization that manufacturers don’t just need information but tailored guidance to navigate this landscape catalyzed the company’s shift from educational pursuits to a more hands-on, consultative approach.

Johner Institute executed a nuanced strategy in response to the industry’s pervasive challenges. It started with fortifying its team through the inclusion of world-class regulatory experts while creating its guidelines. This proactive stance, intertwined with its collaborative ventures with esteemed international institutions, ensured Johner Institute’s counsel stayed current and comprehensive. But the company’s journey was not just about overcoming challenges.

It was about turning those obstacles into opportunities for growth and learning. The insights gained from the journey became the cornerstone of Johner Institute NZ’s offerings when it was established as a subsidiary in 2021. Since then, it has provided a range of services, including regulatory consulting, quality management, training and auditing, all of which have grown leaps and bounds over the years, imbued with the wisdom of Johner Institute’s distinctive journey.

Taking Regulatory Consulting to New Heights

At the heart of Johner Institute NZ’s consulting services is a multi-faceted strategy to help SaMD manufacturers cope with rapid changes in the global regulatory landscape.

Launching a SaMD globally demands the careful consideration of many country-specific regulations. Each country’s regulatory body has varying definitions and criteria for what constitutes SaMD and how to classify its risk level. The risk categories and terminologies defined by the FDA in the U.S. differ from those used by the EU MDR and Medicines and Healthcare products Regulatory Agency (MHRA). SaMD manufacturers must also comply with different quality management systems and standards depending on the country where they want to market their products.

Johner Institute NZ’s team of in-country representatives liaises with local regulatory authorities to manage product registrations for manufacturers and maintain ongoing compliance with post-market surveillance requirements.

In essence, it is a knowledgeable local partner working hand in hand with a client’s team to help them navigate the specific regulatory processes of each country and make international market entry as seamless as possible.

To make the journey simpler, the team of consultants at Johner Institute NZ adopts a step-by-step approach to surmounting every hurdle in the way of product commercialization.

It develops a project landscape in line with a client’s needs to identify their challenges and offer guidance in dealing with them. Once the roadmap is prepared, the team leverages its extensive knowledge and experience to empower manufacturers with all the right tools using the latest technologies, making sure they check off all compliance checklists.

We believe true partnership means providing advice and equipping clients with the tools and knowledge to navigate the complexities of the healthcare industry

Johner Institute NZ’s collaborations with influential organizations also serve as a competitive advantage. With an active presence in the hub of New Zealand’s HealthTech ecosystem, the company’s Christchurch office has fostered partnerships with Callaghan Innovation, the Digital Health Association (DHA), and the Medical Technology Association of New Zealand (MTANZ), delivering specialized solutions to clients in New Zealand and Australia.

“Our network includes offices in the EU, Switzerland, the U.S., Australia, and New Zealand, giving us a truly global perspective and reach,” says Arndt.

Making Clients Regulatory Specialists

Stepping beyond the confines of a consultancy firm, Johner Insititute NZ ensures its clients are well-prepared to thrive and excel in the ever-changing medical device regulation space.

To live up to this promise, Johner Institute NZ has made substantial investments in training and education. Along with hosting day-long seminars and webinars on various aspects medical device regulation, the company has established the Medical Device University program (MDU), a treasure chest of knowledge for professionals in the medical device industry. This game-changing program offers a comprehensive e-learning platform designed to help individuals gain the expertise to fulfil stringent regulatory requirements.

“We believe true partnership means providing advice and equipping clients with the tools and knowledge to navigate the complexities of the healthcare industry,” says Arndt.

Housing a wealth of content, the program includes over 150 video lessons, 10 well-structured courses, and 290 learning units. But that’s hardly the end of the line. Johner Institute NZ also integrates various quality management systems (QMS) and technical documentation templates into its e-learning platform, making it an all-encompassing educational hub.

The beauty of MDU also lies in its flexibility. Clients can learn at their own pace and revisit materials whenever they need. It is not only convenient but a cost-effective solution in a world where time and resources are precious commodities.

Further setting MDU apart is its interactive component. Johner Institute NZ’s consulting team has thoughtfully integrated expert sessions into the platform, facilitating real-time discussions on specific topics. Clients can ask questions, engage in discussions, and gain tailored insights, making the learning experience engaging and dynamic.

What’s more remarkable is how Johner Institute NZ has customized its offerings to accommodate the needs of startups. Acknowledging that early-stage companies often lack the resources for regular external consulting, it has created specialized training opportunities, including hour-long seminars on crucial topics like intended purpose, software development plans, or risk policies. This commitment empowers startups to navigate the complex medical device regulation terrain without the burden of expensive external consultancy services.

Particularly for startups seeking rapid yet comprehensive insights into specific regulatory topics, Johner Institute is introducing a series of specialized seminars to demystify medical device regulations. Named the Medical Device Regulatory Accelerator, this year-long program helps startups accelerate their journey from product ideation to commercialization and is ideal for those in search of targeted information but hesitant to make any long-term commitment to an accelerator program.

When a SaMD manufacturer partners with Johner Institute NZ, they don’t just gain access to a seasoned consultant but tap into a vast and comprehensive educational resource. In an industry as intricate and fast-paced as healthcare, this is an invaluable advantage.

At the Forefront of Innovation

Apart from critical consulting services and comprehensive training programs, Johner Institute NZ is also dedicated to offering advanced software solutions to support client success. Its specialized AI-powered Regulatory Radar and Post Market Radar services is a testament to this dedication.

Adding a distinctive edge to its services, the Regulatory Radar service keeps clients ahead of the latest regulatory changes that could impact their business, while its Post Market Radar services ensure they are up to date with post-market surveillance and vigilance requirements.

Using its proprietary, AI-powered regulatory intelligence platform, the team scans multiple databases daily, covering thousands of regulations from key global markets while continuously monitoring regulation changes and post-market requirements in real-time.

The AI-driven insights allow clients to anticipate changes in the regulatory space and build an optimal strategy to adapt to those amendments, enabling them to meet and often exceed cross-border regulatory requirements. This automated approach also frees up resources while strengthening their focus on innovation and growth.

Acknowledging the importance of a robust quality management system (QMS) in ensuring regulatory compliance, Johner Institute NZ offers JCeQMS, a cloud-based solution that streamlines the entire quality management process for manufacturers, empowering teams to collaborate seamlessly and adhere to quality and safety standards under ISO 13485.

The team is equally mindful of the pivotal role risk management plays in SaMD development. It accordingly assists clients in setting up an intricate risk management framework to identify, evaluate, and mitigate potential defects and cybersecurity risks in the software.

SaMD manufacturers also need to document all modifications related to risk management. This is where Johner Institute’s technical documentation services come into play, assisting manufacturers in regularly updating the changes in software design, implementation, testing, deployment and maintenance. It helps them demonstrate the software’s quality, performance, and safety to regulatory bodies.

A particular instance reiterates this fact. It was when one of Johner Institute NZ’s clients was threatened with a certificate of withdrawal due to inadequate product documentation. They even had to end the partnership with their notified body, an organization designated by an EU-affiliated country to assess the conformity of certain products before bringing them to market.

Upon stepping in, Johner Institute NZ reviewed their technical documentation and quickly identified the missing pieces before initiating necessary corrective actions. The team drew a four-month plan and, within the designated period, assisted the client in screening their technical documentation while looking for a new notified body. It enabled them to redeem the certificate and gain approval for selling their products in Europe.

In Pursuit of Continual Success

Having passed the 150-employee mark, which reflects its growth and ability to attract specialized talent, Johner Institute is foraying into research. It recently hired regulatory science researchers to strengthen its thought leadership in the industry.

The company’s academic collaborations also mark a significant milestone in its growth trajectory. Partnering with world-renowned institutions like Harvard allows it to stay at the forefront of academic insights into regulatory affairs and other key areas.

On the technology front, Johner has embarked on the digital transformation of regulatory approvals. This initiative is being carried out in partnership with TÜV SÜD and represents its commitment to employing innovative approaches to navigate the regulatory landscape.

Through Johner Institute NZ’s winning trifecta of international reach, advanced technology-driven services, and hands-on local expertise, SaMD manufacturers gain the confidence to bring groundbreaking products to the market and emerge victorious in an ever-changing healthcare regulatory landscap to landscape.