This year's Swiss Medtech conference on medical device regulation on 19 October was dominated by the new reality Third countryThe Swiss medical technology industry has been in a state of deadlock with the European Union (EU) - its most important trading partner - since May of this year. What are the consequences of the blockade with the EU on the Swiss medical technology industry, which has so far been marked by success? What are the acute problems and how could they be solved? At the conference, over 500 industry representatives explored these questions. 

Exports: the industry has come to terms

According to Swiss Medtech, the industry has not yet Third country The company has largely anticipated this and has spent two years preparing itself with great commitment to meet the additional requirements for the seamless export of its goods to the EU. These essentially include the appointment of an authorised representative in the EU area, who assumes the manufacturer's tasks and joint and several product liability on behalf of the manufacturer, as well as the re-labelling of the products. Today, almost all companies are set up accordingly. The legal situation is clear: anyone wishing to export MDR¹ products to the EU must comply with the third-country requirements. On the other hand, there is still legal uncertainty with regard to medical devices with existing certificates (so-called MDD² products or old-law products). May they benefit from the transition period until the end of 2024 or not? "The EU says no, Switzerland says yes," the industry association said. Each company must make its own risk assessment in this legal limbo. 

Import: Alarming situation - patient care is at risk

With the entry into force of the national Medical Devices Ordinance (MepV) on 26 May 2021, the Federal Council has set high import barriers for foreign manufacturers. In doing so, Switzerland is not only harming the domestic medtech industry, but is also endangering the healthcare of its own population. According to Swiss Medtech, industry surveys show that one in eight of the medical products currently used in Switzerland will no longer be available in the future. The reason: not all foreign manufacturers are prepared to meet additional requirements solely for the small Swiss market. "At the moment, we are aware of individual examples of supply stoppages. From the second half of next year, there will be broadly noticeable gaps in supply," Daniel Delfosse, Head of Regulatory Affairs at Swiss Medtech, is convinced.

Already in spring this year, the association, together with other health stakeholders, drew attention to the alarming situation in an open letter to the Federal Council. Without success: The MepV was put into force with high import hurdles. 

The association is aware that the Federal Council does not have the MRA³ update and thus the key to free mutual trade in goods in its own hands, but that the EU must also be prepared to do so. "It is all the more important that the Federal Council makes the rules of import, which it can set unilaterally independently of the EU by means of the MepV, for the benefit of Switzerland. That is not the case today," says Delfosse. With the MepV, Switzerland has further tightened the law adopted by the EU (MDR) (Swiss Finish). "The bill does not work in reality. We call for an urgent amendment. With a few adjustments to the ordinance, the looming supply problem could be massively defused. The Swiss government alone has this in its hands," says Delfosse. 

Future: Putting relations with the EU on a sound footing

In addition to the short-term negative consequences, the long-term damage to Switzerland as an attractive medtech location should not be forgotten. "Many decision-makers do not seem to be aware of how much the blockade with the EU has already damaged and will continue to damage Switzerland's attractiveness as a business and research location. The association will therefore continue to work with unwavering commitment with partners and in alliances to ensure that Switzerland's relationship with the EU is placed on a solid and lasting footing," says Beat Vonlanthen, President of Swiss Medtech.

Source: Swiss Medtech

 

Review of the European Medtech-Staccato 

May 26, 2021 was a cut-off date for the medtech industry: The new European Medical Device Regulation (MDR) replaced the old EU Directives (MDD). The national Medical Device Regulation (MepV) came into force. The Federal Council broke off negotiations with the EU on the Institutional Framework Agreement, which abruptly lost the opportunity to update the agreement on the free bilateral trade of medical devices (³Mutual Recognition Agreement, MRA) in a timely manner. The lack of an update of the MRA relegated the Swiss medtech sector to third country status. The EU Commission announced that Swiss certificates would no longer be recognised in the EU with immediate effect, and that products with existing certificates issued by a body in the EU would not be able to benefit from the transition period until May 2024.

Cybersecurity is not just about hackers attacking email systems, company servers or customer databases. Literally everything that is networked can be hacked: from medical devices to the power grid, from the home alarm system to the gas network. These cases are referred to as "operational cybersecurity." For example, if a car was purchased after 2017, it has a SIM card built in as standard that would launch an automatic emergency call in the event of an emergency. A small feature that networks the car with other systems, making it attractive to hackers. For example, in 2015, hackers managed to control a Chrysler Cherokee in a strange way: All without wires, from a great distance and with a laptop. The driver no longer had control over the engine, steering and brakes. Class action lawsuits, court cases, software adjustments and a recall of 1.4 million Chrysler Jeeps were the consequences.

A recent example is the hacker attack on the largest gasoline pipeline in the US, where Colonial Pipeline ended up paying the hackers millions - in US dollars and bitcoins - to regain control of the gasoline supply. To avoid such security breaches wherever possible, processes and products are security tested and certified. "It pays to involve a certification body early on in the development of a product or service, as the development process is an essential element of a certification and cannot be corrected after the fact," explains Jens Henkner, CEO of CertX.

Hacking with honorable intentions?

To make it as difficult as possible for hackers with sinister intentions, manufacturers, industrial users as well as end users need to be aware of security vulnerabilities and strictly adhere to precautionary measures. Attacks like Chrysler's are deliberately undertaken by hackers to alert companies to eminent security vulnerabilities. CertX employees also participate in so-called "ethical hacking" in their free time, so that consumers and companies can be spared greater damage. Jens Henkner emphasizes: "Only if everyone, from the development to the user, develops and handles networked devices correctly, the greatest possible security is guaranteed. Cybersecurity is needed to ensure that safe products from the factory remain safe. Unfortunately, many players still follow the Floriani principle - namely, not to solve the danger situation, but to wait and see what happens first.

Are mistakes teachers or tolggen in the clean book?

"In aviation, people have long been used to sharing mistakes and learning from them together," says Henkner. Most industries are still far from living this culture unconditionally. Public discussions about mistakes like those at Boeing are hard to imagine in the automotive industry, for example. But slowly the attitude towards error culture is changing here as well. Henkner is convinced that standards can play a supporting role in this area: "Standards are experience cast in writing; as an engineer, I see no sense in inventing the wheel twice". This principle is also followed by CertX, which sees itself as a partner and not as a civil servant-like control body. Henkner says: "We are the co-pilot. We read the checklist and ask the right questions so that customers can easily find the right solutions on their own."

Do I still drive my car or am I being driven?

The classic combustion engine is no longer the only dominator on the roads. Electric cars are enriching the road scene more and more. Buzzwords such as "autonomous driving" are fuelling the discussion about safe driving. If you believe the visionaries, road traffic will change fundamentally in the next few years. The fact is that the automotive industry is facing very different challenges today than it did just a few years ago. Building mechanical or electric cars are two completely different disciplines. If, for example, the clutch in the car and thus the manual control to interrupt propulsion suddenly disappears, completely new tests are placed in the path of the manufacturers, which require functionally safe control systems. New pieces of the puzzle, such as charging stations or more power-intensive batteries, appear on the radar. Today, for example, even more electric vehicles are being damaged by fire rather than problems with driver assist systems. "Standards also help in such an innovative environment, serving as best practices and a recipe book during development," Henkner believes. "Employee awareness and training are key contributors to success. For example, we're proud to say that before Covid-19, we trained the most automotive employees in the world on standards."

And what does Henkner think about autonomous driving? He sees great potential for motorway journeys, but he cannot imagine autonomous driving in urban traffic in the near future because of the complexity involved. CertX is convinced of the multimodal transport of the future and is therefore involved in the SwissMoves research project of the University of Applied Sciences in Fribourg, where they contribute their certification knowledge in the field of functional safety and cyber security.

Source: CertX 

And what about artificial intelligence?

Many of today's applications rely on artificial intelligence, especially for image recognition in various areas of automation. The difficulty is that after development, the so-called neural networks become a black box and are difficult to verify. Here, it is all the more important to proceed in a process-related manner and to certify accordingly. If, for example, drivers make mistakes, these are always attributed to the individual human being as a failure and not regarded as a system error. Artificial intelligence must now prove that it operates more safely than humans, does not exceed today's human error rates, and does not cause systematic errors. Practical proof requires an immense amount of testing, which is practically unaffordable in today's development cycles. Additionally, standards in this area are still largely lacking. "The art is no longer to test the end result, but to optimally regulate the development process so that a so-called 'Equivalent Level of Safety' can be achieved. Factors like 4-eyes principle, complete documentation, clean database, digitized tests and so on play an important role in assessing the safety of neural networks. The big challenge is to package agile systems into codified standards. This creates friction between all parties involved in the standardization work, which I consider to be very useful, because it ultimately leads to good results," emphasizes Jens Henkner.

Source: CertX 

World Standards Day takes place annually on 14 October. This year, the theme is "Shared vision for a better world" and aims to draw attention to the role that standardization work plays in achieving the UN's 17 Sustainable Development Goals (SDGs). In order to achieve the defined sustainable development goals by 2030, the cooperation of many public and private partners and the use of all available instruments, including international standards and conformity assessments, is required, emphasizes the Swiss Association for Standardization (SNV). National standardization work supports organizations and other stakeholders in achieving sustainable, economic and social solutions. 

On the basis of weekly Short videos SNV shows the many ways in which national standardization work contributes to the success of the SDGs.

Other topics:

Investments in biodiversity pay off

The recent Capgemini, Sogeti and micro focus published 13th World Quality Report 2021-2022¹ shows, that companies are increasingly recognizing the importance of quality assurance (QA) and taking a more orchestrated approach to it. In addition, the report highlights how the key trends that underscore this overall shift have evolved in the areas of QA and testing-including artificial intelligence (AI), agility, and DevOps, as well as the evolving field of Intelligent Industry².

According to the report, companies are developing increasingly realistic expectations for testing and QA. Key areas of IT strategy such as improving the customer experience (63 percent) and IT security (62 percent), meeting business requirements (61 percent), and developing high-quality software solutions (61 percent) all receive equal weighting.

Confidence in AI in the field of quality assurance is growing

Here's what the report reveals: More and more companies would like to implement AI and machine learning (ML) as part of their quality assurance. Nearly half of respondents (48 percent) already have a relevant contingent of test execution data that AI and ML platforms would need. Forty-two percent of business owners trust the intelligent value AI and ML platforms add to their businesses-46 percent say they would take action based on that intelligence. Confidence in AI in the QA space is now high, with solid plans and strategies already in place in many places. In addition, companies continue to build skills and toolkits to successfully implement AI and ML within their quality assurance operations. However, AI in quality assurance has yet to reach its full potential. According to the report, there continues to be a growing need for testing strategies and test design capabilities with regard to the use of AI. This means that companies are still relatively new and are just beginning to understand the complexity of AI, the challenges it presents, and the difficulties of AI testing.

The added value of agile methods and DevOps in QA

Companies are already benefiting greatly from the implementation of agile methods and DevOps in the context of QA and testing, for example in the form of higher productivity, higher-quality software and cost reductions. The report also notes that those factors that respondents considered most important to a successful DevOps implementation have realigned: With an eleven percent increase, more than half of them (52 percent) described business-related priorities as the most important. The technology stack, on the other hand, became comparatively less important, with only 49 percent putting it first. In 2020, this figure was still 65 percent.

The lack of testing expertise in agile teams remains a challenge, they say. As the lines between software development and testing teams become more blurred, companies need to focus on collaboration and upskilling their quality assurance staff.

The Rise of Intelligent Industry

Quality assurance teams will soon be the foundation for the rapid growth of Intelligent Industry, according to the report. Therefore, companies should start investing time, energy and budget in this area. The most important drivers for Intelligent Industry are a more efficient approach (47 percent), an increase in quality (46 percent), greater agility and flexibility (44 percent) and an optimized customer experience (43 percent). To achieve this, companies must gain management approval and demonstrate feasibility in the initial steps, according to the press release. According to the data, 42 percent of respondents plan to expand their existing test labs to include 5G, Internet of Things (IoT), AI and automated systems. To do this, companies need to invest in products and services that add the most value with limited time and manpower.

"What emerges particularly strongly from this year's World Quality Report is the shifted perception, as well as growing importance, of quality assurance as such," said Mark Buenen, Global Leader, Digital Assurance and Quality Engineering at Capgemini. "As a result of the pandemic, more and more companies across industries are realizing that they need to be flexible in responding to such events and changes. As IT landscapes are modernized and moved to the cloud for greater agility, the relevance and value of quality assurance is increasing. As this happens, we are seeing growing investment in this area - particularly in technologies that support the Intelligent Industry."

"This year's global World Quality Report not only highlights the impact of changing application requirements affected by the pandemic on new delivery methods. It also highlights the growing use of AI, as well as the implementation of agile practices and DevOps in the context of quality assurance," said Rohit de Souza, senior vice president, general manager of the ITOM Product Group as well as the ADM Product Group, head of the CTO Office and Product Security at Micro Focus. "Our customers are constantly looking for ways to improve the quality, speed, productivity and security of their software, as well as the overall customer experience - across multiple devices and environments. The results of our report show that organizations need to drive their modernization efforts using AI-driven quality assurance and test automation tools." (Source: Micro Focus)

For further information and recommendations for action based on the study, please refer to the full report here ready for download.

¹ World Quality Report 2021 Methodology: The annual World Quality Report, launched in 2009, is a global report that looks at application quality analysis and testing trends. This year, the 13th report (2021-22) included computer-assisted telephone interviews, followed by in-depth conversations with 1,750 CIOs and other technology experts (Vice President Applications, IT Director, Quality Assurance/Testing Manager, Chief Data Officer/Chief Marketing Officer, Vice President/Director of Research & Development, and Chief Technology Officer (CTO)/Product Head) from 32 countries and from over ten industries.

² Primarily driven by data, Intelligent Industry is a term coined by Capgemini to describe digital transformation that connects the physical and digital worlds. Intelligent Industry leverages the influence of data to drive innovation, develop new and differentiated "smart" products, improve supply chains, create novel customer experiences, and create new sources of value. It looks at how companies are using software, data, 5G, edge computing, artificial intelligence (AI), automation and the Internet of Things (IoT) to adapt their practices and how they can achieve this transformation.  

Other topics:

Business Agility - Architectural Runway

In order to place products on the EU markets for which a harmonised European standard exists, manufacturers require a CE marking. If no European standards exist, many construction products in Germany require approval by the German Institute for Construction Technology (DIBt). The tests for this are carried out by notified or recognised bodies. VdS Schadenverhütung GmbH supports manufacturers in both procedures - it has now created new information pages with the most important facts on this.

Martin Hesels, Deputy Head of the VdS Certification Body, emphasizes: "For a fast and smooth market launch, we offer all relevant services from a single source - we promote the safe success of fire protection developments with decades of experience around the required processes."

At vds.de/ce-en and vds.de/dibt interested parties will find authoritative knowledge about the "passport for building products" as well as the PÜZ processes (testing, monitoring, certification).

Source: VdS

According to the survey, there is a large gap between aspiration and reality when it comes to reputation: On the one hand, 99 percent of respondents consider the company's good reputation to be very important (70 percent) or important (29 percent). Reputation is thus of outstanding importance in Swiss companies.

On the other hand, only some companies have actually established concrete measures to build up or maintain a good reputation: Only slightly more than half of them have a concrete strategy for building and expanding their reputation (60 percent). One in three companies has no corporate reputation strategy at all (36 percent). Three percent of the communications professionals surveyed do not know whether the company has a strategy in this regard at all.

44 percent of companies do not even check how their reputation is developing. Only one in two companies regularly measures how its own corporate image is doing (49 percent) and seven percent of those surveyed do not know. Nevertheless, of those that do use controlling measures, 93 percent regularly inform top management about the progress of reputation communications. (ots / news aktuell (Switzerland) AG)

Source: Online survey in February 2021 by news aktuell and Faktenkontor, 121 communications professionals from companies, organisations and PR agencies in Switzerland. 

Now the question arises: Which factors are decisive in order to survive in global competition? Productivity, speed and efficiency are the most frequently used buzzwords. The software manufacturer proAlpha shows 8 adjusting screws for the ERP roll-out, with which hidden champions also shine on the international stage.

1. communication is everything

Use the cultural challenges as an opportunity for your business. Because decisions and planning are different in every country. It makes sense to take as much time as possible at the start of the project to agree on a uniform procedure with all those involved. Draw up a plan in which project goals and processes are clearly defined and documented. This way you are protected from misinterpretations from the very beginning. After all, functioning processes are an important basis for being as well networked and successful as possible abroad.

2. skillfully overcome language barriers

In the international environment, English is the established working and project language. But especially between native speakers and non-native speakers, subtleties in communication can quickly get lost - misunderstandings arise, and the project's success falters. Therefore, when preparing your ERP rollout abroad, rely on internationally experienced project managers who are able to confidently navigate linguistic pitfalls.

3. identify local requirements

The legal regulations for companies differ from country to country - often even regionally. In order to be prepared for all eventualities here, you should already inform yourself about the respective framework conditions before establishing a foreign branch. It also makes sense to know the local business practices. A standardised catalogue of questions for the ERP roll-out is not helpful here, as it may not take into account essential criteria for success. In these cases, proAlpha relies on open workshops in which users can openly address their hurdles and define individual requirements. Only afterwards do targeted questions complete the picture.

4. get IT on board from the start

The technical target architecture must be defined as early as possible when using ERP software internationally. Because it is usually not done with a few additional user accounts. Consider the set-up in the backend as an essential success factor for your project.

In one possible scenario, you build your foreign branches as additional clients on an existing database. This saves licensing costs, reduces the implementation time and facilitates data exchange - however, all countries are then dependent on one database server. In order to be able to act more flexibly with regard to maintenance and local requirements, a second scenario is possible: Each location receives its own database, but this is accompanied by additional licensing costs and a higher effort when importing updates.

5 Standardisation and its limits

Individual requirements for workflows and data structures quickly lead to deviations from the standard programming in the ERP system - especially at the company headquarters. However, since most foreign subsidiaries have a more compact set-up and require fewer special tools, adopting the complete architecture is rarely expedient. The solution: Develop a set-up with several country subsidiaries and modify the standard for your subsidiaries as little as possible. Adaptations per client or country can be realized much more easily this way.

6. introduce mandatory master data management

The master client concept is a useful tool in central master data management when processes are similar at all locations and the same data is used. Despite the high effort involved, you thus uncover the potential of a globally uniform ERP system - and make it usable for your company. Master data is stored and maintained centrally and can be replicated in local clients. However, it is important to differentiate between global and local master data in order to take regional and national differences into account, for example when parameterizing country-specific tax laws.

7. national language is trump

ERP systems should be adaptable to the needs of the respective users - not least in terms of the language version. Even if user interfaces and menus in English are often the international standard, masks in the local language make work much easier. If your ERP provider does not have a ready-made language version for your requirements, he should at least provide a translation kit.

8. is on-site consultation necessary?

On-site consultant days are a huge cost when it comes to rolling out an ERP system abroad. Therefore, limit these appointments to the most necessary. In coordination with the project management, define the tasks that must be completed at the respective location. Country-specific settings for the ERP software and other work that does not require customer knowledge can then be completed conveniently and cost-effectively via remote consulting.

With these 8 tips, SMEs are well prepared for the most common hurdles and can optimally configure their ERP system even before venturing into internationalization.

Source: proAlpha

Practical experience with the established cyber security standard VdS 10000 has shown: The formulated requirements and action guidelines are a practicable basis for SMEs to achieve an appropriate level of security in the area of information security. For small and micro enterprises, however, the specifications of VdS 10000 are still too complex, so that this customer group in particular still shies away from a systematic IT security approach. Against this background, VdS has developed the 10005 guidelines. The aim of the framework is to show companies with up to 20 employees a cost-effective way to secure their IT systems and to substantiate them with effective measures.

Web-based guide developed

"How can we make small and micro companies an offer that, on the one hand, scales the technical-organisational measures (TOMs) responsibly and still offers an appropriate level of protection, but on the other hand, does not lose sight of the resource situation and, last but not least, the willingness of the target group to invest? How much may information security cost today?", Markus Edel, VdS department head cyber security and management systems, explains the mental approach to the development of the guidelines VdS 10005. "By dividing the management system aspect out of the requirements. Because by embedding the TOMs in a management system that has the so-called continuous improvement process as a central component, it requires a number of measures that are resource-intensive," he continues.

A web-based guide was also developed for the VdS 10005 guidelines, which guides customers step by step through the requirements. In addition to the text of the guidelines, the guide provides valuable information on interpretation and shows concrete implementation examples from corporate practice. The guide is available at vds.de/guide-vds-10005 is available as an online tool in a chargeable, closed area and provides users with additional convenient features - for example, the ability to display the current implementation status of the VdS 10005 guideline in order to be able to precisely determine the test certificate capability.

No longer certifiable

With the overall package of guideline and guide, the goal of reducing the effort for micro-enterprises could be optimally achieved. Thus, VdS offers interested companies a procedure for less than 650 euros, which enables an adequate protection of their IT landscape, but is no longer certifiable due to the omission of the management system aspect. Instead, the guideline aims at a remote audit-based test certificate without mandatory, annual monitoring, so that cost-intensive on-site audits can be dispensed with. Furthermore, VdS 10005 represent a subset of VdS 10000 and are thus upwardly compatible. An interesting option if, for example, the requirements for information security also increase due to an increase in business or changes in the risk environment.

More info at: www.vds.de/cyber

Other topics:

New cyber insurance for the self-employed and SMEs

Corruption almost always takes place in secret and is often difficult to detect, especially for small and medium-sized enterprises (SMEs) with limited resources. In addition, the numerous export-oriented Swiss SMEs are quickly confronted with corruption abroad. Transparency Switzerland has therefore developed a guide specifically for Swiss SMEs to help them identify their corruption risks and effectively counter them with appropriate measures - and to do so quickly, cost-effectively and sustainably, as the non-governmental organisation writes.

Self-evaluation checklist

The SME guide to corruption prevention is made possible by a Self-evaluation checklistion which enables an initial rapid assessment of the areas in which the SME is exposed to corruption risks and where the greatest need for action exists. In addition to this, Transparency Switzerland has published the topic-specific guides Dealing with whistleblowing and Gifts & Invitations elaborated.

Advisors and guides as well as the checklist are available online and as brochures. The latter can be ordered from the Transparency Switzerland office can be ordered.

Request under info@transparency.ch

Standardized processes, maximum efficiency and lower costs - the reasons for implementing cloud solutions in procurement are manifold. However, many companies are still working with outdated or even analogue processes. Patrick Sommer, Head of Consulting at CNT Management Consulting in Zurich, is aware of the current situation: "Many companies are still hesitant when it comes to digitalization topics. A lack of willingness to make decisions and a sense of purpose ensure that a lot of work is still being done with tried-and-tested business models." The willingness to change something does exist. Very often there is a desire to revise the company's internal individual processes. The expert counters this with cloud solutions: "The cloud has the advantage of building on standardized processes that have all been developed on the basis of best practice.

Especially in times of the Corona pandemic, many companies have recognized the importance of digital solutions and use free resources to implement IT projects. Since purchasing processes are not only necessary in all industries, but 90 percent of them are the same everywhere, cloud solutions are recommended for companies from all sectors.

From tried and tested to fully automated

Companies that have already digitized their business areas usually only need twelve weeks to switch from older on-premise to cloud solutions, but many customers find this too fast. Often, the implementation is then extended to just under six months, but the cloud then works fully from day one. This means, for example, that time-consuming internal operating processes are controlled or automated centrally via a digital interface. From this point on, a fleet of machines can be managed on the move in a single program, in which expenses and expenditures are always kept in view. And the purchasing process is completely paper-free. "By using the cloud, the entire procurement chain is digitized and automated, making error-prone and untraceable paper contracts a thing of the past," Sommer explains. This means that everything from sourcing to supplier and contract management, purchase orders, to invoicing and payment processing, runs completely digitally. The advantages: compliance with operational, contractual and legal regulations can be ensured more easily and employees make purchasing decisions based on the company's specifications. All procurement guidelines are automatically adhered to.

Early integration of suppliers

Despite the numerous advantages, many companies are still undecided about cloud solutions. The high flexibility and unrestricted control over the system are valued in proven on-premise solutions. Collaboration with suppliers also plays a role. "With cloud solutions, the suppliers also have to play along, register in the program and specify their products there. It becomes difficult when the respective supplier itself has not yet arrived in the digital age," Sommer describes. Therefore, it is advisable to pick up the suppliers at an early stage with the help of communication tools such as newsletters, training courses or manuals and thus integrate them into the process.

The right software is only the first step

Companies are often under the misapprehension that they have already mastered the digitization process by opting for on-premise or cloud solutions. While this is an important part of the transformation, it is far from the end: "In order to make the digital implementation successful, all company-specific measures and their scope must be included in the cost-benefit calculation," Sommer points out. It is simply difficult to create roadmaps and KPIs for something of which you yourself have only limited knowledge. "It is much easier to define individual measures if the optimization potential is correctly quantified," emphasizes the expert. Those who question their processes have already done a lot right. 

Source: CNT Management Consulting AG 

In nuclear medicine, a radioactive substance is administered to the patient, which then travels to specific biological targets in the body. Depending on the radioactive properties of the radionuclide, the substance may emit radiation that can be detected with external detectors to visualize the distribution of the nuclide in question (SPECT, PET imaging); alternatively, the substance may emit charged particles such as α- or β-particles that deliver their energy locally (within micrometres to a few millimetres, i.e. from the size of a cell to the size of a metastasis), thereby destroying only cells in the vicinity, for example to treat a cancer with targeted radionuclide therapy (TRNT).

Of the more than 3000 different radionuclides that researchers have synthesized in the laboratory, only a handful are regularly used for medical procedures, mainly for imaging, although interest in TRNT has increased in recent years. One of the main difficulties in developing novel radio-medical products is access to radionuclides during the development and early biomedical research phases. In the context of Prismap - the European Medical Radionuclides Programme - can facilitate this development phase by providing access to novel radionuclides of high purity for medical research.

Generation of radionuclides

The radioactive elements used in nuclear medicine do not exist in nature and must be synthesized in the laboratory. There are two main routes: neutron irradiation in a nuclear research reactor or proton, deuteron or alpha irradiation with a particle accelerator. The size and energy of the particle accelerator determine which radionuclide can be produced: Small, compact devices are available in many hospitals and provide access to the radionuclides in use today. However, for the production of novel radionuclides, which are currently not available, devices with higher energy are needed.

Purification of radionuclides

New challenges arise in the production of these novel radionuclides: the simultaneous production of unwanted radioactivity that could affect the quality of the drug, have adverse effects on the patient and complicate waste management in hospitals. Therefore, novel purification techniques are needed. Within PRISMAP, techniques based on physical mass separation and radiochemistry are being developed to achieve high-purity radionuclide production suitable for pharmaceuticals.

Access and translational research

To support ongoing research across Europe and beyond, Prismap will provide immediate access to new radionuclides. A central access platform has been set up via the website to showcase production and support opportunities.

A network of world-leading European facilities, including nuclear reactors, medium- and high-energy accelerators and radiochemical laboratories, has been formed to offer the broadest possible catalogue of radionuclides for medical research. A mass separation facility is available at the Cern Medicis facility, allowing the physical separation of isotopes of an element. This is complemented by a network of biomedical research facilities that can host external researchers to carry out their research close to the production facility if the radionuclides are not suitable for long transport to their facility or if European approval for novel radionuclides has not yet been granted.

Access to the radionuclides and associated facilities will be granted on the basis of excellence selection. Access to the radionuclides and, where appropriate, to the complementary biomedical facilities will be requested via the Prismap online platform. A selection panel composed of experts in the fields of radionuclide production, molecular imaging and radionuclide therapy will select the best projects among the applicants. The first call for proposals will be launched before the end of 2021 and is expected to be published in the first quarter of 2022. It will be open to all interested parties.

A look into the future

In the rapidly evolving field of nuclear medicine, Prismap is also focused on the future. The European Commission is committed to tackling the societal impact of cancer through Europe's Beating Cancer plan and, in particular, the Samira action plan unveiled earlier this year, which includes the establishment of a European Radionuclide Valley Initiative. Through the Prismap consortium of 23 academic and research institutions across Europe, the development towards upscaling the production of these novel radionuclides is being explored in the form of novel production technologies, new purification methods and proof-of-concept studies. These will demonstrate the development of new treatments from the bench to patient care and feed directly into this Europe-wide plan.

Prismap Consortium

Prisma is a consortium serving a community of early-stage researchers, and aims to establish itself as a community and to host new facilities to extend the capabilities of the programme. New facilities such as the Jules Horowitz reactor at CEA Cadarache (France), the ISOL@MYRRHA mass separator facility at SCK CEN (Belgium), the new SPES accelerator complex at INFN National Laboratories in Legnaro (Italy) are emerging, the European Spallation Source at Lund (Sweden) and finally the new SPIRAL2 facility at GANIL (France), which has recently accelerated its first beams, and the FAIR facility at GSI (Germany), whose construction is progressing. These new facilities will benefit directly from the knowledge gained from Prisma and will help to increase production capacity throughout Europe.

Through the collaboration between research hospitals and metrology institutes, new data will be generated and compiled to allow an immediate and smooth introduction of the novel radionuclides in medicine. All new findings will be used to produce new educational material for professionals in the different fields of this multidisciplinary area, as well as for training the next generation of professionals and advising the European Commission on these novel radionuclides. 

PSI is main partner

The Paul Scherrer Institute is one of the main partners in the Prismap consortium. The researchers use its large-scale research facilities Spallation Neutron Source Switzerland SINQ and Injector 2 as well as the irradiation station IP2 to produce radionuclides for medical purposes. The radionuclides are coupled to a molecular complex, selectively dock onto tumour cells in the body and can destroy them with their particle radiation. The Centre for Radiopharmaceutical Sciences at PSI is one of the few research organisations in Switzerland that is able to develop radiopharmaceuticals not only for research purposes but also for clinical trials. The approval procedure for clinical trials with the promising therapeutic radionuclide terbium-161 is currently underway. In addition, as part of the new BFI project IMPACT (Isotope and Muon Production with Advanced Cyclotron and Target Technology), an upgrade of the high-intensity proton accelerator facility HIPA is planned for the period from 2024 to 2028 to enable the production of new radionuclides for diagnostics and therapy.

Nuclear medicine research is a multidisciplinary approach and progress requires bridges to be built between physicists, engineers, radiochemists, inorganic chemists, structural biologists, clinicians, medical physicists, dosimetrists, pharmacologists and oncologists. Prismap - the European Medical Radionuclides Programme - will support the implementation of a multidisciplinary approach to work in practice.

Source: Paul Scherrer Institute, text based on a communication from the Cern