In the pharmaceutical sector, it takes an average of 12 years to develop a commercial product. For completely new areas of medicine, it can take even longer, up to 30 years. Only one in 5,000 new substances is eventually approved for sale by regulatory authorities such as the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA) in the EU.

So you need persistence, capital and knowledge if you want your innovation to succeed.

Opportunities for public funding

As a result, there are large amounts of funding available, both nationally in Sweden through Vinnova and through various EU funding instruments, which can often cover up to half of the development costs.

Leif Lyckebäck, Business Developer at RISE, has in his role at RISE helped hundreds of innovation-driven small businesses in different industries to find funding for their development and scale-up work. He believes that there is a lot of public funding available for innovation among small and medium-sized enterprises. But you have to navigate the wide range of grants and subsidies, understand the eligibility criteria and what activities you can apply for.

"There is a lot of public support available for innovative SMEs to promote public health. However, you need to understand at what stage of development you should apply. In addition to funding specifically targeted at drug development and life sciences, there is also a lot of funding to stimulate development based on really deep research and in specifically identified 'impact areas', which can sometimes be relevant to drug development companies. Examples include advanced digitalisation, sustainable manufacturing or civil and military innovation. There is simply a lot of funding to apply for, but at the same time it is difficult for an individual innovator who is not an expert to navigate when, for example, they need to find project funding for their next stage of development."

External innovation support a key factor

Anna Minidis believes that a key factor for success as a small company, compared to large companies, is finding external innovation support.

"Companies are often started by researchers, for example a group of doctors with specific expertise in their field. To go from idea to finished drug and market a product, they need to attract and assemble a team with the expertise needed for efficient, high-quality development along the entire value chain. For example, medical, pharmacological, chemical, formulation, process development, scale-up, analytical, toxicological, quality and regulatory expertise."

The development partner accompanies the company all the way

Acting as a link between the research and industrial phases, RISE often acts as a full development partner for smaller companies throughout the entire development journey. It helps the innovator to find the right funding, expertise and guidance at all key stages of development. It also ensures technical expertise and the ability to take the project from the research environment to applied development and scale-up, with the aim of developing industrially and regulatory sustainable methods.

"Companies can gain access to laboratory equipment, method development and prototyping, quality data and quality documentation. We can also play an advisory role and help innovators with a plan and see what development steps the drug needs, adapted to the stage of development it is at," says Anna Minidis.

Just as important as access to funding is ensuring that you own the rights to your innovation. This is critical to the success of a small business.

"RISE has a patent department that can help develop a strategy for securing the intellectual property rights associated with development work. In addition, RISE has a number of other services designed to support innovative small and medium-sized enterprises in various industries – for example, technology readiness assessment, life cycle analysis and various types of certification," says Leif Lyckebäck.

Taking new and better solutions from an idea to something that actually creates value for society, businesses and individuals requires teams of people who are open to change. And within that team, the innovation leader plays a particularly important role. These are people with specific knowledge and experience that make them well-positioned to drive change in the contexts in which they operate.

"Bringing about change within an existing organization is challenging. It's actually easier to start something from scratch, which explains why we have so many start-ups and a demand for better services and user experiences," says Sean McNulty, innovation specialist at Irish company Insight Innovation:

"Some people drive change intuitively and don't need an innovation management guide or standard, but many of us do because we have fixed mindsets and have learned to follow set linear processes. Like quality management, where tomorrow we have to repeat what we did yesterday to establish an expected level of quality."

Innovation is very much about stepping into the unknown, identifying the problems that need to be solved first. Those on the journey must first change their mindset, understand the challenges of having an innovative mindset and managing such a process. Certification as an innovation leader demonstrates to others that you have developed expertise in the field and can share your knowledge and experience in developing systematic innovation work, for example according to ISO 56001 Innovation Management System.

"Confidence in the individual's innovation management skills is important to get the rest of the organization and senior decision makers to listen and trust the framework and processes that need to be implemented to achieve the desired outcomes and impact. Whether that is at the societal, commercial, or systems and policy level," says Sean McNulty.

First to be certified

Mr. McNulty is a member of an international working group for the development of ISO standards. Among other things, he chaired the NSAI team in Ireland that helped develop ISO 56001, the world's first requirements standard for innovation management.

He is also the first Irishman to be certified as an innovation manager. RISE project manager Magnus Karlsson, who played the same leading role as Sean McNulty in the development of ISO 56001 in Sweden, suggested the possibility of certification through RISE. Sean McNulty then opted to complete the process with written and oral exams remotely. Now others driving innovation in Ireland can do the same.

The National Standards Authority of Ireland (NSAI), where Sean McNulty chairs the Innovation Committee, is Ireland's official standardization body. In 2024, the NSAI partnered with RISE to certify innovation leaders in Ireland. Stina Wibom, certification engineer and head of personal certification at RISE, saw no obstacles to bringing Swedish expertise across the North and Irish Seas.

"There are eight of us working on this, and we are based in Stockholm, Gothenburg, Lund and Borås, so it makes no difference if there are one or two national borders between us and the person going through the certification process. Both the written and oral exams are digital and the material submitted is in English, even for our Swedish customers," she explains.

Case shows how knowledge is used

In addition to a written knowledge test, the certification process consists of an assignment in which the candidate must describe a case that demonstrates how the knowledge of innovation management is put into practice. The case is also presented orally in a video meeting.

"I chose to share a situation where I was helping others identify, validate, and implement a new solution, rather than a case from years ago where I was the one implementing the solution. It was more honest to reflect where I am now in my career," says Sean McNulty, who as an innovation specialist helps teams every day to identify problems worth solving, develop new solutions, products and services – and get them implemented."

The fact that NSAI, with the help of Swedish certification engineers, is now able to certify individuals like Sean McNulty illustrates the mission of innovation leaders on an international level, for the benefit of business and society at large.

SSAB is a global steel company specializing in advanced high-strength steels, including steel powders tailored for additive manufacturing (AM). Their membership will broaden the center's expertise in powder manufacturing, and provide key insights into the journey of launching additive manufacturing as a viable alternative alongside traditional metalworking processes. A transition that many sectors of Swedish industry are currently navigating.

“We are very excited to welcome SSAB to the center. Their extensive knowledge in advanced high-strength steels and steel powder manufacturing is highly valuable to us and will greatly support our efforts to democratize and industrialize additive manufacturing. It’s also great to see that SSAB shares our strong focus on a sustainable metal industry, not least in AM, giving us much common ground to build on,” says Marie-Louise Bergholt, Director of the Application Center for Additive Manufacturing.

Jesper Vang, Head of Powder Technology at SSAB, expresses his enthusiasm about joining:

“We are thrilled to be part of the center. I believe that centers like this, with strong industry connections, are essential for achieving realistic progress in additive manufacturing. Having access to the entire value chain, along with the technology spectrum and expertise, is immensely valuable to us,” he says.

As a center partner, SSAB seeks to deepen their knowledge of AM processes, strengthen industry collaborations, and ultimately provide added value to their customers. 

“We view additive manufacturing as an evolution of traditional manufacturing – not as a replacement but as a complementary and enabling technology that will eventually become as mainstream as bending and welding. The objective of our AM venture is to enhance component functionality, provide added value to users, and unlock new performance capabilities. By being part of AM Center, we hope to gain a deeper understanding of the entire additive manufacturing chain and use that insight to further refine our powder designs for printing.”

Photo source: SSAB