Innovation Archives - Basel Area Business & Innovation About Basel Area Business & Innovation Mon, 21 Oct 2024 07:28:16 +0000 en-US hourly 1 https://wordpress.org/?v=6.7.1 https://baselarea.swiss//wp-content/uploads/2019/10/cropped-basel-area-favicon-01-32x32.png Innovation Archives - Basel Area Business & Innovation 32 32 Meet the i4Challenge 2024 winners https://baselarea.swiss/blog-post/meet-the-i4challenge-2024-winners/ Tue, 08 Oct 2024 12:40:37 +0000 https://baselarea.swiss/?post_type=blog_post&p=156452 With the i4Challenge program running for the sixth time, 6 “Innovative Solutions” and 5 “New Ideas” winners showcase their expertise and innovative prowess. From navigating unexplored waters to phygital devices, from data control to AI-powered tracking solutions – there’s no end to the amount of creativity we have had the pleasure of witnessing this year.

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Meet the i4Challenge 2024 winners

10/10/2024

The seventh edition of the i4Challenge accelerator is now underway, with six projects having been selected by our esteemed jury panel.

This year’s selected projects are bringing innovative new solutions in areas ranging from high-resolution printed electronics for robotics, more efficient fuel cells, to next-generation global supply chain and building water supply management solutions. We are looking forward to helping them deliver on their amazing potential: 

Authena supports brands in fighting against product counterfeiting and diversion through an advanced Authenticity and Traceability as a Service platform. By integrating IoT sensors, AI and blockchain into supply chain management, its platform enables real-time tracking and ambient condition monitoring down to the single-unit level. 

DatenBerg’s software enables companies to successfully collect, store and analyze their machine and quality data to optimize the operation, monitoring and process planning of their production lines. 

Inveel provides technology for low-cost and high-speed production of extreme high-resolution printed electronics. Its primary customers are robotics companies for proximity sensors and robot gripper companies using its touch sensors, which benefit from Inveel’s advanced sensory skin technology, enhancing robots’ precision and safety. 

Manukai’s software makes the process of turning CAD designs for metal machining into machine instructions faster and more efficient. It significantly reduces wear of machining tools, and increases production speed and part quality. 

Shayp has developed an IoT-enabled SaaS platform that helps building managers to eliminate water leakages and related anomalies, and improve building water efficiency by up to 22%. 

The team at the Department of Chemistry of the University of Fribourg are developing a patented, multi-stage gas separation device using palladium-coated graphene membranes. This technology aims to significantly improve the long-term efficiency of fuel cells required for the general replacement of combustion engines. 

Once again, I was blown away by the quality of the submissions for this year’s i4Challenge, and our expert jury had another tough time selecting the best applications among them. I am very much looking forward to working with these ventures and witnessing their journeys over the coming years.

Albert HilberManager Industrial Transformation

These companies now have access to an extensive, highly individualized support package, including benefits such as: significant in-kind support; real-world market validation; networking and strategic partnership opportunities; advice from industry experts; visibility at key industry events; and much more.

Are you interested in registering for next year’s i4Challenge? 

Whether you’re an individual with a groundbreaking idea, a startup poised for growth, or an SME ready to pivot, the i4Challenge can help you accelerate your journey. Please feel free to express your interest here and be notified when our 2025 competition opens. 

About the i4Challenge 

The i4Challenge is an initiative of the Industrial Transformation team of Basel Area Business & Innovation to foster regional economic growth and innovation. 

For startups, SMEs and individual innovators who want to bring their industry 4.0 project to market, the i4Challenge is a program that helps them make the next step towards that goal. 

We help entrepreneurs develop proofs of concept and define business models. We enable startups to develop and test their solutions in a secure environment. Finally, when projects are ready for the market, we help ventures connect and establish a successful collaboration with established companies that are looking for solutions like theirs. 

To date, the i4Challenge has supported 52 projects, unlocked CHF1.7m of in-kind benefits, and delivered over 1,000 hours of personalized coaching. 

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Roche investing an additional 1.2 billion Swiss francs in Basel https://baselarea.swiss/blog-post/roche-investing-an-additional-1-2-billion-swiss-francs-in-basel/ Fri, 17 Nov 2023 13:52:06 +0000 https://baselarea.swiss/?post_type=blog_post&p=152536 Roche will be putting an additional 1.2 billion Swiss francs towards the renovation of its site in Basel. This investment will be used to finance another research and development building and the modernization of molecule production, in addition to a building for the Institute of Human Biology.

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Roche investing an additional 1.2 billion Swiss francs in Basel

17.11.2023

Roche will be putting an additional 1.2 billion Swiss francs towards the renovation of its site in Basel. This investment will be used to finance another research and development building and the modernization of molecule production, in addition to a building for the Institute of Human Biology.

Significant investments are being made in the northern part of the site (image: Roche)

Roche announced its plans for the further modernization of the infrastructure at its Basel site. To this end, the pharmaceutical firm will be investing 1.2 billion Swiss francs to upgrade the northern part of the site. Since 2014, the company has already invested a sum of 3 billion Swiss francs in its Basel location.

The investment of 1.2 billion Swiss francs will be used to build another 72-meter-high, 13-story research and development building, among other things. The aim here is to provide attractive laboratory workstations for up to 450 researchers. Moreover, a new production building is to be built for the synthetic and chemical production of medicines. The existing building will also be refurbished and expanded, while the plans additionally include a new building for the Institute of Human Biology with space for up to 250 researchers. For this, an existing building will be converted and fully remodeled.

Big plans also for the southern part

“The new buildings will expand the infrastructure for future innovations along the entire pharmaceutical value chain, from research to production”, comments Jürg Erismann, Head of the Basel site, in the press release. He adds: “This is another clear commitment to the Basel research and production site and to Switzerland”. It is expected that the construction work on the research building and other building renovations will be completed by 2030.

As Roche explains in a video covering its site development plans in Basel, wide, generously proportioned green spaces will be created in the southern part of the area. To this end, the research and office buildings will be removed. According to a press release, the cantonal government of the canton of Basel-Stadt also approved a corresponding development plan on November 17. These plans also include a central building for visitors and employees in the park and a possible third high-rise building depending on Roche’s needs in the future.

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Nouscom secures 67.5 million euros in financing https://baselarea.swiss/blog-post/nouscom-secures-67-5-million-euros-in-financing/ Tue, 14 Nov 2023 13:40:37 +0000 https://baselarea.swiss/?post_type=blog_post&p=152473 Biotech company Nouscom has raised 67.5 million euros in a series C financing round. The Basel-based firm intends to use the funds to advance the clinical development of its portfolio of neoantigen cancer vaccines, including the evaluation of the ongoing randomized Phase 2 trial.

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Nouscom secures 67.5 million euros in financing

14.11.2023

Biotech company Nouscom has raised 67.5 million euros in a series C financing round. The Basel-based firm intends to use the funds to advance the clinical development of its portfolio of neoantigen cancer vaccines, including the evaluation of the ongoing randomized Phase 2 trial.

Nouscom, a Basel-based clinical-stage immuno-oncology company, has raised 67.5 million euros in a Series C financing round. The round was led by Andera PartnersBpifrance (through its InnoBio 2 fund) and M Ventures. Other new and existing investors also participated. As part of this financing, representatives of Andera Partners, Bpifrance and M Ventures were appointed to Nouscom’s Board of Directors, according to a statement.

The Basel-based biotech company is developing standardized and personalized cancer vaccines based on viral vectors targeting neoantigens. According to the statement, the fresh capital will be used to advance Nouscom’s clinical pipeline to the most important clinical endpoints. These include a Phase 2 trial for the treatment of colorectal cancer, an ongoing Phase 1b trial for cancer prophylaxis in Lynch Syndrome carriers, and the completion of a Phase 1b trial for personalized cancer immunotherapy in various indications.

Promising development

If positive, the Phase 2 data for the NOUS-209 vaccine, which simultaneously targets 209 neoantigens, “have the potential to position Nouscom’s neoantigen-based cancer vaccines amongst the most thrilling developments in the field,” commented Nouscom CEO Dr. Marina Udier in the statement. Dr. Sofia Ioannidou, Partner at Andera Partners, believes that the “robustness of the clinical results generated so far positions Nouscom as one of the leading biotech companies in the neoantigen cancer vaccine space”.

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Celebrating six months of innovation: i4Challenge accelerator New Ideas 2022/2023 https://baselarea.swiss/blog-post/i4challenge-accelerator-new-ideas/ Tue, 14 Nov 2023 11:28:43 +0000 https://baselarea.swiss/?post_type=blog_post&p=152184 On the 5th of July 2023, the 3rd iteration of the i4Challenge accelerator program New Ideas came to its conclusion. We hosted a fabulous last event to reflect on six months of groundbreaking innovation in the Basel Area.

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Celebrating six months of innovation: i4Challenge accelerator New Ideas 2022/2023

26.10.2023

On the 5th of July 2023, the 3rd iteration of the i4Challenge accelerator program New Ideas came to its conclusion. We hosted a fabulous last event to reflect on six months of groundbreaking innovation in the Basel Area.

In this summary, you’ll learn more about the i4Challenge, meet the five winning industrial transformation ideas and learn about their point of view on the six-months-long accelerator.

i4Challenge accelerator

The i4Challenge is an initiative of the Industrial Transformation team of Basel Area Business & Innovation to foster regional economic growth and innovation. It serves as a platform for SMEs, startups and individuals exploring Industry 4.0 technologies, helping them navigate the realms of digitization, automation and robotics to better position themselves in the global market.

Although it is called an accelerator, the i4Challenge offers more than what you normally get. As a non-profit organization, our only goal is to help innovative entrepreneurs achieve their full potential through collaboration

We connect them to our vast network of investors, mentors, coaches and potential business partners, who are ready to invest not just their money but their time and expertise tailored to your business’s individual needs.

Six months of idea development

In six months, the candidates went through five phases of MVP development with direct feedback after each iteration, biweekly coaching and various trainings and workshops.

After the six months, the accelerator came to its conclusion with a pitching opportunity in this final event.

The winners of the i4Challenge New Ideas

We’re proud to present the five phenomenal i4Challenge New Ideas winners who showcase the innovation potential of the region in its full effect. Six months ago, they started with an idea. Today, they have MVPs, and some even have clients and investors lined up.

 

Axom — Inspection and counting with AI.

Axom uses AI to inspect pharmaceutical products. Its goal is to ensure that the products are complete in numbers and free of any defects to be safely used by patients.

Tristan Salomon, founder and CEO of Axom, knew about Basel Area Business & Innovation as one of the few institutions that relate to startups in Basel. When he learned about the i4Challenge, he applied right away.

Throughout the i4Challenge accelerator, the structure of his company changed significantly. Thanks to the exchanges with his coach, Tristan realized that his company lacked special expertise in areas he wasn’t familiar with. He filled those gaps with new hires and freelancers under advice of his coach.

Although the six months have helped tremendously, Tristan recognizes there’s still a long way to go. He wants to bring his business from being an idea with a few customers to being one of the main actors in the industry.

His advice to anyone who considers applying?

“Apply! I didn’t expect to get SO much value from it.”

Xsight — Modular and adaptive cybersecurity

Xsight is developing an offensive AI technology to continuously monitor and identify cybersecurity vulnerabilities. This proactive approach aims to significantly reduce the time it takes companies to discover they’ve been hacked, thereby minimizing associated losses.

Yaroslav Pryymak, co-founder of Xsight, applied to numerous acceleration programs. The professional and keen interest shown during his application process at the i4Challenge convinced him to give it a shot. Yaroslav was impressed by the individualized approach. With only a handful of participants, the program delved deep into the startups’ issues, making the mentors feel like an extension of the team, almost like co-founders.

The core idea behind Xsight remains the same, but the way it’s packed into a product drastically improved. Additionally, Yaroslav forged valuable connections that are always available for discussions, providing real, actionable feedback even after the i4Challenge accelerator concluded.

His advice to anyone who considers applying?

“Just apply. It really is worth it to participate.”

B4SIS — Safely start renovating

B4SIS offers a tool that assists homeowners in managing renovation projects. The tool provides realistic cost estimations and facilitates communication between homeowners, financial institutions and architectural firms.

Sarah Ensner, Partner at B4SIS, entered the i4Challenge upon a friend’s suggestion. As a native “Baslerin,” she was excited to apply and innovate in her home region. She didn’t think she’d win but was really keen on the expertise she could access within the i4Challenge accelerator.

In the beginning, Sarah had trouble positioning her idea. The program’s mentorship and workshops let her explore whether she should serve B2B or B2C customers, which ultimately helped her position herself in the market.

Now, with a sharper focus, Sarah aims to automate within her company and find partnerships for collective growth. As the accelerator ended, she felt a blend of nostalgia and eagerness, appreciating the newfound clarity and direction.

DX Analytics

DX Analytics is working on a maintenance toolbox for digital twins to aid in efficiently managing civil infrastructure maintenance.

Vladimir Vilde, founder of DX Analytics, moved from Cambridge to Switzerland, where he found the i4Challenge to connect with the local ecosystem.

Vladimir used to approach potential clients from a technical angle that not everyone understood. While in the i4Challenge accelerator program, he refined DX Analytics’s value proposition to be more benefit-focused and business-oriented.

He most appreciated the weekly contact with his coach. Exchanging insights and getting help developing his sales strategy was a game-changer. But also, the connections to the local community, factories and government are now of immense value.

The technical viability of DX Analytics is proven. Now, Vladimir is working on proving its commercial viability and soon generating income. He doesn’t want to raise money like other startups but rather grow together with his customer base.

His advice to anyone who considers applying?

“Just apply for it! It costs nothing. See how it goes.”

AdVentura Works — Material handling as a service

AdVentura creates a solution for teleoperational forklifts to help logistics and industrial companies tackle employee shortages and improve material handling efficiencies in any environment.

Alexander Manolov, Co-founder and CEO of AdVentura Works, applied upon his friend’s suggestion.

He started with just a small prototype of about 50 cm in height and a few potential clients lined up. Today, he has a working prototype and was able to do several demos with potential clients and investors.

Next to his coaches’ advice, Alexander drew the biggest benefits for his company from the connections he made during the six months of the program.

Currently, AdVentura Works is trying to raise funds, with a few interested investors already lined up!

His advice to anyone who considers applying?

“Just do it! Entrepreneurship is jumping into the deep and figuring it out.”

Insights from our coaches

Our coaches, such as Martin Gysler and Christophe Walch brought a wealth of experience and expertise to the i4Challenge accelerator. 

Their coaching approach is tailored to entrepreneurs’ needs, considering the business idea’s development stage. They acted as sparring partners and trusted advisors, focusing on creating value for customers. Each coachee faced unique challenges and responded to different coaching methods, making every session intense and enriching — more art than science.

Despite the challenging conditions, Martin and Christophe are pleased with the progress they’ve made.

They give a special thanks to Sébastien and Albert for bringing everyone together and making the i4Challenge possible.

Stay up to date

You can be the first one to know what’s going on in the Basel Area by signing up to our newsletter:

If you’re on the edge of a great idea around Industry 4.0 that the world needs to know about, and you don’t want to wait until the next edition of the i4Challenge, contact the Industrial Transformation team directly:

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How open innovation in healthtech hubs is fueling the rise of digital healthcare https://baselarea.swiss/blog-post/pr-innovation-in-healthtech-rise-of-digital-healthcare/ Tue, 14 Nov 2023 11:00:12 +0000 https://baselarea.swiss/?post_type=blog_post&p=152431 How the ever-increasing uptake of digital solutions is enhancing patient engagement, increasing access to care and lowering the cost of drug development.

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How open innovation in healthtech hubs is fueling the rise of digital healthcare

14.11.2023

The average return on investment within pharmaceutical research and development is at an all-time low, and it is frequently observed that billions of euros are poured into the development of drugs that ultimately do not make it to the market. How the ever-increasing uptake of digital solutions is enhancing patient engagement, increasing access to care and lowering the cost of drug development.

Novartis Campus Basel

Fortunately, digital healthcare technologies may hold the key to increasing pipeline efficiencies, and a new breed of startups looks set to revolutionise the sector, provided they can attract the attention of suitable investors. Healthtech hubs – such as the Novartis Campus in Basel, Switzerland – offer these fledgling companies an environment alongside pharmaceutical giants and other innovative corporations, providing a new collaborative culture to drive drug development deep into the 21st century.

The pharmaceutical industry is behind some of the greatest discoveries in the history of humanity, with distinguished medical minds and novel therapies prolonging lifespans and improving well-being. Vaccines have eradicated diseases and helped to fight global pandemics, while ‘miracle drugs’ such as penicillin and insulin have changed the face of clinical practice, saving millions of lives. However, even with the seemingly endless introduction of new medicines to the clinician’s armamentarium, certain disease areas still lack efficacious therapies, leaving unmet needs and opportunities for companies willing to adapt to enhance drug discovery.

Reinventing the pharmaceutical industry

Digital tools emerging from the booming healthtech sector are responding to the demands of the industry, helping it to evolve so that life-saving therapies can continue to solve the world’s health problems. The ever-increasing uptake of digital solutions is already enhancing patient engagement, increasing access to care, and lowering the cost of drug development.

The latter is especially pertinent for large corporations with multiple therapies in the pipeline, as improving process efficiencies could translate to huge savings. This is evident with the emergence of decentralised and hybrid clinical trials – enabled, in part, by digital tools such as wearable devices with remote monitoring – which offer patients far greater levels of comfort and convenience, while lowering overall costs by improving retention rates, reducing operational overheads and accelerating time to market.

With change comes opportunity

The inevitable shift to a more digitalised industry provides ample opportunities for healthtech startups to grow. Many of these companies have potentially game-changing technologies, but often struggle to find the means to get their ideas to fruition. Conversely, the pharmaceutical giants have ample resources and access to worldwide markets, representing the perfect vehicle for startups to scale, expand globally and get their solutions in front of patients.

The challenge, then, is to bridge the interface between two polar-opposite cultures – startup versus corporate – to enable them to establish successful and symbiotic partnerships.  Healthtech startups are often founded by a mingling of brilliant minds – including scientists, software engineers and health informaticians – but they can lack experience in developing clear, long-term business models, especially when collaborating with big pharma and the exponential scaling that follows.

What they do enjoy and rely on for survival is speed as, with limited resources, they need to move fast. This is in stark contrast to the conservative, risk-averse nature of the pharmaceutical industry, which needs to move slowly, because of the enormous cost of drug development and the ramifications of getting it wrong.

Healthtech hubs – a scientific melting pot

Traditionally, the contrast between these business models could have stopped innovation in its stride. However, modern-day approaches to drug development recognise it as a strength, resulting in the establishment of thriving ecosystems replete with companies of all shapes and sizes.

For example, the Novartis Campus in Basel, Switzerland opened its doors to the outside world in 2021. As a result, the Switzerland Innovation Park Basel Area was established on site, offering a place for startups, growing companies and partners in the life sciences to work in close proximity to one of the largest pharmaceutical companies in the world. In fact, many of the spaces are publicly accessible, breaking the shackles of the traditionally private pharma ethos. This provides a unique environment designed to catalyse scientific progress by encouraging collaboration between great minds from all aspects of drug discovery, from microbiologists and chemists to healthtech developers and data scientists.

Matthias Leuenberger, Country President for Novartis in Switzerland, weighed in on the subject, saying: “The Novartis Campus in Basel is a space for dialogue, collaboration and scientific innovation, characterised by its dynamic and lively working environment and its unique atmosphere encompassing parks, restaurants, cafes, event spaces and sports facilities.

“Every architectural and artistic detail has been carefully selected to better foster inspiration and cooperation, providing the ideal environment where researchers, entrepreneurs and other experts in the healthcare industry can meet to work on new ideas and develop partnerships.

“We open our doors to companies and institutions of different sizes to inspire and bring the best minds in the industry together in Basel, which has established itself as one of the most important scientific hubs in the world today.”

We open our doors to companies and institutions of different sizes to inspire and bring the best minds in the industry together in Basel, which has established itself as one of the most important scientific hubs in the world today.

Matthias LeuenbergerCountry President for Novartis in Switzerland

A catalyst for innovation

The Basel area is home to over 700 life sciences companies, comprised of more than 32,000 employees – including 8,000 for Novartis at the campus alone – making finding the right person to pitch to, or company to partner with, an intimidating prospect. The startup mindset may lead to individuals eagerly trying to sell their idea or technology, without considering its relevance to the therapeutic indication of the other company’s portfolio.

On the other side of the table, big pharma can be slow to engage its smaller counterparts, where speed – as well as access to funding and resources – can be make-or-break factors.  A means to ignite the critical conversations that lead to the discovery of mutual interests is often needed, followed by a way to nurture the relationship into a successful long-term collaboration.

A major factor for the ongoing success of this healthtech hub is access to support from Basel Area Business & Innovation, an independent, non-profit agency that provides assistance with the relocation or expansion of companies. The company has helped over 30 startups settle in the Novartis Campus, as well as hundreds more businesses and entrepreneurs in the cantons of Basel-Stadt, Basel-Landschaft and Jura.

A key aspect of its remit is to provide community management activities on campus – including frequent events, roundtable discussions, pitch sessions and more – to generate networking opportunities. Its DayOne Accelerator has also been vital in helping many startups scale their technologies.

Scaling new heights in Basel

Many of these startups are in the rapidly expanding field of AI, offering products or services through partnerships or software licensing deals that can be applied to pharma pipelines. One notable example is Holmusk – a company originally from Singapore – that expanded its operations to the Novartis Campus to capitalise on the robust life sciences and pharma presence in the Basel area, as well as the wealth of specialised talent. The company uses AI-powered analytics to enrich its large mental health platform ‘NeuroBlu.ai’, helping pharmaceutical companies improve drug development and commercialisation.

The future of healthtech

Pioneering ecosystems such as the Novartis Campus – located in an equally scientifically vibrant city – help to not only accelerate drug discovery and development, but also secure a prosperous future for the region by enticing global players to its shores. The world-class resources, state-of-the-art facilities and varied personnel found there only attract more investment, additional startups and other major pharmaceutical companies, perpetuating the innovative environment that is nurtured by local agencies established to accelerate scientific progress. This has led to a healthtech hub bursting with talent and novel ideas that continues to deliver cutting-edge tools to enhance drug discovery, accelerate time to market and improve patient access to care.

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The post How open innovation in healthtech hubs is fueling the rise of digital healthcare appeared first on Basel Area Business & Innovation.

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How to access the U.S. market with your medical device https://baselarea.swiss/blog-post/how-to-access-the-us-market/ Fri, 10 Nov 2023 12:54:53 +0000 https://baselarea.swiss/?post_type=blog_post&p=152294 In one of our latest Venture Mentoring events by Basel Are Business & Innovation, we invited Nila-Pia Rähle to speak on market access for medical devices and in-vitro diagnostics products in the US.

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How to access the U.S. market with your medical device

26.10.2023

In one of our latest Venture Mentoring events by Basel Are Business & Innovation, we invited Nila-Pia Rähle to speak on market access for medical devices and in-vitro diagnostics products in the US. She is co-founder and president of the board of our partner Effectum Medical and has over 20 years of experience working in the field of medical devices.

Impressions of the event

Meet Effectum Medical

Effectum Medical specializing in regulatory affairs and quality management in the medtech industry. The company serves as a trusted partner for medical device startups and established firms alike, guiding them through the complex landscape of global regulatory requirements.

Two service models serve this mission:

Meet Nila-Pia Rähle

The European challenge

Unlike the FDA’s more interactive approach, the European system is difficult and time-consuming to navigate for startups. This complexity can be particularly daunting for startups that don’t have in-house regulatory expertise.

Nila-Pia mentions two more pressing issues.

Delayed Notified Bodies

Notified Bodies, the organisations designated by an EU country to assess the conformity of certain products before being placed on the market, are currently delayed. It takes anywhere between 13 to 18 months just for the technical documentation review.

Lack of guidance

Unlike the FDA, which provides pre-submission meetings and direct feedback to make sure your application is done right, European Notified Bodies generally don’t offer any guidance prior to your submission. This makes the already complex process even more challenging, leaving your startup to navigate the regulatory maze on its own.

 

The advantages of the United States

The United State’s FDA (Food and Drug Administration) offers a simpler, interactive approach. This provides startups that go to market in the US with distinct advantages.

1. Risk-based approach

The FDA categorizes devices into three classes based on their potential risk to patients.

  • Class I: Low-risk devices that generally don’t require premarket approval and are subject to general controls like proper labeling.
  • Class II: Moderate-risk devices that often require special controls and may need premarket notification (510k).
  • Class III: High-risk, often life-supporting or life-sustaining devices that usually require premarket approval (PMA) involving rigorous testing and clinical trials.

2. Pre-submission meetings

The FDA gives you the opportunity for a pre-submission meeting. This meeting allows startups to engage directly with the FDA to discuss their regulatory strategy, ask questions and receive feedback. It helps you tailor your submission to meet all requirements on the first try, reducing the likelihood of delays due to incomplete or incorrect submissions.

3. Simplified approval process

The FDA makes use of a concept called “predicate devices”. These are existing devices that are already marketed in the US and serve as a benchmark for new devices seeking FDA clearance. If you can show that your new device is substantially equivalent to an existing, already marketed device, you can often bypass some of the more rigorous testing requirements and bring your product to market significantly faster.

How to apply for U.S. market access with your medical device

 

Step 1: Ensure the U.S. is the right market for your startup

Evaluate whether the U.S. is really the place you want to go to market in. Be prepared for a highly competitive medical device market with many established and emerging companies vying for market share. Clinical studies might also be more costly than in Europe.

Step 2: Classify your device

Each of the three previously mentioned classes has its own set of regulatory requirements, with Class III being the most stringent due to the higher level of risk associated with these devices. Understanding your device’s classification will help you identify the appropriate regulatory pathway you’ll need to follow.

Step 3: Consult with FDA

Consult with the FDA through a pre-submission meeting. The FDA offers this service free of charge and it provides an opportunity to discuss your device’s regulatory and clinical strategy. This can help you tailor your submissions more precisely and avoid faulty submissions.

Step 4: Choose the right submission pathway

During this meeting, you’ll also learn what type of application is right for your device:

  • 510(k): Pre-market notification for Class I and Class II devices, used to demonstrate that the device is substantially equivalent to an already marketed (predicate) device.
  • 510(k) Exempt: Some Class I and a few Class II devices are exempt from the 510(k) pre-market notification requirement because they are considered to be of lower risk and have a well-understood safety profile.
  • PMA (Pre-Market Approval): Required for Class III devices, this is the most rigorous type of application involving clinical trials to prove safety and effectiveness.
  • HDE (Humanitarian Device Exemption): Devices that are intended to benefit patients with rare conditions (affecting fewer than 8,000 individuals in the U.S. per year) may be approved without needing to demonstrate effectiveness, but they must prove safety and that the probable benefit outweighs the risk.
  • De Novo Classification Request: For low to moderate risk devices that do not have a predicate, this request seeks FDA classification into Class I or II.

Step 5: Prepare documentation

Preparing all the necessary technical documentation can include your device’s specifications, test results and clinical data, if applicable. If you’re going for a 510(k) submission, you’ll also need to identify a predicate device to demonstrate that your device is substantially equivalent to an existing, approved product. Make sure to also have a quality management system in place, as this is a requirement for all classes of medical devices.

Step 6: Register and submit

Your final step is to register your company and product with the FDA. This is a prerequisite for submitting any type of application for product approval. If you’re not not living in the U.S., you need a U.S. agent to represent your company (they must be able to answer questions from the FDA about your device).

The costs of bringing a medical device to the US market

While some aspects, like pre-submission meetings, are currently free of charge, other steps in the process can be costly. These may include fees for submitting applications, costs for clinical trials and expenses related to compiling the necessary documentation.

While most of those costs vary, the FDA publishes its application costs on its website:

* A small business is defined as a business, including its affiliates, whose gross receipts
and sales are less than $100 million for the most recent tax year.

For the most recent information, visit the FDA’s Medical Device User Fee Amendments.

FDA clearance/approval could help with access in the EU

FDA clearance/approval not only facilitates U.S. market entry but also eases global expansion.

Some countries’ regulating bodies have agreements with the FDA, allowing for easier approval of FDA cleared or approved products. This is very helpful for startups aiming for global expansion as it saves them from undergoing multiple full approval processes.

Switzerland, for example, is currently evaluating streamlining the entry of FDA-approved products, offering a quicker and more cost-effective route to market.

Need help?
If you need help bringing your medical device to market, get in touch with our Venture Mentoring team.

We provide unbiased, professional advice to startups and entrepreneurs, looking to turn their invention into a successful business.

Join our next event

Stay ahead of the curve by attending future events. Check out our events calendar or sign up to get the latest invitations straight to your inbox.

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Paradigm shift in pain management https://baselarea.swiss/blog-post/paradigm-shift-in-pain-management/ Fri, 10 Nov 2023 09:48:54 +0000 https://baselarea.swiss/?post_type=blog_post&p=152140 Pain is a crucial sensation for survival, but it can also drive us to depression and long-term suffering if not managed correctly. In response, researchers are exploring ground-breaking ways to manage pain. Fascinating approaches are already finding their place in forward-thinking healthcare institutions, supported by the healthtech sector, which is booming in multiple locations around Europe, especially in the Basel Area.

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Paradigm shift in pain management

10.11.2023

Pain is a crucial sensation for survival, but it can also drive us to depression and long-term suffering if not managed correctly. In response, researchers are exploring ground-breaking ways to manage pain. Fascinating approaches are already finding their place in forward-thinking healthcare institutions, supported by the healthtech sector, which is booming in multiple locations around Europe, especially in the Basel Area.

Alarmingly, chronic pain affects more than 30 percent of people worldwide, [1] yet current treatments can be ineffective or lead to drug dependence, leaving many individuals in dire need of innovative solutions that will help them find relief. New ways to manage pain – from neuroplasticity training through interactive games to therapies that use virtual reality (VR) – promise to shake up the status quo of clinical pain management in the years to come.

Pain is a complex and multifaceted biomechanism that is experienced differently by each person. Its subjective nature means that it can’t be measured or quantified; a person’s perception of pain is unique and influenced by various factors, including genetics, past experiences, and emotional state. Psychosocial elements – such as mood, stress levels, and support systems – also shape how a person perceives and copes with pain. This complex web of factors has plagued healthcare professionals for a long time, making chronic pain treatment incredibly challenging. Traditional therapies offer temporary relief, but long-term use can lead to dependence and addiction, which is evident with the opioid crisis in countries such as the  US. Many clinicians are therefore looking for alternative treatments, while also seeing the benefits of taking a more holistic approach to the pain management paradigm.

Novel solutions for treating pain

Dr Elan Schneider is CEO and Co-founder of the Israeli company TrainPain – comprised of a team of healthcare professionals, scientists, and technology experts who have developed a neuroplasticity training game for chronic pain. Dr Schneider has dedicated the best part of his career to finding novel solutions for treating pain. He explained: “Pain can destroy a person’s quality of life for prolonged periods, yet there isn’t always a clear correlation between the physical damage in the body and the intensity of pain felt. The latest understanding of pain suggests that neuroplastic changes can heighten the sensitivity of the body’s pain-processing nerves. This means that even minor threats to the body can trigger pain, amplifying these nerve signals and resulting in disproportionate levels of pain relative to the actual harm.

“Despite extensive research in this field, many findings haven’t made their way into clinical practice. At TrainPain, we’ve translated some ground-breaking concepts from neuroscience into tangible solutions. Our method is to train the body’s natural ability to regulate pain by enhancing the neural circuits that naturally turn down the volume of pain-related nerve signals sent to the brain. While this approach isn’t new – opioids and cannabinoids, for example, work similarly to mimic the body’s inhibitory neurotransmitters – traditional medications not only come with side effects, but also fail to promote the body’s inherent learning capabilities for long-term changes in pain regulation.”

Transdiagnostic pain management

The team at TrainPain has taken a transdiagnostic approach to pain management, looking at mechanisms that are common across different types of chronic pain. This could help to meet the dire need for novel therapies for neuropathic pain – including fibromyalgia, complex regional pain syndrome, and phantom limb pain – where current treatments are largely ineffective or insufficient.

Dr Schneider continued: “Various conditions display an overlap, with neuroplasticity in the nervous system being a pivotal factor. Engaging in numerous repetitions of therapeutic tasks can help address these maladaptive neuroplastic changes and promote healthier alterations in the nervous system. To this end, our solution harnesses sensory perception tasks, delivered through video games, to provide the necessary engagement and ensure that patients participate for sufficient time to benefit. This form of training aids learning and induces changes in how sensory neurons activate and communicate.”

Basel: a hub for scaling innovation

TrainPain is one of a handful of companies attracted to Basel, Switzerland, which is now arguably the healthtech capital of Europe. Basel and the surrounding area are replete with highly specialized scientific entrepreneurs and large pharmaceutical players, where growing companies such as TrainPain can be immersed in a forward-thinking environment to foster innovation. The company signed up for the DayOne Accelerator with Basel Area Business & Innovation – a non-profit agency that helps innovative companies develop and expand – to make the vital connections it needed to take its ideas to the next level and, ultimately, reach the patients they are designed to help.

Commenting on the accelerator, Dr Schneider said: “Participating in this accelerator gave us the opportunity to talk with the right people at the intersection of pharma and digital health. We learned a lot about the pharmaceutical industry and its needs, where our solution fits, and how to make important collaborations with healthcare organizations to ensure we are ready for the future.”

Another alum of the DayOne Accelerator is Rescape, a Welsh startup that develops VR solutions for reducing pain and anxiety. Rescape knew about the beneficial ecosystem of the Basel area, which helped the company take its innovation from conception to completion. Matt Wordley, Co-founder and Board Director at Rescape, explained: “We don’t get much exposure to pharmaceutical companies in Wales, so spending time in Basel has been crucial for our development as a small startup. It has allowed us to understand the complexities of the pharma world, and network with the right people. In fact, a couple of the collaborations born out of our time in Basel have really helped us fast-track our business, and a number of other opportunities are still being pursued. The team at Basel Area Business & Innovation has also opened the doors to mainland Europe, helping our VR solutions conform to the EU medical device regulations.”

Virtual reality in healthcare

VR is most often associated with gaming, but its applications are being explored in a variety of industries. In healthcare, a recent analysis of VR and augmented reality in scientific literature found more than 8,000 research papers on the topic, with the most common medical conditions under investigation including pain, stroke, anxiety, depression, fear, cancer, and neurodegenerative disorders. [2] Pain and anxiety management have the largest evidence base for the use of VR in medicine, [3] where distraction through immersion – along with neurophysiological changes – contribute to therapeutic effects. This could lead to novel treatment options for patients with chronic pain, potentially reducing the reliance on opioids. [4] In addition, Rescape is already seeing significant benefits in a more acute setting.

Wordley explained: “The brain becomes ensconced in the environment that it is in, as it is not designed to cope with two realities. With VR, we are basically hacking the brain, so it shelves the pain or anxiety the patient is experiencing, and replaces it with a distracting or relaxing environment. We have found some wonderful results in paediatric patients, especially with children who are stressed or anxious about minor procedures, such as those involving needles. VR can actually help to reduce sedation requirements in children, and potentially eliminate the need for anaesthesia for minor operations. This is a huge benefit to both anxious children and stressed parents, as well as healthcare professionals, reducing the risks and recovery times for patients.”

Wordley continued: “VR is also being deployed in palliative care as a temporary respite for patients – a form of escapism – and in intensive care units (ICUs). A nice example in the latter setting involved a patient who was having around 20 panic attacks per day following an extended ICU stay, where he experienced pain and isolation from the outside world. Within a couple of weeks of using VR, he was having just the odd panic attack, and could be moved to a general ward. However, his story didn’t end there. Not long after being discharged, he needed to get his big toe amputated, but the medical team couldn’t use a general anesthetic because of his health, and it would need to be done using a regional block. This caused him to spiral into a panic attack, until he agreed to use VR to calm his nerves, allowing the operation to continue.”

Summary

Pain management has been troubled by its subjective nature, where simply treating the ‘problem’ doesn’t always equate to therapeutic success. This can leave patients with enduring pain and anxiety, and clinicians with few options. The call for novel therapies to fill the gap in managing pain is being answered with the help of extraordinary innovations stemming from the healthtech sector, which are nurtured in thriving hubs such as Basel. Although there is no silver bullet, neuroplasticity training and VR are now additional tools in the clinician’s armamentarium, allowing them to not only reach for their pharmacopeia, but also turn to technology to help improve the lives of their patients in pain.

References
1. Cohen S, Vase L, Hooten W. Chronic pain: an update on burden, best practices, and new advances. The Lancet. 2021;397(10289): 2082- 2097. doi: https://doi.org/10.1016/S0140-6736(21)00393-7
2. Yeung A, Tosevska A, Klager E, et al. Virtual and Augmented Reality Applications in Medicine: Analysis of the Scientific Literature. J Med Internet Res. 2021;23(2):e25499.  doi: https://doi.org/10.2196/25499
3. Rescape. The Evidence for Virtual Reality in the Clinic. 2021. https://www.rescape.health/virtual-reality-white-paper [Accessed 10 July 2023]
4. Gupta A, Scott K, Dukewich M. Innovative Technology Using Virtual Reality in the Treatment of Pain: Does It Reduce Pain  via Distraction, or Is There More to It? Pain Med. 2018  Jan 1;19(1):151-159. doi: https://doi.org/10.1093/pm/pnx109. PMID: 29025113.

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BOOM Summit in Basel accelerates health technology https://baselarea.swiss/blog-post/boom-summit-in-basel-accelerates-health-technology/ Thu, 09 Nov 2023 15:03:40 +0000 https://baselarea.swiss/?post_type=blog_post&p=152423 The BOOM Summit at Messe Basel in April 2024 will be a completely new kind of healthcare conference. The first edition will be dedicated to trends in health technologies that are set to significantly change the healthcare sector.

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BOOM Summit in Basel accelerates health technology

09.11.2023

The BOOM Summit at Messe Basel in April 2024 will be a completely new kind of healthcare conference. The first edition will be dedicated to trends in health technologies that are set to significantly change the healthcare sector.

The inaugural BOOM Summit will take place in April 2024. The venue will be the events hall at Messe Basel. According to a statement, the event will be dedicated to trends in digital health technologies. It will be “a highlight of the European healthtech calendar”, as well as provide an open forum for the discussions and strategies that are set to transform the healthcare sector.

The event is organized by DayOne, an initiative of Basel Area Business & Innovation, the investment and innovation promotion agency, and the Kenes Group, a leading global provider of medical conferences. The main partner is the Basel-based MCH Group, which is supporting the BOOM Summit as part of its strategy to position Basel as a leading hub for life sciences events. “The aim of the BOOM Summit is to promote collaboration and innovation in the field of healthcare technology,” commented Caoimhe Vallely-Gilroy, Director of Strategy DayOne and conference organiser.

Program offers great variety

The event is aimed at all professionals as well as entrepreneurs, investors and political decision-makers. The program includes expert panels, technology presentations, startup pitch sessions and interactive workshops. According to Dr. Leslie Anne Fendt, who is responsible for an advanced digital health project at Roche in Basel, the BOOM Summit will “bring together the best and brightest minds in healthcare technology and hopefully ensure that the latest and most exciting technologies can flourish”.

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Investors stump up 3.7 million Swiss francs in Onena Medicines https://baselarea.swiss/blog-post/investors-stump-up-3-7-million-swiss-francs-in-onena-medicines/ Fri, 03 Nov 2023 13:34:47 +0000 https://baselarea.swiss/?post_type=blog_post&p=152383 Onena Medicines has secured an investment of 3.7 million Swiss francs. The portfolio company of the biotech startup incubator BaseLaunch will therefore be able to drive the development of its antibodies designed to influence the growth of tumors.

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Investors stump up 3.7 million Swiss francs in Onena Medicines

03.11.2023

Onena Medicines has secured an investment of 3.7 million Swiss francs. The portfolio company of the biotech startup incubator BaseLaunch will therefore be able to drive the development of its antibodies designed to influence the growth of tumors.

Onena Medicines has raised a total of 3.7 million Swiss francs as part of a financing round. The venture capital has been provided by the Basel-based asset management firm Avanteca Partners and Zürcher Kantonalbank, the cantonal bank of Zurich. The biopharmaceutical firm Onena, which is headquartered at the Main Campus of Switzerland Innovation Park Basel Area in Allschwil in the canton of Basel-Landschaft, is a portfolio company of BaseLaunch, the biotech startup incubator active within the Basel biotech cluster.

Onena has a pipeline of promising antibody medicines to treat cancer, which neutralize a new class of growth factors called dual SMAD inhibiting proteins (DSIPs) that are responsible for programming the cancer cells to grow and induce resistance to chemotherapy. “Our partners realize, as we do, the incredible opportunity that lies before us to lead the AI drug discovery field”, comments Neethan Lobo, CEO and co-founder of Onena Medicines, in a press release.

Efficacy already shown

Onena intends to put the investment towards its efforts to provide in vivo proof of concept with its most advanced DSIP program (OMED-2). This is a first fully human antibody that targets an as yet undisclosed DSIP target protein. The company believes this has the potential to impact solid tumors such as melanoma.

Onena’s flagship OMED-1 program has already shown efficacy in breast, colorectal and glioblastoma preclinical models in vivo. Onena uses its deep learning pipelines to humanize and optimize the binding affinity of its lead molecules.

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CSL joins Basel Area biotech cluster https://baselarea.swiss/blog-post/csl-joins-basel-biotech-cluster/ Thu, 02 Nov 2023 13:28:13 +0000 https://baselarea.swiss/?post_type=blog_post&p=152350 The research and development department of the globally active Australian biotech company CSL has moved into a new office in the Switzerland Innovation Park Basel Area on the Novartis Campus in Basel. With this move, CSL aims to tap into the region's great potential.

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CSL joins Basel Area biotech cluster

02.11.2023

The research and development department of the globally active Australian biotech company CSL has moved into a new office in the Switzerland Innovation Park Basel Area on the Novartis Campus in Basel. With this move, CSL aims to tap into the region's great potential.

At the CSL office opening in Basel (from left to right): Christof Klöpper, CEO Basel Area Business & Innovation, Emmanuelle Lecomte-Brisset, CSL Head of Global Regulatory Affairs, Eric Teo, CSL Head of Patient Safety (Photo by Arianna Ramirez)

CSL is expanding its research and development (R&D) network in Switzerland. The global biotechnology company, which is headquartered in Melbourne, Australia, officially opened a new office in the Switzerland Innovation Park Basel Area premises on the Novartis Campus in Basel. The contract with the operator includes 18 workstations.

In a statement, CSL describes the move as a “pivotal milestone in strengthening CSL’s R&D network across Switzerland”. It allows for “flexible and activity-based ways of working” and taps into “the region’s great potential” for collaboration along the drug development process.

Access to Basel Area’s talent pool

“This step is not only extending our long-standing strategic partnerships with key players in biotech located in Basel but ensuring access to the region’s talent pool and exploring further opportunities for collaboration”, commented Emmanuelle Lecomte Brisset, CSL’s Head of Global Regulatory Affairs who is leading CSL’s efforts to strengthen its R&D presence in Switzerland.

In May of this year, CSL opened an R&D laboratory on the Biopôle Campus in Lausanne. In August 2022, the company acquired Switzerland’s Vifor Pharma, which has since operated as CSL Vifor. CSL has also established collaborations with academic institutions in Switzerland, such as the Swiss Federal Institute of Technology in Lausanne and Lausanne University Hospital.

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