Q1 | Torys QuarterlyWinter 2024

How can Canada support medical technology innovation: Q&A with Saumik Biswas


  • Saumik Biswas, CEO, President and Founder at Tenomix

Read commentary from Torys for the latest legal and industry trends in our article “AI healthcare companies: navigating the cutting edge of technology with Canada’s regulators”. And for more industry insights, read our in-depth Q&As featuring Lumira Ventures and Abubaker Khalifa, MD, Co-founder and COO, Moonrise Medical.

Medical technologies present efficiencies in diagnosis and treatment plans and a host of other benefits, however, Canada is considered slow at adopting this kind of technology. What steps do you think can be taken to encourage adoption?

Increasing adoption will require a multi-pronged approach involving stakeholders from academia, government, healthcare institutions, industry, and patient advocacy groups. By addressing regulatory, financial, and educational barriers, Canada can harness the potential of medical technologies to improve healthcare delivery and outcomes. Strengthening collaborations between academia and industry foster effective knowledge dissemination through academic publications and the generation of new Canadian intellectual property.

Streamlining and clarifying the regulatory pathway for new medical innovations is also paramount. For budding entrepreneurs, engaging with regulatory bodies can initially appear daunting. To alleviate these concerns, we must establish Health Canada programs that empower startups to collaborate closely with regulatory agencies. These initiatives will help chart and streamline the approval process for medical technologies, ensuring safety and efficacy while expediting time-to-market.

[E]ngage with investors once you've established initial market traction—and seek investors with a specific interest in your field. Do not underestimate this process, as it can take time to build out these relationships.

While Canada has made strides in the area of government non-dilutive funding, as the medtech startup landscape burgeons, it becomes increasingly crucial to offer early-stage government funding for R&D. Moreover, enhancing awareness about available grants, tax incentives, and research institution partnerships can significantly benefit burgeoning medical startups. Boosting investment in research, development, and commercialization of medical technologies is paramount for medical innovation. Attracting both private and public investment can catalyze adoption of state-of-the-art medical technologies. 

Introducing incentive programs for healthcare providers and institutions to adopt and integrate new medical technologies at an early stage is key. Building on the previous point, establishing a funding pool for companies with advanced products/MVPs ready for clinical testing and validation in partnership with clinical facilities is an important step. Outcomes from such studies hold significance for regulatory approvals, investor engagement, forging new clinical partnerships, publication/marketing efforts and potential procurement. Promising programs like OBIO EAHN and CAN Health in Canada are aligning with this initiative. Although implementing, reviewing and updating reimbursement policies to include medical technologies with proven clinical and economic merits takes time, these crucial steps are essential in encouraging payers to support the use of these technologies.

A prime example is INOVAIT, which is leading the way in fostering collaborations between Canada’s private sector and academic institutions in the field of image-guided technologies. INOVAIT, which is hosted by Sunnybrook Research Institute and supported by the Government of Canada’s Strategic Innovation Fund, is supporting projects that integrate artificial intelligence with image-guided technologies. Such initiatives are pivotal in driving new medical innovations, contributing to a better and healthier Canada.

And last but not least, we must build bridges with patients. Actively involving patients in the decision-making process regarding the adoption of medical technologies will also result in more widespread use, as patients who comprehend and value these technologies are more likely to advocate for their integration into relevant organizations and hospital systems. And more medical innovation education in schools will help young healthcare professionals gain an early understanding of the transformative impact medical innovation can have on quality, and length, of life.

How have you seen the industry change in recent years?

The COVID-19 pandemic heightened our collective awareness regarding the critical need for healthcare crisis preparedness. It laid bare the vulnerabilities within our healthcare system—vulnerabilities that may not have been as readily apparent before. Recognizing these limitations and keen to avert future emergencies, the government has proactively committed to increased investment in R&D, and the strategic stockpiling of essential medical technologies and supplies.

Currently, the industry is experiencing a rapid transformation, with a strong emphasis on enhancing patient care, bolstering data security, and embracing cutting-edge technologies. We are witnessing remarkable advancements in healthcare technology, particularly in the realms of artificial intelligence, machine learning, and data analytics. These transformative technologies enable us to harness vast volumes of data, allowing researchers, clinicians, and engineers to dissect and analyze information with unprecedented depth. This allows us to extract invaluable insights, identify meaningful trends, and make informed decisions that can greatly impact patient care and outcomes.

To successfully bring your innovations to the market, companies must start by identifying pain points faced by clinicians and healthcare providers—unmet needs that your product can effectively address.

The current landscape also places a significant emphasis on patient-centric care. Medical technologies are increasingly being designed to enhance patient experiences, foster improved outcomes and promote greater patient engagement where applicable. Wearable devices, health applications, and personalized treatment plans are becoming increasingly prevalent. We are also seeing traditional healthcare providers and medical device manufacturers forge strategic alliances with tech giants such as Google, Apple, and Amazon, leveraging their data analytics and user-friendly interfaces.

The shift towards value-based care models has further underscored the importance of healthcare outcomes and cost-effectiveness. Medical technologies are now expected not only to improve patient outcomes but also to demonstrate clear benefits in terms of reducing healthcare costs and streamlining clinical efficiency.

This transformative environment has attracted a substantial influx of investment in healthcare startups and medical technology companies, particularly in areas such as AI, medical imaging, and robotics. The active participation of venture capital, private equity, and government funding has played a pivotal role in nurturing innovation across these sectors.

There is a lot of dialogue around AI in healthcare, what are your thoughts on the benefits and risks it presents?

There is no doubt that AI in healthcare can offer numerous benefits, including improved diagnosis, personalized treatment, and enhanced efficiency. It has the potential to significantly enhance disease detection, prognosis, and treatment outcomes. AI-driven automation can streamline administrative and labour-intensive tasks, reducing costs and improving efficiency.

However, the adoption of AI in healthcare also comes with challenges. Ensuring data privacy and security is critical due to the sensitivity of medical information. Addressing bias in AI algorithms and navigating complex regulatory frameworks pose additional hurdles. Ethical concerns may arise when AI recommendations conflict with judgements from healthcare providers. Building patient trust and ensuring transparency in AI algorithms are essential for responsible integration. Balancing these benefits and challenges is crucial for the successful and responsible use of AI in healthcare.

Aside from AI, what are some emerging ideas or developments you are seeing across the medtech industry in general that you are most excited about?

The medtech industry is brimming with exciting innovations that hold tremendous promise. These range from cutting-edge imaging technologies to the incredible potential of drug delivery via nanotechnology. What particularly excites me is the convergence of AI with the wealth of data generated by these foundational technologies. This integration has the power to provide clinicians with advanced clinical insights crucial for making informed diagnostic and treatment decisions.

What are the biggest opportunities and challenges facing the medtech industry?

The medtech industry is poised for significant opportunities, primarily in personalized medicine, remote patient monitoring, data-driven healthcare, and the integration of technologies across medical domains to furnish clinicians with vital clinical insights. These advancements have the potential to revolutionize patient care and outcomes.

Yet, challenges loom large, encompassing regulatory complexities that can slow down innovation, heightened data privacy concerns amid the growing digital landscape, and the imperative need for seamless interoperability among diverse technologies and systems.

What are some underserved areas in healthcare that you think would benefit from technology? How so?

Underserved healthcare areas, such as rural regions and mental health, stand to gain significantly from technology’s integration. It enables telemedicine, remote monitoring, streamlined laboratory services and digital mental health support, ultimately bolstering healthcare accessibility and improving patient outcomes. Providing funding for innovation to hospitals in rural areas is pivotal. It not only facilitates the adoption of new technologies in these regions, but is instrumental in ensuring that patients in these areas benefit from cutting-edge innovations, especially critical for diseases where timely treatment is key.

What are your thoughts on how the Canadian government is supporting innovation in this sector, either through investment or regulatory/legislative developments? Where could they improve?

The government is making commendable efforts to support innovation in the healthcare and medtech sectors. They have provided funding programs and grants to foster research and development, which is crucial for innovation in medical technologies. However, there is room for improvement. Increasing funding for R&D can accelerate the development and commercialization of medical innovations. Streamlined processes for clinical trials and regulatory approvals can reduce time-to-market. Robust data infrastructure, clear digital health regulations, and strengthened patient data privacy measures are essential to promote innovation while ensuring safety and effectiveness. Encouraging private sector investment through potential tax incentives and fostering public-private collaboration can stimulate growth in the sector. Additionally, expanding telehealth infrastructure and promoting global integration for Canadian medtech companies can further enhance the country’s position as a hub for healthcare innovation.

What advice can you give to those wanting to launch a medical device or healthcare company and commercialize their offerings?

To successfully launch a medical device or healthcare company and bring your innovations to the market, it's essential to start by pinpointing clear pain points faced by clinicians and healthcare providers. These must be unmet needs that your product can effectively address. Conduct meticulous research on your target customers and end-users, thoroughly analyze the competitive landscape, and delve into the intricacies of regulatory and reimbursement requirements while keeping the end-user's perspective in mind.

Next, identify your strengths and weaknesses and seek team members whose skills complement yours. Assemble a proficient team, including advisors and mentors with industry expertise, and rapidly develop an initial prototype to gather swift feedback from end-users. While progressing with your Minimum Viable Product (MVP), prioritize safeguarding your innovation with intellectual property rights and explore funding opportunities from various government sources to offset initial costs (programs such as Intellectual Property Ontario and ElevateIP).

If applicable, initiate pilot studies or clinical trials for validation and regulatory approval, guided by seasoned regulatory consultants specializing in your technology field. Collaborate closely with industry experts, mentors, and advisors to formulate a well-defined market entry strategy. Maintain a relentless focus on delivering value to healthcare stakeholders and champion a patient-centric approach.

Cultivate robust relationships with key stakeholders, stay adaptable in response to evolving market dynamics and regulatory changes. As you develop your MVP and secure initial market traction through potential clinical collaborations, proactively seek both non-dilutive and dilutive grants to mitigate the substantial R&D expenses associated with product development.

Simultaneously, engage with investors once you've established initial market traction, developed a prototype, and assembled the right team—seek investors with a specific interest in your field (do not underestimate this process, as it can take time to build out these relationships). Additionally, ensure your business strategy has a forward-looking perspective that enables you to plan strategically and achieve your milestones effectively. This holistic approach will serve as your compass in navigating the intricacies of launching a healthcare venture and will significantly contribute to your success.

What is your 10-year forecast for the industry?

There are eight trends I think we are going to see:

  1. Digitalization will continue to be a driving force, with telemedicine, digital health platforms, and wearable devices becoming commonplace.
  2. AI will play an increasingly vital role, revolutionizing diagnostics and personalized treatment.
  3. Genomics and data analytics will advance personalized medicine, while remote patient monitoring will improve chronic disease management.
  4. Robotics will see expanded applications in surgery, pathology, and elderly care, enhancing precision.
  5. Telehealth will further extend access to healthcare, particularly in underserved areas.
  6. Data security and regulatory adaptations will be critical, and global collaboration will accelerate innovation.
  7. The lessons learned from the COVID-19 pandemic will lead to increased investment in healthcare infrastructure and pandemic preparedness.
  8. Despite promising opportunities, challenges related to ethics, healthcare disparities, and equitable technology distribution will also need attention.

Dr. Saumik Biswas is currently the CEO, President and founder of Tenomix, a medical technology company that focuses on developing novel medical technologies that improve inefficiencies in the pathology workflow, optimize cancer care, and reduce healthcare costs. He was named as a young trailblazer and one of London’s Top 20 in their 20s by Business London, and he was featured on the front cover of Schulich’s School of Medicine and Dentistry Alumni Rapport Magazine at Western University (London, ON, Canada). In a short period of time, he helped secure >$4M in non-dilutive and dilutive funding for all of the projects he has been involved with (including recently raising an oversubscribed all-Canadian $2M round in challenging market conditions), published 16 manuscripts, and won several prestigious awards.

To discuss these issues, please contact the author(s).

This publication is a general discussion of certain legal and related developments and should not be relied upon as legal advice. If you require legal advice, we would be pleased to discuss the issues in this publication with you, in the context of your particular circumstances.

For permission to republish this or any other publication, contact Janelle Weed.

© 2024 by Torys LLP.

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