The MedTech field is complex and challenging for the companies and organizations operating in it, this encompasses not only the firms developing medical devices but also their investors, clinical environments, and a large network of related stakeholders. The pace and scope of change is constant and relentless and it is difficult for non-specialists to keep up.
Now with the integration of emerging technology into healthcare including SaMD, AI/ML, Connected devices and Cloud platforms, it is imperative for companies developing medical devices to recognize how the shifting technology landscape affects their product development and strategic plans.
It is this need for knowledge and a better understanding of the complexities of MedTech by stakeholders in the ecosystem that led us to develop a series of seminars and educational initiatives meant to address this challenge.
Organizations with a vested interest in the success of the MedTech startups they work with, such as Incubators, Accelerators, and Investors in particular, understand that their startups need to be keenly aware of the challenges they will face on their medical device development journey from the start. They also see benefits to having all the participants in their cohorts obtain high quality expert knowledge as a group.
Does your organization need to educate its MedTech Startups on QA/RA, Health Canada, the FDA, Clinical Workflow Integration or the impact of emerging technologies in medical device development?
Contact BML Health today and get them the knowledge they need.
By now we have conducted over one hundred seminars and educational initiatives with the majority of leading Incubators and Accelerators in Québec and Ontario, as well as some in the US, and many related stakeholders including industry associations, government programs and professional investors, providing hundreds of their cohort companies with the MedTech knowledge and insights that make a difference to their business trajectory.
Below are some of the education and knowledge sharing initiatives we provide to the MedTech ecosystem including seminars on key topics of high importance to startups, as well as community events where we aim to bring people together to share, learn and grow.
1.) Critical QA/RA considerations for MedTech and Digital Health startups
Presented by BML Health Founder and Managing Director Marc Saab
Seminar 1 (45 mins + Q&A)
This seminar serves as an introduction to key concepts in Medical Device Quality Assurance (QA) and Regulatory Affairs (RA). The goal of this presentation is to better equip founders to design their medical device product development and clinical validation strategies while integrating the appropriate QA/RA considerations at the right stages before they become hurdles in the best case, and detrimental missteps in the worst. The program is designed specifically for early-stage startups, to clarify key concepts and to help founders develop preliminary strategies that can evolve as their businesses do.
2.) Introduction to Clinical Workflow Integration for MedTech and Digital Health startups
Presented by BML Health Founder and Managing Director Marc Saab
Seminar 2 (45 mins + Q&A)
This seminar serves as an introduction to the concept of Clinical Workflow Integration as part of go-to-market strategy and planning. The integration of health technology innovations into the infrastructure of an existing clinical environment is complex, requires the collaboration of several key stakeholder groups, involves change management and risk management, and differs significantly between clinical organizations. Overlooking or misunderstanding these factors has led companies of all sizes to fail in market adoption and add significant costs and delays to their go-to-market strategies.
The goal of this presentation is to alert founders to these challenges early on, so that expectations can be managed and appropriate strategies can be put in place to mitigate risks at every stage of development.
3.) BML Health Community events for MedTech and Digital Health startups
These by-invitation-only events consist of curated fireside chats with industry leaders in medical device product development, company management and corporate development, investing and market entry into the US, sharing their knowledge on what MedTech and digital health startups need to do to succeed. They are attended by startup founders, incubators and accelerators, investors, banks, law firms, federal and provincial governments, clinical leaders and universities.
Take a look at some highlights from previous events:
Building and growing a successful MedTech company is nothing like building a traditional technology company. Even with great ideas, significant funding and high technological skills, most MedTech startups find themselves in over their heads when faced with the safety and efficacy requirements of a highly regulated industry, often under pressure to deliver solutions in unrealistic timelines.
For MedTech startups beginning the medical device development journey the right way, empowered with the knowledge and understanding of the challenges they will face and how to overcome them, is critically important to enhance their probability of success.
If you are an organization that works with MedTech startups seeking to develop medical devices and see the need to level up their knowledge on key issues of strategic importance – Device Compliance, Quality Assurance, Regulatory Affairs, Clinical Integration, Market Readiness – get in touch and let’s talk.
To get started with a MedTech educational program for your organization contact us.
About BML Health
We support innovative Medtech companies that are shaping the future of healthcare. BML Health understands the impact of emerging technology in MedTech and Digital Health. Get in touch with us to learn how our iterative, lean and efficient approach to product development, clinical validation and regulatory affairs can help your organization get its MedTech solutions to market and gain adoption.
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