Last August, I decided to leave my secure, senior position at an exciting US MedTech company. electroCore, Inc. is a pioneer in the field and has successfully commercialised its non-invasive neuromodulation therapy in both the UK and the US. Over the course of almost a decade, I gained a wealth of experience in MedTech market access and commercialisation. I faced many challenges, often presented by a rapidly evolving healthcare system desperately trying to adapt and keep pace with the speed and volume of healthcare innovation being developed. For the past 6 months, I have been sharing the knowledge I've gained with a new wave of inspirational medtech and neurotech founders dedicated to developing and ultimately launching their healthcare innovations. So what are the top 3 topics that I've found myself more regularly discussing within the start-up environment? · Understand the regulatory requirements for your medical device as early as possible: Compliance with EU and UK Medical device regulations takes time and is complicated – find yourself expert partners to help you navigate certification. · Build meaningful healthcare resource utilisation endpoints into your pivotal studies: Creating an economic business case is a crucial component to securing reimbursement, so tracking healthcare economic impact during RCTs and real-world studies is key. · Medical device vs. Wellness product: This is a weekly conversation I find myself having. Exploring “who you are”, ‘what you do” and “why you do it” will help map out the journey ahead of you. Ultimately this exercise will impact bullet points 1 and 2 above – what certification and evidence collection steps do you need to consider to be able to go to market and build a successful commercial company? It would be great to hear what my network is talking about in this space, what are your top 3 hot topics of discussion with Medtech founders? #medtech #neurotech #innovation #healthcare #wellness #founders
Hi Ian, I very much agree with your comments but would add a couple more: IP is really inportant but involves more than a patent. You should always be thinking about your Brand and the equity you are building and how that will be differentiated in the market. Trade secrets is also key to how you protect your assets. Global planning related to your IP, regulatory and marketing plan. With SmartWound, we have prioritised emerging markets which creates a different conversation (especially with investors) to the more traditional ‘US first then everywhere else’ discussion!.
I concur with all that you have described and would add a question we get asked frequently when mentoring start-ups; How/when do we access decision makers and influence them? The challenge and complexity for industry to work with healthcare systems remains one of the most difficult mountains to climb.
Iain Strickland PhD excellent that you are sharing your knowledge. I am proud to have you in my network.
Great insights Iain Strickland PhD and exciting times ahead in the space of Neuroscience and Deeptech. Keep up the work and pleasure to have got to know and work with you in recent months! ✌️
Iain Strickland PhD Love this. Thanks for sharing your insights! The wellness product vs medical device topic is a regular conversation for me as well.
Three areas worthy of dialog. Please keep the VNSociety.org certification course in mind for your colleagues. It launches mid April.
Your comments are spot on