Hindsight 20/20 is a Q&A feature where medtech industry veterans share their long experience taking diverse businesses – be they start-ups or publicly-listed entities – from strength to strength and navigating through times of crises. In this installment, Jon H. Hoem, whose career in the cardiology sector spans more than two decades, explains how his thinking on building a robust clinical strategy has changed; why he believes you should never skimp on hiring talent; and advises on the difficult patches start-ups might hit and how to navigate around them, among other topics.
Jon H. Hoem is all heart – well, almost. During the near-30 years he has worked in the medtech industry, based largely in Europe, over two thirds of this time was spent dealing with cardiovascular technologies. Hoem cut his teeth in the early 1990s in product development at ultrasound specialist Vingmed Sound AS (later to be acquired by GE), then moved on to various senior commercial roles in MediStim Inc., developer of ultrasound imaging systems used in cardiac surgery, then atrial fibrillation treatment company AtriCure Inc.
Since 2008, Hoem has been leading start-ups like Miracor Medical Systems GMBH, which has developed a therapy to improve outcomes of percutaneous coronary intervention in heart attack patients; Ablative Solutions Inc. , which is developing a renal denervation system; and currently, CorFlow Therapeutics AG, an early-stage start-up which he co-founded in August 2016 and which is developing a technology also for improving cardiac revascularization outcomes in heart attack sufferers.
Now, my thinking has been influenced by the “lean start-up” movement and applying the lean philosophy to the world of Class III medical devices. CorFlow is developing a disruptive technology to diagnose and potentially treat Microvascular Obstruction (MVO) in severe heart attack (STEMI) patients and around 50% of all STEMI patients have MVO. In recent clinical trials, MVO has been proven to be an independent marker of short- and long-term outcomes. In my experience, the initial technology and clinical hypotheses are always wrong, which clearly have been shown in other white-space medical device fields like renal denervation. Believing that the initial hypotheses are true without generating fundamental evidence can kill a whole emerging field with enormous opportunity losses. Since our initial hypotheses are always wrong, we embraced the lean start-up approach in CorFlow by going for a minimal, viable clinical device as our first-generation prototype. This first-generation prototype serves as a learning platform without any ambitions for regulatory approvals or market launch. The CorFlow Controlled Flow Infusion (CoFI) Console consists of already known components which together form a new functionality without spending too much money. This initial approach has created a completely new understanding of our technology and coronary physiology. This new understanding in the early non-clinical phase have fundamental implications for our first-in-man clinical trial design.
In my experience, the initial technology and clinical hypotheses are always wrong, which clearly have been shown in other white-space medical device fields like renal denervation. Believing that the initial hypotheses are true without generating fundamental evidence can kill a whole emerging field with enormous opportunity losses.
Where money could be saved would be from overall planning and execution, especially on the product development side. CorFlow began non-clinical validation testing of its CoFI console four months after we signed off on the product specifications. Again, being willing to iterate from the initial assumptions to real solutions without seeking perfection is key to establishing early proof-of-concept. Our worst enemy in early-stage medical device development is to aim for perfection and forgetting about the fundamental hypotheses we need to prove. This is a very fluid environment which the team members need to embrace and change as we discover faults in our original thinking.
I’m also a firm believer in co-location and short communication lines between team members, especially in the early phase. Forget going virtual and long email exchanges – they just don’t work for complex medical devices. Daily face-to-face interaction is a key success factor second only to the quality of the team.
A red zone to look out for is failing to involve the customer at a very early stage…Trying to change customer behavior is not a playing field for start-ups and we should leave that to the corporates which over decades potentially can change behavior.
Finally, we talk a lot about different risks these days: regulatory, clinical, reimbursement and financing risks. However, the number one risk in any start-up is the people and avoiding conflicts over the life-time of the company. This requires alignment of the founding team, the management team and investors. Unfortunately, egos sometime get in the way for the overall good of the company which is devastating and toxic. Therefore, avoiding conflicts and spending a lot of time in forming these teams are key success factors for any company including start-ups.
CorFlow is now entering the second stage of the company development where clinical trial design and execution will be in the forefront. There are many medical device professionals who only master part of the solution whereas in a start-up each person needs to contribute on a wide spectrum of skills – they need to be comfortable wearing many hats each day. For instance, I expect my VP Clinical to contribute on the clinical trial design, the study center selection process, the training activities, the interaction with key opinion leaders, as well as study nurses, and to deliver on a successful publication strategy. That’s a pretty tall order for one individual. But these professionals do exist and will thrive in a start-up environment.
Finally, my years in the US gave me a lot of respect for the professional medical device sales representative. I met sales reps coming to the launch meetings having read all publications on the technology. And they were able to pitch the technology to KOLs the next week. Unfortunately, as an engineer I was not educated to understand the keys to sales success. I was trained to believe that every answer is correct and has two lines under it. Not so in sales - it took me more than 10 years of intense trying and failing to learn how to be successful in sales.
New product development and technology launches carry a high-risk profile especially when we talk about Class III devices. However, by proper training and education the risks can substantially be reduced and balanced to the treatment effect for the patients. With technologies that are being developed for acute clinical care, the support and education issues are in the forefront and how to properly address them is a constant challenge. My current thinking is that physician training has to be repeated in a simulated setting and that the first acute cases have to be performed in the day time so that all support structures are in place. Also, the devices have to be designed for usability so that the cath lab staff can use the devices without clinical application support. This approach reduces the risk profile and improves adaption substantially.