Excerpts from our Foundation Series webinar with Kuldeep Singh Rajput, CEO Biofourmis
Starting a healthcare start-up is brutal; the process is slow and takes a long time requiring a lot of patience from the founders and even the investors. Unlike any other tech startup, pivoting in a healthcare startup isn’t easy.
So, what can you do to minimise setbacks while planning to grow and scale your healthtech startup? Here are the key insights from Mr. Kuldeep Singh Rajput from his journey as CEO, Biofourmis.
Choosing the Wrong Indication for the Technology
Often it happens that a startup’s technology has potential for multiple clinical indications, meaning the technology can either address multiple disease conditions or therapeutic areas. Typically founders choose to focus on a particular indication depending on their experience and familiarity with the medical subject. However, decision making on t he basis of familiarity need not always be to the benefit of the startup as one must be critical in choosing the right indication for the technology. Time spent in evidence generation in the wrong first indication will drain resources and can be fatal to the company.
Failure to Properly Articulate the Value Proposition to Different Stakeholders.
A value proposition is your next elevator pitch. Most healthcare start-ups describe themselves as faster, better and cheaper than currently available market solution. But this is never enough. Healthcare start-ups need to critically evaluate and quantify how their solution is better, or how much faster or how much cheaper than the existing standard of care.
It is important to design your value proposition with the different stakeholders in mind, whether they are hospital systems, payors, patients, physicians, policymakers or manufacturers.
Failure to have an Evidence Generation and Regulatory Strategy
Healthcare start-ups need to face a lot of regulatory hurdles and amass enough evidence to support their value proposition and achieve key milestones. Key milestones may include raising capital, regulatory clearance or even convincing customers or reimbursement partners to pay.
The key to success is that your healthcare start-up’s evidence generation and regulatory strategy is not focussed to solely address short term milestones. Another common hurdle for healthcare start-ups is that while they are able to clear the regulatory hurdle, but they end up having a cash crunch as the evidence and strategy to convince a paying customer is not ready.
The two important learnings here are:
- Design clinical studies not just for clinical evidence generation but also with ahealth economic lens so as to establish evidence for cost effectiveness for your product.
- Start conversations with potential customers, regulatory bodies and other stakeholders very early and involve them early on in the development process.
Further, it is important to build healthtech products with a pharmaceutical mindset i.e. in accordance to existing cGMP standards, quality systems and be mindful of the biopharma processes while designing a path to market. This could involve conducting translational research, design pilot studies and working closely with the FDA regulators for pre-submission and eventual approval.
Product Doesn’t Fit into a Clinical Workflow
The important question to address here is whether your solution can disrupt the industry and seamlessly integrate with the current clinical workflow. One may assume that a solution may be easily adopted due to its potential clinical and economic benefits, but it may not be the case as personnel in the healthcare ecosystem are often burdened with heavy loads and are not open to large changes in their workflows.
Keep in mind that while digital therapeutics regulatory processes are similar to any other therapeutic development process. Thus,, upon clearance, systems may not be in place for your solution to be easily distributed to end customers ornotified to reimbursement bodies. So, it is important to understand the different channels to reach providers and patients and to integrate your product/solution into existing clinical workflows.
Avoid Death by Pilots
While pilot programs with large corporations are important at an early stage, healthcare startups can end up spending too much time and effort on their pilot studies without having clearly defined milestones. Be aware that a pilot program may not always translate to a commercially profitable partnership.
Ensure that your clinical studies are designed to collect enough evidence for both clinical and health-economics end points, so that those results can be leveraged for driving conversations with large companies or corporations who could be your potential partners.
Lacking a Laser Sharp Focus
As an entrepreneur it is always tempting, especially when there is interest and money on the table, to pivot from your initial focus and use your solution/platform for other therapeutic areas or indication where it may be applicable. However, such deviations can become a roadblock to scaling successfully.
Several successful startups have shown that a demonstrated success for a niche unmet need and a strong focus on execution has always been a stepping stone towards successful scaling of their products globally.
Biofourmis is a fast-growing digital health company filled with committed, passionate people who are on a mission of Powering Personized Predictive Care and empowering people with complex chronic conditions to live better and healthier lives. Biofourmis was founded in 2016 and was incubatee at NUS Enterprise Hanger. Today, they have raised more than $45 million in venture funding, completed two strategic acquisitions, grown from 35 to over 130 full-time staff and have four offices across the world.
It’s clear that an idea alone is often not enough to become a MedTech success, however, the best entrepreneurs are motivated to maximize all the support available in their ecosystem to become next big stars. Choosing the right accelerator and support mechanism can deeply impact your success rate at commercialsation.
At JUMPstart (Joint University MedTech Programme), we drive innovative biomedical research to new venture creation through an integrated product and business development approach. Learn more about our program and join us to gain unprecedented access to a modular and customized program that boosts your chance at finding commercial success.
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