Six Costly Mistakes to Avoid While Creating Your MedTech Success

Excerpts from our Foundation Series webinar with Kuldeep Singh Rajput, 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.

So, it is critical to conduct a detailed value proposition analysis by looking at the market size, competitive landscape, patient adoption and your own competitive advantage. It is also important to be specific and detailed in understanding the critical clinical unmet need in the chosen indication.

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.

Today, healthcare start-ups need to be adept at communicating their value proposition from a health economics point of view to cater to multiple stakeholders across the entire healthcare value chain.

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.

A critical mistake founders often do is to think linearly about their evidence generation strategy sufficient only to meet the next key milestones. Thinking this way can be very costly for the startup and can create significant hurdles for the startup to scale and succeed.

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:

1. 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.
2. 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.

One way to mitigate potential lack of product adoption is to conduct discoveries, focus groups and conduct user testing with every stakeholder along the clinical workflow. Mapping the clinical workflow and elucidation clear understanding of the value your solution brings is paramount to gaining buy-in from potential users.

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.

When working with pilot partners, ensure that your pilot is small but sizeable enough to deliver on pre-agreed milestones that will enable a conversion to larger commercial contracts.

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.

It pays to have a strong focus and demonstrate success for one unmet clinical need in one therapeutic area. Nevertheless, think of designing products that are modular and customizable so that it can be easily adapted to different therapeutic areas.

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.

About Biofourmis

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.

Final Thoughts

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.