Why Early-Stage Technical Risk Reduction is Crucial for Medical Device Startups

Making the leap from physician to entrepreneur was a huge risk for Diality CEO Osman Khawar, but one he doesn't regret taking. As a board-certified nephrologist with over a decade of experience in this field, Osman saw the opportunity to provide value-based care to dialysis patients and decentralize dialysis delivery in the US. 

Diality was birthed with the primary purpose of offering freedom and choice in the dialysis space. The company is working on a mobile hemodialysis machine that brings immense versatility to the table, allowing patients to receive treatment in different settings of their choice, including clinics and homes. 

Because of its continuous monitoring feature, cloud connectivity, and electronic medical records (EMR) system compatibility, Diality's system will enable nephrologists to make data-driven decisions and create personalized experiences for each patient regardless of their treatment setting. 

The patient-inspired hemodialysis system will also facilitate shorter training times for healthcare professionals and care partners through its easy-to-navigate interface and automated treatment setup. 

In early 2022, Diality closed a $24 million Series B investment round, bringing their total funding amount to over $54 million. The Series B2 funding round will be used to support the device's 510(k) clearance, home clinical trial studies, and commercialization. 

As Diality closes in on its much-anticipated market entry, Osman's team continues to focus on developing a versatile, market-ready product capable of delivering a wide range of dialysis prescriptions. 

In this Medsider episode, Osman talks about the importance of early-stage technical risk reduction and building collaborative relationships with regulatory agencies and value-based care providers. He also discusses how getting the right team members and investors on board is paramount to building a sustainable and successful medtech startup. 

Key Learnings from Osman's Experiences 

• One of the most common shortcomings of medtech companies is the lack of early-stage technical risk reduction. Reducing uncertainties during the initial phases of development can save you a ton of trouble down the road and give investors the confidence they need to support your venture. 

• The effort needed to build collaborative relationships with the right stakeholders is sometimes underappreciated. For example, one of the best ways to ensure a smooth regulatory clearance process and efficient clinical adoption of your product is to prioritize building alignment with the right people and organizations. 

• The team members and investors you bring on board can make or break your company's success, especially in its earlier stages. A great way to build a mission-driven, patient-centric group of people is to connect them with real-life patients and consumers.