Successfully bringing digital health tech to market is as much of a test of your stamina and endurance, as it is the quality of your product. Manufacturers must balance innovation and safety, speed and thoroughness. Regulation can often feel like an unnecessary drain of your time and money. Here we discuss some of the common pitfalls and how to efficiently navigate the health tech regulatory jungle.
Safety as a Paperwork Exercise
With so many competing demands, innovators can be tempted to view medical regulation as last-minute box ticking process. The end result is often a scramble to meet regulatory expectations and a more costly and inefficient compliance process which complicates procurement and jeopardises sales. Patient safety and regulatory compliance should be promoted by the leadership as a competitive benefit and resourced appropriately. What makes your product a safer choice in the market compared to your competitors?
Siloes within the Workplace
Responsibly producing, deploying and maintaining a safe digital health product requires collaboration across the whole organisation. All departments should be aware of their responsibilities in relation to patient safety, and how relatively small product, security or deployment alterations can cause considerable negative downstream consequences. Maintaining constant dialogue between colleagues and your safety teams allows for these faults to be identified and addressed early.
The Retrospective Risk Hunt
By far the most common pitfall that we see and often associated with organisations who do not fully prioritise their regulatory journey. Whether this is due to confusion, naivety, or willful neglect, a considerable number of companies leave their clinical risk management and regulatory approval process to the very last minute. Attempting risk identification and mitigation once your product is largely assembled is an overly cumbersome, costly, unproductive affair, which delays your go-to-market strategy.
Machine Learning and Artificial Intelligence
AI tools are increasingly being utilised to assist in in the diagnosis and treatment of conditions through the rapid assimilation and analysis of clinical data. Yet these systems often represent “black boxes”, making decision without clear explanations. When a clinician cannot see the reasoning behind an AI diagnosis or treatment recommendation, trust collapses and responsibility blurs. Skillfully assessing the risk of AI in healthcare requires a patient safety and risk management expert, confident in the application of AI guardrails, ISO 42001, BS 30440 and AMLAS guidance.
DIY Risk Management
With the never-ending demands placed on budgets it can be tempting to keep risk management and regulatory compliance in house. Occasionally this can be entirely appropriate and an efficient use of limited resources, especially if you have a qualified clinical safety officer within your team already. However, a word of warning: just like attempting to proofread your own essay, attempting to spot faults within your own health technology can be challenging. Common risks may be overlooked, the latest regulatory principles misapplied.
A client rejecting your safety documentation compromises the whole procurement process. Is this a risk worth taking?
Building a Culture of Safety
Digital health is changing quickly. Understanding the safety pitfalls and carefully solving regulatory challenges allows you to efficiently navigate your regulatory journey and stay ahead of your competition.
The most effective digital health organisations create an atmosphere in which everyone is accountable for hazard reduction, patient risks are raised without fear of blame, and safety is seen as part of quality. They establish effective governance, led by a Clinical Safety Officer who is an expert in Clinical Risk Management.