Medical Device Startups: 5 Risk Management Essentials

Even when you have created a brilliant and innovative medical device your startup journey is going to be challenging and there will be risks you have to manage along the way before you achieve success.

Risk management is continually a hot topic of conversation when it comes to medical device startups. You have to be able to identify and manage these risks.

From sourcing the right contract manufacturing for your medical device to managing cash flow requirements, here are some of the essentials that need to be covered.

It starts with managing all of your records

One of your first priorities is to create a risk management file that allows you to keep track of all documentation. Whether it is a patent application or licensing applications, you need to be highly organized so that you don’t miss important deadlines or lose control of the paper trail you are creating in bringing your medical device to market.

Create a detailed plan

Once you have a system in place you need to focus your attention on all of the planning and due diligence that goes hand in hand with designing, creating, and manufacturing a medical device.

The plan should have risk estimates and evaluations. This will enable you to mitigate and manage the risks you have identified more easily.

Creating a prototype

Even when everything looks good on paper and you are getting good signs from your analysis and feedback that your device will be well received in the market you still need to see that your idea can be created without any issues.

Having developed a relationship with a contract medical device manufacturer who has the know-how and experience to produce your product in large quantities, an early priority would be to create a prototype.

Having this prototype allows you to evaluate the product more accurately and make changes where required before going into production.

Managing risks identified through the manufacturing process

It is highly likely that you will identify certain risks that become apparent during the manufacturing process.

Put in quality control systems to help you manage and reduce potential risks that could derail your product launch plans. It may be the case that clinical trial data will be required to verify the efficiency and veracity of your medical device.

Anticipate these potential risks and look to manage them accordingly.

Reviewing your risk management systems and protocols

Last but not least, you should carry out a risk management review at the point when you have reached the final phase of trials and your medical device is considered ready to go into production.

Your risk management plan should also incorporate any post-production risks that need to be controlled going forward.

In order for your startup to successfully launch it is clear that your medical device needs to have been created on the back of a highly detailed plan of action and a risk management strategy that identifies potential issues and outlines how to deal with them.

To bring your medical device idea to fruition there needs to be a fair amount of planning. It also requires a robust risk management strategy that ensures you successfully manage every obstacle that tries to stand in your way.