Everything we do involves a certain level of risk. No matter how mundane the activity is, there are always risks involved. Product development is no different. If you learn to embrace risks and use them to your advantage, the end result may be a safer product for everyone. Medical device product development is complex because you have all sorts of hurdles to jump over. Apart from the fact that the user is not as well defined as in other fields, there are also a lot of regulatory bodies that determine what you can and cannot do, and design control that needs to be understood, but in the end, the goal is the same as other device industries: to create a great product that everyone is going to be excited about. But what is the best way to embrace risk for safer medical devices?
 
1. Avoid the Regurgitated Solution
We see it every day. Engineers approach the problem with what they know, closing off their minds to any new ideas. The end product is another version of what already existed. However, this is what we get and we are forced to go with it. These are self-inflicted wounds that can be avoided by taking risks and experimenting with bold new ideas. Make some unexpected steps and learn from your mistakes. After a project is complete, it is easy to see what went wrong and what could have been avoided. Unavoidable risks are part of making something new.
 
We also see it in how people get hung up on implementing specific features that are in vogue or trending or simply only fundamental, without actually adding any value to the product itself. People might get caught up on incorporating fundamental features that they see from popular everyday devices such as Wi-Fi capabilities, but these are often not central to the value proposition of the product itself.
 
2. Define Your Value Proposition
What do you need to consider when defining your product's value proposition?
 

• Novelty: A novel idea does not have to be something completely new. It can improve on something existing.
• Meeting design expectations: The average user today has high expectations. You should set out to try as hard as you can to meet these expectations.
• Stepping outside of specifications

 
The value proposition for any product is the vision for what you expect the product to be. It takes a strong project manager to clearly define what this is.
 
3. Find Ways to be Novel
New products often face a lot of difficulties when it comes to meeting regulatory specifications. If your product is completely different, it may not fit in with what is already in existence. Novelty, when taken advantage of in the right way, is an element of risk that primarily benefits its users above all else.
 
A novelty in one field may not be a novelty in all fields. For example, touch screens took a while to get into the medical field. Wireless technology is also not where it could be in the medical profession. A product may be novel for one industry but not be novel overall, and this assists in convincing regulators that this is a solution that could work.
 
Alternatively, a novel product can offer something different than what is already there. Novelty can also be in terms of good industrial design. A good industrial design does not impact the regulatory approach while having an impact on user experience.
 
4. Identify and Evaluate Risks
You need to critically think about your situation. What are the current risks that you face? What are the potential risks that you might face? Identify and analyze them all. You need to be honest about what you know, what you don’t know, and everything in between. Identify all types of risks.
 
5. Mockups and Prototypes
When you build your mockups and prototypes, they do not need to be high quality. They should work, but leaving them in a raw, in-progress state is acceptable as long as they convey the idea you intend. Focus on the lesson you are trying to garner from the experience. Building is part of the learning process.
 
6. Some Risks Are Worth Taking
Risk taking has been getting lots of bad press in recent years. However, isn't life itself a huge risk? Everything we do is risky. Most people think the risk is a bad thing. They ignore risk. Have a different mindset. Seek out the best risks to take and pounce on them.
 
7. There are Good and Bad Risks
The trick is to identify which risks are bad and which are good. Identify, analyze, compare them to your overall goal and pounce.
 
Conclusion
Embrace the idea or concept of risk to ensure your product is safer and better overall. Have an awareness of the things you can manage versus what you can't control. Approach your risk factors from a project management perspective. What do you need to do? How will you frame or gather data needed to make the project as successful as possible? Now you’re ready to get out there and start taking smart risks.
 

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Rilind Elezaj is an experienced digital marketing specialist with a demonstrated history of working in the marketing and advertising industry. He possesses a strong entrepreneurial mindset and has devoted his career to enhancing the sphere of digital marketing. Elezaj recently founded a website called Probleme.me, which focuses on everything related to medicine, healthcare, and wellness.