While we might sometimes think many of the events that occur in our day-to-day lives are life-or-death situations – for example, “If I don’t get that presentation done my boss is going to kill me” or “If I don’t cut the grass my wife is going to kill me,” or “If I have to sit through another 8-hour meeting, I’m going to die” – the truth is that these situations are probably not the ones that are going to have you joining the afterlife anytime soon.
When it comes to the development of medical designs, the stakes really are that high. One critical failure could literally mean the difference between life and death for a patient who must put blind faith in their care provider as well as the designers, engineers and companies behind the devices used for a given medical procedure.
So let’s start by defining what we mean by medical devices:
‘Medical device’ means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of:
- Diagnosis, prevention, monitoring, treatment or alleviation of disease,
- Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
- Investigation, replacement or modification of the anatomy or of a physiological process,
- Control of conception,
- And which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.*
*[European Council Directive 93/42/EEC]
That’s certainly a mouthful but when developing such devices, there are many regulations, guidelines and best practices that must be followed. For the purposes of this blog, we’ve focused on the following five best practices, which should get you off to a good start:
- Solve a relevant problem by gaining a thorough understanding of an existing clinical challenge.
In other words, don’t develop a “solution looking for a problem.” Interview doctors and nurses to identify an existing need and determine how to best apply your particular field of expertise to solve the problem. And once you’ve identified a particular need, don’t take the word of just one caregiver, team, hospital or clinic that there will be a broad demand for the solution and hence, a valid commercial opportunity. Corroborate your findings with others in the field.
- Conduct user analysis to develop a comprehensive list of design specifications.
The list of design specifications for medical device design can be overwhelming and is too lengthy to include here, but at a high level, it encompasses items such as anticipated structural, loading and environmental conditions, dimensional requirements, regulations/standards compliance, and marketing restrictions.
- Follow a structured process to develop creative designs and apply analytical techniques to optimize the design iterations.
Once you have your design specifications, you can start a Design Review, Verification and Validation process, similar to the Waterfall Design Process depicted in the graphic below (figure used with permission of Medical Devices Bureau, Health Canada).
Simply put, you develop your design requirements, design a device to meet those requirements, evaluate the design, transfer to production, and then manufacture the device. And, there should also be feedback paths between each phase of the process to represent the iterative nature of product development.
- Know the hospital, clinic or environment in which the device will be used.
For example, resources such as electricity, oxygen supplies, sterilization techniques, health worker skillsets, etc., can vary widely from one facility to the next and from one country to another. And in general, resources in developing countries are typically very different from those found in developed countries.
- Become familiar with and follow FDA regulations and guidelines (and those of other relevant international governing bodies) for the specific type of device or equipment being designed.
This, of course, goes without saying, but there’s also a wealth of resources available from the FDA, The European Commission, and others that will get you started down the right path to successful product development that leads to a successful commercial product launch.
Now that you know some of the best practices to follow when developing a medical device, check out our life sciences page to read white papers, see ProNova’s cancer-killing cyclotron in action, hear from customers, and learn how you can bring your next medical breakthrough to market in record time.