The development of medical devices can present a number of safety and regulatory challenges, with a rush to complete the programme often leaving key regulatory and usability aspects overlooked or, even worse, applied only as a last-minute measure with potentially dangerous, expensive, or legal consequences.
That’s why it couldn’t be more essential to plan the development of medical devices as carefully as possible, and to avoid some of the common pitfalls that arise for developers at all stages of the process.
Here are a few top tips to help.
#1 Gaining An Early Competitive Advantage
While it may appear difficult to plan, if the regulatory and usability aspects of medical technology are integrated with its functional, commercial, and clinical aspects right from the start of the project, repetition can be greatly reduced. As a result, time is saved in the long-run, and that can give the organisation a clear competitive advantage.
In a cross-function development project for medical products that involve physical devices, drug delivery, patient data, software, apps, and electronics, having a strong plan that has basic resources firmly in place is the best foundation when it comes to managing the ever-growing complexities across the various technical disciplines.
So, with this in mind, this could help to ensure that development plans for medical devices are successful from the outset.
#2 Clarify The Clinical Benefit’s Underlying Vision
When the product has a clear vision, it’s unlikely that the developers will end up going off on a tangent. While the way the vision is achieved could change somewhere along the line, the vision that underlies it should not.
The design specification of the device as well as its clinical evaluation plan must outline the clinical benefits that the device will bring its intended user, not solely its technical features.
#3 Prioritising Stakeholder Requirements
All-too-often, stakeholders have contradicting requirements when it comes to developing medical products. It’s imperative to understand which requirements are most essential when creating the first viable product, then which may be left until the second version is created.
Spending time upfront on prioritising the stakeholder requirements before going on to implement most of the development instead of rushing in, changing requirements along the way, and redoing chunks of work at an additional cost is well worth it in terms of effort and money saved.
#4 The Importance of Team Vision
It couldn’t be more important to put together a knowledgeable team of experts that all share the product vision and who are each able to communicate their own expertise.
#5 Defining Applicable Markets and Regulatory Context
All regulatory scope, compliance paths and jurisdictions for the product must be properly understood and a classification and qualification rationale must be compiled to ensure success.
Carrying out an analysis of any regulatory requirement gaps is key and developing a framework to demonstrate compliance will ensure that you’re ready for the notified body conformity assessment.
#6 Getting Early Feedback
All medical devices are not created equal, and regulations therefore cannot always maintain pace with each new device development permutation. That’s why it’s imperative to get feedback at an early stage and to be precise when describing the product.
Illustrated, detailed specifications are extremely helpful, and anything that needs to be questioned should be done with objective evidence and supporting rationales.
#7 Championing The Users from The Get-Go
If you define the product’s intended use at an early stage, you can more easily identify any use-related risks. When executed methodically, you’ll then be able to perform your pre-formative studies at an earlier date. Ultimately, championing user experience will lead to a medical product that’s more pleasurable, simple, and safe to use.
#8 Make A Backup Plan
When you test your product, the outcomes may not perform as you intended. In fact, outright failure is always a possibility.
Therefore, having a backup plan examined at an early stage of development for different designs, manufacturing methods, and materials is always a good idea, along with any commercial and regulatory implications they may hold, as you will then be able to recover from such setbacks more quickly.
#9 Agility Is Key When Implementing or Revising Your Plan
Although planning is important, it’s vital not to be too rigid. Openness to opportunity which could benefit your development significantly is key. You may even need to drop the project entirely if there’s no way to obtain a good return on the investment or a pathway for adoption.
Being agile and flexible is the best way to ensure a successful project from the get-go.