Developing Medical Devices is complex. While many industries have limited or no constraints regarding the process behind a product’s development, for Medical Devices it is quite the opposite. To make matters worse, the efficacy of any device needs to be demonstrated beyond a shadow of a doubt or demonstrated as equivalent to a predicate device.
There are many challenges in adhering to requirements of different regulatory bodies though out the world, and the industry bodies constantly improving standards and norms. In order to maintain the sale-ability of a Medical Device and its potentially lucrative consumables, it requires constant effort and attention to detail to ensure continued compliance of the Medical Device.
No project in the Medical space is a one person job. It requires capital, people power, experts, high integrity manufacturing, never ending sales and support, and broad ranging consensus about many aspects of the end solution.
The future is bright, and the number of patients whose quality of life can be positively impacted is literally endless.
So how can EXA Product Development help?
For many organisations looking to develop Medical Devices, outsourcing is one of the best options. Working with established consultancy firms and product development houses has many advantages, for example:
- Comply with ISO 13485 before establishment of your own QMS
- Turn resources on and off without continued expenditure
- Leverage experts in the field with knowledge of prior art
- Leverage best in class established development process
- Leverage existing labs and supply chains before you establish your own
- Use globally distributed sites for around the clock burn to speed up development
- Fresh eyes outside an established (stagnant?) team often find new solutions
- Access work place cultures where people work harder than you can imagine…
Equally, there are big challenges:
- Who is the best fit for your organisation culturally?
- Who do they want you to partner with, but who should you partner with?
- What experience do they have that you want to leverage?
- Paying how much an hour?!
- Intellectual Property and its security
- Tiered-rate vs. Average-rate fee structures
- Estimating the costs transparently
- Estimating the duration transparently
- Estimating the effort transparently
- Managing program risks
- Managing technical risks
- Managing the financial burn
- How good are they really?
- Are you getting the best thing for you, or is this the best thing for them?
- What reporting do you need and when?
- What should you do yourself vs. outsource?
- What does handover look like when they are finished?
- Who are you going to need internally and when?
- Communication, churn, and the availability of everyone and anyone..
All of this is very manageable.
EXA Product Development can advise and support you in finding the right development partners. We can aid heavily in managing the challenges highlighted above, and more.
We encourage you to get in touch.
Device classifications and standards regulations are the backbone of Medical Device development. You need to get this right at the beginning of formal development if you want to sell your product for use in the medical industry.
EXA Product Development can help you classify your device if it falls into existing device categories for Europe, Australia, Canada or the USA. Additionally, we can assist in the engagement of regulatory bodies where the classification is unclear or requires clarification.
EXA Product Development is experienced in establishing which standards and rules you need to comply with based on your class of device, type of device, and intended regions of sale under the following regulatory bodies and schemes:
- FDA – Food and Drug Administration (USA)
- OSHA – U.S. Occupational Safety and Health Administration (USA)
- EU – European Union (Europe)
- TGA – Therapeutic Goods Administration (Australia)
- CSA Group – Canadian Standards Association (Canada)
- CFDA – The China Food and Drug Administration (China)
- CMDE – The Center for Medical Device Evaluation (China)
- CB Scheme – National Certification Bodies (Global)
The scale of a device’s regulatory requirements can be so large that a development can’t always afford to take on every region of sale simultaneously. EXA Product Development can help establish development and release strategies to get you selling in your preferred markets sooner.
We encourage you to get in touch.
The key to successful Medical Device development lies in effective Systems Engineering management. This discipline has significant impact on reducing R&D spend and end solution cost, resulting in an earlier realised and greater ROI.
EXA Product Development is experienced in the application of Systems Engineering for the development of Medical Devices.
We can support you in areas such as:
- Validation of your systems and tools
- Elicitation and validation of System Requirements (Business, User, Life-cycle, etc.)
- Requirements trace-ability
- Interpreting standards, and translating them to implementable requirements
- Managing project artefacts and records
- Concept evaluations and trade studies
- Developing sub-system requirements specifications for outsourcing
- Driving solutions and clarity system-wide in consideration of the Complete Problem
- Facilitation of the PHRA and ISO 14971 Risk Management related activities
- Verification of the end solution
- and more…
Wherever your project is in its development, we can help.