3 reasons why you should consider changing the way your Business of Engineering is done today
Medical device manufacturers operate in an increasingly regulated, safety-critical environment, and frequently have many variants of parts, products, and product lines. Medical Device PLM provides essential engineering support to equip these device makers with efficient solutions to these key business challenges.
Medical Device PLM provides traceability across requirements, designs, and test protocols to address complex regulatory compliance reporting. Risk and hazard management provides coverage of risk with measurable controls and satisfies key regulatory reporting requirements of the European EU MDR/EU IVDR, the American FDA CFR 21 Part 820 and the MDSAP, which will cover Canada, Brazil, Australia, and Japan. Finally, sophisticated reuse capabilities for variant management of parts, products, or product lines reduces duplicate data and rework.
Risk management activities are critical to ensuring the delivery of safe and effective medical devices. All hazards must undergo complete risk analysis to uncover potential safety or usability issues. If a risk is discovered, it needs to be evaluated and, if warranted, actively managed with risk control measures. Both risks and associated control measures must be traceable to design artifacts (e.g. requirements, design specifications, test protocols) so status can be tracked and updated as development proceeds and requirements and designs are updated. Engineering teams often rely on Word documents or Excel spreadsheets to capture these artifacts, but these tools cannot provide the traceability or visibility needed to effectively manage risk.
1. Are you working smart today? If not, you should!
A lot of companies arrive at this “chaos slide” situation through rapid growth. Other companies end up at this point by having employees who autonomously apply quick-fix solutions to a problem within a department. I’m sure many of you can reflect on your own journey.
But you need to ask yourself, is this really the smartest way to work?
- If your data is not connected, how do you trace the impact of a change to a requirement?
- And how can you make sure that your documentation, product specification, cost estimate, CAD drawings, marketing, validation, and your verification plans are updated to the latest version?
The point is, do you have smart processes within your organization? And if not, how can you optimize?
2. Your engineers should spend their time on engineering!
Speaking about working smart. Do you know what your engineers are spending most of their time doing? Most likely, it’s not engineering.
Engineers are problem solvers by nature. If they need a spreadsheet, an application or even a paper process to handle their data, they will create it.
The problem with this process is; engineers are not necessarily good at looking at how these small quick-fix solutions affect the bigger picture in the organization. Thus, if you have several separate applications within your organization, you will end up with a lot of small non-connected data islands.
And unfortunately, that process leads to:
- Duplicate data
- Processes being done in several places with the risk of no data visibility or traceability
- No single source of the truth
Your engineers should not be spending time on filling out spreadsheets or forms or participating in status meetings. They should spend their time on value-added activities like actual engineering.
You need to make sure that your organization has access to a system that supports the flow of data throughout your organization.
3. Convince your CFO that better systems and processes are worth the investment!
It might seem unfair to you that you must justify the need for better systems and processes to your CFO. After all, your “Business of Engineering” is helping drive the revenue, right? But upgrading or even changing your organization’s data management system is quite a substantial investment in terms of time and money. So, it is obvious that any corporate CFO would like to have their say.
To put it into terms that your CFO may understand:
Dear CFO, how would you feel if you had one spreadsheet for your receivables, another spreadsheet for your payables, and a network drive to hold all your purchase order documents. For fun, you can reconcile the cash on hand with a bank statement.
Apply your challenges to their situation. Maybe they will look at it from another perspective.
Now I know it is easy for me to come up with ideas for change. I am not the one to implement the changes in the organization. But if you want to push the organization forward and improve the processes, these pointers are a good way to start.
If you’re interested in hearing how we have helped other companies improve the way they do their “Business of Engineering”, please contact me at firstname.lastname@example.org.
As always, I’m interested in your comments!