Mederi Therapeutics is a resource-strapped startup that designs medical products to treat diseases affecting the human gastrointestinal tract.
To accelerate new product introduction cycles and reduce errors, Mederi’s COO Oleg Shikhman turned to Arena’s cloud-based product lifecycle management (PLM). “The fact that Arena PLM is a SaaS solution was certainly a plus for me over other PLM systems that required me to buy additional hardware and store it locally. We are a small company who is really trying to minimize an investment in the infrastructure.”
We recently interviewed Shikhman to get his insights on the keys to ensuring new product introduction success.
Arena: How did Arena PLM help?
Shikhman: The ease of Arena’s implementation allows us to delay the need for us to hire a document control person, which is a big deal for a small company. The benefit with Arena is the solution makes it almost impossible for us to make a document control mistake. I know that if something is in Arena PLM, then it went through the proper channels and was approved.
Arena: In addition to documentation control, how else did Arena PLM help?
Shikhman: The need for a robust ‘quality’ system is probably our number one concern and number one benefit of using Arena PLM.
Arena: How does a medical device company with limited resources go to market?
Shikhman: If you want a medical device to get to market in a timely fashion, you must have a quality system in place; you must have document control; you must control your bill of materials (BOM). These are all resource consuming activities.
The way I look at Arena PLM is as a tool, a resource, and another supplier in my supply chain. I outsource manufacturing. I outsource distribution. I outsource a lot of different things. I am essentially outsourcing my document control to Arena PLM. Yes, I need to be part of the process but it is just an additional resource to me.
Arena: Is Arena easy for new users to get started?
Shikhman: Your system is a perfect fit. And the more I use it, the more I feel that it was the right choice. I send positive feedback to your technical support team, and am happy to see some of my suggestions implemented.
Arena: What tips do you have for medical device companies to ensure streamlined design processes?
Shikhman: My advice is for manufacturers to keep engineering change notices (ECNs) focused on a single issue and that will make the review process quicker and easier.
Keep ECNs streamlined, focused and don’t cram in too much. Don’t combine multiple issues, multiple changes, or unrelated changes into one ECN. The reason is, in this instance it would require a lot more people to get involved who may not be relevant to that process. For example, certain team members might be meaningful to be involved in one part of the ECN, but not part of another ECN.
If you put 20 different documents in a single ECN and post them all at once, the whole review process becomes cumbersome. It may at first blush appear easier as you don’t need to chase as many signatures, but ultimately it becomes more complicated to review as if that were to occur, some in the review audience wouldn’t understand why you’re asking them to review this ECN in the first place.
If you’re a company that’s overcome limited resources to punch above your weight class and successfully go to market in the face of increasingly complex regulations, then we’d love to hear your story. Please share in the comment section below and let us know how PLM helped your company find success.