If you want something done right, sometimes you have to do it yourself.
So began Ed Arkans’ journey into contract manufacturing. Decades later, San Diego-based ACI Medical still makes its own products – they represent 30 percent of sales – and also makes specialized parts for dozens of medical device manufacturers.
President and Founder Ed Arkans sat down with us to explain.
Ed Arkans: Thanks for having ACI Medical today, Joe! We specialize in injection molding, electronics design, and manufacturing. We also make proprietary products.
Joe Hage: It’s atypical to make your own products as well as contract out for others, yes?
Ed Arkans: Yes. It makes us more sensitive to the needs of our customers since we go through the same regulatory and business issues as our customers.
Joe Hage: So being empathetic to what your customers experience gives you a competitive advantage?
Ed Arkans: I’d say so and I’m still “in there” with them: 30 percent of our sales are from proprietary products. We use contract manufacturers too.
Joe Hage: My readers include #MedDevice manufacturers. Who might benefit from contacting you and why?
Ed Arkans: I’d say those who need micromolding, thermoplastic elastomers, and insert molding. We provide design assistance and work with customers with difficult challenges (especially at the R&D level) because we do R&D on our own projects. We can share how we have overcome similar challenges from development to product launch and into production.
Joe Hage: You were saying “you’ve gotten a lot of work” because your competitors shy away from the business?
Ed Arkans: True. For example and with a little creativity we figured out a way to micromold a part around a piece of tubing .003 ID without crushing it.
We also did an insert mold combining optical components with electronic integrated circuits using a gel type elastomeric resin. And we’ve taken on molding with very difficult part geometries and can integrate pneumatics seamlessly into devices.
Joe Hage: All your manufacturing is done in the US. Is that correct? And do you consider that a selling point?
Ed Arkans: Yes, we do it all in the U.S. We use low cost approaches that compete very well against Asian sources and nothing is lost in translation. We’re 100 percent American: We speak English and the language of product development and design. Plus, we have ISO 13485 quality certification.
Joe Hage: Yes, I see ISO:13485 questions come up often in the Medical Devices Group. Members ask if each component part needs that level of quality.
Ed Arkans: Yes, FDA requires manufacturers to ensure their suppliers are providing quality components and our ISO certification makes that job a lot easier.
Joe Hage: If you went out of business and your customer said, “Wow, Ed, what should I do now?” … what would you tell them?
Ed Arkans: I’d tell them to seek out a large contract manufacturer w/ a broad spectrum of capabilities w/ISO cert and good luck with the big guys.
The ArtAssist Arterial Pump
Joe Hage: Before we go, I see on the ACIMedical website, you invented the ArtAssist Arterial Pump. Tell us a bit about it.
Ed Arkans: The ArtAssist is our flagship product that prevents amputations in patients w/arterial disease in the legs (PAD). The ArtAssist pump is used at home and right now it’s patient-pay but we expect Medicare reimbursement sometime soon.
Our limb salvage rate is in the high 80-percent range for patients that can’t undergo surgery to fix the problem.
Joe Hage: Wow. And you go direct to patient AND have no reimbursement besides Veteran’s Insurance?!
Ed Arkans: We advertise in the Journal of Vascular Surgery and physicians prescribe the ArtAssist for their patients.
Joe Hage: I’ll add your website video at the end of our write-up. Ed, thanks for taking the time with me today. I like to conclude by asking, “What can Medical Devices Group members do for you?”
Ed Arkans: I’d say if your readers aren’t delighted with their current contract manufacturer, give me a ring!
