MPMN_Medical Product Manufacturing News

Medical Product Manufacturing News, March/April 2015

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M E D I C A L P R O D U C T M A N U F A C T U R I N G N E W S Q M E D . C O M / M P M N 3 0 M A R C H / A P R I L 2 0 1 5 M edtech companies can reap plenty of benefits when it comes to going the contract manufacturing route. But jump into it without asking too many questions, and there's a chance you might wish you went skinny dipping with piranhas instead. Qmed editors recently visited the Medical Devices Group website to ask about potential contract manufacturing snags. Here are five important pitfalls gleaned from the conversation: 1. Your Partner Has a Spotty Record Everyone should try to get better, but the past cannot be ignored when manufacturing or other functions are outsourced. Dipankar (Dipu') Ganguly, a San Jose, CA– based technology commercialization consultant, had some tips on what to look out for: "ISO and FDA certifications of the CM are key issues to look at, as well as their experience with devices similar to what you need manufactured. Also, look very carefully at their CAPA procedures and the number of FDA audits they have had to deal with." A company hiring a contract manufacturer is responsible for auditing the contractor in order to verify to FDA that all GMP requirements are documented and met, according to Burrell (Bo) Clawson, chief technology officer and founder of All-In-One Diagnostics (Newport Beach, CA). 2. Unaligned Business Needs Companies can end up needing quite different things from a contract manufacturer, says Jerrold Shapiro, president and CEO of Fem-Medical LLC (Bedford, MA), which helps overseas medtech companies introduce products in the United States. "Some companies protect their intellectual property by using several contract manufacturers, one for each part or subassembly. Other U.S.- based companies will use domestic contract manufacturers to not only design and manufacture the entire product but to do the packaging, sterilization, and shipping as well, an idea-to- shipped-product kind of company," Shapiro said. No matter what, it is important to recognize that you are competing with the contractor's other customers for their time and resources. 3. Not Doing Your Homework Up Front Once program budget and timing agreements are signed, it's too late to fact-find, says Kirk Becker, sales engineer at Crescent Industries (New Freedom, PA). Here are several basic fact-finding steps, courtesy of Becker: • What are the device's requirements? The customer or start-up needs to describe this fully. But a good contract manufacturer will have an eye toward 'design for manufacturability' and related issues. • This leads to quality requirements. Says Becker: "Be sure to review how the CM's systems will integrate with the customers." • Visit each other's facilities. Understanding is always better when you can see and touch each other's capabilities. • Provide examples of which technology will be used to produce the product—and identify the quality risks in using that technology (human assembly versus automation). • Confidentiality. How is proprietary information going to be protected? • Capacity. The contract manufacturer should show how shipment requirements are going to be met. "Again, it should be the CM leading the way on this, since the customer may not have any manufacturing experience," Becker says. • And don't forget logistical details, packaging requirements, and the wording of the actual program budget and timing agreements. 4. Being a Jerk Most contract firms want you to treat them as a key member of your team—not just somebody to call up and yell at when things go wrong. It may sound obvious, but working together as a single team is much more productive. Working together as a team requires having a shared culture and language, as well as a commitment to working together as a single entity. A contract manufacturer should be viewed as an off-site facility or as an extension of the contracting company, according to Mark Trebilcock, a strategic business unit manager at St. Jude Medical. "Given that the same way that an organization would monitor and manage its off-sites, the same must be done with contract manufacturers," Trebilcock says. "Know the team members on both sides. Who will be your ... folks for purchasing agreement questions, legal questions, regulatory, quality, engineering, etc?" 5. Having Your Partner Clean Things Up A complete and verified development plan is needed for all of a device's needed technology. A contract manufacturer cannot be expected to fill in the blanks, Clawson says. "If you don't know the how and why of your product design technology and all of its manufacturing steps, you have a potential show stopper if you just hand it off to production to 'clean it up,'" Clawson says. "I think it is a bad business concept to design a product with unsolved issues and then think the outsourcing firm will solve the technical challenges.... The time and money lost can be huge." Carl Lincoln of Integrated Technologies Ltd (Ashford, Kent, UK) agrees: "In our experience it is much more valuable for the customer to deal with these issues than risk manufacturing something that doesn't end up working and needs the R&D work anyway." SPECIAL FEATURE: ENGINEERING INSIGHT

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