CHALLENGE: NEW PRODUCT DESIGN FLAWS RISK TIMELY MARKET ENTRY.
Medical device manufacturer partners with RH USA to bring a prototype product to market. RH identifies several design flaws that must be remedied prior to manufacture and release. The new projected product release date was expected to miss target market launch by more than 90 days-unacceptable!
RH USA SOLUTION:
RH created a highly specialized engineering task force to work with OEM developers, resulting in expeditious design improvements. RH implemented significant quality improvements to bolster overall product performance and reliability. The resourceful and dedicated RH team effectively brought the new medical device to market within days of the original launch date. Problem Solved.
CHALLENGE: OEM PARTNER NEEDS TO OUTSOURCE SERVICE, IN 2 WEEKS
Existing OEM partner wishes to expand the relationship with RH beyond manufacturing and logistics. Because RH is more intimately familiar with the technical aspects of their product, and can offer comprehensive after market service, the OEM partner wishes to transfer this responsibility to RH as well. The challenge: the transfer needs to be complete within two weeks!
RH USA SOLUTION:
An RH service team engages key OEM managers to efficiently transfer existing support records and loaner inventory. RH identifies shortcomings and executes improvements, resulting in enhanced quality and improved customer satisfaction. Complete after-market service transfer accomplished within 14 days, with no adverse customer impact.
CHALLENGE: NEW PRODUCT MANUFACTURING: OUTSOURCE OR INVEST?
A medical device start-up is considering whether to outsource or invest in internal capabilities toward their prototype instrument launch. Their needs include: advanced engineering support, pilot lot builds, fulfillment of ISO, FDA and CE mark obligations and mature product manufacturing. Extensive requirements on a limited budget and an aggressive timeline!
RH USA SOLUTION:
RH managers prepared a detailed project plan addressing every OEM need and concern. Extensive experience with like projects provided RH with the knowledge to efficiently identify challenges and expedite solutions. ISO quality operations and intimate familiarity with regulatory obligations allowed RH to guide and streamline approvals. State-of-the-art RH operations provided the OEM with all the tools necessary for success, with none of the investment. The full service capability of RH USA allowed the OEM to focus on, and invest in, development.
CHALLENGE: CURRENT CONTRACT MANUFACTURER FALLS SHORT OF EXPECTATION.
OEM is disappointed in the performance and quality of their current contract manufacturer (CM). Their CM has failed to achieve ISO certification and CE mark for their product as promised. After more than a year of patience, OEM seeks an alternative solution.
RH USA SOLUTION:
Based on prior experience, success and ISO certification, RH management was confident in executing an aggressive project timeline for attaining product CE mark. Additionally RH outlined a comprehensive approach to improve quality and reduce supply chain costs. Performance so exceeded OEM’s expectations, that all operations functions were transferred to RH USA.