Stryker's strategic recovery plan for Neptune 2 device recall

Stryker Organizational Strategic Plan

Stryker is a world leader in medical technology and works to make healthcare much better. Stryker offers innovative medical devices and technologies reported to include "reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. Stryker products and services are available in over 100 countries." (Stryker.com, 2014, p. 1) Stryker reports having spent $471 million on research and development during 2012 and 5 to 6.3% of its sales invested each year since 2000 are in research and development having assisted 4,768 patients on a global basis in 2012. Stryker has been recognized by Fortune 500 and is a Gallup Great Workplace Award Winner as well as being recognized by Fortune Magazine as one of the top 100 that are best to work for. While Stryker is a successful company it has recently reported a problem with an urgent medical device due to recall and specifically the Stryker Neptune Waste Management System. According to the report there have been adverse events reported, additional actions recommended for continued use of the devices, additional actions that Stryker will take, and the pre-market status of each device. The adverse events include reports relating serious injury or even death when the Neptune 2 was connected to a passive chest drainage tube or closed wound drainage device following surgery. Due to the repeat of these negative events there has been a recall of these devices. This strategic plan sets out how Stryker can recover from these adverse events caused by the use of its device the Neptune 2.

Objective

The objective of this study is to draft an implementation plan for Stryker including the objectives, functional tactics, action items, milestones deadline and tasks ownership as well as resource allocation all in relation to the situation faced by Stryker with the negative events associated with the Neptune 2 Device.

Task Ownership

The company CEO and staff will be tasked with notification of all individuals using the Neptune 2 device. Recall and recovery of all Neptune 2 devices will be the responsibility of representatives of the company that issued or sold the devices. Itemization will be undertaken by a specially appointed staff that will be tasked with interviewing the individuals who were harmed or the representatives of individuals who were harmed by the Neptune 2 device. The organization's legal department will be tasked with consulting with legal counsel on the company's liability and potential financial responsibility in regards to the adverse events cause by the Neptune 2 device. Finally, all parties mentioned will be tasked with collaborative meeting and discussion of the potential financial budgeting needs to provide compensation to the victims of adverse events in relation to use of the Neptune 2 device. The organization wishes to provide compensation rather than enter into litigation with those harmed by the Neptune 2 device. The engineering team will be tasked with identifying a replacement device for the Neptune 2 that is safer and that has been tested and proven safe for use in place of the Neptune 2 device.

Key Success Factors

Key success factors include the following accomplishments:

(1) assessment of damage caused and preferment of appropriate compensation in a timely manner;

(2) Rapid recovery of faulty devices;

(3) Rapid replacement of Neptune 2 with alternate effective and safe device.

(4) Proper training for using the Device for customers who wish to continue using the device.

(5) Team collaboration tying up all loose ends and moving forward past these incidents.

Training Requirements

Training requirements are reported by Stryker to include the following specifics in training:

(1) Do not apply high flow suction or allow extended exposure of suction to tissue associated with procedures that require either no suction, low vacuum or low flow suction, for example passive chest drainage;

(2) Do not use these devices to provide suction to other suction powered accessories

(3) Do not use these devices with closed wound drainage systems;

(4) Do not use this device for post-operative use;

(5) Always consider the type of tissue associated with surgical procedure prior to using this system;

(6) Ensure that in low level suction applications the appropriate suction device is used;

(7) Ensure the user has a clear understanding of the units of measure;

(8) Ensure the level of suction has been checked and is appropriate for the procedure planned;

(9) Ensure the device control panel is clearly seen;

(10) Ensure that all users of this device are property trained

Budget Forecasted Financials

Estimations of damages that will have to be paid in compensation total $500,000.00. The following breakeven analysis demonstrates the time that it would take for the company to break even following the identification of an alternate replacement device for the Neptune 2.

BREAK-EVEN CALCULATOR

Monthly

24

Average price of each product/service sold

Average cost of each product/service to make/deliver

Fixed costs for the month/year

18000

Percentage of price that is profit

#DIV/0!

64

Total sales needed to break-even

#DIV/0!

$500,000.00

Number of units sold needed to break-even

#DIV/0!

98

Total Sales Needed Per Month

4.08

Risk Management Plan

The Risk management plan for implementation of these strategic plans includes company representatives making on-site visits to check for proper training and assess customer for proper use of the device in cases where customers wish to continue using the Neptune 2 device.

Summary and Conclusion

This study has set out the objectives of the strategic plan and has assigned the tasks to the various company actors that will be responsible for the implementation of this plan. The Neptune 2 device has caused adverse events including deaths due to improper use. The engineering staff at Stryker has been tasked with the identification of a device to replace the Neptune 2. Upon identification of such device it is estimated that the company will require four to five months to break even on the investment in the new technology to replace the Neptune 2.