September 26, 2012 -- Medical device Research and Development (R&D) directors very often come up with brilliant product ideas but do not necessarily plan the development process properly, according to Christian Haller, Director – MPR Product Development. They end up spending substantially more time and money developing a product than they really need to. A solution provider at the marcus evans Medical Device R&D Summit 2010 taking place in June 20-22, Haller discusses best practices for product development and risk management.
What long-term strategies and best practices would you recommend?
Christian Haller: One of our primary approaches is to manage risks; not only technical risks but product and development risks, such as marketing, reimbursement, and regulatory approval. In our experience, many companies do not put sufficient effort upfront into planning out a detailed vision of what the product is, how it is going to be used and paid for, the business case of the product from the buyer’s point of view, and the user experience. While mostly everyone gets around to these activities, much time and effort can be saved by spending more time up front on these issues.
Medical device R&D directors should take more time planning, talking to potential users to find out what they really want from the product, and identifying how the product fits into the business model, not only as a manufacturer but how it fits into the consumers’ business model. They need to focus on the final outcome as early on as possible. This will mean fewer changes in the development process. Very often, people come up with an initial idea but do not think through all of these issues and they have to continually redefine the image of the product. They spend more time re-developing the product and as a result, substantially more money than they really need to.
These strategies also help in decreasing the time to market. We have reduced our average time of filing very complex devices to a year or just under. Compared to industry averages, we are proud of this metric. Of course, you cannot guarantee how long the US Food and Drug Administration (FDA) will take to approve a product, but planning upfront and a proactive approach with the FDA helps speed things up.
What challenges are medical device R&D directors in North America facing?
Christian Haller: The market is focused on coming up with new products with fewer resources. Many companies are cutting R&D budgets ahead of the taxes on medical devices, which will be imposed by the Health Care Reform Bill. People will have to keep doing more with less, in addition to having to come up with products that work better in order to be approved for use by the Bill.
There are also significant modifications to the FDA rules which we are not used to; there are many unknowns in that regard. From our experience, it is important to take a cooperative and proactive approach with regulators. R&D directors should spend a lot of time on due diligence and determining the best regulatory strategies, going to the FDA with their plans, defining their own recommended regulatory path and working to build consensus upfront. You have to be your own advocate with the FDA. Talk early and talk often, is what we tell to our clients.
How can the product lifecycle be extended?
Christian Haller: In the effort to get to the market quicker, we advise clients not to add too many features that are not absolutely essential. We have found that one of the best ways to extend the lifecycle of a product is to define the architecture of the device, so that additional features and applications can be added cost effectively later on. By defining the architecture appropriately, you enable the ability to refresh the product at a later stage.
When outsourcing parts of the R&D process, how can manufacturers ensure everything is in sync?
Christian Haller: Firstly, they need a detailed written plan from all solution providers that covers the entire development process. When we start a project, we give the client a very detailed plan covering all the stages of the project, all the deliverables and activities defined, with a detailed listing of what will and will not be included. It is important to communicate that effectively. Everything should be written down, from beginning to end. The two parties have to reach complete agreement on the plan and the review process before starting.
Secondly, the parties have to establish regular scheduled meetings, perhaps once a week either in person or via teleconference, to walk through the status of the job.
Thirdly, it is necessary to have a team at the outsourced end that is dedicated, and a project manager who is constantly in contact with the client, who will oversee the project from beginning to end. The team at the outsourced company should be an extension of the manufacturer’s own development team.
Lastly, the way we see it, it is more efficient to have third party suppliers who can do the entire job. One could hire a software company, an electronics company, and a mechanical design company, but that generally means getting all those different outsourced resources working together harmoniously, often a full time job. Going to a company with a proven track record that is able to do the entire job is key. People will be more motivated to cooperate with each when there are fewer companies involved.
marcus evans, Summits Division
Tel: + 357 22 849 313
About the Medical Device R&D Summit 2010
This unique forum will take place at the Red Rock Casino Resort & Spa, Las Vegas, Nevada, June 20-22, 2010. Offering much more than any conference, exhibition or trade show, this exclusive meeting will bring together esteemed industry thought leaders and solution providers to a highly focused and interactive networking event. The summit includes presentations on emerging technologies, speeding product development and addressing the challenges of outsourcing.
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