I think we have to look at where Design Inputs come from. In medical devices Design Inputs come from the following.

Industry standards
Regulations
Previous projects / products
Competitor products
End-users
Prototypes

So marketing will certainly have a role in developing the inputs by gather VOC from the end-user. As well as R&D, Regulatory,…[Read more]

In my company I support contract manufacturing. So while we also have very similar processes to those mentioned above for internal design changes, I will go into the process when we have a design change at a contract manufacturer. Generally a change can be initiated internally or from the contract manufacturer (CM). When the CM initiates a change…[Read more]

In addition to doing a strong stakeholder analysis and getting input from those stakeholders into the risk planning process, it is important to make sure that risk management is done throughout the project cycle. The project manager. In terms of project risk, the risk management plan should include what happens if a risk is identified during the…[Read more]

When developing packaging for medical devices there are two primary concerns. The first is maintaing product integrity throughout the shipping and storage process. This means we want to make sure the device does not get damanged between the time it is packaged and the time in goes into the hands of the physician or patient. To determine that we…[Read more]

Hi, so here we are talking about two different kinds of Risk Managment Plans. In project management the Risk management plan is how we identify risk throughout the project. At the start of the project the project team will identify potential risks and how that would impact the cost, timeline, or quality of the overall project. They can then…[Read more]

I have recently come across another example of a challenge in the global regulatory involvement and that involves continuous improvement. When a product is launched, often times the manufacturing process or product quality or cost are not as efficient and cost effective as it could be. So we go through the process of improving the product over…[Read more]

I have been in the medical device industry for 14 years and have worked on many aspects of design controls. Most of our recent projects have been where instead of developing a device from the beginning internally, we purchase a device that was developed by a smaller company. This device may already be on the market or may be nearing launch. A…[Read more]

The project proposal or project charter is the document approved by Management for a project to get underway. It actually will not usually include a Gantt Chart but instead a rough estimate of the timeline including major project milestones and estimated dates. The real details come after the project charter is approved.

Other than the…[Read more]

Now that we are 1 year in to this administration and the announcement to overhaul the FDA regulations, I thought this might be a interesting topic to revive. How do you think President Trump’s promise to simplify FDA regulations has been accomplished?

Well, so far no medical device regulations have been changed as far as I know. A new FDA head,…[Read more]

I have had the opportunity over the last 10 years to work with Drug-Eluting Coronary stents. These stents are delivered by a catheter, used to prop open the coronary artery and are coated with a drug that is absorbed into the surrounding tissue. The primary mode of action (PMOA) is to open the coronary artery. The secondary mode of action (drug)…[Read more]

Early on in the initiation and planning phases it is important to understand GMP requirements and how they relate to the project. For example, if your company is now developing a combination device and they have not before, they will be required to meet a whole additional set of standards. These quality system updates will need to be factored…[Read more]

I work for Cordis, part of Cardinal Health and the organization is highly matrixed. I report to my supervisor within supplier quality and also serve on project teams for various internal projects. I have life cycle management responsibilities related exisiting suppliers that include minor project changes, to supplier CAPA management, risk…[Read more]

I have worked in the medical device industry for the last 14 years. The last 10 years have been at Cordis which recently became part of Cardinal Health (previously part of Johnson and Johnson). I have always used Microsoft project to manage projects. Johnson and Johnson had very advanced project management awareness with a dedicated project…[Read more]