Over the last few weeks, i have had several conversations with potential clients, entrepreneurs, start-ups and consultants, which raise the question of when you should have “the talk” with a medical device start-up/entrepreneur. Some of these conversations have left me hopeful, thinking “you still have time.” Others have left me feeling a bit sorry for the teams, knowing that although it’s never too late to start, there will be a great deal of work ahead, which may seem overwhelming. Also, the cost of having “the talk” later in the game can be substantially more expensive. Not having “the talk”, well let’s just say, it won’t be pretty. It may be fine for a while. But when the FDA comes knocking on your door, the pain will be excruciating.
“The talk” is about what it takes to get a medical device to market.
There are two aspects of getting medical devices to market that are must-haves, whether you are a single product company or a major Fortune 500 company. The first is a Quality Management System (QMS). This is a companywide set of procedures, processes, and the responsibilities for policies and objectives used to ensure that quality is built into every product developed, manufactured, released, and serviced. There are several ways in which a company can create a QMS. The first is to write all the documents internally. For large companies, this is not a huge task. If they are already established, the most likely have their policies and procedures written. They may need to be updated, digitized or additional procedures/policies written to comply with ISO 13485 medical devices – Quality Management Systems – requirements for regulatory purposes. Overall, it should not take a tremendous amount of effort to reach ISO 13485 compliance levels. For start-ups, it can be more laborious and costly.
When starting from scratch, policies, procedures, and responsibilities must be defined, documented, approved and maintained. There are several ways to start this process. The first is to write them all from scratch internally. In a start-up, this can be difficult since there is so much work to be done developing. The team must have experience writing the documents or spend time researching. There are templates that can be purchased, which is helpful, but they still must be completed. A second option is to hire a consultant to write the documentation. Most of us that do this have done enough to not be too expensive when writing them. They obviously must be customized, as do templates, but it frees up most of the development team to do development. Alternatively, a start-up can hire someone full time to create the QMS. This is not a bad option since eventually a quality engineer will be required. At some point it is a cost benefit analysis. The option i suggest to my clients is to purchase QMS software. Yes, it takes money out of my pocket and moves it to another vendor, but i am still needed to customize the templates in the system. But to me, it is a more sustainable, long term solution with built-in features that make implementation and maintenance less complicated.
As a note, a QMS system for a start-up does not need to happen overnight. It can be done in phases as the new product progresses through design control. Also, to most people i talk to, it is not a huge surprise, since most companies have policies and procedures in place regardless of what they do. The look of bewilderment comes when discussing Design Control. Design Control is a procedure that is required by the FDA for the development of medical devices. The phases are defined with deliverables. Following Design Control is not only difficult, but also good engineering. So, it is never too soon to have “the talk”. If an entrepreneur has an idea they want to take to fruition, they should know and plan for what lies ahead. Medical device development is an expensive process, and the cost goes up the longer you wait to implement the requirements of design control. If you use the analogy of building a house, developing a medical device without design control is like building a house without plumbing and electricity. You are going to have to go back and put them in before inspection (aka regulatory approval and going to market), and it’s a great deal easier if you think about plumbing and electricity starting at the planning phase and put them in as you build.
The biggest aspect of Design Control for most people to come to terms with is the amount of documentation and planning required. Many clients get frustrated with the time it takes before we start building. But just like you would not want to build a house without planning, building a device must be planned. This is not to say that there is not prototyping done before design control. It is not to say there is not testing done before design control. But at the point where an idea becomes a real concept and serious money is being spent, it is time to do the planning.
This is not written to be an educational piece on how to follow Design Control. It is more to give an understanding of when Design Control should be part of the conversation and the risk of not having “the talk” sooner rather than later. One aspect important to discuss is Project Initiation/Phase 0, in which the completion is Milestone 1, and after signing off on Milestone 1, is the point at which Design Controls starts. Project Initiation is an undefinable timeframe in which concepts are being realized as potential products. It’s the phase in which entrepreneurs raise seed capital, hire employees, move into space, and start spending money. Most clients i see are new to the medical device industry, so they don’t know much about Design Control, phases, etc. They know they will need regulatory approval and patents (sometimes) but that is it.
Project Initiation has very specific deliverables. If you think back to building a house, before breaking ground you would analyze the lot, get feedback from the potential owners before drawing up plans, review regulatory requirements (city zoning, etc.), determine market values, and make sure that your concept for design is safe. The same thought process is required in building a medical device (and yes, medical device software). The deliverables, per the Design Control SOP’s i write, are the following:
1. Business Inputs
2. Design and Development Plan
3. Software Development Plan (where applicable as a seperate document)
4. User Needs/Design Inputs
5. Process/Procedure/Use Hazard Analysis
The Business Inputs document is similar to a Business Plan but includes aspects specific to medical devices. It is the document that indicates, as a company, the research has been done to understand the market, clarify the intended use of the product, prepare a regulatory strategy, understand the supply chain, and secure intellectual property. It also pushes the entrepreneur to describe clearly, what they plan on developing.
The Development Plans force the entrepreneur to plan. The Design and Development Plan describes or references the design and development activities and defines the responsibility for implementation of each of the design and development activities. The DDP should identify and describe the interfaces with different groups or activities that provide or result in input to the design and development process.
User Needs and Design Inputs are a critical component to Design Control. It is the foundation of what the final device is and how it should be tested. One of the biggest gaps i see with clients is the understanding that they are not the user. Regardless of their experience with similar technology and the fact they create their concept to fill their need. Unless they want to be the only person to use it, they are wasting time and money. The other gap i see is to understand all users. Often with medical devices, the entrepreneur, if a medical professional, focuses only on the clinician that would use the device. Yet, if it is used on people, the patient is also a User. The business (entrepreneur’s company) could be a User, administrators in software are users. Ancillary staff could be users. So to prevent having to change designs later in the process, it is critical to get inputs from the different types of users. In addition, it must be acknowledged that, even for clinicians, training, a geographic location, experience, size, and several other variables determine specific needs. The other source of inputs that must be considered are those of the applicable standards and regulatory requirements.
I have been asked by engineers, “Why are we doing a hazard analysis when we don’t know what the device will look like?” My answer is simple. If you do it now, you can save time and money by preventing a design that has a risk needing to be mitigated. During the Project Initiation stage, there are several sources available for the analysis: users of similar devices, FDA databases of compliants, literature, experience, etc. This is an exercise that can take time and should be done with a team as brainstorming sessions. The goal is to determine where potential designs can fail, therefore can be mitigated before a concept moves into the design control phase, and thus requires change control to make changes. I know many companies do not do this during Project Initiation but i require my teams to do it as to not waste client money and time.
At the end of Project Initiation, when ready to build a functional prototype, a Design Review is required to sign off on the required documents (per your Design Control SOP, Design Review SOP, Signature Authorization SOP). Once Milestone 1 is approved and the design review is held, the project is officially in Design Control required territory. So, as for “the talk”, if you haven’t had it yet, with every dollar spent, dollars are wasted. In addition, the clear delineation of development and meeting regulatory requirements are lost until there is definition of a design control process.
Oh, and the short answer to when a company should hear “the talk” is when they go to raise capital and start their company.
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