Dr John FitzGerald writes ...
"Having worked for 28 years as a management system consultant, I've learned a lesson or two (including some bitter ones) on setting up and running a successful management consultancy business. So I'd like to share my experience with you in this article. This time, in relation to Consulting in Medical Device Management Systems (MDMS).
Of course, you must use the information and suggestions here at your own risk; ultimately, it is you who must decide whether this life is for you. And if you don't find the prospect of working as a medical device sector consultant exciting, don't do it. If you do, read on."
First, we'll consider 'What it Takes' and then examine 'Business start-up plan for the MDMS Consultant - a 12-step plan'.
Note: You don't need to be a Regulatory Affairs Expert to work successfully as a consultant in this sector (see Lnowledge & Expertise, below).
To be a successful ISO 13485 or MDMS Consultant, you will need capabilities and competencies under five headings: fortitude, finance, experience, knowledge & expertise, and personal attributes. You will need to be able to tick every box, almost.
If you want to start a business based on OHSMS consultancy, there are twelve steps you need to go through:
Begin by identifying the economic or market niche that aligns with your skill set
While certification and membership are not typically barriers to working as an ISO 13485 consultant, they can help build credibility with prospective clients.
An ISO 13485 Consultant and Lead Auditor Diploma from deGRANDSON will both provide you credibility when you present yourself to a potential client and, most importantly, fill in the inevitable gaps in your skills and knowledge. The large volume of documentation, sample procedures, and sample records included in this course will prove invaluable. Additionally, an ISO 14971 Rsk Management Course at Advanced is needed as this is an area where most clients will require guidance.
Set goals for your business and personal life, looking ahead three months, one year, and 10 years.
Discuss and agree on these goals with your spouse or partner. The stress and financial pressure of being self-employed can be very destructive to relationships, especially when the other person is naturally risk-averse.
Identify organizations and organization types in your market sector that can benefit from the use of your services for a short period.
Focus on sectors experiencing, or about to experience, significant statutory or regulatory changes, or those that have had a recent occupational health disaster.
Here, the disruptive event creates an opportunity for you – people are more likely than usual to listen and be willing to accept the changes you suggest.
What needs, problems, and opportunities can your target organizations successfully address using your services?
You need to be able to tell your clients why they need you:
The old adage is very true: organizations that fail to plan plan to fail. No startup business plan has ever closely matched the outcome, but if you can't make it work on paper, you won't be able to make it work.
Preparing a business plan yourself is a significant learning experience in itself and is critically important.
Except perhaps for financial projections, you cannot/must not outsource this aspect of starting your consultancy. Like marketing and sales for a new business, you must do it yourself.
When you fail to reach your short-term turnover targets fully, and you will (ask any self-employed consultant you know), you do not want any regular monthly outgoings that can be avoided.
Work from home, avoid taking on any mortgages or borrowings, rent a car on a month-to-month basis, and buy second-hand equipment. You want to survive while building your business.
However, you will need an appropriate car and be well-dressed. If you don't appear successful, you won't attract many business opportunities. Prospects will judge you on appearances – do you look and sound professional? They have little else to judge you on. You must look the business to do the business.
If no one knows you and you know no one in your field, you may find yourself in the midst of a disaster soon. It is essential to begin building your network as soon as you have decided to become a consultant.
A strong network of contacts ensures you have access to potential job opportunities. A professional network, coupled with a social network, can help you market and advertise your business.
References are also an important way to find work in the niche. Rely on your initial contact base to build your network.
As a beginner, you may not receive high fees as a consultant. Your charges increase as you become known as a consultant. Keep in mind your credentials and experience, as well as market conditions, your target group, and your competitors when setting your fees.
Also, decide how you will bill clients. Most management system consultants charge by the day or half-day and invoice at the end of the month (or on completion, if before month-end). Payment within 7 days is usually requested.
Forget about advertising, whether traditional or online. It is expensive and unlikely to produce results quickly. Instead, take the time to build a social media presence, including…
A prospective customer can use these media to judge your capabilities. Without them, a prospect will ask themselves why you do not have an online presence.
You may find it easier to handle all tasks of your business on your own when you start. However, once your consulting business is up and running, you may need the help of others and decide to employ Staff.
Verify both legal and tax details before proceeding. You may also outsource some tasks that do not require your immediate attention.
Ensure the tasks are unrelated to your consulting business. For example, you can outsource website maintenance for a consulting business, but not when it is your niche.
Don't give up the 'day job' and start consulting. Wait until all the previous 10 steps are essentially completed, and seek out a 'banker' contract. For example, get one or more contracts working, say, 4/5 days a year, maintaining an organization's MDMS – use your network of contacts to seek out such opportunities.
Many ISO 13485 consultants also have ongoing relationships with Certification Bodies, where they act as lead auditors and team auditors – an intermittent (and legitimate) arrangement that suits both parties.
Only when you are confident that you can make a living from consulting should you give up the day job. And then 'go for it', working harder and longer than you have ever done before.
Best of luck!
In
We have chosen ISO 21001 certification because, unlike IRCA and Exemplar badges (which, in our opinion, are commercially compromised), it is based on an independent third-party assessment. It is a 'university grade' standard in use globally by schools, colleges, and universities to demonstrate their competence.
We provide Courses for ISO 9001, ISO 13485, ISO 14001, ISO 17025, ISO 27001, Iso 45001, Data Protection, Risk Management, and more.