Posts Tagged ‘
engineering ’
Tuesday, August 11th, 2009
Whether you are putting together an executive team, your board of directors, advisors, or your employees, people will make or break your success. A leader needs to focus on recruiting the best people possible. Everything else will fall into place if the right people are there to make it happen. The people you want are as positive and passionate about your business as you are.
Many early stage startups will bring in employees or consultants that are friends or family of the founders or management and are asked to perform functions that they are not experienced in performing. It is definitely easier and quicker to hire friends and family, especially when you are working long hours and need someone immediately, but some time needs to be spent handpicking people based on needed skill requirements if you want your business to succeed. It really is extremely easy to bring in experienced personnel or consultants to assist in the areas where they are experts and the tasks will be completed much faster and more efficient, resulting in less rework in the future.  This will save the company money and time in the long run. There are talented and skilled people who can wear more than one hat and they may not always be your friends and relatives. Always hire people who can add value to the company and its operations.
There also needs to be a certain sense of objectivity and accountability in the workplace. Friends and family do expect to be held to a different standard and they should be, away from your business, but never in it.
Tags: blog, engineering, entrepreneur, globalmed, goals, medical device, square pegs, startup, Tips
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Friday, August 7th, 2009
Medical device startups need a strong surgeon/clinical advisory board for providing input and feedback. They should be incorporated early on in the design process, as scope changes at a later date can cause great delays and disrupt project budgets. The founders and management team need to create the corporate vision and goals, but the details of the product design should be reviewed by these prospective customers (surgeons). The company should engage in regular surgeon meetings to discuss ideas and evaluate designs and prototypes. The definition of regular surgeon meetings is your decision, but having them every quarter or biannually is advised. These meetings can be at industry conferences (an inexpensive option as they should already be attending), at your facility, an offsite location, or even as a webinar. The surgeons must feel that they are truly involved in the development process or you will likely see a reduction in attendance for each subsequent meeting.Â
The founders may have pre-conceived ideas for the details of the design as they have been involved from day one. Â Because of this reason, every product needs an expert, outside opinion as to the design and functionality of the products. Â Review the Founder’s Syndrome from Tip #4, as you don’t want to force feed the surgeon community your ideas, especially if they are investors.
Tags: blog, engineering, founder, globalmed, medical device, startup, surgeon, Tips
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Thursday, August 6th, 2009
 These are the profound words of the great Popeye the Sailor Man who knew his strengths and who he was. He never tried to be somebody or something he wasn’t, which is great advice for a startup that is trying to find itself. Everyone involved with the early stage startup should contribute based off their strengths and not try to assume roles that they are not experienced. I am not saying you shouldn’t try to expand your skill set and wander outside your comfort level (you need to at a startup), but if someone in the company has that skill set, let them lead those tasks and assist if needed. Everyone needs to leave their ego at the door and understand your team’s strengths, trust your fellow team members, and be open to solutions no matter where they come from.Â
One issue in many startups that I have read quite a bit of information about is something called Founder’s Syndrome. I thought this was something that I just experienced with startups, but it is a real issue with many startups. This issue is where the founder(s) make all of the decisions and do all of the planning within the company and they are not done collectively by the management team. The management team is basically a support network and doesn’t really have much input because the founder(s) do not want to lose control of their “baby”. One example (I can make the case for some founding engineers as well) is if the company was founded by surgeons (obviously not all surgeons), they need to focus on the needs of the surgeon community and give their expert opinion as to what would help patients. They are surgeons and typically do not have the time or the knowhow to run an emerging medical device company.  If the founders follow tip #2, they will bring in a qualified CEO that will have the same vision and drive and then they must give up control to the CEO and the subsequent management team. The founders then become the main surgical influence on the company, but should not be active in the day to day activities and tasks, and trust their expert management team who has the experience needed for success.
Tags: blog, engineering, globalmed, medical device, startup, Tips
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Thursday, August 6th, 2009
You must truly understand the market(s) that your products will compete in. This includes the competition, market trends and size of each target market, and regulatory strategies (US and each potential targeted country). You also must understand what people will actually pay for your products in each market. You don’t want to spend time developing a country and securing future customers only to find out that the regulatory landscape takes longer than expected or your sale price is not cost effective for the company.Â
Start networking early with individuals or organizations that are in the know within each target market that you anticipate. When networking, solicit multiple sources from each target market to receive diverse opinions. By understanding your market and pricing, it helps create an accurate and focused plan and vision that we discussed in tip #1.
Tags: blog, engineering, globalmed, market, medical device, pricing, startup, Tips
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Tuesday, August 4th, 2009
The founders may get the company through the concept stage, but may not be the best candidate for the CEO position beyond that point. The founders need to search for a CEO with a proven track record for raising money, maintaining budgets, building an appropriate team, leading people, success in a medical device startup, and focused on relentless execution. A CEO with these qualities will greatly increase your odds in being successful.Â
- Raising money provides the necessary resources for product development and other necessary expenses.
- Maintaining budgets ensures the money is used to achieve the company vision and goals and not for frivolous expenses (often happens once money is raised).
- The CEO should be adept at hiring people that are experts in the field, great leaders, and have a strong work ethic. Building a management team that is focused, dedicated, and aligned with the company’s vision and goals is crucial to the company’s success. In the early stages of the company, the CEO needs to delegate the specific department responsibilities and hold management accountable, which will keep this demanding, hectic startup environment streamlined and organized.
- The CEO needs to be a strong leader and a great motivational influence within the company. With the rollercoaster experience that is a startup, the CEO must be that stabilizing force inside the company that people look up to, which keeps the employees motivated, positive, and enthusiastic.
- Having at least one proven successful early stage medical device company under his/her belt is important. I am not saying that the company must have been sold for $300 million, but the CEO should have been responsible for many rounds of funding, growing the company from a few employees to many, and revenue growth of $0 to a few million, etc. Learning from mistakes of past ventures is great knowledge, but until you have had even a little success, you don’t know what it tastes like.
- During the interviews with potential CEO candidates, the board must evaluate the drive and focus of the candidate. The company needs to have a relentless visionary as a CEO. The CEO needs to understand short-term and long-term goals, what it takes to meet these goals, and have a proven record of accomplishing what was promised to investors.
It is difficult to find this perfect person, but try and find someone that has many of these qualities and shares the founder’s passion for the product(s). Also, the founders (if they don’t have a lot of business experience) should consult with people on how to interview these candidates and how to judge what a qualified CEO looks and sounds like. This leader hired for the startup is one of the most critical pieces to making your startup successful.
Tags: blog, CEO, engineering, entrepreneur, globalmed, medical device, startup, Tips
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Monday, August 3rd, 2009
July’s Medtech financings had a very large volume (>$440 million) for 2009. Hopefully, we will see financings continue to rise.
We should not be too optimistic just yet. We will see over the next few months if this is really is a positive trend or the financing of SBI ($108M) and ConforMIS ($50M) just skewed the month higher. I am assuming that you all agree with me and hope it is the former.
http://ow.ly/iJPZ
Comments are always welcome here.
Thanks for reading,
Steven
Tags: blog, engineering, globalmed, medical device
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Monday, August 3rd, 2009
 This is a key piece of any startup business plan. It defines the purpose of why the company exists and what differentiates the company from the competition (product innovation, customer focus, lowest cost products, highest quality, etc.). Everything you do moving forward (choosing a CEO, raising money, hiring of employees, assembly of an advisory board, etc) will be for the purpose of realizing this vision. Based on this vision, you will be able to set SMART (Specific, Measurable, Attainable, Realistic, and Timely) goals which will provide a harmonized focus throughout the company and help achieve these goals.
Tags: blog, business plan, engineering, globalmed, goals, medical device, startup, Tips, vision
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Monday, August 3rd, 2009
I am posting my tips to building a successful medical device startup through my Twitter and LinkedIn accounts, as well as my websites. I will be posting one tip per day throughout the month of August 2009.
I will post the explanations on this blog so you can view them in one place. I also welcome comments that you may have regarding any tip or explanation. I will also provide a full PDF download of the entire document towards the end of August on www.medicaldevicedesignexpert.com
Tags: blog, engineering, globalmed, medical device, startup, Tips
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Monday, August 3rd, 2009
The GlobalMed Engineering Blog has been developed, tested (great results with Baboons and Sheep), approved by the powers to be (me), and is oficially in clinical trials. Data will be collected for the safety and efficacy for all mankind.
Tags: blog, engineering, globalmed, medical device
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