Before StarFish, I was a founder of a company which successfully developed, performed clinical trials and CE marked a medical device. This took a long time; much longer than I expected when I left my cushy university job and went full time with the fledgling company to hopefully flip and make millions.
The reason for so much time? Literally years were spent fundraising. This did nothing to progress the development of the product, nor did it help the founder’s equity position as we burned our way through the last dregs of founder and seed investment.
Looking back, the company only really achieved professional equity investment after a competent skeleton team were put in place or ready to be in place. My subsequent experience working with other small companies has illustrated why it is so important to have a minimum number of the right people in place when trying to develop a medical device product.
Below is my shortlist of job descriptions for the roles required by a fledgling medical device company trying to develop a complex, novel medical device.
1) Leader: One of the company lynch-pins, the Leader brings the vision and the general company direction. There are three stages of start-up Leadership– all involve staffing a Medical Device Start-Up:
Seed fund/Angel Stage. Leadership at this stage is pivotal as the whole venture hinges on whether the project can get off the ground. The Leader is often the CEO and normally a founder, who often has not developed a medical device before. They have the difficult job of raising the first, high risk funding in conjunction with applying for and obtaining grants, and understanding reimbursement. They must also develop a comprehensive business plan that will pass muster with later-stage investors. Their technical responsibility is ensuring the seed funding delivers a proof of concept prototype which, along with the business plan, brings in more money for product development.
Development Stage: Leadership at this stage ensures that the right product is delivered for the right budget in the right timescales. Sometimes investors require a CEO experienced in development as a condition, and the initial CEO/founder may have to take a sideways move. The technical Leader then runs the development program, which can last several years depending on device complexity. During this time the company grows from a start-up into a ‘proper’ medical device company with staff, facilities and a functioning Quality Management System (QMS).
Product Launch Stage: Once the device is developed, validated and has regulatory clearance, launching the product begins. Some (including myself originally) assume that once regulatory clearance has been achieved, the company would be sold for millions of dollars. However, acquirers generally need to see proof of market pull before releasing their hard earned cash. Market pull is the difference between giving a product away and people buying it. A leader who knows about market roll-outs to build this confidence is essential.
It is difficult for a single person to have the right skills for all these stages, and it is even more difficult for someone who has built up a company in the first two stages to hand over the reins for the third stage. Regardless, the first two stages need a ‘hands on’ Leader rather than someone from a corporate background, more used to delegating.
2) Technical Lead: The title is less important than their function – it can be CTO, VP or Director Development. The key function of this person is to be a direct interface with the development team, whether sub-contractors or in-house. Sub-contractors are much more productive if they are working with someone who is directly engaged in brainstorm meetings, design reviews, feedback on solutions, etc.
The Technical Lead does not have to be an expert in medical device development – that is what the subcontractor is for. They must be an expert in the company’s particular device, or be prepared to become one. It can be very limiting as a subcontractor working with a non-technical sign-off authority (such as a CEO) who has limited bandwidth, is unable to adequately define the product requirements, and thus unable to evaluate the subcontractor’s deliverables.
3) Quality Role: One of the differences between the FDA and CE marking is that, for the FDA, one does not have to demonstrate a working QMS before applying for regulatory clearance. CE Marking requires having a working quality system as part of the certification process. Because of this, sometimes the Quality Role is seen as something to be added at market launch, but it is essential to have this role in place ahead of launch when CE Marking.
Quality is also important for demonstrating one is a grown up medical device company, and it can also be an investor milestone. Having someone responsible to setup, manage and train everyone in the quality system is essential. Important for shared roles, the Quality role should not be conflicted by manufacturing and/or release responsibilities. In some companies, this person may also manage Regulatory, which is related, but different.
4) Operations Role: Some may wonder why operations are needed before the product is launched. Even before the product is finished, consideration to transferring the product to manufacturing is essential. For example, if injection molded tooling is required, will these be validated or will inspection and test be performed? Will any manufacturing process validation be required, such as gluing, welding etc.? What about setting up sterilized packaging and subsequent validation? Someone whose attention is focused on these things earlier is preferable to getting a 510(k), and then worrying about the issues.
For CE Marking, this role is critical as a small pilot batch is usually required to validate that all manufacturing processes are correct. Finally, in some companies the operations role is also shared with the regulatory role, depending on device complexity.
5) Regulatory Role: Understanding and managing regulatory compliance issues (such as consensus standards, HIPAA requirements, and bio-compatibility) takes time during development, even before the regulatory submission. If the product is novel, then clinical studies may be required to demonstrate safety and efficacy, hence close liaison is required between Clinical and Regulatory to understand the desired endpoints. Even if clinical studies are not required, the effort for developing and managing regulatory submissions in different jurisdictions can be significant. This role may be shared with Quality or Operations, depending on device complexity and regulatory strategy.
6) Clinical Role: This role may not be necessary for ‘me too’ devices, but if clinical studies are required in order to demonstrate safety and efficacy for novel devices, then this can be significant effort. Working with Bio-statisticians, working with principle investigators, drafting investigation protocols, working with IRB and fulfilling clinical governance requirements, site initiations, clinical study monitoring, and clinical study reports are just some of the things that this role manages.
As noted above, some of these roles can be combined – for example, Regulatory and Operation or Regulatory and Quality, depending what the scope of the development activities encompasses. Also, some roles can be shared, such as Technical sharing Regulatory with Operations. However, the Leader role is key as they must manage investors and funding.
Depending on the workload, some roles may also be part time. Also, a note of caution: a team which is too small, yet takes on multiple roles usually works less well. In these situations, treading water/fire-fighting seems to be more common rather than making actual progress.
Some readers may be exploding right now, thinking that I am over simplifying, that there may be insufficient cash for all these bodies, or that investors hate paying salaries. However, burning through cash and failing to deliver helps no-one. Expanding a team from one FTE in the seed fund raising stage, two FTEs in the proof of concept stage, three FTEs in the Alpha development Stage, four FTEs in the Beta Development stage, five FTEs in the Transfer stage and six FTEs in the product launch stage makes more sense.
This blog discusses the importance of staffing a Medical Device Start-Up and building the correct team to take a product from concept to a marketable device. Along with my guidelines above, lots of flexibility is paramount. After all, if your medical device product gets to market, achieves sales and brings a return on investment, then there is no wrong way. I wish my readers the best of luck and look forward to hearing about their experiences and advice.
Image: Vincent Crabtree
Vincent Crabtree, PhD is a StarFish Medical Project Manager and Regulatory Advisor, with an emphasis on Project Leadership. He is passionate about commercializing innovative technology, and brings an entrepreneurial perspective to all he does.