Board Support
The path of medical technology innovation is littered with failed start-up efforts. More often than not, it's not due to limitations in the technology. Funding cycles, market timing, team composition, development processes, risk management, clinical design, usability, culture, communication and a multitude of other factors are critical to guiding a great idea into a clinical and commercial success.
At the board level, companies must be constantly searching for opportunities and risks from outside the organization as well as from within. Sadly, the board of many product development companies lack a technical person. This often renders the board unable to detect or help with development challenges that could cost time, money or potentially the entire company.
Our contribution to any kind of advisory board draws on decades of experience bringing new products to market and the knowledge of many companies that didn't succeed. We bring the logic to not cut corners and do things right the first time, the leadership to ensure that we have a capable team, and the tools that recognize the urgency start-ups face and deliver results.
At the board level, companies must be constantly searching for opportunities and risks from outside the organization as well as from within. Sadly, the board of many product development companies lack a technical person. This often renders the board unable to detect or help with development challenges that could cost time, money or potentially the entire company.
Our contribution to any kind of advisory board draws on decades of experience bringing new products to market and the knowledge of many companies that didn't succeed. We bring the logic to not cut corners and do things right the first time, the leadership to ensure that we have a capable team, and the tools that recognize the urgency start-ups face and deliver results.
Elements of Success
They say that 1 in 10 start-ups succeed. A medical technology start-up is certainly a complex endeavor to successfully pull off with countless potential pitfalls along the way. Here are just a few areas that we've seen start-ups error. Any one or a combination of them could be enough to lose favor of investors and miss out entirely.
Regulatory
- Regulatory agencies are staffed with experts that know the regulations and our industry. It's most efficient to engage regulatory agencies early to have their buy-in on your plans. Companies that go it alone and expect a regulatory approval the first time they file may be disappointed. That said, it's important to approach regulatory agencies with a draft to review and not ask the open-ended question of "What should we do?" Inevitably, the conservative response you receive will be more than you were hoping to do.
Board Composition
- Boards should include people that can speak with expertise to the various aspects of a company, including business, finance, marketing, sales, and engineering. We have seen companies without technical leadership on the board miss the signs of an ineffective technical team and/or a technology that needs to pivot.
Staffing
- Pre-commercialization companies must be extremely cash efficient. Gone are the days where investors will throw $10M at an interesting idea. Hence, start-up teams should grow carefully and slowly. The saying "Hire slow and fire fast" rings true when every dollar spent is intended to bring us one more step closer to the next milestone. Rule of thumb: if the role isn’t consistently full-time and mission-critical, keep them as a consultant. We’ve watched programs implode because someone who should’ve stayed a contractor got hired full-time. The former-contractor had excess bandwidth to over-engineer, overstep and/or interfere, ultimately derailing a company.”
Hiring Leaders
- With limited funds, it's essential to engage team members that will actually move the ball forward. Every person on the team will be a leader in some capacity. It can be a challenge for small teams that may be hiring outside of their area of expertise. We can assist with vetting potential candidates. Once hired, it's important to ensure that the person has the support they need and are able to contribute.
Phase-Appropriate Systems
- Quality systems grow with an organization. We have seen on more than one occasion a start-up hire a person from a large medical device company to lead Quality. That person inevitably brings the large-company paradigm to the start-up with numerous, hefty and burdensome operating procedures to follow. This fails a start-up in multiple ways. Resources are redirected to training and SOP maintenance instead of product development. Complicated and lengthy procedures provide more ways to be non-compliant and take more resources to maintain. In the end, rapid development of a product can lose priority.
Program Management
- Many startups skip detailed scheduling—and pay the price. Schedules are key day-to-day prioritization and board oversight.
Back-Up plans
Startups need robust contingency plans for both technology and scheduling. We help companies proactively identify risks and mitigations, ensuring that new discoveries cause minimal disruption to timelines.
Culture
- Culture of a company can make or break it. We've seen pre-commercialization start-ups take a comfortable, 9 to 5 culture which led to lack of ownership and slipped milestones. Culture comes from the top down and requires careful management through the development of a company to ensure a professional, supportive, and trustworthy team that delivers on promises.
Communication
- Whether it is a technician that is reluctant to share a possible improvement, an engineer that doesn't report a test failure, or a CEO that thinks they can handle board meetings solo, lack of communication through out an organization can spell trouble. We work with our clients to ensure all stake holders are informed and participate in communicating the accomplishments, risks and possibilities within an organization.
Regulatory
- Regulatory agencies are staffed with experts that know the regulations and our industry. It's most efficient to engage regulatory agencies early to have their buy-in on your plans. Companies that go it alone and expect a regulatory approval the first time they file may be disappointed. That said, it's important to approach regulatory agencies with a draft to review and not ask the open-ended question of "What should we do?" Inevitably, the conservative response you receive will be more than you were hoping to do.
Board Composition
- Boards should include people that can speak with expertise to the various aspects of a company, including business, finance, marketing, sales, and engineering. We have seen companies without technical leadership on the board miss the signs of an ineffective technical team and/or a technology that needs to pivot.
Staffing
- Pre-commercialization companies must be extremely cash efficient. Gone are the days where investors will throw $10M at an interesting idea. Hence, start-up teams should grow carefully and slowly. The saying "Hire slow and fire fast" rings true when every dollar spent is intended to bring us one more step closer to the next milestone. Rule of thumb: if the role isn’t consistently full-time and mission-critical, keep them as a consultant. We’ve watched programs implode because someone who should’ve stayed a contractor got hired full-time. The former-contractor had excess bandwidth to over-engineer, overstep and/or interfere, ultimately derailing a company.”
Hiring Leaders
- With limited funds, it's essential to engage team members that will actually move the ball forward. Every person on the team will be a leader in some capacity. It can be a challenge for small teams that may be hiring outside of their area of expertise. We can assist with vetting potential candidates. Once hired, it's important to ensure that the person has the support they need and are able to contribute.
Phase-Appropriate Systems
- Quality systems grow with an organization. We have seen on more than one occasion a start-up hire a person from a large medical device company to lead Quality. That person inevitably brings the large-company paradigm to the start-up with numerous, hefty and burdensome operating procedures to follow. This fails a start-up in multiple ways. Resources are redirected to training and SOP maintenance instead of product development. Complicated and lengthy procedures provide more ways to be non-compliant and take more resources to maintain. In the end, rapid development of a product can lose priority.
Program Management
- Many startups skip detailed scheduling—and pay the price. Schedules are key day-to-day prioritization and board oversight.
Back-Up plans
Startups need robust contingency plans for both technology and scheduling. We help companies proactively identify risks and mitigations, ensuring that new discoveries cause minimal disruption to timelines.
Culture
- Culture of a company can make or break it. We've seen pre-commercialization start-ups take a comfortable, 9 to 5 culture which led to lack of ownership and slipped milestones. Culture comes from the top down and requires careful management through the development of a company to ensure a professional, supportive, and trustworthy team that delivers on promises.
Communication
- Whether it is a technician that is reluctant to share a possible improvement, an engineer that doesn't report a test failure, or a CEO that thinks they can handle board meetings solo, lack of communication through out an organization can spell trouble. We work with our clients to ensure all stake holders are informed and participate in communicating the accomplishments, risks and possibilities within an organization.
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